CYSTAGON Hard capsule Ref.[113968] Active ingredients: Mercaptamine

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Recordati Rare Diseases, Tour Hekla, 52, avenue du Général de Gaulle, F-92800 Puteaux, France

Product name and form

CYSTAGON 50 mg hard capsules.

Pharmaceutical Form

Hard capsule.

White, opaque hard capsules with CYSTA 50 on the body and RECORDATI RARE DISEASES on the cap.

Qualitative and quantitative composition

Each hard capsule contains 50 mg of cysteamine (as mercaptamine bitartrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mercaptamine

Mercaptamine reduces corneal cystine crystal accumulation acting as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides.

List of Excipients

Capsule content:

Microcrystalline cellulose
Pregelatinized starch
Magnesium stearate/sodium lauryl sulfate
Colloidal silicon dioxide
Croscarmellose sodium

Capsule shell:

Gelatin
Titanium dioxide
Black ink on hard capsules containing E172

Pack sizes and marketing

HDPE bottles of 100 and 500 hard capsules. A desiccant unit containing black activated carbon and silica gel granules is included in the bottle.

Not all pack sizes may be marketed.

Marketing authorization holder

Recordati Rare Diseases, Tour Hekla, 52, avenue du Général de Gaulle, F-92800 Puteaux, France

Marketing authorization dates and numbers

EU/1/97/039/001 (100 hard capsules per bottle)
EU/1/97/039/002 (500 hard capsules per bottle)

Date of first authorisation: 23 June 1997
Date of latest renewal: 23 June 2007

Drugs

Drug Countries
CYSTAGON Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom, United States

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