Cystadrops

RSS

mercaptamine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Cystadrops. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cystadrops.

For practical information about using Cystadrops, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/09/2021

Authorisation details

Product details
Name
Cystadrops
Agency product number
EMEA/H/C/003769
Active substance
mercaptamine hydrochloride
International non-proprietary name (INN) or common name
mercaptamine
Therapeutic area (MeSH)
Cystinosis
Anatomical therapeutic chemical (ATC) code
S01XA21
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Recordati Rare Diseases
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
18/01/2017
Contact address

Immeuble le Wilson
70, avenue du Général de Gaulle
92800 Puteaux
France

Product information

15/09/2021 Cystadrops - EMEA/H/C/003769 - R/0022

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.

Assessment history

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