Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cystagon   
Auth. number : EU/1/97/039
INN : Mercaptamine bitartrate
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: A16AA04 - Mercaptamine
(See WHO ATC Index)
Indication: CYSTAGON is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Marketing Authorisation Holder: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-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
24/06/1997 Centralised - Authorisation EMEA/H/C/125 (97)1850 of 23/06/1997
04/03/1998 Centralised - Notification EMEA/H/C/125/N/3 (1998)541 of 03/03/1998
21/04/1999 Centralised - Annual reassessment EMEA/H/C/125/S/5 (1999)1003 of 19/04/1999
09/07/1999 Centralised - Variation EMEA/H/C/125/I/6 (1999)1902 of 01/07/1999
01/03/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/I/12
22/03/2000 Centralised - Variation EMEA/H/C/125/II/10 (2000)721 of 16/03/2000
22/03/2000 Centralised - Annual reassessment EMEA/H/C/125/S/11 (2000)719 of 16/03/2000
27/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/I/13
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/I/16
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/I/15
04/12/2000 Centralised - Variation EMEA/H/C/125/I/14 (2000)3400 of 29/11/2000
30/01/2001 Centralised - Annual reassessment EMEA/H/C/125/S/17 (2001)99 of 29/01/2001
06/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/I/19
07/05/2001 Centralised - Variation EMEA/H/C/125/II/18 (2001)917 of 03/05/2001
31/01/2002 Centralised - Annual reassessment EMEA/H/C/125/S/20 (2002)409 of 28/01/2002
14/10/2002 Centralised - Renewal EMEA/H/C/125/R/21 (2002)3917 of 10/10/2002
17/07/2003 Centralised - Variation EMEA/H/C/125/II/22 (2003)2643 of 15/07/2003
23/12/2003 Centralised - Variation EMEA/H/C/125/IA/24
Updated with Decision(2004)3261 of 18/08/2004
13/01/2004 Centralised - Annual reassessment EMEA/H/C/125/S/23 (2004)57 of 09/01/2004
23/08/2004 Centralised - Variation (2004)3261 of 18/08/2004
30/09/2004 Centralised - Annual reassessment EMEA/H/C/125/S/25
11/07/2005 Centralised - Variation EMEA/H/C/125/II/26 (2005)2695 of 07/07/2005
05/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/IA/30
11/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/IA/32
15/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/IA/33
16/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/IA/35
19/04/2007 Centralised - Annual reassessment EMEA/H/C/125/S/28 (2007)1799 of 17/04/2007
25/06/2007 Centralised - Renewal EMEA/H/C/125/R/34 (2007)3144 of 21/06/2007
12/09/2007 Centralised - Variation EMEA/H/C/125/IA/36
Updated with Decision(2008)1758 of 25/04/2008
12/10/2007 Centralised - Variation EMEA/H/C/125/IA/37
Updated with Decision(2008)1758 of 25/04/2008
29/04/2008 Centralised - Variation (2008)1758 of 25/04/2008
08/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/125/IB/39
12/04/2012 Centralised - Notification EMEA/H/C/125/N/41
Updated with Decision(2013)5928 of 12/09/2013
17/08/2012 Centralised - Notification EMEA/H/C/125/N/42
Updated with Decision(2013)5928 of 12/09/2013
16/09/2013 Centralised - Modification EMEA/H/C/125/PSUV/43 (2013)5928 of 12/09/2013
19/12/2013 Centralised - Variation EMEA/H/C/125/IG/392