Produkte und Projekte Pharmathek Active Product (German) Product (English) Official Name Yeast Saccharomyces Kapseln 125 mg Saccharomyces capsules 125 mg Saccharomyces boulardii Yeast Saccharomyces Kapseln 250 mg Saccharomyces capsules 250 mg Yeast Saccharomyces Beutel 250 mg Saccharomyces Sacchets 250 mg Yeast Saccharomyces Kapseln 375 mg Saccharomyces capsules 375 mg Herbal tincture ArniKa Gel 20 % Arnica Gel 20% AGON Produkte und Projekte20142407.xlsx Other Name Yeast Français : lévure de bière Saccharomyces Yeast boulardii Français : lévure de bière Saccharomyces Yeast boulardii Français : lévure de bière Saccharomyces Yeast boulardii Français : lévure de bière Tinktur aus Tincture of Arnikablüten Arnica flowers Francais Tincture fleur de Arnica HMPC Monograph Indication Status Prevention and symptomatic treatment of Diarrhoea. Adjuvant treatment of acne eCTD Dossier ready for submission Prevention and symptomatic treatment of Diarrhoea. Adjuvant treatment of acne eCTD Dossier ready for submission Prevention and symptomatic treatment of Diarrhoea. Adjuvant treatment of acne Final AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] Prevention and symptomatic treatment of Diarrhoea. Adjuvant treatment of acne eCTD Dossier D marketing authorisation Traditional hebal medicinal product for the relief of bruises, sprains and localised muscular pain Formulation development 24.07.2014 1 von 15 Produkte und Projekte Pharmathek Herbal tincture ArniKa Spray 20 % Arnica Spray 20% Tinktur aus Arnikablüten Tincture of Arnica flowers Francais Tincture fleur de Arnica Final Traditional hebal medicinal product for the relief of bruises, sprains and localised muscular pain Formulation development Herbal extract Baldrian Dragee 445 mg Valerian film coated tablet Valeriana officinalis Français Valériane Final Herbal medicinal product for the relief of mild nervous tension and sleep disorders eCTD Dossier Herbal extract Kava -Kava Kapsel Kava Kava Capsule Piper methysticum Français Rhizom de Kava Nervous tension and anxiety VG Köln hat den Widerruf der Zulassung am 20.05.2014 aufgehoben- Berufung des BfArM anhängig Herbal extract Kava -Kava Lösung Kava Kava Solution Piper methysticum Français Rhizom de Kava Nervous tension and anxiety VG Köln hat den Widerruf der Zulassung am 20.05.2014 aufgehoben- Berufung des BfArM anhängig Herbal extract Efeu Lösung 0,792 g/100 g Ivy solution Hedera helix Français : Lierre Final WEU eCTD Dossier Herbal extract Efeu Lösung Stick packs 2ml 0,792 g/100g Efeu Tropfen 1,98 g/100g Ivy solution stick packs 2 ml Hedera helix Francais : lierre Final Herbal medicinal product used as an expectorant in case of productive cough Herbal medicinal product used as an expectorant in case of productive cough Ivy drops Hedera helix Français : Lierre Final Herbal extract AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] Herbal medicinal product used as an expectorant in case of productive cough Technical development WEU eCTD Dossier 24.07.2014 2 von 15 Produkte und Projekte Pharmathek Herbal medicinal product used as an expectorant in case of productive cough Herbal medicinal product used as an expectorant in case of productive cough Herbal medicinal product used as an expectorant in case of productive cough WEU eCTD Dossier Herbal extract Efeu Pastille 26 mg Ivy oral gum Hedera helix Français : Lierre Final Herbal extract Efeu Kapsel 26mg Ivy capsule Hedera helix Français : Lierre Final Hedera helix Français : Lierre Final Hedera helix Francais Lierre Final Herbal medicinal product used as an expectorant in case of productive cough WEU eCTD Dossier Hedera helix Francais Lierre Final Herbal medicinal product used as an expectorant in case of productive cough Formulation development Einnahme ohne Wasser möglich Rhodiola radix Français : Racine d´Orpin rose Final Traditional herbal medicinal product for temporary relief symptoms of stress, such as fatigue and sensation of weakness Formulation development Herbal extract Herbal extract Herbal extract Herbal extrakt Efeu Ivy orodispersible Schmelztablette tablet 26 mg Efeu Ivy effervescent Brausetablette tablet 50 mg Efeu Brausedirekt- Ivy effervescent granulat direct powder 50 mg Rhodiola Kapsel Rhodiola capsule AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] WEU eCTD Dossier Formulation development 24.07.2014 3 von 15 Produkte und Projekte Pharmathek Herbal extrakt Passion flower Capsule 280 mg Passiflora incarnata Français : Passiflore Final Essential oil Eucalyptusöl-kapsel Eucalyptus oil capsule (magensaft(gastroresistant) resistent) 200 mg Eucalyptus globulus Français : Eucalyptus officinal Rapporteur assigned Cineol capsules 100 mg (gastroresistant) Cineol Cineol capsules 200 mg (gastroresistant) Cineol Essential oil Essential oil Passionsblume Kapsel 280 mg Cineol Kapseln 100 mg (magensaftresistent) Cineol Kapseln 200 mg (magensaftresistent) AGON Produkte und Projekte20142407.xlsx Traditional herbal medicinal Formulation development in D product for relief of mild zum Verkauf außerhalb der symptoms of mental stress and Apotheke zugelassen to aid sleep The product is a traditional herbal medicinal product for the use in the specified indications exclusively based upon long-standing use Supportive Treatment of respiratory tract infections, e.g. bronchitis or sinusitis Formulation development finished Francais : Cineéole Supportive Treatment of respiratory tract infections, e.g. bronchitis or sinusitis Formulation development finished Francais : Cineéole Supportive Treatment of respiratory tract infections, e.g. bronchitis or sinusitis Formulation development finished AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] 24.07.2014 4 von 15 Produkte und Projekte Pharmathek Lavender Oil Capsules 80 mg (gastroresistant) Essential oil Lavendelöl Kapsel 80 mg (magensaftresistent) Essential oil Peppermint oil Pfefferminzölcapsule Kapsel 182 mg (magensaft- (gastroresistant) resistent) Lavender Oil Francais : Lavande vraie Final Traditional herbal medicinal product for relief of mild symptoms of mental stress and exhaustion and to aid sleep. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Formulation development finished Mentha piperita Français: Menthe poivrée Final Herbal medicinal product for the symptomatic relief of minor spasms of the gastrointestinal tract, flatulence and abdominal pain, especially in patients with irritable bowel syndrom WEU eCTD Dossier Essential oil Pfefferminz Gel Peppermint Gel Mentha piperita Français: Menthe poivrée Final Herbal medicinal product for the symptomatic relief of mild tension type headache Formulation development Herbal extract Echinacea Lösung 80 g/100ml Echinacea liquid Echinacea purpurea Français : Echinacée Final Herbal medicinal product for the short-term prevention and treatment of common cold eCTD Dossier Herbal extract Echinacea Lösung Tierarzneimittel Echinacea liquid Vererinary Drug Echinacea purpurea Français : Echinacée Equines Sarkom Galenic development finished Patent pending AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] 24.07.2014 5 von 15 Produkte und Projekte Pharmathek Herbal extract Beinwell Salbe Comfrey Cream Symphytum Herbal extract Herbal extract Herbal extract Thymian Lösung Thyme solution Thymian vulgaris Thymian Salbe Thyme ointment Hypericum Filmtablette 600 mg Solidago Kapsel 360 mg St. Johns wort coated tablet Thymian vulgaris Hypericum perforatum Français : Thym Français : Thym Français : Millepertuis Golden rod capsule Solidago virgaurea Français : Verge d'or Herbal extract AGON Produkte und Projekte20142407.xlsx Francais: Racine de Consoude Traditional herbal medicinal product used for the symptomatic treatment of minor sprains and bruises The product is a traditional herbal medicinal product for the use in the specified indication exclusivly based upon longstanding use, Formulation development Treatment of Acne Formulation development Treatment of Acne Formulation development Final Symptomatic treatment of anxiety, neuralgia, nervous tension eCTD Dossier Final Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract a adjuvant in minor urinary complaints. The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use eCTD Dossier Draft AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] 24.07.2014 6 von 15 Produkte und Projekte Pharmathek Herbal extract Orthosiphonis Kapsel 277,5 mg Java Tea capsule Herbal extract Artischocken Filmtablette 600 mg Artichoke film coated tablet AGON Produkte und Projekte20142407.xlsx Ortosiphonis stamineus Cynarae scolymus Final Traditional herbal medicinal product used to increase the amount of urine to achieve flushing of the urinary tract as adjuvant in minor urinary complaints. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use eCTD Dossier Final Traditional herbal medicinal product for the symptomatic relief of digestive disorders such as dyspepsia with a sensation of fullness, bloating and flatulence. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon longstanding use. eCTD Dossier Français : Thé de Java Français : Artichaut AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] 24.07.2014 7 von 15 Produkte und Projekte Pharmathek Herbal extract Eleutherococcus Kapsel 50 mg Eleutheroccocus capsule Eleutherococcus senticosus Francais : Ginseng de Siberie Monograph Final List Final Traditional herbal medicinal product for symptoms of asthenia such as fatigue and weakness. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use eCTD Dossier Herbal extract Eleutherococcus Lösung 100ml Eleutheroccocus liquid Eleutherococcus senticosus Francais : Ginseng de Siberie Monograph Final List Final Traditional herbal medicinal product for symptoms of asthenia such as fatigue and weakness. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use eCTD Dossier Herbal extract Eibisch Lutschpastille 67,5mg Francais: Altheé Final Traditional herbal medicinal product for the use as an demulcent preparation for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Formulation development finished in D zum Verkauf außerhalb der Apothke zugelassen Marshmallow oral Altheaea gum officinalis radix AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] 24.07.2014 8 von 15 Produkte und Projekte Pharmathek Herbal extract Eibisch Schmelztablette 67,5mg Marshmallow orodispersible tablet Altheaea officinalis radix Francais: Altheé Final Traditional herbal medicinal Formulation development in product for the use as an D apothekenpflichtig demulcent preparation for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Herbal extract Eibisch Syrup 22,3 g /100g Marshmallow Syrup Altheaea officinalis radix Francais: Altheé Final Traditional herbal medicinal product for the use as an demulcent preparation for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] Formulation development finished in D zum Verkauf außerhalb der Apothke zugelassen 24.07.2014 9 von 15 Produkte und Projekte Pharmathek Herbal extract Eibisch Saft 22,3 g /100g Marshmallow Solution Altheaea officinalis radix Francais: Altheé Final Traditional herbal medicinal Formulation development product for the use as an alkoholfree-sugarfree, in D demulcent preparation for the apothekenpflichtig symptomatic treatment of oral or pharyngeal irritation and associated dry cough. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Herbal extract Eibisch Brausedirektgranulat Marshmallow effervescent powder Altheaea officinalis radix Francais: Altheé Final Traditional herbal medicinal product for the use as an demulcent preparation for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] Formulation development Einnahme ohne Wasser möglich in D apothekenpflichtig 24.07.2014 10 von 15 Produkte und Projekte Pharmathek Herbal extract Süßholzwurzel Kapsel 350 mg Liquorize Capsule Liquritia radix Francais: Réglisse Herbal Extract Rotes Weinlaub Creme 10% Red Vine leaf Creme Vitis vinifera Francais: Vigne AGON Produkte und Projekte20142407.xlsx Tradtional herbal medicinal product for the relief of digestive symptoms including burning sensation and dyspepsia. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Formulation development Traditional Herbal medicinal Monograph product to reklieve symptoms of List Final Formulation development finished Final AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] discomfort and heaviness of legs related to minor venous circulatory disturbances Traditional herbal medicinal product for symptomatic trelief of itching and burning associatred with haemorrhoids Traditional herbal medicinal product for symptomatic treatment of cutaneous capillary fragility. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use 24.07.2014 11 von 15 Produkte und Projekte Pharmathek Herbal Extract Cardui mariae Kapseln (traditionell) Herbal extract Bärentraubenblätter Tablette 625 mg Milk Thistle capsules (traditional) Silybum marianum Bearberry leaf Arctostaphylos Film coated tablet uva-ursi folium AGON Produkte und Projekte20142407.xlsx Français Rapporteur Chardon Marie assigned Francais Busserole Final AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] Traditional herbal medicinal Stability tests running product for the symptomatic relief of disorders of the liver and gall bladder. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Traditional herbal medicinal product used for tretment of eaarly symptoms of mild urinary tract infections such as burning sensation during urination and/or frequent urination The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Formulation development 24.07.2014 12 von 15 Produkte und Projekte Pharmathek Herbal extract Urtica Kapsel Nettle root capsule Urtica dioica Urtica urens Francais Ortie Final Traditional herbal medicinal Updating dossier Germany MA product for the relief of available lowerurinary tract symptoms related to benign prostatic hyperplasia after serious conditions have been excluded by a medical doctor. The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use Herbal substance Sloslim® Kapsel Sloslim® Capsule Fucus vesiculosus Francais Thalle de Fucus Draft Traditional herbal medicinal product used as an adjuvant to reduce calorie diet to help weight loss in overweight adults, after serious conditions have been excluded by a medical doctor. AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] Formulation development 24.07.2014 13 von 15 Produkte und Projekte Pharmathek Vitamin / Mineral Mefenaminsäure Tabletten 250 mg Mefenanminic acid tablets 250 mg Mefenaminic acid Pain, Dysmenorrhea, Menorhagia, Migraine, Hemorhage, Arthritiden, Arthrosis and Spondylarthrosis, Rheumatic pain. eCTD Dossier Synthetic active Mefenaminsäure Tabletten 500 mg Mefenanminic acid tablets 500 mg Mefenaminic acid Pain, Dysmenorrhea, Menorhagia, Migraine, Hemorhage, Arthritiden, Arthrosis and Spondylarthrosis, Rheumatic pain. eCTD Dossier Synthetic active ASS Tabletten 80 ASS film-coated mg magensaft- tablets 80 resistent mg gastroresistent Acetylsalicylic acid For the secondary prevention of thrombotic cerebrovascular or cardivascular disease and following by-pass surgery eCTD Dossier Acetylsalicylic acid For the secondary prevention of thrombotic cerebrovascular or cardivascular disease and following by-pass surgery eCTD Dossier Synthetic active ASS Tabletten 160 ASS film-coated mg tablets magensaft-resistent 160 mg gastroresistent AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] 24.07.2014 14 von 15 Produkte und Projekte Pharmathek Synthetic active Omeprazol Creme Omeprazole ointment Omeprazole Allergic Dermatitis, Neurodermitis, under development Patent pending Synthetic active Omeprazol Creme Tierarzneimittel Omeprazole Horses Summer Eczema under development Patent pending Synthetic active Butylscopolamin Filmtablette Omeprazole ointmentVeterinary Drug Butyl scopolamine film coated tablet Butyl scopolamin bromide To treat pain and discomfort caused by abdominal cramps, menstrual cramps, or other spasmodic activity in the digestive system. Formulation development Synthetic active Flurbiprofen Lutschpastille Flurbiprofen Oral Gum Flurbiprofen Short time symptomatic treatment of sore throat. Formulation development AGON Produkte und Projekte20142407.xlsx AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected] 24.07.2014 15 von 15
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