Table of contents
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.
Cystadrops : EPAR - Summary for the public (PDF/96.91 KB)
First published: 22/02/2017
Last updated: 22/02/2017
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|International non-proprietary name (INN) or common name||
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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.
Recordati Rare Diseases
|Date of issue of marketing authorisation valid throughout the European Union||
Immeuble le Wilson
15/09/2021 Cystadrops - EMEA/H/C/003769 - R/0022
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.