Products for which the marketing authorisations are recommended for
suspension by the CHMP on 22 January 2015
Some of these medicinal products may be considered critical by the individual EU Member States. The
suspension of the concerned marketing authorisation(s) may be deferred by the period for which the
medicinal product is considered critical.
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
EEA)
Austria
Arcana Arzneimittel GmbH
Esomeprazole
Esomeprazol Arcana 20
Huetteldorfer Straße 299
magnesium
mg magensaftresistente
1140 Wien
20 mg
capsule, hard
Hartkapseln
Austria
Austria
Arcana Arzneimittel GmbH
Esomeprazole
Esomeprazol Arcana 40
Huetteldorfer Straße 299
magnesium
mg magensaftresistente
1140 Wien
40 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria
Austria
Arcana Arzneimittel GmbH
Esomeprazole
Neximyl 20 mg
Huetteldorfer Straße 299
magnesium
magensaftresistente
1140 Wien
20 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria
Austria
Arcana Arzneimittel GmbH
Esomeprazole
Neximyl 40 mg
Huetteldorfer Straße 299
magnesium
magensaftresistente
1140 Wien
40 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria
Austria
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 4mg
Huetteldorfer Straße 299
cilexetil
Tabletten
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 8mg
Huetteldorfer Straße 299
cilexetil
Tabletten
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 16mg
Huetteldorfer Straße 299
cilexetil
Tabletten
4 mg
Tablet
Oral use
8mg
Tablet
Oral use
16 mg
Tablet
Oral use
1140 Wien
Austria
Austria
1140 Wien
Austria
Austria
1140 Wien
Austria
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
32 mg
Tablet
Oral use
5 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Strength
EEA)
Austria
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 32mg
Huetteldorfer Straße 299
cilexetil
Tabletten
Nebivolol
Nebivolol Genericon 5 mg
1140 Wien
Austria
Austria
Genericon Pharma GmbH
Hafnerstr. 211
Tabletten
8054 Graz
Austria
Austria
ratiopharm Arzneimittei-
Desloratadine
Vertriebs-GmbH
Desloratadin ratiopharm
2,5 mg Schmelztabletten
tablet
Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Austria
ratiopharm Arzneimittei-
Desloratadine
Vertriebs-GmbH
Desloratadin ratiopharm 5
5 mg
mg Schmelztabletten
Orodispersible
Oral use
tablet
Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Belgium
Apotex Europe B.V.
Desloratadine
Desloratadine Apotex
5 mg
Darwinweg 20
Film - coated
Oral use
tablet
NL 2333 CR Leiden
Netherlands
Belgium
Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium
Donepezil
Donepezil Odis Mylan
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Belgium
Mylan bvba/sprl
Donepezil
Donepezil Odis Mylan
10 mg
Terhulpsesteenweg 6A
tablet
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan 0,5 mg
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
Pharma
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan 1 mg
Pharma
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan 2mg
Pharma
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Candesartan
Candesartan Mylan
8 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
16 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
32 mg
Tablet
Oral use
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
EEA)
Belgium
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
20 mg
Terhulpsesteenweg 6A
capsule, hard
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
40 mg
Terhulpsesteenweg 6A
Gastro - resistant
Oral use
capsule, hard
1560 Hoeilaart
Belgium
Belgium
Takeda Belgium
Alendronic acid
Alendromono
70 mg
Tablet
Oral use
Desloratadine
Desloratadine Teva
2,5 mg
Orodispersible
Oral use
Gentsesteenweg 615
1080 Brussels
Belgium
Belgium
Teva Pharma Belgium NV
Laarstraat 16
tablet
2610 Wilrijk
Belgium
Belgium
Teva Pharma Belgium NV
Desloratadine
Desloratadine Teva
5 mg
Laarstraat 16
Orodispersible
Oral use
tablet
2610 Wilrijk
Belgium
Bulgaria
Accord Healthcare Limited
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Ropinirole
Ropinirole Accord
0,5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
1 mg
Sage House, 319 Pinner
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
2 mg
Sage House, 319 Pinner
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
5 mg
Sage House, 319 Pinner
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Bulgaria
Alkaloid - INT d.o.o.
Cefpodoxime
FOXERO
200 mg
Tablet
Oral use
Quetiapine
Aquatiapine
25 mg
Film - coated
Oral use
Šlandrova 4
1231 Ljubljana - Črnuče
Slovenia
Bulgaria
Aquachim AD
blvd. Prof. Tsvetan Lazarov
83
Sofia 1582
Bulgaria
tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Bulgaria
Aquachim AD
Quetiapine
Aquatiapine
100 mg
blvd. Prof. Tsvetan Lazarov
tablet
83
Sofia 1582
Bulgaria
Bulgaria
Aquachim AD
Quetiapine
Aquatiapine
200 mg
blvd. Prof. Tsvetan Lazarov
Film - coated
Oral use
tablet
83
Sofia 1582
Bulgaria
Bulgaria
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
Esopragen
20 mg
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL
United Kingdom
Bulgaria
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
Esopragen
40 mg
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL
United Kingdom
Bulgaria
Glenmark Pharmaceuticals
Trimetazidine
s.r.o.
Apstar 35 mg
35 mg
prolonged-release tablets
Prolonged -
Oral use
release tablet
Hvězdova 1716/2b
14078 Praha 4
Czech Republic
Bulgaria
Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France
Trimetazidine
Trimetazigen MR
35 mg
Prolonged release tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Bulgaria
Neo Balkanika EOOD
Nebivolol
Bivolet
5 mg
Tablet
Oral use
Trimetazidine
Energotrim
35 mg
Prolonged -
Oral use
35 Zemliane Str.
Sofia 1618
Bulgaria
Bulgaria
Sandoz Pharmaceuticals d.d.
Verovskova 57
release tablet
Ljubljana SI-1000
Slovenia
Bulgaria
Tchaikapharma Highquality
Bosentan
Pulmohyperta
62,5 mg
Medicines
Film - coated
Oral use
tablet
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
Bulgaria
Tchaikapharma Highquality
Bosentan
Pulmohyperta
125 mg
Medicines
Film - coated
Oral use
tablet
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
Croatia
Alkaloid d.o.o.
Cefpodoxime
Ulica grada Vukovara 226 F
Rexocef 200 mg filmom
200 mg
obložene tablete
Film - coated
Oral use
tablet
Zagreb 10000
Croatia
Croatia
Belupo, lijekovi i kozmetika
d.d.
Ulica Danica 5
Koprivnica 48000
Croatia
Desloratadine
Alerdin 2,5 mg raspadljive
tablete za usta
2,5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Croatia
Belupo, lijekovi i kozmetika
Desloratadine
d.d.
Alerdin 5 mg raspadljive
5 mg
tablete za usta
tablet
Ulica Danica 5
Koprivnica 48000
Croatia
Croatia
Fidifarm d.o.o.
Desloratadine
Obrtnička 37, Bestovje
Sinalerg 5 mg filmom
5 mg
obložene tablete
Film - coated
Oral use
tablet
Rakitje 10437
Croatia
Croatia
Jadran Galenski Laboratorij
Desloratadine
d.d.
Escontral direkt 2,5 mg
2,5 mg
raspadljiva tableta za usta
Orodispersible
Oral use
tablet
Svilno 20, Rijeka
51000
Croatia
Croatia
Jadran Galenski Laboratorij
Desloratadine
d.d.
Escontral direkt 5 mg
5 mg
raspadljiva tableta za usta
Orodispersible
Oral use
tablet
Svilno 20, Rijeka
51000
Croatia
Croatia
PharmaS d.o.o.
Tramadol/paraceta
Tramadol/Paracetamol
37,5
Film - coated
Radnička cesta 47
mol
PharmaS 37,5 mg/
mg/325 mg
tablet
10 mg
Film - coated
Zagreb 10000
325 mg filmom obložene
Croatia
Croatia
PharmaS d.o.o.
tablete
Escitalopram
Escitalopram PharmaS 10
Radnička cesta 47
mg filmom
Zagreb 10000
obložene tablete
Croatia
Oral use
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Croatia
Sandoz d.o.o.
Trimetazidine
Vazidin 35 mg tablete s
Maksimirska 120
hydrochloride
produljenim oslobađanjem
35 mg
Alendronic acid
Alendronic Acid Accord
70 mg
Tablet
Oral use
Entacapone
Nobat
200 mg
Film - coated
Oral use
release tablet
Zagreb 10000
Croatia
Cyprus
Accord Healthcare Limited
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Cyprus
Delorbis Pharmaceuticals Ltd
17 Athinon Street
tablet
Ergates Industrial Area
2643 Ergates
P.O. Box 28629
2081 Lefkosia
Cyprus
Cyprus
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan/Hctz Fair-med
DE-22765 Hamburg
160
Film - coated
mg/12,5
tablet
Oral use
mg
Germany
Cyprus
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Argyroupoli
164-51 Athens
Greece
Donepezil/Generics
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Cyprus
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Donepezil/Generics
10 mg
tablet
Argyroupoli
164-51 Athens
Greece
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
0,25 mg
Film - coated
Oral use
tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
0,5 mg
Film - coated
Oral use
tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
1 mg
Film - coated
Oral use
tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Ropinirole Lambda
2 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
5 mg
tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Wockhardt UK Limited
Clopidogrel
Ash Road North
hydrochloride
Clopidogrel/Wockhardt
75 mg
Film - coated
Oral use
tablet
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
Purcema 5 mg
5 mg
Film - coated
Oral use
tablet
160 00 Praha 6 - Hadovka
Office Park
Czech Republic
Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
Purcema 10 mg
10 mg
Film - coated
Oral use
tablet
160 00 Praha 6 - Hadovka
Office Park
Czech Republic
Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
160 00 Praha 6 - Hadovka
Office Park
Czech Republic
Purcema 15 mg
15 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
Purcema 20 mg
20 mg
tablet
160 00 Praha 6 - Hadovka
Office Park
Czech Republic
Czech Republic
Actavis Group PTC ehf.
Metformin
Metformin Actavis Retard
Reykjavikurvegi 76-78
hydrochloride
500 mg
Actavis Group PTC ehf.
Metformin
Metformin Actavis Retard
Reykjavikurvegi 76-78
hydrochloride
750 mg
Actavis Group PTC ehf.
Metformin
Metformin Actavis Retard
Reykjavikurvegi 76-78
hydrochloride
1000 mg
Cefpodoxime
Forexo 200 mg
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Czech Republic
750 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Czech Republic
1000 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Czech Republic
Alkaloid - INT d.o.o.
Šlandrova 4
200 mg
potahované tablety
Film - coated
Oral use
tablet
1231 Ljubljana - Črnuče
Slovenia
Czech Republic
Alvogen IPCo S.ar.l.
Desloratadine
Rue Heienhaff 5
Desloratadin Alvogen 5
5 mg
mg potahované tablety
Film - coated
Oral use
tablet
L-1736 Senningerberg
Luxembourg
Czech Republic
Alvogen IPCo S.ar.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg
Desloratadine
Desloratadin Alvogen 0,5
mg/ml perorální roztok
0,5 mg/ml
Oral solution
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Czech Republic
Apotex Europe B.V.
Trimetazidine
Darwinweg 20
dihydrochloride
Apo-trimetazidin 35 mg
35 mg
release tablet
NL 2333 CR Leiden
Netherlands
Czech Republic
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
Esomylan 40 mg
40 mg
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL
United Kingdom
Czech Republic
Generics (UK) Ltd
Rizatriptan
Station Close, Potters Bar
benzoate
Rizatriptan Mylan 5 mg
5 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL
United Kingdom
Czech Republic
Generics (UK) Ltd
Rizatriptan
Station Close, Potters Bar
benzoate
Rizatriptan Mylan 10 mg
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL
United Kingdom
Czech Republic
Generics (UK) Ltd
Donepezil
Station Close, Potters Bar
hydrochloride
Donepezil Mylan 10 mg
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL
United Kingdom
Czech Republic
Glenmark Pharmaceuticals
Trimetazidine
Portora 35 mg tablety s
s.r.o.
dihydrochloride
prodlouženým
Hvězdova 1716/2b
35 mg
Prolonged -
Oral use
release tablet
uvolňováním
14078 Praha 4
Czech Republic
Czech Republic
GNR Czech s.r.o.
Slavojova 579/9
128 00 Praha 2
Czech Republic
Desloratadine
Geslora 5 mg
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Czech Republic
Labormed-Pharma, SA
Desloratadine
Desloratadin Labormed
Theodor Pallady, 44B
2,5 mg tablety
032266 Bucharest
dispergovatelné v ústech
2,5 mg
tablet
Romania
Czech Republic
Labormed-Pharma, SA
Desloratadine
Desloratadin Labormed 5
Theodor Pallady, 44B
mg tablety
032266 Bucharest
dispergovatelné v ústech
5 mg
Orodispersible
Oral use
tablet
Romania
Czech Republic
Mylan SAS
Trimetazidine
Trimetazidin Mylan 35 mg
35 mg
117 allée des Parcs
Prolonged -
Oral use
release tablet
69792 Saint-Priest Cedex
France
Czech Republic
SVUS Pharma a.s.
Desloratadine
Smetanovo nábřeží 1238/20a
Lotera 5 mg potahované
5 mg
tablety
Film - coated
Oral use
tablet
500 02 Hradec Králové
Czech Republic
Denmark
Actavis Group PTC ehf.
Metformin
Metformin "Actavis PTC"
500 mg
Reykjavikurvegi 76-78
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Denmark
Actavis Group PTC ehf.
Metformin
Metformin "Actavis PTC"
750 mg
Reykjavikurvegi 76-78
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Denmark
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland
Metformin
Metformin "Actavis PTC"
1000 mg
Prolonged release tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Denmark
Bluefish Pharmaceuticals AB
Fluconazole
Fluconazol "Bluefish"
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol "Bluefish"
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol "Bluefish"
200 mg
Capsule, hard
Oral use
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazi
160
Film - coated
Oral use
Planckstrasse 13
orothiazide
d "Fair-Med"
mg/12,5
tablet
Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark
DE-22765 Hamburg
mg
Germany
Denmark
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazi
320
Film - coated
Planckstrasse 13
orothiazide
d "Fair-Med"
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany
Denmark
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazi
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
d "Fair-Med"
mg
tablet
Eletriptan
Eletriptan Mylan
40 mg
Film - coated
Oral use
DE-22765 Hamburg
Germany
Denmark
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
EEA)
Denmark
Mylan AB
Esomeprazole
Esomeprazol Mylan
20 mg
PO Box 230 33
capsule, hard
SE-104 35 Stockholm
Sweden
Denmark
Mylan AB
Esomeprazole
Esomeprazol Mylan
40 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm
Sweden
Denmark
Mylan AB
Rizatriptan
Rizatriptan Mylan
10 mg
PO Box 230 33
Orodispersible
Oral use
tablet
SE-104 35 Stockholm
Sweden
Denmark
Stadapharm GmbH
Entacapone
Entacapon STADA
200 mg
Stadastr. 2-18
Film - coated
Oral use
tablet
D-61118 Bad Vilbel
Germany
Estonia
Accord Healthcare Limited
Alendronic acid
Sage House, 319 Pinner
ALENDRONIC ACID
70 mg
Tablet
Oral use
35 mg
Modified -
Oral use
ACCORD 70mg
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Estonia
Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia
Trimetazidine
ZIDMETIN
release tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Finland
Actavis Group PTC ehf.
Metformin
Metformin Actavis
500 mg
Reykjavikurvegi 76-78
release tablet
220 Hafnarfjördur
Iceland
Finland
Actavis Group PTC ehf.
Metformin
Metformin Actavis
750 mg
Reykjavikurvegi 76-78
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Finland
Actavis Group PTC ehf.
Metformin
Metformin Actavis
1000 mg
Reykjavikurvegi 76-78
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Finland
Bluefish Pharmaceuticals AB
Fluconazole
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Eletriptan
Eletriptan Mylan
40 mg
Film - coated
Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Finland
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Finland
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Finland
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Finland
Mylan AB
Repaglinide
Repaglinid Mylan
0,5 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
1 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
2 mg
Tablet
Oral use
Valsartan
VALSARTAN ORION
40 mg
Film - coated
Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland
Orion Corporation
Orion Pharma
tablet
PO BOX 65
02101 Espoo
Finland
Finland
Orion Corporation
Valsartan
VALSARTAN ORION
80 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Finland
Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland
Valsartan
VALSARTAN ORION
160 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Finland
Orion Corporation
Valsartan
VALSARTAN ORION
320 mg
Orion Pharma
tablet
PO BOX 65
02101 Espoo
Finland
Finland
ratiopharm GmbH
Desloratadine
Desloratadine Ratiopharm
2,5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Finland
ratiopharm GmbH
Desloratadine
Desloratadine Ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
France
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
ESCITALOPRAM ABBOTT
5 mg
5mg, comprimé pelliculé
Film - coated
Oral use
tablet
92150 Suresnes
France
France
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
ESCITALOPRAM ABBOTT
10 mg
10mg, comprimé pelliculé
Film - coated
Oral use
tablet
92150 Suresnes
France
France
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
ESCITALOPRAM ABBOTT
15 mg
15mg, comprimé pelliculé
Film - coated
Oral use
tablet
92150 Suresnes
France
France
Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France
Escitalopram
ESCITALOPRAM ABBOTT
20mg, comprimé pelliculé
20 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
France
ACCORD HEALTHCARE
Ropinirole
France SAS
Ropinirole Accord 0,25mg,
0,25 mg
comprimé pelliculé
tablet
45 Rue de Fbg de Roubaix
59000 Lille
France
France
ACCORD HEALTHCARE
Ropinirole
France SAS
Ropinirole Accord 0,5mg,
0,5 mg
comprimé pelliculé
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix
59000 Lille
France
France
ACCORD HEALTHCARE
Ropinirole
France SAS
Ropinirole Accord 1mg,
1 mg
comprimé pelliculé
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix
59000 Lille
France
France
ACCORD HEALTHCARE
Ropinirole
France SAS
Ropinirole Accord 2mg,
2 mg
comprimé pelliculé
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix
59000 Lille
France
France
ACCORD HEALTHCARE
France SAS
45 Rue de Fbg de Roubaix
59000 Lille
France
Ropinirole
Ropinirole Accord 5mg,
comprimé pelliculé
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN 5
5, Marryat Close
mg, comprimé pelliculé
Hounslow
sécable
5 mg
tablet
TW4 5DQ Middlesex
United Kingdom
France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN
5, Marryat Close
10 mg, comprimé pelliculé
Hounslow
sécable
10 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex
United Kingdom
France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN
5, Marryat Close
15 mg, comprimé pelliculé
Hounslow
sécable
15 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex
United Kingdom
France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN
5, Marryat Close
20 mg, comprimé pelliculé
Hounslow
sécable
20 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex
United Kingdom
France
Brown & Burk UK, Ltd.
Ebastine
EBASTINE BROWN &
5, Marryat Close
BURK 10 mg, comprimé
Hounslow
orodispersible
10 mg
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex
United Kingdom
France
Cristers
Desloratadine
DESLORATADINE
22, quai Galliéni
CRISTERS
92150 Suresnes
5 mg
France
comprimé pelliculé
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
France
Cristers
Ibuprofen
IBUPROFENE CRISTERS
22, quai Galliéni
400 mg
92150 Suresnes
comprimé pelliculé
400 mg
tablet
France
France
Laboratoires Biogaran
Ebastine
15, boulevard Charles de
EBASTINE BIOGARAN 10
10 mg
mg comprimé pelliculé
Film - coated
Oral use
tablet
Gaulle
92707 Colombes Cedex
France
France
Laboratoires Biogaran
Ebastine
EBASTINE BIOGARAN 10
15, boulevard Charles de
mg comprimé
Gaulle
orodispersible
10 mg
Orodispersible
Oral use
tablet
92707 Colombes Cedex
France
France
Laboratoires GERDA
Desloratadine
DESLORATADINE ARROW
24 rue Erlanger
5 mg
75016 PARIS
comprimé pelliculé
5 mg
Film - coated
Oral use
tablet
France
France
Medipha Sante
Tramadol/paraceta
TRAMADOL PARACETAMOL
37,5
Film - coated
Les Fjords - Immeuble Oslo
mol
NIALEX 37,5 mg/325 mg
mg/325 mg
tablet
19 avenue de Norvège
91953 Courtaboeuf Cedex
France
comprimé pelliculé
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
France
Medipha Sante
Desloratadine
DESLORATADINE GNR
Les Fjords - Immeuble Oslo
5 mg
19 avenue de Norvège
comprimé pelliculé
5 mg
tablet
91953 Courtaboeuf Cedex
France
France
Mylan SAS
Rizatriptan
117 allée des Parcs
RIZATRIPTAN MYLAN
5 mg
5mg, orodispersible tablet
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex
France
France
Mylan SAS
Rizatriptan
117 allée des Parcs
RIZATRIPTAN MYLAN 10
10 mg
mg, orodispersible tablet
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex
France
France
Mylan SAS
Ebastine
117 allée des Parcs
EBASTINE MYLAN 10mg,
10 mg
film-coated tablet
Film - coated
Oral use
tablet
69792 Saint-Priest Cedex
France
France
Mylan SAS
Ebastine
117 allée des Parcs
EBASTINE MYLAN 10mg,
10 mg
orodispersible tablet
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex
France
France
Mylan SAS
Trimetazidine
TRIMETAZIDINE MYLAN
117 allée des Parcs
35 mg Modified Release
69792 Saint-Priest Cedex
Tablets
35 mg
Modified -
Oral use
release tablet
France
France
Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France
Candesartan
CANDESARTAN MYLAN 32
mg, comprimé secable
32 mg
Tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
France
Mylan SAS
Donepezil
117 allée des Parcs
DONEPEZIL MYLAN 5 mg,
5 mg
orodispersible tablet
tablet
69792 Saint-Priest Cedex
France
France
Mylan SAS
Donepezil
117 allée des Parcs
DONEPEZIL MYLAN 10
10 mg
mg, orodispersible tablet
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex
France
France
Mylan SAS
Esomeprazole
ESOMEPRAZOLE MYLAN
117 allée des Parcs
PHARMA 20mg, DR
69792 Saint-Priest Cedex
capsule
20 mg
Gastro - resistant
Oral use
capsule, hard
France
France
Mylan SAS
Esomeprazole
ESOMEPRAZOLE MYLAN
117 allée des Parcs
PHARMA 40mg, DR
69792 Saint-Priest Cedex
capsule
40 mg
Gastro - resistant
Oral use
capsule, hard
France
France
Mylan SAS
Desmopressin
DESMOPRESSINE MYLAN
117 allée des Parcs
60 µg, orodispersible
69792 Saint-Priest Cedex
tablet
0,06 mg
Orodispersible
Oral use
tablet
France
France
Mylan SAS
Desmopressin
DESMOPRESSINE MYLAN
117 allée des Parcs
120 µg, orodispersible
69792 Saint-Priest Cedex
tablet
0,12 mg
Orodispersible
Oral use
tablet
France
France
Mylan SAS
Desmopressin
DESMOPRESSINE MYLAN
117 allée des Parcs
240 µg, orodispersible
69792 Saint-Priest Cedex
tablet
France
0,24 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
800 mg
Tablet
Oral use
200 mg
Tablet
Oral use
200 mg
Tablet
Oral use
70 mg
Tablet
Oral use
10 mg
Film - coated
Oral use
Strength
EEA)
France
Ranbaxy Pharmacie
Aciclovir
Generiques
Aciclovir Ranbaxy 800 mg,
comprimé
11-15 Quai Dion Bouton
92800 Puteaux
France
France
Ranbaxy Pharmacie
Aciclovir
Generiques
Aciclovir Ranbaxy 200 mg,
comprimé
11-15 Quai Dion Bouton
92800 Puteaux
France
France
Ranbaxy Pharmacie
Aciclovir
Generiques
Aciclovir Almus 200 mg,
comprimé
11-15 Quai Dion Bouton
92800 Puteaux
France
France
Ranbaxy Pharmacie
Alendronic acid
Acide Alendronique
Generiques
Ranbaxy 70 mg,
11-15 Quai Dion Bouton
comprimé
92800 Puteaux
France
France
Sanofi Aventis France
Ebastine
1-13 bd Romain Rolland
EBASTINE ZENTIVA 10 mg
comprimé pelliculé
tablet
75159 Paris Cedex 14
France
France
Sanofi Aventis France
1-13 bd Romain Rolland
75159 Paris Cedex 14
France
Ebastine
EBASTINE ZENTIVA 10 mg
comprimé orodispersible
10 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
France
Teva Sante
Desloratadine
DESLORATADINE TEVA
Cœur Défense - 100-110
SANTE
Esplanade du Général de
5 mg
Gaulle
comprimé pelliculé
5 mg
tablet
92931 La Défense Cedex
France
France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBOUDA 10 mg comprimé
10 mg
pelliculé
Film - coated
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBARREN 10 mg
10 mg
comprimé pelliculé
Film - coated
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBONDE 10 mg comprimé
10 mg
pelliculé
Film - coated
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBONTAN 10 mg
10 mg
comprimé orodispersible
Orodispersible
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
4 Bureaux de la Colline
92213 Saint-Cloud
France
Ebastine
EBACHOI 10 mg
comprimé orodispersible
10 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
France
Venipharm SAS
Ibuprofen
IBUPROFENE ZYDUS
4 Bureaux de la Colline
FRANCE 200 mg
92213 Saint-Cloud
comprimé pelliculé
200 mg
tablet
France
France
Zydus France
Ibuprofen
IBUPROFENE ZYDUS
Zacles Hautes Patures
FRANCE 400 mg
25 Rue des Peupliers
comprimé pelliculé
400 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes
France
France
Zydus France
Tramadol/paraceta
TRAMADOL PARACETAMOL
37,5
Film - coated
Zacles Hautes Patures
mol
ZYDUS FRANCE
mg/325 mg
tablet
400 mg
Film - coated
37,5
25 Rue des Peupliers
mg/325 mg comprimé
92752 Nanterre Cedes
pelliculé
Oral use
France
France
Zydus France
Ibuprofen
Zacles Hautes Patures
IBUPROFENE ZF 400 mg
comprimé pelliculé
Oral use
tablet
25 Rue des Peupliers
92752 Nanterre Cedes
France
France
Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France
Desloratadine
DESLORATADINE ZYDUS 5
mg comprimé pelliculé
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
France
Zydus France
Escitalopram
Zacles Hautes Patures
ESCITALOPRAM ZYDUS 5
5 mg
mg, comprimé pelliculé
tablet
25 Rue des Peupliers
92752 Nanterre Cedes
France
France
Zydus France
Escitalopram
ESCITALOPRAM ZYDUS 10
Zacles Hautes Patures
mg, comprimé pelliculé
25 Rue des Peupliers
sécable
10 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes
France
France
Zydus France
Escitalopram
ESCITALOPRAM ZYDUS 15
Zacles Hautes Patures
mg, comprimé pelliculé
25 Rue des Peupliers
sécable
15 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes
France
France
Zydus France
Escitalopram
ESCITALOPRAM ZYDUS 20
Zacles Hautes Patures
mg, comprimé pelliculé
25 Rue des Peupliers
sécable
20 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes
France
Germany
Accord Healthcare Limited
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Alendronic acid
ALENDRONIC ACID
ACCORD 70MG
70 mg
Tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Germany
betapharm Arzneimittel
Levetiracetam
GmbH
Levetiracetam beta 250
250 mg
mg, Filmtabletten
tablet
Kobelweg 95
D-86156 Augsburg
Germany
Germany
betapharm Arzneimittel
Levetiracetam
GmbH
Levetiracetam beta 500
500 mg
mg, Filmtabletten
Film - coated
Oral use
tablet
Kobelweg 95
D-86156 Augsburg
Germany
Germany
betapharm Arzneimittel
Levetiracetam
GmbH
Levetiracetam beta 750
750 mg
mg, Filmtabletten
Film - coated
Oral use
tablet
Kobelweg 95
D-86156 Augsburg
Germany
Germany
betapharm Arzneimittel
Levetiracetam
GmbH
Levetiracetam beta 1000
1000 mg
mg, Filmtabeltten
Film - coated
Oral use
tablet
Kobelweg 95
D-86156 Augsburg
Germany
Germany
Fair-Med Healthcare GmbH
Irbesartan
Planckstrasse 13
Irbesartan Tablets
75 mg
75mg
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Germany
Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany
Irbesartan
Irbesartan Tablets
150mg
150 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Germany
Fair-Med Healthcare GmbH
Irbesartan
Planckstrasse 13
Irbesartan Tablets
300 mg
300 mg
tablet
DE-22765 Hamburg
Germany
Germany
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan HCTZ Fair-Med
150
Film - coated
Planckstrasse 13
hlorothiazide
150+12,5 mg
mg/12,5
tablet
Filmtabletten
mg
DE-22765 Hamburg
Oral use
Germany
Germany
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan HCTZ Fair-Med
300
Film - coated
Planckstrasse 13
hlorothiazide
300+12,5 mg
mg/12,5
tablet
Filmtabletten
mg
DE-22765 Hamburg
Oral use
Germany
Germany
Fair-Med Healthcare GmbH
Irbesartan/hydroc
300 mg/25
Film - coated
Planckstrasse 13
hlorothiazide
300+25 mg Filmtabletten
Irbesartan HCTZ Fair-Med
mg
tablet
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
160
Film - coated
Planckstrasse 13
orothiazide
Healthcare 160 mg/12.5
mg/12,5
tablet
mg Filmtabletten
mg
Oral use
DE-22765 Hamburg
Germany
Germany
DE-22765 Hamburg
Oral use
Germany
Germany
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
320
Film - coated
Planckstrasse 13
orothiazide
Healthcare 320 mg/12,5
mg/12,5
tablet
mg Filmtabletten
mg
DE-22765 Hamburg
Oral use
Germany
Germany
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
Healthcare 320 mg/25 mg
mg
tablet
DE-22765 Hamburg
Germany
Filmtabletten
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Germany
Fair-Med Healthcare GmbH
Venlafaxine
Planckstrasse 13
Venlafaxin Fair-Med 37,5
37,5 mg
mg Hartkapseln, retardiert
release capsule,
DE-22765 Hamburg
hard
Germany
Germany
Fair-Med Healthcare GmbH
Venlafaxine
Planckstrasse 13
Venlafaxin Fair-Med 75 mg
75 mg
Hartkapseln, retardiert
Prolonged -
Oral use
release capsule,
DE-22765 Hamburg
hard
Germany
Germany
Fair-Med Healthcare GmbH
Venlafaxine
Planckstrasse 13
Venlafaxin Fair-Med 150
150 mg
mg Hartkapseln, retardiert
Prolonged -
Oral use
release capsule,
DE-22765 Hamburg
hard
Germany
Germany
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
Planckstrasse 13
Healthcare 500 mg
DE-22765 Hamburg
Filmtabletten
500 mg
Film - coated
Oral use
tablet
Germany
Germany
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
Planckstrasse 13
Healthcare 750 mg
DE-22765 Hamburg
Filmtabletten
750 mg
Film - coated
Oral use
tablet
Germany
Germany
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
Planckstrasse 13
Healthcare 250 mg
DE-22765 Hamburg
Filmtabletten
250 mg
Film - coated
Oral use
tablet
Germany
Germany
Heumann Pharma GmbH &
Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany
Irbesartan
Irbesartan Heumann 75
mg Filmtabletten
75 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Germany
Heumann Pharma GmbH &
Irbesartan
Co. Generica KG
Irbesartan Heumann 150
150 mg
mg Filmtabletten
tablet
Südwestpark 50
90449 Nürnberg
Germany
Germany
Heumann Pharma GmbH &
Irbesartan
Co. Generica KG
Irbesartan Heumann 300
300 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Südwestpark 50
90449 Nürnberg
Germany
Germany
Heumann Pharma GmbH &
Irbesartan/hydroc
Irbesartan
150
Film - coated
Co. Generica KG
hlorothiazide
Hydrochloorthiazide
mg/12,5
tablet
Südwestpark 50
heumann 150mg/12,5mg
mg
90449 Nürnberg
Filmtabletten
Oral use
Germany
Germany
Heumann Pharma GmbH &
Irbesartan/hydroc
Irbesartan
300
Film - coated
Co. Generica KG
hlorothiazide
Hydrochloorthiazide
mg/12,5
tablet
Südwestpark 50
heumann 300mg/12,5mg
mg
90449 Nürnberg
Filmtabletten
Oral use
Germany
Germany
Heumann Pharma GmbH &
Irbesartan/hydroc
Irbesartan
300 mg/25
Film - coated
Co. Generica KG
hlorothiazide
Hydrochloorthiazide
mg
tablet
Südwestpark 50
heumann 300mg/25mg
90449 Nürnberg
Filmtabletten
Germany
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
Germany
Heumann Pharma GmbH &
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
150
Film - coated
Co. Generica KG
hlorothiazide
azid Heumann 150
mg/12,5
tablet
mg/12.5 mg Filmtabletten
mg
Südwestpark 50
90449 Nürnberg
Germany
Germany
Heumann Pharma GmbH &
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
300
Film - coated
Co. Generica KG
hlorothiazide
azid Heumann 300
mg/12,5
tablet
mg/12.5 mg Filmtabletten
mg
Südwestpark 50
Oral use
90449 Nürnberg
Germany
Germany
Heumann Pharma GmbH &
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
300 mg/25
Film - coated
Co. Generica KG
hlorothiazide
azid Heumann 300 mg/25
mg
tablet
200 mg
Film - coated
Südwestpark 50
Oral use
mg Filmtabletten
90449 Nürnberg
Germany
Germany
Hormosan Pharma GmbH
Cefpodoxime
Cefpodoxim-
Wilhelmshoeher Str. 106
proxetil
Hormosan
D-60389 Frankfurt
200mg
06 Hessen
Filmtabletten
Oral use
tablet
Germany
Germany
Lupin (Europe) Limited
Trimetazidine
Lupamadazine 35 mg
Victoria Court, Bexton Road
hydrochloride
Retardtabletten
Knutsford, Cheshire WA16
0PF
United Kingdom
35 mg
Controlled release tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
Escitalopram-Micro Labs 5
5 mg
mg Filmtabletten
tablet
D-60528 Frankfurt/Main
Germany
Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
Escitalopram-Micro Labs
10 mg
10 mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main
Germany
Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
Escitalopram-Micro Labs
15 mg
15 mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main
Germany
Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
Escitalopram-Micro Labs
20 mg
20 mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main
Germany
Germany
Mylan dura GmBh
Repaglinide
Wittichstrasse 6
Repaglinid Mylan 0,5 mg
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
Tabletten
64295 Darmstadt
Germany
Germany
Mylan dura GmBh
Repaglinide
Wittichstrasse 6
Repaglinid Mylan 1 mg
Tabletten
64295 Darmstadt
Germany
Germany
Mylan dura GmBh
Wittichstrasse 6
64295 Darmstadt
Germany
Repaglinide
Repaglinid Mylan 2 mg
Tabletten
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Germany
Mylan dura GmBh
Rizatriptan
Wittichstrasse 6
Rizatriptan Mylan dura 5
5 mg
mg Schmelztabletten
tablet
64295 Darmstadt
Germany
Germany
Mylan dura GmBh
Rizatriptan
Wittichstrasse 6
Rizatriptan Mylan dura 10
10 mg
mg Schmelztabletten
Orodispersible
Oral use
tablet
64295 Darmstadt
Germany
Germany
Panacea Biotec Germany
Tacrolimus
GmbH
Tacpan 0.5 mg
0,5 mg
Capsule, hard
Oral use
Hartkapseln
Landshuter Allee 8-10
D-80637 München
Germany
Germany
Panacea Biotec Germany
Tacrolimus
Tacpan 1 mg Hartkapseln
1 mg
Capsule, hard
Oral use
Tacrolimus
Tacpan 5 mg Hartkapseln
5 mg
Capsule, hard
Oral use
Entacapone
Entacapon STADA 200 mg
200 mg
Film - coated
Oral use
GmbH
Landshuter Allee 8-10
D-80637 München
Germany
Germany
Panacea Biotec Germany
GmbH
Landshuter Allee 8-10
D-80637 München
Germany
Germany
Stadapharm GmbH
Stadastr. 2-18
D-61118 Bad Vilbel
Germany
Filmtabletten
tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Germany
Unichem Laboratories Ltd.
Irbesartan
Studio 8B Ard Gaoithe
Irbesartan Unichem 150
150 mg
mg Filmtabletten
tablet
Commercial Centre, Business
Park
Cashel Road Clonmel,
Co Tipperary
Ireland
Germany
Unichem Laboratories Ltd.
Irbesartan
Studio 8B Ard Gaoithe
Irbesartan Unichem 300
300 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Commercial Centre, Business
Park
Cashel Road Clonmel,
Co Tipperary
Ireland
Germany
Welding GmbH & Co. KG
Irbesartan/hydroc
Irbesartan +
300
Film - coated
Esplanade 39
hlorothiazide
Hidroclorotiazida Welding
mg/12,5
tablet
D-20354 Hamburg
Oral use
mg
Germany
Germany
Welding GmbH & Co. KG
Irbesartan/hydroc
Irbesartan +
150
Film - coated
Esplanade 39
hlorothiazide
Hidroclorotiazida Welding
mg/12,5
tablet
D-20354 Hamburg
Oral use
mg
Germany
Germany
Welding GmbH & Co. KG
Irbesartan/hydroc
Irbesartan +
300 mg/25
Film - coated
Esplanade 39
hlorothiazide
Hidroclorotiazida Welding
mg
tablet
D-20354 Hamburg
Germany
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Germany
Welding GmbH & Co. KG
Irbesartan
Irbesartan Welding
75 mg
Esplanade 39
tablet
D-20354 Hamburg
Germany
Germany
Welding GmbH & Co. KG
Irbesartan
Irbesartan Welding
150 mg
Esplanade 39
Film - coated
Oral use
tablet
D-20354 Hamburg
Germany
Germany
Welding GmbH & Co. KG
Irbesartan
Irbesartan Welding
300 mg
Esplanade 39
Film - coated
Oral use
tablet
D-20354 Hamburg
Germany
Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
Savandra
5 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
Savandra
10 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
Agiou Dimitriou 63
Alimos 17456
Greece
Savandra
15 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
Savandra
20 mg
tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Greece
Genepharm S.A.
Desloratadine
Desloratadine/Genepharm
18 Km Marathon Avenue,
5 mg δισκία επικαλυμμένα
15351 Pallini
με υμένιο,
5 mg
Film - coated
Oral use
tablet
Greece
Greece
Genepharm S.A.
Desloratadine
Desloratadine/Genepharm
18 Km Marathon Avenue,
2,5 mg δισκία
15351 Pallini
διασπειρόμενα στο στόμα
2,5 mg
Orodispersible
Oral use
tablet
Greece
Greece
Genepharm S.A.
Desloratadine
Desloratadine/Genepharm
18 Km Marathon Avenue,
5 mg δισκία διασπειρόμενα
15351 Pallini
στο στόμα
5 mg
Orodispersible
Oral use
tablet
Greece
Greece
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Donepezil/ Generics
5 mg
Orodispersible
Oral use
tablet
Argyroupoli
164-51 Athens
Greece
Greece
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Argyroupoli
164-51 Athens
Greece
Donepezil/ Generics
10 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Greece
Generics Pharma Hellas Ltd
Esomeprazole
577a Vouliagmenis Avenue
magnesium
Esomeprazole/ Generics
40 mg
release capsule
Argyroupoli
164-51 Athens
Greece
Greece
Sieger Pharma A.E.
Desloratadine
Desloratadine/Sieger
5 mg
Marathonos Avenue 106
Film - coated
Oral use
tablet
Pikermi 19009
Greece
Greece
Sieger Pharma A.E.
Desloratadine
Desloratadine/Sieger
2,5 mg
Marathonos Avenue 106
Orodispersible
Oral use
tablet
Pikermi 19009
Greece
Greece
Sieger Pharma A.E.
Desloratadine
Desloratadine/Sieger
5 mg
Marathonos Avenue 106
Orodispersible
Oral use
tablet
Pikermi 19009
Greece
Hungary
Actavis Group PTC ehf.
Metformin
Gluforlyn XR 500 mg
Reykjavikurvegi 76-78
hydrochloride
retard tabletta
Desloratadine
Alvotadin 5 mg
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur
Iceland
Hungary
Alvogen IPCo S.ar.l.
Rue Heienhaff 5
5 mg
filmtabletta
Film - coated
Oral use
tablet
L-1736 Senningerberg
Luxembourg
Hungary
Alvogen IPCo S.ar.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg
Desloratadine
Alvotadin 2.5 mg szájban
diszpergálódó tabletta
2,5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Hungary
Alvogen IPCo S.ar.l.
Desloratadine
Rue Heienhaff 5
Alvotadin 5 mg szájban
5 mg
diszpergálódó tabletta
tablet
L-1736 Senningerberg
Luxembourg
Hungary
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 20 mg
Station Close, Potters Bar
magnesium
gyomornedv-ellenálló
Hertfordshire, EN6 1TL
20 mg
Gastro - resistant
Oral use
capsule, hard
kemény kapszula
United Kingdom
Hungary
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 40 mg
Station Close, Potters Bar
magnesium
gyomornedv-ellenálló
Hertfordshire, EN6 1TL
40 mg
Gastro - resistant
Oral use
capsule, hard
kemény kapszula
United Kingdom
Hungary
Glenmark Pharmaceuticals
Trimetazidine
Apstar 35 mg retard
s.r.o.
dihydrochloride
tabletta
Desloratadine
Inaller 5 mg filmtabletta
35 mg
Prolonged -
Oral use
release tablet
Hvězdova 1716/2b
14078 Praha 4
Czech Republic
Hungary
Goodwill Pharma Kft.
5 mg
H-6724 Szeged
Film - coated
Oral use
tablet
Cserzy Mihály u. 32.
Hungary
Hungary
Goodwill Pharma Kft.
H-6724 Szeged
Cserzy Mihály u. 32.
Hungary
Desloratadine
Inaller 0.5 mg/ml
belsőleges oldat
0,5 mg/ml
Oral solution
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Hungary
Mylan SAS
Trimetazidine
117 allée des Parcs
Trimetazidine Mylan 35
35 mg
mg retard tabletta
release tablet
69792 Saint-Priest Cedex
France
Hungary
Sandoz Hungária Kft.
Trimetazidine
Trimetazidine Sandoz 35
H-1114 Budapest
dihydrochloride
mg retard tabletta
Desloratadine
Desloratadin Teva 2.5 mg
35 mg
Prolonged -
Oral use
release tablet
Bartók Béla út 43-47.
Hungary
Hungary
Teva Gyógyszergyár Zrt.
H-4042 Debrecen
szájban diszpergálódó
Pallagi út 13.
tabletta
2,5 mg
Orodispersible
Oral use
tablet
Hungary
Hungary
Teva Gyógyszergyár Zrt.
Desloratadine
Desloratadin Teva 5 mg
H-4042 Debrecen
szájban diszpergálódó
Pallagi út 13.
tabletta
5 mg
Orodispersible
Oral use
tablet
Hungary
Iceland
ratiopharm GmbH
Desloratadine
Desloratadine ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Ireland
Accord Healthcare Limited
Ropinirole
Ropinirole 0.25 mg Film-
Sage House, 319 Pinner
hydrochloride
coated Tablets
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
0,25 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Ireland
Accord Healthcare Limited
Ropinirole
Ropinirole 0.5 mg Film-
Sage House, 319 Pinner
hydrochloride
coated Tablets
Accord Healthcare Limited
Ropinirole
Ropinirole 1 mg Film-
Sage House, 319 Pinner
hydrochloride
coated Tablets
Accord Healthcare Limited
Ropinirole
Ropinirole 2 mg Film-
Sage House, 319 Pinner
hydrochloride
coated Tablets
Accord Healthcare Limited
Ropinirole
Ropinirole 5 mg Film-
Sage House, 319 Pinner
hydrochloride
coated Tablets
0,5 mg
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Ireland
1 mg
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Ireland
2 mg
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Ireland
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Pharmaceutical
Route of
Form
administration
70 mg
Tablet
Oral use
Valsartan/Hydrochlorothia
160
Film - coated
Oral use
zide Fair-Med 160
mg/12,5
tablet
mg/12.5 mg film-coated
mg
Invented name
Strength
EEA)
Ireland
Accord Healthcare Limited
Alendronic acid
Sage House, 319 Pinner
Alendronic Acid Once
Weekly 70 mg Tablets
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Ireland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
DE-22765 Hamburg
Germany
Ireland
tablets.
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
DE-22765 Hamburg
Germany
Ireland
Valsartan/Hydrochlorothia
320
Film - coated
zide Fair-Med 320
mg/12,5
tablet
mg/12.5 mg film-coated
mg
Oral use
tablets
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
DE-22765 Hamburg
Valsartan/Hydrochlorothia
320 mg/25
Film - coated
zide Fair-Med 320 mg/25
mg
tablet
120 mg
Film - coated
Oral use
mg film-coated tablets
Germany
Ireland
Fannin (UK) Ltd
Fexofenadine
Fexofenadine 120 mg
42-46 Booth Drive
hydrochloride
film-coated tablets
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Ireland
Fannin (UK) Ltd
Fexofenadine
Fexofenadine 180 mg
42-46 Booth Drive
hydrochloride
film-coated tablets
Donepezil
Aripil Orotab 5mg
180 mg
tablet
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom
Ireland
McDermott Laboratories Ltd
t/a Gerard Laboratories
5 mg
Orodispersible Tablet
Orodispersible
Oral use
tablet
35/36 Baldoyle Industrial
Estate
Grange Road
Dublin 13
Ireland
Ireland
McDermott Laboratories Ltd
Donepezil
t/a Gerard Laboratories
Aripil Orotab 10mg
10 mg
Orodispersible Tablet
Orodispersible
Oral use
tablet
35/36 Baldoyle Industrial
Estate
Grange Road
Dublin 13
Ireland
Ireland
McDermott Laboratories Ltd
Esomeprazole
Esomeprazole Mylan 20
t/a Gerard Laboratories
mg Gastro-resistant
35/36 Baldoyle Industrial
Capsules, hard
Estate
Grange Road
Dublin 13
Ireland
20 mg
Gastro - resistant
capsule
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
EEA)
Ireland
McDermott Laboratories Ltd
Esomeprazole
Esomeprazole Mylan 40
t/a Gerard Laboratories
mg Gastro-resistant
35/36 Baldoyle Industrial
Capsules, hard
40 mg
capsule
Estate
Grange Road
Dublin 13
Ireland
Ireland
McDermott Laboratories Ltd
Candesartan
t/a Gerard Laboratories
Candesartan Mylan 4mg
4 mg
Tablet
Oral use
8 mg
Tablet
Oral use
16 mg
Tablet
Oral use
Tablets
35/36 Baldoyle Industrial
Estate
Grange Road
Dublin 13
Ireland
Ireland
McDermott Laboratories Ltd
Candesartan
t/a Gerard Laboratories
Candesartan Mylan 8 mg
Tablets
35/36 Baldoyle Industrial
Estate
Grange Road
Dublin 13
Ireland
Ireland
McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial
Estate
Grange Road
Dublin 13
Ireland
Candesartan
Candesartan Mylan 16 mg
Tablets
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
32 mg
Tablet
Oral use
250 mg
Film - coated
Oral use
Strength
EEA)
Ireland
McDermott Laboratories Ltd
Candesartan
t/a Gerard Laboratories
Candesartan Mylan 32 mg
Tablets
35/36 Baldoyle Industrial
Estate
Grange Road
Dublin 13
Ireland
Ireland
Morningside Healthcare
Phenoxymethyl
Phenoxymethylpenicillin
Limited
penicillin
250mg Film-coated
115 Narborough Road
tablet
Tablets
Leicester, LE3 0PA
United Kingdom
Ireland
Niche Generics Limited
Amlodipine
Amlodipine Niche 5mg
1 The Cam Centre
besilate
tablets
Niche Generics Limited
Amlodipine
Amlodipine Niche 10mg
1 The Cam Centre
besilate
Tablets
Irbesartan
Irbesartan Niche 150mg
5 mg
Tablet
Oral use
10 mg
Tablet
Oral use
150 mg
Film - coated
Oral use
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom
Ireland
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom
Ireland
Niche Generics Limited
1 The Cam Centre
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom
film coated tablets
tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Ireland
Niche Generics Limited
Irbesartan
1 The Cam Centre
Irbesartan Niche 300mg
300 mg
film coated tablets
tablet
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom
Ireland
Wockhardt UK Limited
Clopidogrel
Clopidogrel 75mg film-
Ash Road North
hydrochloride
coated tablets
Metoclopramide
METOCLOPRAMIDE
75 mg
Film - coated
Oral use
tablet
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
Italy
Accord Healthcare Italia S.r.l.
Largo Esterle, 4
10 mg
Tablet
Oral use
ACCORD
20052 Monza
Italy
Italy
Accord Healthcare Limited
Alendronic acid
ALENDRONATO AHCL
10 mg
Tablet
Oral use
Alendronic acid
ALENDRONATO AHCL
70 mg
Tablet
Oral use
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Italy
Accord Healthcare Limited
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Italy
Doc Generici SRL
Desloratadine
Via Turati, 40
DESLORATADINA DOC
5 mg
GENERICI
tablet
20121 Milano
Italy
Italy
Doc Generici SRL
Desloratadine
Via Turati, 40
DESLORATADINA DOC
2,5 mg
GENERICI
Orodispersible
Oral use
tablet
20121 Milano
Italy
Italy
Doc Generici SRL
Desloratadine
Via Turati, 40
DESLORATADINA DOC
5 mg
GENERICI
Orodispersible
Oral use
tablet
20121 Milano
Italy
Italy
Farmaceutici Caber S.P.A.
Valsartan
VALSOTEN
40 mg
Viale Citta' D'Europa, 681
Film - coated
Oral use
tablet
00144 Rome
Italy
Italy
Farmaceutici Caber S.P.A.
Valsartan
VALSOTEN
80 mg
Viale Citta' D'Europa, 681
Film - coated
Oral use
tablet
00144 Rome
Italy
Italy
Farmaceutici Caber S.P.A.
Valsartan
VALSOTEN
160 mg
Viale Citta' D'Europa, 681
Film - coated
Oral use
tablet
00144 Rome
Italy
Italy
Farmaceutici Caber S.P.A.
Viale Citta' D'Europa, 681
00144 Rome
Italy
Valsartan
VALSOTEN
320 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
EEA)
Italy
Mylan S.P.A.
Esomeprazole
Via Vittor Pisani, 20
magnesium
ESOMEPRAZOLO MYLAN
20 mg
capsule, hard
20124 Milan
Italy
Italy
Mylan S.P.A.
Esomeprazole
Via Vittor Pisani, 20
magnesium
ESOMEPRAZOLO MYLAN
40 mg
Gastro - resistant
Oral use
capsule, hard
20124 Milan
Italy
Italy
Mylan S.P.A.
Rizatriptan
RIAZATRIPTAN MYLAN
Via Vittor Pisani, 20
benzoate
GENERICS
Mylan S.P.A.
Rizatriptan
RIAZATRIPTAN MYLAN
Via Vittor Pisani, 20
benzoate
GENERICS
Mylan S.P.A.
Donepezil
DONEPEZIL MYLAN
Via Vittor Pisani, 20
hydrochloride
GENERICS ITALIA
Mylan S.P.A.
Donepezil
DONEPEZIL MYLAN
Via Vittor Pisani, 20
hydrochloride
GENERICS ITALIA
Repaglinide
REPAGLINIDE MYLAN
5 mg
Orodispersible
Oral use
tablet
20124 Milan
Italy
Italy
10 mg
Orodispersible
Oral use
tablet
20124 Milan
Italy
Italy
5 mg
Orodispersible
Oral use
tablet
20124 Milan
Italy
Italy
10 mg
Orodispersible
Oral use
tablet
20124 Milan
Italy
Italy
Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy
0,5 mg
Tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Italy
Mylan S.P.A.
Repaglinide
REPAGLINIDE MYLAN
1 mg
Tablet
Oral use
Repaglinide
REPAGLINIDE MYLAN
2 mg
Tablet
Oral use
Alendronic acid
Alendronato Pensa
70 mg
Tablet
Oral use
70 mg
Tablet
Oral use
20 mg
Film - coated
Oral use
Via Vittor Pisani, 20
20124 Milan
Italy
Italy
Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy
Italy
Pensa Pharma S.P.A.
Via Rossellini Ippolito, 12
70 mg compresse
20124 Milan
Italy
Italy
Ranbaxy Italia S.P.A.
Alendronic acid
Piazza Filippo Meda, 4, 3
ALENDRONATO RANBAXY
ITALIA
20121 - Milano
Italy
Italy
Tecnigen S.R.L.
Leflunomide
LEFLUNOMIDE TECNIGEN
Via Galileo Galilei 40
tablet
20092 Cinisello Balsamo,
Milan
Italy
Italy
Tecnigen S.R.L.
Via Galileo Galilei 40
20092 Cinisello Balsamo,
Milan
Italy
Leflunomide
LEFLUNOMIDE TECNIGEN
10 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Modified -
Oral use
EEA)
Latvia
Sandoz Pharmaceuticals d.d.
Trimetazidine
Verovskova 57
dihydrochloride
Zidmetin
35 mg
release tablet
Ljubljana SI-1000
Slovenia
Lithuania
Accord Healthcare Limited
Alendronic acid
Alendronic acid Accord
70 mg
Tablet
Oral use
Ropinirole
Ropinirole Lambada
0,5 mg
Film - coated
Oral use
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Lithuania
Lambda Therapeutic Limited
Sage House
tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania
Lambda Therapeutic Limited
Ropinirole
Ropinirole Lambada
1 mg
Sage House
Film - coated
Oral use
tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania
Lambda Therapeutic Limited
Sage House
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Ropinirole
Ropinirole Lambada
2 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Lithuania
Lambda Therapeutic Limited
Ropinirole
Ropinirole Lambada
5 mg
Sage House
tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania
Torrent Pharma GmbH
Irbesartan
Irbesartanas Torrent
75 mg
Südwestpark 50
Film - coated
Oral use
tablet
90449 Nürnberg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan
Irbesartanas Torrent
150 mg
Südwestpark 50
Film - coated
Oral use
tablet
90449 Nürnberg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan
Irbesartanas Torrent
300 mg
Südwestpark 50
Film - coated
Oral use
tablet
90449 Nürnberg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartanas/Hidrochloroti
150
Film - coated
Südwestpark 50
hlorothiazide
azidas Torrent
mg/12,5
tablet
90449 Nürnberg
Oral use
mg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartanas/Hidrochloroti
300
Film - coated
Südwestpark 50
hlorothiazide
azidas Torrent
mg/12,5
tablet
90449 Nürnberg
Germany
mg
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
Lithuania
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartanas/Hidrochloroti
300 mg/25
Film - coated
Südwestpark 50
hlorothiazide
azidas Torrent
mg
tablet
Repaglinide
Repaglinide Mylan Pharma
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
20 mg
Gastro - resistant
Oral use
90449 Nürnberg
Germany
Luxembourg
Mylan bvba/sprl
Terhulpsesteenweg 6A
0,5 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan Pharma
1 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan Pharma
2 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
Terhulpsesteenweg 6A
capsule, hard
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
40 mg
Terhulpsesteenweg 6A
Gastro - resistant
Oral use
capsule, hard
1560 Hoeilaart
Belgium
Malta
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazi
160
Film - coated
Planckstrasse 13
orothiazide
d "Fair-Med" Coated
mg/12,5
tablet
tablets
mg
DE-22765 Hamburg
Germany
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
Malta
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazi
320
Film - coated
Planckstrasse 13
orothiazide
d "Fair-Med" Coated
mg/12,5
tablet
tablets
mg
DE-22765 Hamburg
Germany
Malta
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazi
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
d "Fair-Med" Coated
mg
tablet
250 mg
Film - coated
DE-22765 Hamburg
Oral use
tablets
Germany
Malta
Fair-Med Healthcare GmbH
Ciprofloxacin
Planckstrasse 13
Ciprofloxacin Fair-Med
Coated Tablets
Oral use
tablet
DE-22765 Hamburg
Germany
Malta
Fair-Med Healthcare GmbH
Ciprofloxacin
Planckstrasse 13
Ciprofloxacin Fair-Med
500 mg
Coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Malta
Fair-Med Healthcare GmbH
irbesartan
Planckstrasse 13
Irbesartan Fairmed 75mg
75 mg
Film-coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Malta
Fair-Med Healthcare GmbH
irbesartan
Planckstrasse 13
Irbesartan Fairmed 150mg
150 mg
Film-coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Malta
Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany
irbesartan
Irbesartan Fairmed 300mg
Film-coated Tablets
300 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
Malta
Malta
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
150
Film - coated
Planckstrasse 13
hlorothiazide
azide Fairmed
mg/12,5
tablet
DE-22765 Hamburg
150mg/12.5mg film-
mg
Germany
coated tablets
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
300
Film - coated
Planckstrasse 13
hlorothiazide
azide Fairmed
mg/12,5
tablet
300mg/12.5mg film-
mg
DE-22765 Hamburg
Germany
Malta
Malta
coated tablets
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
300 mg/25
Film - coated
Planckstrasse 13
hlorothiazide
azide Fairmed
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
300mg/25mg film-coated
Germany
tablets
Fair-Med Healthcare GmbH
Oral use
Venlafaxine
Venlafaxine Fair-Med
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Oral use
Germany
Malta
Fair-Med Healthcare GmbH
Venlafaxine
Venlafaxine Fair-Med
75 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Malta
Fair-Med Healthcare GmbH
Venlafaxine
Venlafaxine Fair-Med
150 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Malta
Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
Clopidogrel
Clopidogrel 75mg Filmcoated Tablets
75 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Malta
Wockhardt UK Limited
Clopidogrel
Ash Road North
Clopidogrel 75mg Coated
75 mg
Tablets
tablet
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
Norway
Bluefish Pharmaceuticals AB
Fluconazole
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Esomeprazole
Esomeprazol Mylan
20 mg
Gastro - resistant
Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Norway
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Norway
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Norway
Mylan AB
PO Box 230 33
capsule, hard
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Esomeprazole
Esomeprazol Mylan
40 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Eletriptan
Eletriptan Mylan
20 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Norway
Mylan AB
Eletriptan
Eletriptan Mylan
40 mg
PO Box 230 33
tablet
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
Kandrozid
4 mg
tablet
Oral use
Kandrozid
8 mg
tablet
Oral use
Kandrozid
16 mg
tablet
Oral use
Kandrozid
32 mg
tablet
Oral use
Mylcande
8 mg
tablet
Oral use
Mylcande
16 mg
tablet
Oral use
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
Mylcande
32 mg
tablet
Oral use
RIZATRIPTAN MYLAN 10
10 mg
Orodispersible
Oral use
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Rizatriptan
PO Box 230 33
mg, orodispersible tablet
tablet
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Quetiapin
PO Box 230 33
fumarate
Quetiapin Sandoz
50 mg
Prolonged -
Oral use
release tablet
SE-104 35 Stockholm
Sweden
Norway
ratiopharm GmbH
Desloratadine
Desloratadin Ratiopharm
2,5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Norway
ratiopharm GmbH
Desloratadine
Desloratadin Ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Poland
Abbott Laboratories Poland
Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland
Escitalopram
Savandra
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Poland
Abbott Laboratories Poland
Escitalopram
Savandra
10 mg
Sp. z o.o.
tablet
ul. Postępu 21B
02-676 Warszawa
Poland
Poland
Abbott Laboratories Poland
Escitalopram
Savandra
15 mg
Sp. z o.o.
Film - coated
Oral use
tablet
ul. Postępu 21B
02-676 Warszawa
Poland
Poland
Abbott Laboratories Poland
Escitalopram
Savandra
20 mg
Sp. z o.o.
Film - coated
Oral use
tablet
ul. Postępu 21B
02-676 Warszawa
Poland
Poland
Actavis Group PTC ehf.
Metformin
Metformin SR Actavis
500 mg
Reykjavikurvegi 76-78
Film - coated
Oral use
tablet
220 Hafnarfjördur
Iceland
Poland
Actavis Group PTC ehf.
Metformin
Metformin SR Actavis
750 mg
Reykjavikurvegi 76-78
Film - coated
Oral use
tablet
220 Hafnarfjördur
Iceland
Poland
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland
Metformin
Metformin SR Actavis
1000 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Poland
Adamed Sp. z o.o.
Desloratadine
Desada
5 mg
Pieńków 149
tablet
05-152 Czosnów k.
Warszawy
Poland
Poland
Adamed Sp. z o.o.
Desloratadine
Hitaxa Fast
2,5 mg
Pieńków 149
Orodispersible
Oral use
tablet
05-152 Czosnów k.
Warszawy
Poland
Poland
Adamed Sp. z o.o.
Desloratadine
Hitaxa
2,5 mg
Pieńków 149
Orodispersible
Oral use
tablet
05-152 Czosnów k.
Warszawy
Poland
Poland
Adamed Sp. z o.o.
Desloratadine
Hitaxa
5 mg
Pieńków 149
Orodispersible
Oral use
tablet
05-152 Czosnów k.
Warszawy
Poland
Poland
Aflofarm Farmacja Polska Sp.
z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Poland
Desloratadine
Teslor
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Poland
Aflofarm Farmacja Polska Sp.
Desloratadine
Teslor fast
5 mg
z o.o.
tablet
ul. Partyzancka 133/151
95-200 Pabianice
Poland
Poland
Aflofarm Farmacja Polska Sp.
Desloratadine
Teslor fast junior
2,5 mg
z o.o.
Orodispersible
Oral use
tablet
ul. Partyzancka 133/151
95-200 Pabianice
Poland
Poland
Apotex Europe B.V.
Trimetazidine
ApoTrimet PR
35 mg
Darwinweg 20
Prolonged -
Oral use
release tablet
NL 2333 CR Leiden
Netherlands
Poland
Bio-Profil Polska Sp. z o.o.
Desloratadine
Desloratadine Peseri
5 mg
Trakt Lubelski 135
Film - coated
Oral use
tablet
04-790 Warszawa
Poland
Poland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan HCT Fair-Med
DE-22765 Hamburg
320
Film - coated
mg/12,5
tablet
Oral use
mg
Germany
Poland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
DE-22765 Hamburg
Germany
Valsartan HCT Fair-Med
320 mg/25
Film - coated
mg
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Poland
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
250 mg
Planckstrasse 13
tablet
DE-22765 Hamburg
Germany
Poland
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
500 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Fair-Med Healthcare GmbH
Irbesartan
Irbesartan Fair-Med
75 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Fair-Med Healthcare GmbH
Irbesartan
Irbesartan Fair-Med
150 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Fair-Med Healthcare GmbH
Irbesartan
Irbesartan Fair-Med
300 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Planckstrasse 13
hlorothiazide
Irbesartan HCT Fair-Med
DE-22765 Hamburg
150
Film - coated
mg/12,5
tablet
Oral use
mg
Germany
Poland
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Planckstrasse 13
hlorothiazide
DE-22765 Hamburg
Germany
Irbesartan HCT Fair-Med
300
Film - coated
mg/12,5
tablet
mg
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
300 mg/25
Film - coated
Oral use
mg
tablet
160
Film - coated
mg/12,5
tablet
Strength
EEA)
Poland
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Planckstrasse 13
hlorothiazide
Irbesartan HCT Fair-Med
DE-22765 Hamburg
Germany
Poland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan HCT Fair-Med
DE-22765 Hamburg
Oral use
mg
Germany
Poland
Fair-Med Healthcare GmbH
Venlafaxine
VENLAFAXINE FAIR-MED
37,5 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Poland
Fair-Med Healthcare GmbH
Venlafaxine
VENLAFAXINE FAIR-MED
75 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Poland
Fair-Med Healthcare GmbH
Venlafaxine
VENLAFAXINE FAIR-MED
150 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Poland
Generics (UK) Ltd
Candesartan
Station Close, Potters Bar
cilexetil
Kangen
8 mg
Tablet
Oral use
Kangen
16 mg
Tablet
Oral use
Hertfordshire, EN6 1TL
United Kingdom
Poland
Generics (UK) Ltd
Candesartan
Station Close, Potters Bar
cilexetil
Hertfordshire, EN6 1TL
United Kingdom
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Poland
Ibermedgen, S.A.
Desloratadine
Ronda de Valdecarrizo
Desloratadyna
5 mg
IBERMEDGEN
tablet
28760 Tres Cantos, Madrid
Spain
Poland
Labormed-Pharma, SA
Desloratadine
Desloratadine Labormed
2,5 mg
Theodor Pallady, 44B
Orodispersible
Oral use
tablet
032266 Bucharest
Romania
Poland
Labormed-Pharma, SA
Desloratadine
Desloratadine Labormed
5 mg
Theodor Pallady, 44B
Orodispersible
Oral use
tablet
032266 Bucharest
Romania
Poland
Medicplast Polska Sp. z o.o
Desloratadine
Desalergo
5 mg
ul. Wólczyńska 232
Film - coated
Oral use
tablet
01-919 Warszawa
Poland
Poland
Medicplast Polska Sp. z o.o
Desloratadine
Desalergo
2,5 mg
ul. Wólczyńska 232
Orodispersible
Oral use
tablet
01-919 Warszawa
Poland
Poland
Medicplast Polska Sp. z o.o
ul. Wólczyńska 232
01-919 Warszawa
Poland
Desloratadine
Desalergo
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Poland
Orion Corporation
Valsartan
Valsartan Orion
40 mg
Orion Pharma
tablet
PO BOX 65
02101 Espoo
Finland
Poland
Orion Corporation
Valsartan
Valsartan Orion
80 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Poland
Orion Corporation
Valsartan
Valsartan Orion
160 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Poland
Orion Corporation
Valsartan
Valsartan Orion
320 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Poland
Peseri Trading Limited
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus
Desloratadine
Desloratadine Peseri
2,5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Poland
Peseri Trading Limited
Desloratadine
Desloratadine Peseri
5 mg
20 Queen Frederica Street
tablet
El-Greco House, office 301
1066 Nicosia
Cyprus
Poland
Ranbaxy (Poland) Sp. z o.o.
Alendronic acid
Alendran 70
70 mg
Tablet
Oral use
Trimetazidine
Dimesar
35 mg
Prolonged -
Oral use
Kubickiego 11
02-954 Warszawa
Poland
Poland
Sandoz GmbH
Biochemiestrasse 10
release tablet
A-6250 Kundl
Austria
Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
5 mg
ul. Kiełczowska 2
Film - coated
Oral use
tablet
55-095 Mirków
Poland
Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
2,5 mg
ul. Kiełczowska 2
Orodispersible
Oral use
tablet
55-095 Mirków
Poland
Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
5 mg
ul. Kiełczowska 2
Orodispersible
Oral use
tablet
55-095 Mirków
Poland
Poland
SymPhar Sp. z o.o.
ul. Włoska 1
00-777 Warszawa
Poland
Desloratadine
Symdes
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Poland
Tactica Pharmaceuticals sp. z
Desloratadine
Goldesin
5 mg
o.o.
tablet
ul. Bankowa 4
44-100 Gliwice
Poland
Poland
US Pharmacia Sp. z o.o.
Desloratadine
Aleric Deslo
5 mg
ul.Ziębicka 40
Film - coated
Oral use
tablet
50-507 Wrocław
Poland
Poland
US Pharmacia Sp. z o.o.
Desloratadine
Aleric Deslo
2,5 mg
ul.Ziębicka 40
Orodispersible
Oral use
tablet
50-507 Wrocław
Poland
Poland
US Pharmacia Sp. z o.o.
Desloratadine
Aleric Deslo Active
5 mg
ul.Ziębicka 40
Orodispersible
Oral use
tablet
50-507 Wrocław
Poland
Poland
Wockhardt UK Limited
Clopidogrel
Clopidogrel Wockhardt
75 mg
Ash Road North
Film - coated
Oral use
tablet
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
Portugal
Accord Healthcare Limited
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Alendronic acid
Ácido alendrónico Accord
70 mg
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Portugal
Alkaloid - INT d.o.o.
Cefpodoxime
Cefpodoxima Alkaloid
200 mg
Tablet
Oral use
Brown & Burk UK, Ltd.
Tramadol/paraceta
Tramadol + Paracetamol
37,5
Film - coated
Oral use
5, Marryat Close
mol
Brown
mg/325 mg
tablet
Trimetazidine
Trimetazidina Brown
35 mg
Modified -
Šlandrova 4
1231 Ljubljana - Črnuče
Slovenia
Portugal
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Brown & Burk UK, Ltd.
5, Marryat Close
Oral use
release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram Brown
10 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram Brown
15 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Brown & Burk UK, Ltd.
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom
Escitalopram
Escitalopram Brown
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Portugal
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram Brown
20 mg
5, Marryat Close
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Brown & Burk UK, Ltd.
Ebastine
Ebastina Brown
10 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Brown & Burk UK, Ltd.
Ebastine
Ebastina Brown
20 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Daquimed - Comércio de
Produtos Farmacêuticos, S.A.
Av. Associação Comercial e
Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fânzeres
Portugal
Quetiapine
Quetiapina Daquimed
25 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Portugal
Daquimed - Comércio de
Quetiapine
Quetiapina Daquimed
100 mg
Produtos Farmacêuticos, S.A.
tablet
Av. Associação Comercial e
Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fânzeres
Portugal
Portugal
Daquimed - Comércio de
Quetiapine
Quetiapina Daquimed
150 mg
Produtos Farmacêuticos, S.A.
Film - coated
Oral use
tablet
Av. Associação Comercial e
Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fânzeres
Portugal
Portugal
Daquimed - Comércio de
Produtos Farmacêuticos, S.A.
Av. Associação Comercial e
Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fânzeres
Portugal
Quetiapine
Quetiapina Daquimed
200 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Portugal
Daquimed - Comércio de
Quetiapine
Quetiapina Daquimed
300 mg
Produtos Farmacêuticos, S.A.
tablet
Av. Associação Comercial e
Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fânzeres
Portugal
Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
50 mg/12,5
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
tablet
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
75
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/18,75
tablet
Oral use
2700-487 Amadora
Portugal
Portugal
2700-487 Amadora
Oral use
mg/200 mg
Portugal
Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
100 mg/25
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
tablet
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
125
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/31,250
tablet
Oral use
2700-487 Amadora
Portugal
Portugal
2700-487 Amadora
Oral use
mg/200 mg
Portugal
Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
150
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/37,5
tablet
2700-487 Amadora
Portugal
mg/200 mg
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
175
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/43,75
tablet
2700-487 Amadora
mg/200 mg
Portugal
Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
200 mg/50
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
tablet
Entacapone
Entacapona Generis
200 mg
Film - coated
Oral use
2700-487 Amadora
Portugal
Portugal
Generis Farmacêutica, S. A.
Rua João de Deus, 19
Oral use
tablet
2700-487 Amadora
Portugal
Portugal
Labesfal, Genéricos, S.A.
Desloratadine
Desloratadina Labesfal OD
2,5 mg
Av. Dr. Afonso Costa, nº
Orodispersible
Oral use
tablet
1370
3465-051 Campo de
Besteiros
Portugal
Portugal
Labesfal, Genéricos, S.A.
Av. Dr. Afonso Costa, nº
1370
3465-051 Campo de
Besteiros
Portugal
Desloratadine
Desloratadina Labesfal OD
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Portugal
Labesfal, Genéricos, S.A.
Alendronic acid
Ácido alendrónico Labesfal
70 mg
tablet
Oral use
Donepezil
Donepezilo Anova
5 mg
Orodispersible
Oral use
Av. Dr. Afonso Costa, nº
1370
3465-051 Campo de
Besteiros
Portugal
Portugal
Laboratórios Anova Produtos Farmacêuticos, Lda.
tablet
Rua Doutor António Loureiro
Borges
Edíficio Arquiparque 1, R/C
Esqº
1499-016 Algés
Portugal
Portugal
Laboratórios Anova Produtos Farmacêuticos, Lda.
Rua Doutor António Loureiro
Borges
Edíficio Arquiparque 1, R/C
Esqº
1499-016 Algés
Portugal
Donepezil
Donepezilo Anova
10 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
EEA)
Portugal
Laboratórios Anova -
Esomeprazole
Esomeprazol Anova
20 mg
Produtos Farmacêuticos, Lda.
capsule, hard
Rua Doutor António Loureiro
Borges
Edíficio Arquiparque 1, R/C
Esqº
1499-016 Algés
Portugal
Portugal
Laboratórios Anova -
Esomeprazole
Esomeprazol Anova
40 mg
Produtos Farmacêuticos, Lda.
Gastro - resistant
Oral use
capsule, hard
Rua Doutor António Loureiro
Borges
Edíficio Arquiparque 1, R/C
Esqº
1499-016 Algés
Portugal
Portugal
Laboratórios Azevedos -
Venlafaxine
Venlafaxina Azevedos
37,5 mg
Prolonged -
Indústria Farmacêutica, S.A.
release capsule,
Edifícios Azevedos - Estrada
hard
Oral use
Nacional 117-2, Alfragide
2614-504 Amadora
Portugal
Portugal
Laboratórios Azevedos -
Venlafaxine
Venlafaxina Azevedos
75 mg
Prolonged -
Indústria Farmacêutica, S.A.
release capsule,
Edifícios Azevedos - Estrada
hard
Nacional 117-2, Alfragide
2614-504 Amadora
Portugal
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Portugal
Laboratórios Azevedos -
Venlafaxine
Venlafaxina Azevedos
150 mg
Indústria Farmacêutica, S.A.
release capsule,
Edifícios Azevedos - Estrada
hard
Nacional 117-2, Alfragide
2614-504 Amadora
Portugal
Portugal
Laboratórios Basi - Indústria
Fluconazole
Fluconazol Basi
50 mg
Capsule
Oral use
Fluconazole
Fluconazol Basi
150 mg
Capsule
Oral use
Fluconazole
Fluconazol Basi
200 mg
Capsule
Oral use
Desloratadine
Desloratadina Labormed
5 mg
Orodispersible
Oral use
Farmacêutica, S.A
Parque Industrial Manuel
Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal
Portugal
Laboratórios Basi - Indústria
Farmacêutica, S.A
Parque Industrial Manuel
Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal
Portugal
Laboratórios Basi - Indústria
Farmacêutica, S.A
Parque Industrial Manuel
Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal
Portugal
Labormed-Pharma, SA
Theodor Pallady, 44B
032266 Bucharest
Romania
tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Portugal
Labormed-Pharma, SA
Desloratadine
Desloratadina Labormed
2,5 mg
Theodor Pallady, 44B
tablet
032266 Bucharest
Romania
Portugal
Lupin (Europe) Limited
Cefpodoxime
Cefpodoxima Lupin
200 mg
Victoria Court, Bexton Road
Film - coated
Oral use
tablet
Knutsford, Cheshire WA16
0PF
United Kingdom
Portugal
Mylan, Lda.
Esomeprazole
Esomeprazol Mylan
20 mg
Parque Expo, Edifício
Gastro - resistant
Oral use
capsule, hard
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Esomeprazole
Esomeprazol Mylan
40 mg
Parque Expo, Edifício
Gastro - resistant
Oral use
capsule, hard
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Parque Expo, Edifício
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Atorvastatin
Atorvastatina Anova
10 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
20 mg
Parque Expo, Edifício
tablet
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
40 mg
Parque Expo, Edifício
Film - coated
Oral use
tablet
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
80 mg
Parque Expo, Edifício
Film - coated
Oral use
tablet
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Parque Expo, Edifício
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Donepezil
Donepezilo Mylan
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Portugal
Mylan, Lda.
Donepezil
Donepezilo Mylan
10 mg
Parque Expo, Edifício
tablet
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Trimetazidine
Trimetazidina Mylan
35 mg
Parque Expo, Edifício
Modified -
Oral use
release tablet
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Candesartan
Candesartan Mylan
4 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
8 mg
Tablet
Oral use
Parque Expo, Edifício
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Parque Expo, Edifício
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Portugal
Mylan, Lda.
Candesartan
Candesartan Mylan
16 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
32 mg
Tablet
Oral use
10 mg
Film - coated
Oral use
Parque Expo, Edifício
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Parque Expo, Edifício
Atlantis, Avenida D. João II,
Lote 1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Pentafarma - Sociedade
Leflunomide
Leflunomida Pentafarma
Técnico-Medicinal, S.A.
tablet
Rua da Tapada Grande, nº2
- Abrunheira
2710-089 Sintra
Portugal
Portugal
Pentafarma - Sociedade
Leflunomide
Leflunomida Pentafarma
20 mg
Técnico-Medicinal, S.A.
Film - coated
Oral use
tablet
Rua da Tapada Grande, nº2
- Abrunheira
2710-089 Sintra
Portugal
Portugal
Peseri Trading Limited
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus
Desloratadine
Desloratadina Peseri
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Portugal
Peseri Trading Limited
Desloratadine
Desloratadina Peseri
5 mg
20 Queen Frederica Street
tablet
El-Greco House, office 301
1066 Nicosia
Cyprus
Portugal
Peseri Trading Limited
Desloratadine
Desloratadina Peseri
0,5 mg/ml
Oral solution
Oral use
Desloratadine
Desloratadina Peseri
2,5 mg
Orodispersible
Oral use
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus
Portugal
Peseri Trading Limited
20 Queen Frederica Street
tablet
El-Greco House, office 301
1066 Nicosia
Cyprus
Portugal
Pharmakern Portugal Produtos Farmacêuticos,
Sociedade Unipessoal, Lda.
Edifício Atlas II, Av. José
Gomes Ferreira, N.º 11 - 3º,
Sala 31 - Miraflores
1495-139 Algés
Portugal
Trimetazidine
Trimetazidina Pharmakern
35 mg
Modified release tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Portugal
Ratiopharm - Comércio e
Desloratadine
Desloratadina Ratiopharm
2,5 mg
Indústria de Produtos
tablet
Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A,
Piso 2
2740-245 Porto Salvo
Portugal
Portugal
Ratiopharm - Comércio e
Desloratadine
Desloratadina Ratiopharm
5 mg
Indústria de Produtos
Orodispersible
Oral use
tablet
Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A,
Piso 2
2740-245 Porto Salvo
Portugal
Portugal
Sandoz Farmaceutica Lda.
Trimetazidine
Trimetazidina Itraxel
35 mg
Avenida Professor Doutor
Prolonged -
Oral use
release tablet
Cavaco Silva, n. 10E
Taguspark
2740-255 Porto Salvo
Portugal
Portugal
Teva Pharma - Produtos
Farmacêuticos,Lda.
Edificio Tejo, Rua Quinta do
Pinheiro, 16 - 6º
2790-143 Carnaxide
Portugal
Desloratadine
Desloratadina Teva
2,5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Portugal
Teva Pharma - Produtos
Desloratadine
Desloratadina Teva
5 mg
Farmacêuticos,Lda.
tablet
Edificio Tejo, Rua Quinta do
Pinheiro, 16 - 6º
2790-143 Carnaxide
Portugal
Romania
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
SAVANDRA 5 mg
5 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes
France
Romania
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
SAVANDRA 10 mg
10 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes
France
Romania
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
SAVANDRA 15 mg
15 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes
France
Romania
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
SAVANDRA 20 mg
20 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes
France
Romania
Alkaloid - INT d.o.o.
Šlandrova 4
1231 Ljubljana - Črnuče
Slovenia
Cefpodoxime
Forexo 200 mg
comprimate filmate
200 mg
Tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Romania
Alvogen IPCo S.ar.l.
Desloratadine
Rue Heienhaff 5
Desloratadina Alvogen 5
5 mg
mg comprimate filmate
tablet
L-1736 Senningerberg
Luxembourg
Romania
Alvogen IPCo S.ar.l.
Voriconazole
Rue Heienhaff 5
Conaverifin 50 mg
50 mg
comprimate filmate
Film - coated
Oral use
tablet
L-1736 Senningerberg
Luxembourg
Romania
Alvogen IPCo S.ar.l.
Voriconazole
Rue Heienhaff 5
Conaverifin 200 mg
200 mg
comprimate filmate
Film - coated
Oral use
tablet
L-1736 Senningerberg
Luxembourg
Romania
Dr. Reddy’s Laboratories
Levetiracetam
Levetiracetam Dr.
Romania SRL
Reddy’s, 250 mg,
71st-73rd Nicolae Caramfil,
comprimate filmate
250 mg
Tablet
Oral use
500 mg
Tablet
Oral use
750 mg
Tablet
Oral use
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania
Dr. Reddy’s Laboratories
Levetiracetam
Levetiracetam Dr.
Romania SRL
Reddy’s, 500mg,
71st-73rd Nicolae Caramfil,
comprimate filmate
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania
Dr. Reddy’s Laboratories
Levetiracetam
Levetiracetam Dr.
Romania SRL
Reddy’s, 750 mg,
71st-73rd Nicolae Caramfil,
comprimate filmate
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
1000 mg
Tablet
Oral use
40 mg
Tablet
Oral use
80 mg
Tablet
Oral use
Tablet
Oral use
Tablet
Oral use
Strength
EEA)
Romania
Dr. Reddy’s Laboratories
Levetiracetam
Levetiracetam Dr.
Romania SRL
Reddy’s, 1000 mg,
71st-73rd Nicolae Caramfil,
comprimate filmate
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania
Dr. Reddy’s Laboratories
Telmisartan
Romania SRL
Telmisartan Dr. Reddy's
40 mg comprimate
71st-73rd Nicolae Caramfil,
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania
Dr. Reddy’s Laboratories
Telmisartan
Romania SRL
Telmisartan Dr. Reddy's
80 mg comprimate
71st-73rd Nicolae Caramfil,
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania
Dr. Reddy’s Laboratories
Telmisartan/
Telmisartan HCT Dr.
40 mg/12,5
Romania SRL
hydrochlorothiazid
Reddy’s 40 mg/12,5 mg
mg
71st-73rd Nicolae Caramfil,
e
comprimate
Dr. Reddy’s Laboratories
Telmisartan/
Telmisartan HCT Dr.
80 mg/12,5
Romania SRL
hydrochlorothiazid
Reddy’s 80 mg/12,5 mg
mg
71st-73rd Nicolae Caramfil,
e
comprimate
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Gastro - resistant
Oral use
EEA)
Romania
Dr. Reddy’s Laboratories
Telmisartan/
Telmisartan HCT Dr.
80 mg/25
Romania SRL
hydrochlorothiazid
Reddy’s 80 mg/25 mg
mg
71st-73rd Nicolae Caramfil,
e
comprimate
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 20 mg
Station Close, Potters Bar
magnesium
capsule gastrorezistente
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 40 mg
Station Close, Potters Bar
magnesium
capsule gastrorezistente
Generics (UK) Ltd
Donepezil
Donepezil Mylan 5 mg
Station Close, Potters Bar
hydrochloride
comprimate
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania
20 mg
capsule, hard
Hertfordshire, EN6 1TL
United Kingdom
Romania
40 mg
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL
United Kingdom
Romania
Hertfordshire, EN6 1TL
5 mg
Orodispersible
Oral use
tablet
orodispersabile
United Kingdom
Romania
Generics (UK) Ltd
Donepezil
Donepezil Mylan 10 mg
Station Close, Potters Bar
hydrochloride
comprimate
Hertfordshire, EN6 1TL
10 mg
Orodispersible
Oral use
tablet
orodispersabile
United Kingdom
Romania
Generics (UK) Ltd
Repaglinide
Station Close, Potters Bar
Repaglinida Generics 0.5
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
mg comprimate
Hertfordshire, EN6 1TL
United Kingdom
Romania
Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom
Repaglinide
Repaglinida Genericsl 1
mg comprimate
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
2 mg
Tablet
Oral use
4 mg
Tablet
Oral use
8 mg
Tablet
Oral use
16 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
Strength
EEA)
Romania
Generics (UK) Ltd
Repaglinide
Station Close, Potters Bar
Repaglinida Generics 2
mg comprimate
Hertfordshire, EN6 1TL
United Kingdom
Romania
Generics (UK) Ltd
Candesartan
Candesartan Mylan 4 mg
Station Close, Potters Bar
cilexetil
comprimate
Generics (UK) Ltd
Candesartan
Candesartan Mylan 8 mg
Station Close, Potters Bar
cilexetil
comprimate
Generics (UK) Ltd
Candesartan
Candesartan Mylan 16 mg
Station Close, Potters Bar
cilexetil
comprimate
Generics (UK) Ltd
Rizatriptan
Rizatriptan Mylan 5 mg
Station Close, Potters Bar
benzoate
comprimate
Hertfordshire, EN6 1TL
United Kingdom
Romania
Hertfordshire, EN6 1TL
United Kingdom
Romania
Hertfordshire, EN6 1TL
United Kingdom
Romania
Hertfordshire, EN6 1TL
tablet
orrodispersabile
United Kingdom
Romania
Generics (UK) Ltd
Rizatriptan
Rizatriptan Mylan 10 mg
Station Close, Potters Bar
benzoate
comprimate
Hertfordshire, EN6 1TL
10 mg
Orodispersible
Oral use
tablet
orrodispersabile
United Kingdom
Romania
Glenmark Pharmaceuticals
Trimetazidine
Apstar 35mg
s.r.o.
Comprimate cu
Hvězdova 1716/2b
eliberare
14078 Praha 4
prelungită
Czech Republic
35 mg
Modified release tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Romania
Ibermedgen, S.A.
Desloratadine
Ronda de Valdecarrizo
Desloratadina Ibermedgen
5 mg
5 mg comprimate filmate
tablet
28760 Tres Cantos, Madrid
Spain
Romania
Labormed Pharma SA
Desloratadine
Desloratadine Labormed
Bd. Theodor Pallady nr. 44 B
2.5 mg comprimate
032266, sector 3, Bucureşti
orodispersabile
2,5 mg
Orodispersible
Oral use
tablet
România
Romania
Labormed Pharma SA
Desloratadine
Desloratadine Labormed 5
Bd. Theodor Pallady nr. 44 B
mg comprimate
032266, sector 3, Bucureşti
orodispersabile
5 mg
Orodispersible
Oral use
tablet
România
Romania
Mylan SAS
Trimetazidine
Trimetazidina Mylan 35
117 allée des Parcs
mg comprimate filmate cu
69792 Saint-Priest Cedex
eliberare prelungita
35 mg
Prolonged -
Oral use
release tablet
France
Romania
Sandoz Pharma Services SRL
Quetiapine
Eufrenin V 50 mg
Calea Floreasca Street
fumarate
comprimate cu eliberare
No 169A, district 2
50 mg
Prolonged -
Oral use
release tablet
prelungită
Bucharest
Romania
Romania
Sandoz Pharma Services SRL
Trimetazidine
Trimeluzine Limited 35 mg
Calea Floreasca Street
comprimate filmate cu
No 169A, district 2
eliberare modificata
Bucharest
Romania
35 mg
Modified release tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Romania
STADA Hemofarm S.R.L.
Entacapone
Calea Torontalului km 6 -
ENTTANIDA 200
200 mg
comprimate filmate
tablet
PITT
300633 Timişoara
Romania
Romania
Teva Pharmaceuticals S.R.L.
Desloratadine
Desloratadina Teva 5 mg
Str. Domniţa Ruxandra nr.
comprimate
12, parter, sector 2,
orodispersabile
5 mg
Orodispersible
Oral use
tablet
Bucureşti, România
Romania
Torrent Pharma SRL
Irbesartan
Irbesartan Torrent 75 mg
Str. Stirbei Voda nr. 36
comprimate
et. 2, biroul A, sector 1
filmate
75 mg
Film - coated
Oral use
tablet
Bucharest
Romania
Romania
Torrent Pharma SRL
Irbesartan
Irbesartan Torrent 150 mg
Str. Stirbei Voda nr. 36
comprimate
et. 2, biroul A, sector 1
filmate
150 mg
Film - coated
Oral use
tablet
Bucharest
Romania
Romania
Torrent Pharma SRL
Irbesartan
Irbesartan Torrent 300 mg
Str. Stirbei Voda nr. 36
comprimate
et. 2, biroul A, sector 1
filmate
300 mg
Film - coated
Oral use
tablet
Bucharest
Romania
Romania
Torrent Pharma SRL
Irbesartan/hydroc
Irbesartan Torrent
150
Film - coated
Str. Stirbei Voda nr. 36
hlorothiazide
Hidrochlorotiazida
mg/12,5
tablet
et. 2, biroul A, sector 1
150/12,5mg comprimate
mg
Bucharest
filmate
Romania
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
Romania
Torrent Pharma SRL
Irbesartan/hydroc
Irbesartan Torrent
300
Film - coated
Str. Stirbei Voda nr. 36
hlorothiazide
Hidrochlorotiazida
mg/12,5
tablet
et. 2, biroul A, sector 1
300/12,5mg comprimate
mg
Bucharest
filmate
Romania
Romania
Torrent Pharma SRL
Irbesartan/hydroc
Irbesartan Torrent
300 mg/25
Film - coated
Str. Stirbei Voda nr. 36
hlorothiazide
Hidrochlorotiazida
mg
tablet
200 mg
Film - coated
et. 2, biroul A, sector 1
300/25 mg comprimate
Bucharest
filmate
Oral use
Romania
Slovak
Alkaloid - INT d.o.o.
Republic
Šlandrova 4
Cefpodoxime
FOREXO 200 mg filmom
obalené tablety
Oral use
tablet
1231 Ljubljana - Črnuče
Slovenia
Slovak
Alvogen IPCo S.àr.l.
Republic
412F Route d'Esch
Desloratadine
Dezloratadin Alvogen 5
5 mg
mg filmom obalené tablety
Film - coated
Oral use
tablet
L - 2086
Luxembourg
Slovak
Genericon s.r.o.,
Republic
Anny Letenské 1108/15,
Desloratadine
GESLORA 5 mg
5 mg
Film - coated
Oral use
tablet
120 00 Praha 2 - Vinohrady
Czech Republic
Slovak
Generics (UK) Ltd
Donepezil
Donepezil Mylan 5 mg
Republic
Station Close, Potters Bar
hydrochloride
orodispergovateľné tablety
Hertfordshire, EN6 1TL
United Kingdom
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Slovak
Generics (UK) Ltd
Donepezil
Donepezil Mylan 10 mg
Republic
Station Close, Potters Bar
hydrochloride
orodispergovateľné tablety
Rizatriptan Mylan 10 mg
10 mg
tablet
Hertfordshire, EN6 1TL
United Kingdom
Slovak
Generics (UK) Ltd
Rizatriptan
Republic
Station Close, Potters Bar
benzoate
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL
United Kingdom
Slovak
Glenmark Pharmaceuticals
Republic
s.r.o.
Trimetazidine
Apstar 35 mg tablety s
35 mg
predĺženým uvoľňovaním
Modified -
Oral use
release tablet
Hvězdova 1716/2b
14078 Praha 4
Czech Republic
Slovak
Mylan SAS
Republic
117 allée des Parcs
Trimetazidine
Trimetazidin Mylan 35 mg
35 mg
Modified -
Oral use
release tablet
69792 Saint-Priest Cedex
France
Slovak
SVUS Pharma a.s.
Republic
Smetanovo nábřeží 1238/20a
Desloratadine
LOTERA 5 mg filmom
5 mg
obalené tablety
Film - coated
Oral use
tablet
500 02 Hradec Králové
Czech Republic
Slovak
Teva Pharmaceuticals
Republic
Slovakia s.r.o.
Teslova 26
821 02 Bratislava
Slovak Republic
Desloratadine
Dezloratadin Teva
OROTAB 2,5 mg
2,5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Slovak
Teva Pharmaceuticals
Republic
Slovakia s.r.o.
Desloratadine
Dezloratadin Teva
5 mg
OROTAB 5 mg
tablet
Teslova 26
821 02 Bratislava
Slovak Republic
Slovenia
Alkaloid - INT d.o.o.
Cefpodoxime
Šlandrova 4
Trexodo 200 mg filmsko
200 mg
obložene tablete
Film - coated
Oral use
tablet
1231 Ljubljana - Črnuče
Slovenia
Slovenia
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 20 mg
Station Close, Potters Bar
magnesium
trde gastrorezistentne
Hertfordshire, EN6 1TL
20 mg
Gastro - resistant
Oral use
capsule, hard
kapsule
United Kingdom
Slovenia
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 40 mg
Station Close, Potters Bar
magnesium
trde gastrorezistentne
Hertfordshire, EN6 1TL
40 mg
Gastro - resistant
Oral use
capsule, hard
kapsule
United Kingdom
Slovenia
Generics (UK) Ltd
Donepezil
Donepezil Mylan 5 mg
Station Close, Potters Bar
hydrochloride
orodisperzibilne tablete
Generics (UK) Ltd
Donepezil
Donepezil Mylan 10 mg
Station Close, Potters Bar
hydrochloride
orodisperzibilne tablete
5 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL
United Kingdom
Slovenia
Hertfordshire, EN6 1TL
United Kingdom
10 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
Slovenia
Lek farmacevtska družba
Trimetazidine
Trimeluzine 35 mg tablete
d.d.
hydrochloride
s podaljšanim
Verovškova 57
35 mg
release tablet
sproščanjem
1526 Ljubljana
Slovenia
Spain
Accord Healthcare, S.L.U.
Metoclopramide
METOCLOPRAMIDA
Moll de Barcelona s/n. World
ACCORD 10 mg
Trade Center. Edifici Est 6ª
COMPRIMIDOS EFG
10 mg
Tablet
Oral use
5 mg
Film - coated
Oral use
planta,
8039 Barcelona
Spain
Spain
Spain
Apotex Europe B.V.
Desloratadine
DESLORATADINA APOTEX
Darwinweg 20
5 mg COMPRIMIDOS
NL 2333 CR Leiden
RECUBIERTOS CON
Netherlands
PELICULA EFG
Brown & Burk UK, Ltd.
Ebastine
EBASTINA BROWN 10 mg
5, Marryat Close
COMPRIMIDOS
Hounslow
BUCODISPERSABLES EFG
tablet
10 mg
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex
United Kingdom
Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
160
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL 160
mg/12,5
tablet
28108 Madrid
MG/12,5 mg
mg
Spain
COMPRIMIDOS
RECUBIERTOS CON
PELICULA EFG
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
160 mg/25
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg
tablet
28108 Madrid
160/25 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
PELICULA EFG
Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
320
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg/12,5
tablet
28108 Madrid
320/12.5 mg
mg
Spain
COMPRIMIDOS
Oral use
RECUBIERTOS CON
PELICULA EFG
Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
320 mg/25
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg
tablet
28108 Madrid
320/25 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
Oral use
PELICULA EFG
Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
80 mg/12,5
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg
tablet
5 mg
Film - coated
28108 Madrid
80/12.5 mg
Spain
COMPRIMIDOS
Oral use
RECUBIERTOS CON
PELICULA EFG
Spain
Laboratorios Combix, S.L.U.
Desloratadine
DESLORATADINA COMBIX
C/ Badajoz 2, Edificio 2
5 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELÍCULA EFG
Spain
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Spain
Laboratorios Combix, S.L.U.
Desloratadine
DESLORATADINA FLAS
C/ Badajoz 2, Edificio 2
COMBIX 5 mg
Pozuelo de Alarcon
COMPRIMIDOS
Madrid 28223
BUCODISPERSABLES EFG
5 mg
tablet
Spain
Spain
Laboratorios Combix, S.L.U.
Escitalopram
ESCITALOPRAM COMBIX
C/ Badajoz 2, Edificio 2
10 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
10 mg
Film - coated
Oral use
tablet
Spain
Spain
Laboratorios Combix, S.L.U.
Escitalopram
ESCITALOPRAM COMBIX
C/ Badajoz 2, Edificio 2
15 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
15 mg
Film - coated
Oral use
tablet
Spain
Spain
Laboratorios Combix, S.L.U.
Escitalopram
ESCITALOPRAM COMBIX
C/ Badajoz 2, Edificio 2
20 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
20 mg
Film - coated
Oral use
tablet
Spain
Spain
Laboratorios Combix, S.L.U.
Escitalopram
ESCITALOPRAM COMBIX 5
C/ Badajoz 2, Edificio 2
mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
Spain
5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
70 mg
Tablet
Oral use
10 mg
Orodispersible
Oral use
Strength
EEA)
Spain
Laboratorios Ranbaxy, S. L
Alendronic acid
ACIDO ALENDRONICO
U.
SEMANAL RANBAXY 70 mg
Paseig de Gracia 9
COMPRIMIDOS EFG
7a Pl
Barcelona 08007
Spain
Spain
Mylan Pharmaceuticals, S.L.
Donepezil
Plom 2-4, 5º Planta
PHARMACEUTICALS 10 mg
8038 Barcelona
COMPRIMIDOS
Spain
Spain
Mylan Pharmaceuticals, S.L.
Spain
Spain
DONEPEZILO FLAS MYLAN
Plom 2-4, 5º Planta
PHARMACEUTICALS 5 mg
8038 Barcelona
COMPRIMIDOS
Mylan Pharmaceuticals, S.L.
ESOMEPRAZOL MYLAN 20
mg CAPSULAS
8038 Barcelona
GASTRORRESISTENTES
Spain
EFG
Esomeprazole
ESOMEPRAZOL MYLAN 40
Plom 2-4, 5º Planta
mg CAPSULAS
8038 Barcelona
GASTRORRESISTENTES
Spain
EFG
Mylan Pharmaceuticals, S.L.
Plom 2-4, 5º Planta
8038 Barcelona
Spain
5 mg
Orodispersible
Oral use
tablet
BUCODISPERSABLES EFG
Esomeprazole
Plom 2-4, 5º Planta
Mylan Pharmaceuticals, S.L.
tablet
BUCODISPERSABLES EFG
Donepezil
Spain
Spain
DONEPEZILO FLAS MYLAN
Repaglinide
REPAGLINIDA MYLAN 0,5
mg COMPRIMIDOS EFG
20 mg
Gastro - resistant
Oral use
capsule
40 mg
Gastro - resistant
Oral use
capsule
0,5 mg
Tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
10 mg
Orodispersible
Oral use
Strength
EEA)
Spain
Mylan Pharmaceuticals, S.L.
Repaglinide
Plom 2-4, 5º Planta
REPAGLINIDA MYLAN 1
mg COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain
Mylan Pharmaceuticals, S.L.
Repaglinide
Plom 2-4, 5º Planta
REPAGLINIDA MYLAN 2
mg COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain
Mylan Pharmaceuticals, S.L.
Rizatriptan
RIZATRIPTAN MAX MYLAN
Plom 2-4, 5º Planta
10 mg COMPRIMIDOS
8038 Barcelona
BUCODISPERSABLES EFG
tablet
Spain
Spain
PENSA PHARMA, S.A.U
Alendronic acid
ACIDO ALENDRONICO
Jorge Comín (médico
SEMANAL PENSA 70 mg
pediatra)
COMPRIMIDOS EFG
70 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
3 - bajos
46015– Valencia (Valencia)
Spain
Spain
Pharmagenus, S.A.,
Desloratadine
DESLORATADINA
Avda. Camí Real, 51-57,
PHARMAGENUS 2,5 mg
08184 Palau-solita i
COMPRIMIDOS
Plegamans (Barcelona)
BUCODISPERSABLES EFG
tablet
Spain
Spain
Pharmagenus, S.A.,
Desloratadine
DESLORATADINA
Avda. Camí Real, 51-57,
PHARMAGENUS 5 mg
08184 Palau-solita i
COMPRIMIDOS
Plegamans (Barcelona)
BUCODISPERSABLES EFG
Spain
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Spain
Teva Pharma S.L.U.
Desloratadine
DESLORATADINA TEVA 5
C/ Anabel Segura, 11
mg COMPRIMIDOS
Edificio Albatros B, 1ª planta
BUCODISPERSABLES EFG
5 mg
tablet
Madrid 28108
Spain
Spain
Welding GmbH & Co. KG
IRBESARTAN/HIDROCLOR
150
Film - coated
Esplanade 39
Irbesartan
OTIAZIDA WELDING 150
mg/12,5
tablet
D-20354 Hamburg
mg/12.5 mg
mg
Germany
COMPRIMIDOS
Oral use
RECUBIERTOS CON
PELICULA EFG
Spain
Welding GmbH & Co. KG
IRBESARTAN/HIDROCLOR
300
Film - coated
Esplanade 39
Irbesartan
OTIAZIDA WELDING 300
mg/12,5
tablet
D-20354 Hamburg
mg/12.5 mg
mg
Germany
COMPRIMIDOS
Oral use
RECUBIERTOS CON
PELICULA EFG
Spain
Welding GmbH & Co. KG
Irbesartan
IRBESARTAN/HIDROCLOR
300 mg/25
Film - coated
Esplanade 39
OTIAZIDA WELDING 300
mg
tablet
D-20354 Hamburg
mg/25 mg COMPRIMIDOS
Germany
RECUBIERTOS CON
70 mg
Tablet
Oral use
PELICULA EFG
Sweden
Accord Healthcare Limited
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Alendronic acid
Alendronat Accord
Veckotablett
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
Sweden
Alternova A/S
Clindamycin
Lodshusvej 11
hydrochloride
Clindamycin Alternova
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Generics (UK) Ltd
Donepezil
Donezil
5 mg
Orodispersible
Oral use
Station Close, Potters Bar
hydrochloride
DK-4230 Skælskør
Denmark
Sweden
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Sweden
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Sweden
Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden
Sweden
tablet
Hertfordshire, EN6 1TL
United Kingdom
Sweden
Generics (UK) Ltd
Donepezil
Station Close, Potters Bar
hydrochloride
Donezil
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL
United Kingdom
Sweden
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Donepezil
Donepezil Mylan
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
Sweden
Mylan AB
Donepezil
Donepezil Mylan
10 mg
PO Box 230 33
tablet
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
Rizatriptan
Rizatriptan Mylan
10 mg
PO Box 230 33
Orodispersible
Oral use
tablet
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
Repaglinide
Repaglinid Mylan
0,5 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
1 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
2 mg
Tablet
Oral use
Esomeprazole
Esomeprazol Mylan
20 mg
Gastro - resistant
Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
PO Box 230 33
capsule, hard
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Esomeprazole
Esomeprazol Mylan
40 mg
Gastro - resistant
capsule, hard
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
Sweden
Mylan AB
Eletriptan
Eletriptan Mylan
20 mg
PO Box 230 33
tablet
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
Eletriptan
Eletriptan Mylan
40 mg
PO Box 230 33
Film - coated
Oral use
tablet
SE-104 35 Stockholm
Sweden
Sweden
Orion Corporation
Valsartan
Valsartan Orion
40 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Sweden
Orion Corporation
Valsartan
Valsartan Orion
80 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Sweden
Orion Corporation
Valsartan
Valsartan Orion
160 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Sweden
Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland
Valsartan
Valsartan Orion
320 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
70 mg
Tablet
Oral use
200 mg
Film - coated
Oral use
Strength
EEA)
Sweden
Ranbaxy UK Ltd.
Alendronic acid
Alendronat Ranbaxy
Building 4, Chiswick Park
Veckotablett 70 mg
566 Chiswick High Road
tabletter
London, W4 5YE
Untied Kingdom
Sweden
Stada Arzneimittel AG
Entacapone
Entakapon STADA
Stadastrasse 2-18
tablet
DE-61118 Bad Vilbel
Germany
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner
Ropinirole
Ropinirol Accord 5 mg,
5 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner
Ropinirole
Ropinirol Accord 0,25 mg
0,25 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Ropinirole
Ropinirol Accord 0,5 mg
filmomhulde tabletten
0,5 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner
Ropinirole
Ropinirol Accord 1 mg
1 mg
filmomhulde tabletten
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner
Ropinirole
Ropinirol Accord 2 mg
2 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner
Alendronic acid
Alendroninezuur Accord
10 mg
Tablet
Oral use
70 mg
Tablet
Oral use
10mg Tabletten
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Alendronic acid
Alendroninezuur Accord
70mg Tabletten
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
37,5 mg
Prolonged -
Oral use
Strength
EEA)
The
Accord Healthcare Limited
Metoclopramide
Metoclopramidemonohydr
Netherlands
Sage House, 319 Pinner
hydrochloride
ochloride Accord 10 mg,
Road
Tabletten
North Harrow HA1 4HF
Middlesex
United Kingdom
The
Alembic Pharmaceuticals
Venlafaxine
Venlafaxine HCl Retard
Netherlands
Europe Limited
Alembic 37,5 mg, capsule
release capsule,
Palazzo Pietro Stiges, 103,
met verlengde afgifte,
hard
Strait Street
hard
VLT 1436 Valletta
Malta
The
Alembic Pharmaceuticals
Netherlands
Europe Limited
Venlafaxine
Venlafaxine HCl Retard
Alembic 75 mg, capsule
75 mg
Prolonged release capsule,
Palazzo Pietro Stiges, 103,
met verlengde afgifte,
hard
Strait Street
hard
Oral use
VLT 1436 Valletta
Malta
The
Alembic Pharmaceuticals
Netherlands
Europe Limited
Alembic 150 mg, capsule
release capsule,
Palazzo Pietro Stiges, 103,
met verlengde afgifte,
hard
Strait Street
hard
VLT 1436 Valletta
Malta
Venlafaxine
Venlafaxine HCl Retard
150 mg
Prolonged -
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
The
Brown & Burk UK, Ltd.
Netherlands
5, Marryat Close
Ebastine
Ebastine BB 10 mg
orodispergeerbare
Hounslow
tabletten
10 mg
tablet
TW4 5DQ Middlesex
United Kingdom
The
Centrafarm B.V.
Netherlands
Nieuwe Donk 3
Entacapone
Entacapone CF 200 mg,
200 mg
filmomhulde tablet
Film - coated
Oral use
tablet
4879 AC Etten Leur
The Netherlands
The
Fair-Med Healthcare GmbH
Netherlands
Planckstrasse 13
Ciprofloxacin
Ciprofloxacine Fair-Med
250 mg, filmomhulde
DE-22765 Hamburg
tabletten
250 mg
Film - coated
Oral use
tablet
Germany
The
Fair-Med Healthcare GmbH
Netherlands
Planckstrasse 13
Ciprofloxacin
Ciprofloxacine Fair-Med
500 mg, filmomhulde
DE-22765 Hamburg
tabletten
500 mg
Film - coated
Oral use
tablet
Germany
The
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacine Fair-Med
Netherlands
Planckstrasse 13
750 mg, filmomhulde
DE-22765 Hamburg
tabletten
750 mg
Film - coated
Oral use
tablet
Germany
The
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
160
Film - coated
Netherlands
Planckstrasse 13
orothiazide
160 mg/12,5 mg,
mg/12,5
tablet
filmomhulde tabletten
mg
DE-22765 Hamburg
Oral use
Germany
The
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
320
Film - coated
Netherlands
Planckstrasse 13
orothiazide
320 mg/12,5 mg,
mg/12,5
tablet
filmomhulde tabletten
mg
DE-22765 Hamburg
Germany
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
The
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
320 mg/25
Film - coated
Netherlands
Planckstrasse 13
orothiazide
320 mg/25 mg,
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
filmomhulde tabletten
Germany
The
Fair-Med Healthcare GmbH
Venlafaxine
Venlafaxine Fair-Med 37,5
Netherlands
Planckstrasse 13
mg capsules met
release capsule,
DE-22765 Hamburg
verlengde afgifte, hard
hard
Oral use
Germany
The
Fair-Med Healthcare GmbH
Venlafaxine
Venlafaxine Fair-Med 75
75 mg
Prolonged -
Netherlands
Planckstrasse 13
mg capsules met
release capsule,
DE-22765 Hamburg
verlengde afgifte, hard
hard
Oral use
Germany
The
Fair-Med Healthcare GmbH
Netherlands
Planckstrasse 13
Venlafaxine
mg capsules met
Venlafaxine Fair-Med 150
150 mg
Prolonged release capsule,
DE-22765 Hamburg
verlengde afgifte, hard
hard
Oral use
Germany
The
Mylan B.V.
Netherlands
Dieselweg 25
Esomeprazole
Esomeprazol Mylan 20
mg, maagsapresistente
3752 LB Bunschoten
capsules, hard
20 mg
Gastro - resistant
Oral use
capsule, hard
The Netherlands
The
Mylan B.V.
Netherlands
Dieselweg 25
Esomeprazole
Esomeprazol Mylan 40
mg, maagsapresistente
3752 LB Bunschoten
capsules, hard
40 mg
Gastro - resistant
Oral use
capsule, hard
The Netherlands
The
Mylan B.V.
Rizatriptan
Rizatriptan SmeltTab
Netherlands
Dieselweg 25
Mylan 5 mg,
3752 LB Bunschoten
orodispergeerbare
The Netherlands
tabletten
5 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
The
Mylan B.V.
Netherlands
Dieselweg 25
Mylan 10 mg,
3752 LB Bunschoten
orodispergeerbare
The Netherlands
tabletten
The
Netherlands
Ranbaxy UK Ltd.
Rizatriptan
Alendronic acid
Building 4, Chiswick Park
Rizatriptan SmeltTab
Alendroninezuur 70
10 mg
tablet
70 mg
Tablet
Oral use
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
10 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Ranbaxy, tabletten 70 mg
566 Chiswick High Road
London, W4 5YE
Untied Kingdom
The
Sandoz B.V.
Netherlands
Veluwezoom 22
Clonazepam
Clonazepam Sandoz 0,5
mg, tabletten
1327 AH Almere
The Netherlands
The
Sandoz B.V.
Netherlands
Veluwezoom 22
Clonazepam
Clonazepam Sandoz 2 mg,
tabletten
1327 AH Almere
The Netherlands
The
Sandoz B.V.
Netherlands
Veluwezoom 22
Clobazam
Clobazam Sandoz 10 mg,
tabletten
1327 AH Almere
The Netherlands
The
Teva Nederland B.V.
Desloratadine
Desloratadine Smelttablet
Netherlands
Swensweg 5
2,5 mg Teva,
2031 GA Haarlem
orodispergeerbare
The Netherlands
tabletten
tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
The
Teva Nederland B.V.
Netherlands
Swensweg 5
5 mg Teva,
2031 GA Haarlem
orodispergeerbare
The Netherlands
tabletten
The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
Desloratadine
Clonazepam
Desloratadine Smelttablet
Clonazepam TioFarma 0,5
5 mg
tablet
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
10 mg
Tablet
Oral use
20 mg
Tablet
Oral use
75 mg
Film - coated
Oral use
mg tabletten, tabletten
3261 LW Oud-Beyerland
The Netherlands
The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
Clonazepam
Clonazepam TioFarma 2
mg tabletten, tabletten
3261 LW Oud-Beyerland
The Netherlands
The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
Clobazam
Clobazam TioFarma 10
mg, tabletten
3261 LW Oud-Beyerland
The Netherlands
The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
Clobazam
Clobazam TioFarma 20
mg, tabletten
3261 LW Oud-Beyerland
The Netherlands
The
Torrent Pharma GmbH
Netherlands
Südwestpark 50
90449 Nürnberg
Germany
irbesartan
Irbesartan Torrent 75 mg
filmomhulde tabletten
tablet
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
The
Torrent Pharma GmbH
Netherlands
Südwestpark 50
irbesartan
Irbesartan Torrent 150 mg
150 mg
filmomhulde tabletten
tablet
90449 Nürnberg
Germany
The
Torrent Pharma GmbH
Netherlands
Südwestpark 50
irbesartan
Irbesartan Torrent 300 mg
300 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
90449 Nürnberg
Germany
The
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartan
150
Film - coated
Netherlands
Südwestpark 50
hlorothiazide
tablet
Hydrochloorthiazide
mg/12,5
90449 Nürnberg
Torrent 150 mg/12,5 mg
mg
Germany
filmomhulde tabletten
The
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartan
300
Film - coated
Netherlands
Südwestpark 50
hlorothiazide
Hydrochloorthiazide
mg/12,5
tablet
90449 Nürnberg
Torrent 300 mg/12,5 mg
mg
Germany
filmomhulde tabletten
The
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartan
300 mg/25
Film - coated
Netherlands
Südwestpark 50
hlorothiazide
Hydrochloorthiazide
mg
tablet
150 mg
Film - coated
90449 Nürnberg
Torrent 300 mg/25 mg
Germany
filmomhulde tabletten
The
Unichem Laboratories Ltd.
Netherlands
Studio 8B Ard Gaoithe
Commercial Centre, Business
Park
Cashel Road Clonmel,
Co Tipperary
Ireland
irbesartan
Irbesartan Unichem 150
mg filmomhulde tabletten
tablet
Oral use
Oral use
Oral use
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
The
Unichem Laboratories Ltd.
Netherlands
Studio 8B Ard Gaoithe
irbesartan
Irbesartan Unichem 300
300 mg
mg filmomhulde tabletten
tablet
Commercial Centre, Business
Park
Cashel Road Clonmel,
Co Tipperary
Ireland
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner
Ropinirole
Ropinirole 0.25mg film-
0,25 mg
coated tablets
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner
Ropinirole
Ropinirole 0.5mg film-
0,5 mg
coated tablets
Film - coated
Oral use
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
Ropinirole
Ropinirole 1mg filmcoated tablets
1 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner
Ropinirole
Ropinirole 2mg film-
2 mg
coated tablets
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner
Alendronic acid
alendronic acid 10mg
10 mg
Tablet
Oral use
70 mg
Tablet
Oral use
10 mg
Tablet
Oral use
Tablets
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner
Alendronic acid
alendronic acid 70mg
Once Daily Tablets
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
United
Accord Healthcare Limited
Metoclopramide
metoclopramide
Kingdom
Sage House, 319 Pinner
hydrochloride
hydrochloride 10mg
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
tablets
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner
Ropinirole
Ropinirole 5mg film-
5 mg
coated tablets
tablet
Road
North Harrow HA1 4HF
Middlesex
United Kingdom
United
Kingdom
Aptil Pharma Limited
Fluconazole
9th Floor, CP House
Fluconazole 50mg
50 mg
Capsule, hard
Oral use
150 mg
Capsule, hard
Oral use
200 mg
Capsule, hard
Oral use
2 mg
Tablet
Oral use
capsules
97-107 Uxbridge Road
London W5 5TL
United Kingdom
United
Aptil Pharma Limited
Kingdom
9th Floor, CP House
Fluconazole
Fluconazole 150mg
capsules
97-107 Uxbridge Road
London W5 5TL
United Kingdom
United
Aptil Pharma Limited
Kingdom
9th Floor, CP House
Fluconazole
Fluconazole 200mg
capsules
97-107 Uxbridge Road
London W5 5TL
United Kingdom
United
Auden McKenzie Limited
Kingdom
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom
Dexamethasone
Dexamethasone 2mg
Tablets
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
United
Auden McKenzie Limited
Thiamine
Kingdom
McKenzie House
hydrochloride
Tyvera 50mg Tablets
50 mg
Tablet
Oral use
Tyvera 100mg Tablets
100 mg
Tablet
Oral use
Clonazepam 500mcg
0,5 mg
Tablet
Oral use
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom
United
Auden McKenzie Limited
Thiamine
Kingdom
McKenzie House
hydrochloride
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom
United
Auden McKenzie Limited
Kingdom
McKenzie House
Clonazepam
Tablet
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom
United
Auden McKenzie Limited
Kingdom
McKenzie House
Clonazepam
Clonazepam 2mg Tablet
2 mg
Tablet
Oral use
Clonazepam
Clonazepam 10mg Tablet
10 mg
Tablet
Oral use
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom
United
Auden McKenzie Limited
Kingdom
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
United
Brown & Burk UK, Ltd.
Phenoxymethyl
Phenoxymethylpenicillin
Kingdom
5, Marryat Close
penicillin
250mg Film-coated
Hounslow
250 mg
tablet
Tablets
TW4 5DQ Middlesex
United Kingdom
United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 5mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
5 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 10mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
10 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 15mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
15 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 20mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
Hounslow
TW4 5DQ Middlesex
United Kingdom
20 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
United
Brown & Burk UK, Ltd.
Tramadol
Aceon 100mg Prolonged-
Kingdom
5, Marryat Close
hydrochloride
release tablets
100 mg
release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Brown & Burk UK, Ltd.
Tramadol
Aceon 150mg Prolonged-
Kingdom
5, Marryat Close
hydrochloride
release tablets
150 mg
Prolonged -
Oral use
release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Brown & Burk UK, Ltd.
Tramadol
Aceon 200mg Prolonged-
200 mg
Prolonged -
Oral use
Kingdom
5, Marryat Close
hydrochloride
release tablets
Valsartan
Valsartan 40mg Capsules
40 mg
Capsule
Oral use
Valsartan
Valsartan 80mg Capsules
80 mg
Capsule
Oral use
release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Valsartan
Valsartan 160mg Capsules
160 mg
Capsule
Oral use
Valsartan
Valsartan 320mg Capsules
320 mg
Capsule
Oral use
Levetiracetam
Levetiracetam 250mg
250 mg
Film - coated
Oral use
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
film-coated tablets
tablet
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Levetiracetam
Levetiracetam 500mg
500 mg
film-coated tablets
Film - coated
Oral use
tablet
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
Levetiracetam
Levetiracetam 750mg
film-coated tablets
750 mg
Film - coated
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Levetiracetam
Levetiracetam 1000mg
1000 mg
film-coated tablets
tablet
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Pioglitazone
Pioglitazone 15mg Tablets
15 mg
Tablet
Oral use
Pioglitazone
Pioglitazone 30mg Tablets
30 mg
Tablet
Oral use
Pioglitazone
Pioglitazone 45mg Tablets
45 mg
Tablet
Oral use
Dipyridamole
Attia 200mg Modified
200 mg
Modified -
Oral use
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
Release Capsules
release capsule,
hard
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Telmisartan
Telmisartan 20mg Tablets
20 mg
Tablet
Oral use
Telmisartan
Telmisartan 40mg Tablets
40 mg
Tablet
Oral use
Telmisartan
Telmisartan 80mg Tablets
80 mg
Tablet
Oral use
Tablet
Oral use
Tablet
Oral use
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Telmisartan/
Telmisartan/Hydrochloroth
40 mg/12,5
Kingdom
Limited
hydrochlorothiazid
iazide 40mg/12.5mg
mg
6 Riverview Road, Beverley
e
Tablets
East Yorkshire HU17 0LD
United Kingdom
United
Dr Reddy's Laboratories (UK)
Telmisartan/
Telmisartan/Hydrochloroth
80 mg/12,5
Kingdom
Limited
hydrochlorothiazid
iazide 80mg/12.5mg
mg
6 Riverview Road, Beverley
e
Tablets
East Yorkshire HU17 0LD
United Kingdom
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Film - coated
Oral use
EEA)
United
Dr Reddy's Laboratories (UK)
Telmisartan/
Telmisartan/Hydrochloroth
80 mg/25
Kingdom
Limited
hydrochlorothiazid
iazide 80mg/25mg Tablets
mg
6 Riverview Road, Beverley
e
Irbesartan 75mg Film-
75 mg
East Yorkshire HU17 0LD
United Kingdom
United
Fair-Med Healthcare GmbH
Kingdom
Planckstrasse 13
irbesartan
coated Tablets
tablet
DE-22765 Hamburg
Germany
United
Fair-Med Healthcare GmbH
Kingdom
Planckstrasse 13
irbesartan
Irbesartan 150mg Film-
150 mg
coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
United
Fair-Med Healthcare GmbH
Kingdom
Planckstrasse 13
irbesartan
Irbesartan 300mg Film-
300 mg
coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
United
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
150
Film - coated
Kingdom
Planckstrasse 13
hlorothiazide
azide 150mg/12.5mg film-
mg/12,5
tablet
coated tablets
mg
DE-22765 Hamburg
Oral use
Germany
United
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
300
Film - coated
Kingdom
Planckstrasse 13
hlorothiazide
azide 300mg/12.5mg film-
mg/12,5
tablet
coated tablets
mg
DE-22765 Hamburg
Oral use
Germany
United
Fair-Med Healthcare GmbH
Irbesartan/hydroc
Irbesartan/Hydrochlorothi
300 mg/25
Film - coated
Kingdom
Planckstrasse 13
hlorothiazide
azide 300mg/25mg film-
mg
tablet
DE-22765 Hamburg
Germany
coated tablets
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Pharmaceutical
Route of
Form
administration
150 mg
Capsule, hard
Oral use
120 mg
Film - coated
Oral use
Strength
EEA)
United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
Fluconazole
Fluconazole 150mg
capsule
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom
United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
Fexofenadine
Fexofenadine 120mg filmcoated tablets
tablet
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom
United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
Fexofenadine
Fexofenadine 180mg film-
180 mg
coated tablets
Film - coated
Oral use
tablet
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom
United
FDC Pharma
Kingdom
Unit 6, Fulcrum 1, Solent
Way
Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom
Amlodipine
Amlodipine 5mg Tablets
5 mg
Tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
EEA)
United
FDC Pharma
Kingdom
Unit 6, Fulcrum 1, Solent
Amlodipine
Amlodipine 10mg Tablets
10 mg
Tablet
Oral use
Repaglinide
Repaglinide Mylan 0.5mg
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
Way
Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom
United
Generics (UK) Ltd
Kingdom
Station Close, Potters Bar
Tablets
Hertfordshire, EN6 1TL
United Kingdom
United
Generics (UK) Ltd
Kingdom
Station Close, Potters Bar
Repaglinide
Repaglinide Mylan 1mg
Tablets
Hertfordshire, EN6 1TL
United Kingdom
United
Generics (UK) Ltd
Kingdom
Station Close, Potters Bar
Repaglinide
Repaglinide Mylan 2mg
Tablets
Hertfordshire, EN6 1TL
United Kingdom
United
Generics (UK) Ltd
Donepezil
Donepezil Hydrochloride
Kingdom
Station Close, Potters Bar
hydrochloride
5mg Orodispersible Tables
tablet
Hertfordshire, EN6 1TL
United Kingdom
United
Generics (UK) Ltd
Donepezil
Donepezil Hydrochloride
Kingdom
Station Close, Potters Bar
hydrochloride
10mg Orodispersible
Hertfordshire, EN6 1TL
United Kingdom
Tables
10 mg
Orodispersible
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
EEA)
United
Generics (UK) Ltd
Rizatriptan
Rizatriptan 10mg
Kingdom
Station Close, Potters Bar
benzoate
Orodispersible Tablet
Esomeprazole 20mg
10 mg
tablet
Hertfordshire, EN6 1TL
United Kingdom
United
Generics (UK) Ltd
Esomeprazole
Kingdom
Station Close, Potters Bar
magnesium
Hertfordshire, EN6 1TL
20 mg
Gastro-resistant Capsules,
Gastro - resistant
Oral use
capsule
hard
United Kingdom
United
Generics (UK) Ltd
Esomeprazole
Kingdom
Station Close, Potters Bar
magnesium
Hertfordshire, EN6 1TL
Esomeprazole 40mg
40 mg
Gastro-resistant Capsules,
Gastro - resistant
Oral use
capsule
hard
United Kingdom
United
Generics (UK) Ltd
Levodopa/carbidop
Levodopa/Carbidopa/Enta
150
Film - coated
Kingdom
Station Close, Potters Bar
a/entacapone
capone film-coated tablets
mg/37,5
tablet
150/37.5/200mg
mg/200 mg
Pantoprazole 20mg
20 mg
Hertfordshire, EN6 1TL
Oral use
United Kingdom
United
Lupin (Europe) Limited
Kingdom
Victoria Court, Bexton Road
Pantoprazole
Gastro-Resistant tablets
Gastro - resistant
Oral use
tablet
Knutsford, Cheshire WA16
0PF
United Kingdom
United
Lupin (Europe) Limited
Kingdom
Victoria Court, Bexton Road
Knutsford, Cheshire WA16
0PF
United Kingdom
Pantoprazole
Pantoprazole 40mg
Gastro-Resistant tablets
40 mg
Gastro - resistant
tablet
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
EEA)
United
Morningside Healthcare
Phenoxymethyl
Phenoxymethylpenicillin
Kingdom
Limited
penicillin
250mg Film-coated
115 Narborough Road
250 mg
tablet
Tablets
Leicester, LE3 0PA
United Kingdom
United
Morningside Healthcare
Metformin
Bolamyn/Metabet SR
Kingdom
Limited
hydrochloride
1000mg Prolonged
115 Narborough Road
1000 mg
Prolonged -
Oral use
release tablet
Release Tablets
Leicester, LE3 0PA
United Kingdom
United
Niche Generics Limited
Kingdom
1 The Cam Centre
irbesartan
Irbesartan Niche 150mg
150 mg
film-coated tablets
Film - coated
Oral use
tablet
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom
United
Niche Generics Limited
Kingdom
1 The Cam Centre
irbesartan
Irbesartan Niche 150mg
150 mg
film-coated tablets
Film - coated
Oral use
tablet
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom
United
Ranbaxy UK Ltd.
Kingdom
Building 4, Chiswick Park
Alendronic acid
Alendronic Acid 70mg
70 mg
Tablet
Oral use
Oral use
Tablets
566 Chiswick High Road
London, W4 5YE
Untied Kingdom
United
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartan
150
Film - coated
Kingdom
Südwestpark 50
hlorothiazide
tablet
Hydrochlorothiazide
mg/12,5
90449 Nürnberg
150mg/12.5mg Film-
mg
Germany
coated tablets
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
EEA)
United
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartan
300
Film - coated
Kingdom
Südwestpark 50
hlorothiazide
Hydrochlorothiazide
mg/12,5
tablet
90449 Nürnberg
300mg/12.5mg Film-
mg
Germany
coated tablets
United
Torrent Pharma GmbH
Irbesartan/hydroc
Irbesartan
300 mg/25
Film - coated
Kingdom
Südwestpark 50
hlorothiazide
Hydrochlorothiazide
mg
tablet
75 mg
Film - coated
90449 Nürnberg
300mg/25mg Film-coated
Germany
United
Torrent Pharma GmbH
Kingdom
Südwestpark 50
Oral use
tablets
irbesartan
Irbesartan 75mg Filmcoated tablets
Oral use
tablet
90449 Nürnberg
Germany
United
Torrent Pharma GmbH
Kingdom
Südwestpark 50
irbesartan
Irbesartan 150mg Film-
150 mg
coated tablets
Film - coated
Oral use
tablet
90449 Nürnberg
Germany
United
Torrent Pharma GmbH
Kingdom
Südwestpark 50
irbesartan
Irbesartan 300mg Film-
300 mg
coated tablets
Film - coated
Oral use
tablet
90449 Nürnberg
Germany
United
Waymade PLC
Venlafaxine
Venlasov XL 75mg
Kingdom
Sovereign House
hydrochloride
Modified Release Capsules
Miles Grat Road, Basildon
Essex SS14 3FR
United Kingdom
75 mg
Prolonged release capsule,
hard
Oral use
Member
Marketing Authorisation
State (in
Holder
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
EEA)
United
Waymade PLC
Venlafaxine
Venlasov XL 150mg
Kingdom
Sovereign House
hydrochloride
Modified Release Capsules
150 mg
release capsule,
Miles Grat Road, Basildon
hard
Essex SS14 3FR
United Kingdom
United
Wockhardt UK Limited
Kingdom
Ash Road North
Clopidogrel
Clopidogrel 75mg Film-
75 mg
coated Tablets
Film - coated
Oral use
tablet
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
United
YJBPort Limited
Kingdom
74 Briarwood Drive
Hydrocortisone
Hydrocortisone 10mg
10 mg
Tablet
Oral use
20 mg
Tablet
Oral use
Tablets
Northwood Hills
Middlesex HA6 1PL
United Kingdom
United
YJBPort Limited
Kingdom
74 Briarwood Drive
Northwood Hills
Middlesex HA6 1PL
United Kingdom
Hydrocortisone
Hydrocortisone 20mg
Tablets

Indeling docenten en klassen kerstfeest 19 december 2014 in de

MPL CHANGES JUNE 2014

Aggrenox - Boehringer Ingelheim

Autonomous sensors for quantifying mesopelagic carbon flux

bestmed medicine formulary non-cdl

ANDAMIO DOMÉSTICO FIJO DE ALUMINIO Ref.: 2400/010

1 97AR5022 XP44 Base (excl.PC,Tooling,Vac.pump)