Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Cystadane   
Auth. number : EU/1/06/379
Active substance : Betaine anhydrous
Orphan market exclusivity for "Treatment of homocystinuria" (based on designation EU/3/01/045) started on 19/02/2007
   10 years of market exclusivity
   This orphan market exclusivity has ended on 19/02/2017
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AA - Amino acids and derivatives
Chemical substance: A16AA06 - Betaine
(See WHO ATC Index)
Indication: 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.
Marketing Authorisation Holder: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/02/2007 Centralised - Authorisation EMEA/H/C/678 (2007)541 of 15/02/2007
25/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/678/IA/1
09/10/2007 Centralised - Variation EMEA/H/C/678/IA/2
Updated with Decision(2008)2026 of 20/05/2008
26/11/2007 Centralised - Variation EMEA/H/C/678/IB/3
Updated with Decision(2008)2026 of 20/05/2008
22/05/2008 Centralised - Variation (2008)2026 of 20/05/2008
31/07/2008 Centralised - Variation EMEA/H/C/678/IB/4
Updated with Decision(2009)1652 of 04/03/2009
06/03/2009 Centralised - Variation (2009)1652 of 04/03/2009
04/03/2011 Centralised - Notification EMEA/H/C/678/N/5
Updated with Decision(2012)1039 of 13/02/2012
27/09/2011 Centralised - Variation EMEA/H/C/678/IG/111
Updated with Decision(2012)1039 of 13/02/2012
15/02/2012 Centralised - Renewal EMEA/H/C/678/R/6 (2012)1039 of 13/02/2012
12/09/2012 Centralised - Notification EMEA/H/C/678/N/9
Updated with Decision(2014)786 of 06/02/2014
21/02/2013 Centralised - Variation EMEA/H/C/678/II/8
Updated with Decision(2014)786 of 06/02/2014
19/12/2013 Centralised - Variation EMEA/H/C/678/IG/392
Updated with Decision(2014)786 of 06/02/2014
10/02/2014 Centralised - Yearly update (2014)786 of 06/02/2014
23/11/2015 PSUSA - Modification EMEA/H/C/678/PSUSA/390/201502 (2015)8278 of 19/11/2015
23/11/2016 Centralised - Renewal EMEA/H/C/678/R/24 (2016)7686 of 21/11/2016
12/12/2016 PSUSA - Modification EMEA/H/C/678/PSUSA/390/201602 (2016) 8512 of 08/12/2016
14/02/2017 Centralised - Variation EMEA/H/C/678/IG/773/G
19/02/2017 Centralised - (orphan status)