Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70, Avenue du Général de Gaulle, 92800 Puteaux, France
Cystadrops 3.8 mg/mL eye drops solution.
| Pharmaceutical Form |
|---|
|
Eye drops solution. Viscous, clear solution. |
Each mL contains mercaptamine hydrochloride equivalent to 3.8 mg mercaptamine (cysteamine).
Excipient with known effect:
Each mL of eye drops solution contains 0.1 mg of benzalkonium chloride.
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 |
|---|
|
Benzalkonium chloride |
5 mL solution in a 10 mL amber glass vial closed by a bromobutyl stopper and sealed with an aluminium tear-off cap. A PVC dropper applicator with HDPE closure is packed separately and included in each carton box.
Each carton box contains 1 vial and 1 dropper applicator.
Pack of 1 carton box or multipack containing 4 carton boxes.
Not all pack sizes may be marketed.
Recordati Rare Diseases, Immeuble “Le Wilson”, 70, Avenue du Général de Gaulle, 92800 Puteaux, France
EU/1/15/1049/001
EU/1/15/1049/002
Date of first authorisation: 19 January 2017
| Drug | Countries | |
|---|---|---|
| CYSTADROPS | Austria, Canada, Estonia, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom, United States |
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