Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ribavirin Mylan   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Ribavirine Mylan (NL)
Auth. number : EU/1/10/634
Active substance : 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: Ribavirin Mylan is indicated for the 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). Ribavirin monotherapy must not be used.

There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e., not alfa-2b).
Please refer also to the interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.

Naïve patients
Adult Patients(18 years of age or older): Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA

Paediatric patients (children 3 years of age and older and adolescents): Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy can induce a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case by case basis.

Previously treatment failure patients
Adult patients: Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
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 - Notification 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 - Yearly update (2013)9718 of 18/12/2013
11/03/2014 Centralised - Variation EMEA/H/C/1185/IB/17
Updated with Decision(2015)873 of 11/02/2015
12/03/2014 Centralised - Variation EMEA/H/C/1185/IA/16
Updated with Decision(2015)873 of 11/02/2015
30/04/2014 PSUSA - Modification EMEA/H/C/1185/PSU/10007 (2014)2928 of 28/04/2014
21/08/2014 Centralised - Variation EMEA/H/C/1185/IB/19
Updated with Decision(2015)873 of 11/02/2015
13/02/2015 Centralised - Renewal EMEA/H/C/1185/R/21 (2015)873 of 11/02/2015
04/08/2016 Centralised - 2-Monthly update EMEA/H/C/1185/IB/25 (2016)5084 of 29/07/2016