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

AGON Produkte und Projekte20162208.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

Final

Indication

Status

Prevention and symptomatic treatment of Diarrhoea. Adjuvant treatment of acne

eCTD Dossier

Prevention and symptomatic treatment of Diarrhoea. Adjuvant treatment of acne

eCTD Dossier Neue Stabilitätschargen + Hersteller under work

Prevention and symptomatic treatment of Diarrhoea. Adjuvant treatment of acne

Formulation development

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

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Produkte und Projekte Pharmathek

Herbal tincture

Arnika Spray 20 %

Arnica Spray

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 entsp 60 mg Kavapyrone Kava -Kava Lösung entsp 60 mg Kavapyrone

Kava Kava Capsule

Piper methysticum

Nervous tension and anxiety

Präparat ist mit Auflagen des Stufenplans marktfähig

Kava Kava Solution

Piper methysticum

Français Rhizom de Kava Français Rhizom de Kava

Nervous tension and anxiety

Präparat ist mit Auflagen des Stufenplans marktfähig

Herbal extract

Holunderblüten Lutschpastille

Elder Flower Oral Gum

Sambucus Flos

Français Fleur des sureau

Final

Herbal medicinal product traditionally used for the relief of early symptoms of common cold

Formulation development

Herbal extract

Efeu Lösung 0,545 g/100 g

Ivy solution

Hedera helix

Français : Lierre

Final

Formulation development finished Sampless available

Herbal extract

Efeu Pastille 26 mg

Ivy oral gum

Hedera helix

Français : 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

Herbal extract

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Formulation development finished Sampless available

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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

Formulation development

Final

Herbal medicinal product used as an expectorant in case of productive cough

Formulation development

Francais Lierre

Final

Herbal medicinal product used as an expectorant in case of productive cough

Formulation development Intake without water possible

Avena sativa

Français : Avoine

Final

Traditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep

Formulation development

Passiflora incarnata

Français : Passiflore

Final

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

Herbal extract

Efeu Kapsel 26mg

Ivy capsule

Hedera helix

Français : Lierre

Final

Herbal extract

Efeu Brausetablette 50 mg Efeu Brausegranulat 50 mg Efeu DrektGranulat 50 mg Avena Filmtablette

Ivy effervescent tablet

Hedera helix

Francais Lierre

Final

Ivy effervescent granules

Hedera helix

Francais Lierre

Ivy orodispersible granules

Hedera helix

Avena coated tablet

Passion flower coated tablet 280 mg

Herbal extract Herbal extract Herbal extract

Herbal extract

Citormin® Passionsblume Filmtablette 280 mg

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AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

Formulation development

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Produkte und Projekte Pharmathek

Herbal extract

Echinacea Kapsel 133,33 mg

Echinacea capsule

Echinacea purpurea

Français : Echinacée

Final

Herbal medicinal product for the short-term prevention and treatment of common cold

eCTD Dossier ready for submission ICH-Stability running

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

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22.08.2016 4 von 18

Produkte und Projekte Pharmathek

Herbal extract

Echinacea Spray Tierarzneimittel

Echinacea Spray Vererinary Drug

Echinacea purpurea

Herbal extract

Beinwell Salbe 10 %

Comfrey Cream

Symphytum

AGON Produkte und Projekte20162208.xlsx

Equines Sarkom

Galenic development Patent pending

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

Français : Echinacée

Francais: Racine de Consoude

Final

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Produkte und Projekte Pharmathek

Francais: Racine de Consoude

Final

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

Thyme-Primula Oral Gum

Thymus vulgaris ThymePrimula eliator Racine de primevere

Final

Traditional herbal medicinal product used as an expectorant in cough associated with cold

Formulation development finished

Thymian Lösung gegen Akne

Thyme solution

Thymian vulgaris

Français : Thym

Treatment of Acne

Formulation development

Thymian Salbe gegen Akne

Thyme ointment

Thymian vulgaris

Français : Thym

Treatment of Acne

Formulation development

Herbal extract

Beinwell Spray 10 %

Comfrey Spray

Herbal extract

Tomillo® Thymian -Primel Lutschpastille

Herbal extract

Herbal extract

AGON Produkte und Projekte20162208.xlsx

Symphytum

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

22.08.2016 6 von 18

Produkte und Projekte Pharmathek

Herbal extract

Hypericum Filmtablette 600 mg

St. Johns wort coated tablet

Hypericum perforatum

Français : Millepertuis

Final

Herbal medicinal product for the symptomatic treatment of mild depressive episodes

eCTD Dossier

Herbal extract

Hypericum Filmtablette 900 mg

St. Johns wort coated tablet

Hypericum perforatum

Français : Millepertuis

Final

Herbal medicinal product for the symptomatic treatment of mild depressive episodes

Formulation development

Herbal extract

Solidago Kapsel 360 mg

Golden rod capsule

Solidago virgaurea

Français : Verge d'or

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

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22.08.2016 7 von 18

Produkte und Projekte Pharmathek

Herbal extract

Orthosiphonis Kapsel 277,5 mg

Java Tea capsule

Herbal extract

Spasmovent® Artischocken Filmtablette 600 mg

Artichoke film coated tablet

AGON Produkte und Projekte20162208.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 under work stability running

Français : Thé de Java

Français : Artichaut

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

22.08.2016 8 von 18

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

NTA 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

NTA Dossier

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22.08.2016 9 von 18

Produkte und Projekte Pharmathek

Herbal extract

Eibisch Lutschpastille 125 mg

Marshmallow oral Altheaea gum 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

Herbal extract

Eibisch Brausetablette 250 mg

Marshmallow efferescent tablet

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

AGON Produkte und Projekte20162208.xlsx

Altheaea officinalis radix

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

Formulation development finished Samples available in D zum Verkauf außerhalb der Apothke zugelassen

22.08.2016 10 von 18

Produkte und Projekte Pharmathek

Herbal extract

Eibisch Schmelztablette 125 mg

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 6,75 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 Projekte20162208.xlsx

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

Formulation development finished in D zum Verkauf außerhalb der Apothke zugelassen

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Produkte und Projekte Pharmathek

Herbal extract

Eibisch Saft 6,75 g /100g zuckerfrei

Herbal Extract

Rotes Weinlaub Creme

Marshmallow Altheaea Solution sugarfree officinalis radix

Red Vine leaf Creme

AGON Produkte und Projekte20162208.xlsx

Vitis vinifera

Francais: Altheé

Francais: Vigne

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

Traditional Herbal medicinal Monograph product to reklieve symptoms of List Final

Formulation development

discomfort and heaviness of legs related to minor venous circulatory disturbances - The product is a tradtional herbal medicinal product for use in specified indication exclusivly based upon long-standing use

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22.08.2016 12 von 18

Produkte und Projekte Pharmathek

Herbal extract

Bärentraubenblätter Tablette 625 mg

Bearberry leaf Arctostaphylos Film coated tablet uva-ursi folium

Francais Busserole

Final

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

Herbal extract

Crataegus Filmtablette 450 mg

Hawthorn coated Crataegus folium tablet con flore

Francais Aubepine

Draft

THMP used to relieve symptoms of temporary nervous cardiac complaints (e.g. palpitations, percceived extra heart beat, due to mild anxiety) after serious conditions have been excluded by a medical doctor THMP for relief of mild symptomsof mental stress and to aid sleep

NTA Dossier

AGON Produkte und Projekte20162208.xlsx

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

22.08.2016 13 von 18

Produkte und Projekte Pharmathek

Herbal extract

Mencaps® Urtica Kapsel 240 mg

Nettle root capsule

Urtica dioica Urtica urens

Francais Ortie

Final

Traditional herbal medicinal product for the relief of 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 extract

Mencaps® Kürbis Filmtablette 152 mg

Pumpkin coated tablet

Cucurbitae semen

Francais Courge ou Citrouille

Final

Traditional herbal medicinal product for the relief of lowerurinary tract symptoms related to benign prostatic hyperplasia or related to a overactive bladder 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

AGON Produkte und Projekte20162208.xlsx

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

NTA Dossier Germany MA available

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Produkte und Projekte Pharmathek

Herbal extract

Essential oil

Women Tabs Kürbis Filmtablette 152 mg

Pumpkin coated tablet

Peppermint oil Spasmovent® capsule Pfefferminzöl(gastroresistant) Kapsel 182 mg (magensaftresistent)

AGON Produkte und Projekte20162208.xlsx

Cucurbitae semen

Francais Courge ou Citrouille

Final

Traditional herbal medicinal product for the relief of lowerurinary tract symptoms related to a overactive bladder 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

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

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

WEU eCTD Dossier

22.08.2016 15 von 18

Produkte und Projekte Pharmathek

Essential oil Pfefferminz Gel 10 % Spray

Essential oil

Pfefferminz medizinischer Schaum10 % Spray

Peppermint Gel 10 % Spray

Mentha piperita

Français: Menthe poivrée

Final

Herbal medicinal product for the symptomatic relief of mild tension type headache

Formulation development

Peppermint Medical foam 10 % Spray

Mentha piperita

Français: Menthe poivrée

Final

Herbal medicinal product for the symptomatic relief of mild tension type headache

Formulation development

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Produkte und Projekte Pharmathek

Essential oil Pfefferminz Gel 10 %

Peppermint Gel 10 %

Mentha piperita

Français: Menthe poivrée

Final

Herbal medicinal product for the symptomatic relief of mild tension type headache

Formulation development

Draft

Traditional herbal medicinal product for the symptomatic relief of digestive disorders such as bloating and flatulence

Formulation development

Supportive Treatment of respiratory tract infections, e.g. bronchitis or sinusitis

Formulation development finished Stability running

Essential oil

Kümmelöl Kapsel 137 mg

Caraway Oil capsule

Carum carvi aetherolum

Français: Huile essentielle de Carvi

Essential oil

Nesthäkchen® Cineol Kapseln 100 mg (magensaftresistent)

Cineol capsules 100 mg (gastroresistant)

Cineol

Francais : Cineéole

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Produkte und Projekte Pharmathek

Supportive Treatment of respiratory tract infections, e.g. bronchitis or sinusitis

Formulation development finished Stability running

Omeprazole

Allergic Dermatitis, Neurodermitis,

under development EU Patent granted US Patent pending

Omeprazole ointmentVeterinary Drug

Omeprazole

Horses Summer Eczema

under development EU Patent granted US Patent pending

Flurbiprofen Flurbiprofen Oral Lutschpastille 8,75 Gum mg

Flurbiprofen

Short time symptomatic treatment of sore throat.

Formulation development

Essential oil

Neofloral® Cineol Kapseln 200 mg (magensaftresistent)

Cineol capsules 200 mg (gastroresistant)

Cineol

Synthetic active

Omeprazol Creme

Omeprazole ointment

Synthetic active

Omeprazol Creme Tierarzneimittel

Synthetic active

AGON Produkte und Projekte20162208.xlsx

Francais : Cineéole

AGON Pharma GmbH Stuttgarter Straße 2 D-73240 Wendlingen Germany [email protected]

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