Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Cotronak
Auth. number : EU/1/99/106
INN : ribavirin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AB - Nucleosides
Chemical substance: J05AB04 - Ribavirin
(See WHO ATC Index)
Indication: Treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naïve patients with clinically stable HIV co-infection. The best way to use PegIntron in this indication is in combination with ribavirin.
Marketing Authorisation Holder: Schering-Plough Europe
Rue de Stalle, 73, 1180 Bruxelles, Belgique / Stallestraat, 73, 1180 Brussel/Bruxelles, Belgique/België

  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
17/05/1999 Centralised - Authorisation EMEA/H/C/247 (1999)1271 of 07/05/1999
07/08/2000 Centralised - Variation EMEA/H/C/247/II/3 (2000)2324 of 27/07/2000
28/03/2001 Centralised - Variation EMEA/H/C/247/II/5 (2001)793 of 26/03/2001
09/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/247/I/7
26/06/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/247/II/6
07/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/247/II/9
16/04/2002 Centralised - Variation EMEA/H/C/247/II/8 (2002)1491 of 12/04/2002
15/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/247/I/11, 12
29/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/247/II/14
07/10/2003 Centralised - Variation EMEA/H/C/246/II/10 (2003)3615 of 03/10/2003
16/12/2003 Centralised - Notification EMEA/H/C/247/N/16 (2003)5020 of 12/12/2003
10/03/2004 Centralised - Withdrawal (2004)813 of 08/03/2004