Final Belgian list: DAXAS (Last update 07/04/2014) Active substance BRENTUXIMAB VEDOTINE RIOCIGUAT LARONIDASE FORBETAPIR (F-18) Q.S. OFATUMUMAB 20.00 MG/ML NELARABINE 5.00 MG/ML ANTITHROMBIN ALFA TERIFLUNOMIDE BELIMUMAB MIRABEGRON NEISSERIA MENINGITIDES B, RECOMBINANT, COMPONENT, ADSORBED Q.S. COLESTILAN BOSUTINIB (MONOHYDRATE) 100.00 MG ACLIDINIUM (BROMURE) VORTIOXETINE VANDETANIB HISTAMINE DIHYDROCHLORIDE VARENICLINE (TARTRATE) ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG C1-INHIBITOR 500.00 IU ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG CLEVIDIPINE BUTYRATE LINACLOTIDE COPPER (64-CU) CHLORIDE Q.S. DECITABINE ROFLUMILAST 500.00 MCG ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG ROFLUMILAST DEFITELIO DEFIBROTIDE Gentium DIACOMIT STIRIPENTOL ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG BIOCODEX PASS New biological, authorised under exceptional circumstances Conditional auth BAYER N.V. PASS marketing name ADCETRIS ADEMPAS ALDURAZYME AMYVID ARZERRA ATRIANCE ATRYN AUBAGIO BENLYSTA BETMIGA BEXSERO BINDREN BOSULIF BRETARIS GENUAIR BRINTELLIX CAPRELSA CEPLENE CHAMPIX CHLOE CINRYZE CLAUDIA - 35 CLEVIPREX CONSTELLA CUPRYMINA DACOGEN DALIRESP DAPHNE DIANE-35 MAH TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD Bayer Pharma AG GENZYME EUROPE B.V. ELI LILLY NEDERLAND BV GLAXO GROUP LTD GLAXO GROUP LTD GTC BIOTHERAPEUTICS UK LIMITED SANOFI-AVENTIS GROUPE GLAXO GROUP LTD ASTELLAS PHARMA EUROPE B.V. Reason on list New AS, Cond Auth, PASS New AS Auth under excep circumstances, PASS New AS Conditional auth, PASS Auth under excep circumstances Auth under excep circumstances, PASS New AS New AS New AS NOVARTIS VACCINES & DIAGNOSTICS S.R.L. New AS NOVARTIS VACCINES & DIAGNOSTICS S.R.L. PFIZER LIMITED ALMIRALL S.A H. LUNDBECK A/S ASTRAZENECA AB MEDA AB PFIZER LIMITED New AS New AS, Cond Auth, PASS New AS, PASS New AS New AS, Cond Auth Auth under excep circumstances PASS MITHRA PHARMACEUTICALS S.A. PASS VIROPHARMA BVBA PASS SANDOZ N.V. PASS THE MEDICINES COMPANY UK LTD ALMIRALL S.A SPARKLE S.R.L JANSSEN-CILAG INTERNATIONAL NV NYCOMED GMBH New AS New AS New AS New AS PASS MITHRA PHARMACEUTICALS S.A. PASS NYCOMED GMBH DIFICLIR EDARBI EDURANT EKISTOL EKLIRA GENUAIR ELAPRASE ELIQUIS ELISAMYLAN 35 ELVANSE / TYVENSE ENUREV BREEZHALER EPERZAN ERIVEDGE ESBRIET EURARTESIM EVARREST FIDAXOMICIN AZILSARTAN MEDOXOMIL (POTASSIUM) RILPIVIRINE (HYDROCHLORIDE) CILOSTAZOL ACLIDINIUM (BROMURE) IDURSULFASE APIXABAN ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG LISDEXAMPHETAMINE GLYCOPYRRONIUM (BROMIDE) ALBIGLUTIDE VISMODEGIB PIRFENIDONE PIPERAQUINE TETRAPHOSPHATE (TETRAHYDRATE) , DIHYDROARTEMISININ (DHA) ASTELLAS PHARMA EUROPE B.V. TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD JANSSEN-CILAG INTERNATIONAL NV ??? ALMIRALL S.A. SHIRE HUMAN GENETIC THERAPIES AB BRISTOL MYERS SQUIBB/PFIZER EEIG New AS New AS New AS Outcome Referral Art 31, PASS New AS, PASS Auth under excep circumstances New AS MYLAN BVBA/SPRL PASS BRYSTOL MYERS SQUIBB/ PFIZER EEIG NOVARTIS EUROPHARM LIMITED GlaxoSmithKline Trading Services Limited ROCHE REGISTRATION LIMITED INTERMUNE EUROPE LTD New AS New AS, PASS New AS New AS, Cond Auth New AS, PASS SIGMA-TAU INDUSTRIE FARMAC. RIUNITE SPA New AS, PASS FIBRINOGEN, HUMAN Q.S., THROMBIN, HUMAN Q.S. OMRIX BIOPHARMACEUTICALS N.V. New Biological EVOLTRA EXJADE EYLEA FAMPYRA FIRDAPSE FLUENZ FLUENZ TETRA FORXIGA FYCOMPA GILENYA GIOTRIF ENOFOVIR DISOPROXIL (FUMARATE) , EMTRICITABINE , RILPIVIRINE (HYDROCHLORIDE) CLOFARABINE DEFERASIROX AFLIBERCEPT FAMPRIDINE AMIFAMPRIDINE (PHOSPHATE) INFLUENZA VIRUS, LIVE, ATTENUATED Q.S. INFLUENZA VIRUS (LIVE, ATTENUATED Q.S., NASAL) DAPAGLIFLOZIN (PROPANEDIOL MONOHYDRATE) PERAMPANEL FINGOLIMOD (HYDROCHLORIDE) 0.50 MG AFATINIB GLYBERA ALIPOGENE TIPARVOVEC Q.S. UNIQURE BIOPHARMA B.V GRASTOFIL FILGASTRIM ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG ERIBULIN (MESYLATE) 0.44 MG/ML Apotex Europe Auth under excep circumstances PASS New AS New AS, Cond Auth Auth under excep circumstances, PASS New AS New AS New AS New AS New AS, PASS New AS New AS, Auth under excep circumstances, PASS New Biological 3DDD PHARMA N.V. PASS EISAI LIMITED New AS EVIPLERA GRATIELLA 35 HALAVEN GILEAD SCIENCES LTD New AS GENZYME EUROPE B.V. NOVARTIS EUROPHARM LIMITED BAYER AG BIOGEN IDEC LTD BIOMARIN EUROPE LTD MEDIMMUNE LLC MEDIMMUNE LLC BRISTOL MYERS SQUIBB/ASTRAZENECA EEIG EISAI EUROPE LTD NOVARTIS EUROPHARM LIMITED Boehringer Ingelheim International HEXACIMA HEXYON Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and SANOFI PASTEUR SA Haemophilus influenzae type B conjugate vaccine (adsorbed) Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and SANOFI PASTEUR MSD Haemophilus influenzae type B conjugate vaccine (adsorbed) New Biological New Biological HIZENTRA IMMUNOGLOBULIN HUMAN NORMAL 200.00 MG/ML BIOCLS GMBH New Biological HYQVIA IMMUNOGLOBULIN HUMAN NORMAL 100.00 MG/ML BAXTER INNOVATIONS GMBH New Biological ICLUSIG ILARIS IMNOVID (POMALIDOMIDE CELGENE) PONATINIB (HYDROCHLORIDE) CANAKINUMAB ARIAD PHARMA LTD NOVARTIS EUROPHARM LIMITED New AS Auth under excep circumstances, PASS POMALIDOMIDE CELGENE EUROPE LIMITED New AS, PASS IMVANEX INCIVO INCRELEX INCRESYNC INFLECTRA INFLUSPLIT TETRA INLYTA INVIRASE INVOKANA IOA Modified Vaccinia Ankara virus - Bavarian Nordic (MVA-BN) live virus TELAPREVIR MECASERMIN ALOGLIPTIN/PIOGLITAZONE NFLIXIMAB Influenza virus inactivated split virion AXITINIB SAQUINAVIR (MESILATE) CANAGLIFLOZIN BAVARIAN NORDIC A/S JANSSEN-CILAG INTERNATIONAL NV IPSEN PHARMA Takeda Pharma HOSPIRA UK LTD GLAXO GROUP LTD PFIZER LIMITED ROCHE REGISTRATION LIMITED Janssen-Cilag International N.V. New AS, Auth under excep circumstances New AS Auth under excep circumstances, PASS New AS New Biological Biological New AS PASS New AS PASS IPREZIV JAKAVI JAYDESS MERCK SHARP & DOHME NOMOGESTROL ACETATE / ESTRADIOL HEMIHYDRATE AZILSARTAN MEDOXOMIL (POTASSIUM) TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD RUXOLITINIB (PHOSPHATE) NOVARTIS EUROPHARM LIMITED LEVONORGESTREL 13.50 MG BAYER N.V. JENTADUETO METFORMIN HYDROCHLORIDE , LINAGLIPTIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS JETREA JEVTANA KADCYLA KALYDECO KRYSTEXXA OCRIPLASMIN CABAZITAXEL TRASTUZUMAB EMTANSINE IVACAFTOR PEGLOTICASE THROMBOGENICS NV SANOFI-AVENTIS GROUPE Roche Registration Ltd VERTEX PHARMACEUTICALS LIMIT SAVIENT PHARMA IRELAND LIMITED New AS New AS New AS New AS, PASS New AS, PASS New AS New AS, PASS PASS LACTEST LATUDA LEMTRADA LIBERTEK GASILOXE LURASIDONE ALEMTUZUMAB ROFLUMILAST Lactest S.L. / Venter Pharma S.L. Takeda Pharma A/S GENZYME THERAPEUTICS LTD NYCOMED GMBH LOJUXTA LOMITAPIDE (MESYLATE) AEGERION PHARMACEUTICALS LONQUEX LYXUMIA MACI NAGLAZYME NEURACEQ LIPEGFILGRASTIM LIXISENATIDE CHONDROCYTES, AUTOLOGOUS CULTURED Q.S. GALSULFASE FLORBETABEN (18F) PROTEOLYTIC ENZYMES (CONCENTRATE) ENRICHED IN BROMELAIN NEISSERIA MENINGITIDES A+C+W+Y, POLYSACCHARIDE CONJ. TO TETANUS TOXOID Q.S. Turoctocog alfa CATRIDECACOG BELATACEPT EPTOTERMIN ALFA TEVA PHARMA BV SANOFI-AVENTIS GROUPE GENZYME EUROPE B.V. BIOMARIN EUROPE LTD Piramal Imaging GmbH New AS New AS New Biological PASS New AS, Auth under excep circumstances New AS, PASS New AS New AS Auth under excep circumstances, PASS New AS TEVA PHARMA GMBH New AS, PASS GLAXOSMITHKLINE BIOLOGICALS S.A. New AS, PASS NOVO NORDISK A/S NOVO NORDISK A/S BRISTOL-MYERS SQUIBB PHARMA EEIG OLYMPUS BIOTECH LTD NEXOBRID NIMENRIX NOVOEIGHT NOVOTHIRTEEN NULOJIX OPGENRA OPSUMIT OPTIMARK ORPHACOL OSSEOR OVALEAP PANDEMRIX PERJETA PICATO PIXUVRI PLETAL PRIALT PROTELOS MACITENTAN Actelion Registration Ltd GADOVERSETAMIDE CHOLIC ACID STRONTIUM RANELATE FOLLITROPIN ALPHA INFLUENZA VIRUS (INACTIVATED) Q.S. PERTUZUMAB INGENOL MEBUTATE PIXANTRONE (DIMALEATE) CILOSTAZOL ZICONOTIDE (ACETATE) STRONTIUM RANELATE MALLINCKRODT MEDICAL GMBH LABORATOIRES CTRS SERVIER, LES LABORATOIRES Teva Pharma GLAXOSMITHKLINE BIOLOGICALS S.A. ROCHE REGISTRATION LIMITED LEO PHARMA A/S CTI LIFE SCIENCES LTD ??? EISAI LIMITED SERVIER, LES LABORATOIRES New AS New AS New AS PASS New AS PASS Auth under excep circumstances PASS New Biological PASS New AS New AS New AS, Cond Auth Outcome Referral Art 31, PASS Auth under excep circumstances, PASS PASS PROVENGE AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS ACTIVATED WITH PAP-GM-CS Q.S. DENDREON UK LIMITED New AS, PASS RELVAR ELLIPTA REMSIMA REPLAGAL REVESTIVE RIENSO Fluticasone furoate/vilanterol trifenatate INFLIXIMAB AGALSIDASE ALFA TEDUGLUTIDE FERUMOXYTOL Glaxo Group Ltd CELLTRION HEALTHCARE HUNGARY KFT. SHIRE HUMAN GENETIC THERAPIES AB NYCOMED DANMARK APS TAKEDA PHARMA A/S New AS, PASS New Biological Auth under excep circumstances, PASS New AS, PASS New AS RYZODEG SEEBRI BREEZHALER SELINCRO SIGNIFOR SIRTURO SOMATROPIN BIOPARTNERS SOVALDI SPEDRA STIVARGA INSULIN ASPART 30.00 UML, INSULIN DEGLUDEC 70.00 UML GLYCOPYRRONIUM (BROMIDE) NALMEFENE (HYDROCHLORIDE DIHYDRATE) PASIREOTIDE (DIASPARTATE) BEDAQUILINE SOMATROPIN NOVO NORDISK A/S New AS NOVARTIS EUROPHARM LIMITED LUNDBECK A/S NOVARTIS EUROPHARM LIMITED Janssen-Cilag International N.V. New AS, PASS New AS New AS New AS, conditional auth BIOPARTNERS New Biological Gilead Sciences International Limited VIVUS BV BAYER AG New AS New AS New AS GILEAD SCIENCES LTD New AS GLAXOSMITHKLINE TRADING SERVICES LIMITED New AS NORDIC GROUP BV New AS, PASS ViiV Healthcare UK Limited NOVARTIS EUROPHARM LIMITED New AS New AS, PASS TIVICAY TOVANOR BREEZHALER SOFOSBUVIR AVANAFIL REGORAFENIB TENOFOVIR DISOPROXIL (FUMARATE) , EMTRICITABINE , ELVITEGRAVIR , COBICISTAT DABRAFENIB TEGAFUR , GIMERACIL , OTERACIL (MONOPOTASSIUM) DOLUTEGRAVIR GLYCOPYRRONIUM (BROMIDE) TRAJENTA LINAGLIPTIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS TRESIBA TROBALT TYBOST TYGACIL TYSABRI TYVERB INSULIN DEGLUDEC RETIGABINE COBICISTAT TIGECYCLINE NATALIZUMAB LAPATINIB (DITOSYLATE MONOHYDRATE) INDACATEROL (MALEATE) 85.00 MCG/DO, GLYCOPYRRONIUM (BROMIDE) 43.00 MCG/DO PANITUMUMAB 20.00 MG/ML TOCOPHEROL D-ALPHA (AS TOCOFERSOLAN) INFLUENZA VIRUS (INACTIVATED) Q.S. BOCEPREVIR ALOGLYPTIN / METFORMIN ALOGLYPTIN ELVITEGRAVIR FACTOR VIII HUMAN 1000.00 IU, FACTOR VON WILLEBRAND 2400.00 IU EVEROLIMUS NOVO NORDISK A/S GLAXO GROUP LTD Gilead Sciences PFIZER LIMITED BIOGEN IDEC LTD GLAXO GROUP LTD New AS New AS New AS PASS PASS Conditional auth NOVARTIS EUROPHARM LIMITED PASS AMGEN EUROPE BV ORPHAN EUROPE SARL BAXTER INNOVATIONS GMBH MERCK SHARP & DOHME LTD Takeda Pharma Takeda Pharma Gilead Sciences International Ltd Conditional auth Auth under excep circumstances, PASS New AS New AS New AS New AS New AS TEVA PHARMA BV New Biological NOVARTIS EUROPHARM LIMITED Conditional auth STRIBILD TAFINLAR TEYSUNO ULTIBRO BREEZHALER VECTIBIX VEDROP VEPACEL VICTRELIS VIPDOMET VIPIDIA VITEKTA VONCENTO VOTUBIA Bayer Pharma AG TEVA PHARMA BV ASTELLAS PHARMA EUROPE B.V. CROMA-PHARMA GMBH BRISTOL-MYERS SQUIBB PHARMA EEIG PHARMA MAR SA SANOFI-AVENTIS GROUPE ROCHE REGISTRATION LIMITED Auth under excep circumstances, New AS, PASS Auth under excep circumstances New AS, Cond Auth PASS New biological New AS New AS New AS PASS New AS New AS New AS, PASS Auth under excep circumstances New AS New AS ASTRAZENECA AB New AS VYNDAQEL TAFAMIDIS (MEGLUMINE) PFIZER LIMITED XAGRID XALKORI XARELTO XGEVA XIAPEX XIGDUO XOFIGO XOTERNA BREEZHALER XTANDI YELLOX YERVOY YONDELIS ZALTRAP ZELBORAF XAGRID CRIZOTINIB RIVAROXABAN 10.00 MG DENOSUMAB COLLAGENASE CLOSTRIDIUM HISTOLYTICUM DAPAGLIFLOZIN/METFORMIN Radium Ra 223 dichloride INDACATEROL / GLYCOPYRRONIUM ENZALUTAMIDE BROMFENAC (SODIUM SESQUIHYDRATE) IPILIMUMAB TRABECTEDIN AFLIBERCEPT VEMURAFENIB CEFTAROLINE FOSAMIL (ACETIC ACID SOLVATE MONOHYDRATE) SHIRE PHARMACEUTICAL CONTRACTS LTD PFIZER LIMITED BAYER SCHERING PHARMA AG AMGEN EUROPE BV AUXILIUM UK LIMITED ZINFORO ZOELY ZYTIGA THERAMEX S.r.l. NOMOGESTROL ACETATE / ESTRADIOL HEMIHYDRATE ABIRATERONE ACETATE JANSSEN-CILAG INTERNATIONAL NV NOTE In Red in Black in blue in grey New AS New Biological PASS Bristol-Myers Squibb/AstraZeneca EEIG commercialised / commercialisé / gecommercialiseerd not commercialised / pas commercialisé / niet gecommercialiseerd info not yet available / info non disponible / info niet beschikbaar New addition of this month / nouvelle addition de ce mois / nieuwe toevoeging van deze maand nouvelle substance active / nieuw actief bestanddeel nouveau médicament biologique / nieuwe biologische geneesmiddel Etude de sécurité post-autorisation / post-autorisatie veiligheidsstudies PASS New AS Conditional auth Auth under excep circumstances Autorisé sous certaines conditions / vergund onder bepaalde voorwaarden autorisé sous circonstances exceptionnelles / vergund onder uitzonderlijke omstandigheden Product informations / informations informations sursur lesles produits produits/productinformatie / produkten informaties http://www.fagg-afmps.be/search?language=fr&search_field=notice
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