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
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Orphan Europe S.A.R.L.
|Date of issue of marketing authorisation valid throughout the European Union||
24/07/2018 Cystadane - EMEA/H/C/000678 - N/0031
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.