Cystadrops

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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 30/11/2018

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
Orphan

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
Orphan Europe S.A.R.L.
Revision
3
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
FR-92800 Puteaux
France

Product information

07/11/2018 Cystadrops - EMEA/H/C/003769 - N/0009

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

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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