Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ribavirin Mylan   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Ribavirine Mylan (NL)
Auth. number : EU/1/10/634
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 chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (3 years of age and older) and adolescents)
Marketing Authorisation Holder: Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

  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
14/06/2010 Centralised - Authorisation EMEA/H/C/1185 (2010)3879 of 10/06/2010
03/01/2011 Centralised - Variation EMEA/H/C/1185/IB/2
Updated with Decision(2011)564 of 27/01/2011
03/01/2011 Centralised - Variation EMEA/H/C/1185/IA/3
Updated with Decision(2011)564 of 27/01/2011
03/01/2011 Centralised - Variation EMEA/H/C/1185/IB/1
Updated with Decision(2011)564 of 27/01/2011
23/02/2011 Corrigendum (2011)564 of 21/02/2011
23/02/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1185/T/4 (2011)564 of 27/01/2011
14/03/2011 Centralised - Variation EMEA/H/C/1185/N/5
Updated with Decision(2012)7893 of 29/10/2012
20/08/2012 Centralised - Variation EMEA/H/C/1185/IB/9/G
Updated with Decision(2012)7893 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7893 of 29/10/2012
11/01/2013 Centralised - Variation EMEA/H/C/1185/IB/12/G
Updated with Decision(2013)9718 of 18/12/2013
01/08/2013 Centralised - Variation EMEA/H/C/1185/IB/14
Updated with Decision(2013)9718 of 18/12/2013
20/12/2013 Centralised - Variation (2013)9718 of 18/12/2013
11/03/2014 Centralised - Variation EMEA/H/C/1185/IB/17
12/03/2014 Centralised - Variation EMEA/H/C/1185/IA/16
30/04/2014 Centralised - Modification EMEA/H/C/1185/PSU/10007 (2014)2928 of 28/04/2014