This is a summary of the European public assessment report (EPAR) for Cystadane. 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 Cystadane.
For practical information about using Cystadane, patients should read the package leaflet or contact their doctor or pharmacist.
Cystadane : EPAR - Summary for the public (PDF/75.42 KB)
First published: 05/03/2007
Last updated: 06/01/2017
Cystadene : EPAR - Risk management plan summary (PDF/96.31 KB)
First published: 23/09/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Recordati Rare Diseases
|Date of issue of marketing authorisation valid throughout the European Union||
Immeuble le Wilson
19/07/2021 Cystadane - EMEA/H/C/000678 - IB-38
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.
Other alimentary tract and metabolism products
Adjunctive treatment of homocystinuria, involving deficiencies or defects in:
- cystathionine beta-synthase (CBS);
- 5,10-methylene-tetrahydrofolate reductase (MTHFR);
- cobalamin cofactor metabolism (cbl).
Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.