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Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ribavirin Teva Pharma BV   
Auth. number : EU/1/09/527
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: Ribavirin Teva Pharma B.V. is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age or older and adolescents and must only be used as part of a combination regimen with interferon alfa 2b. 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).

Naïve patients
Adult patients: Ribavirin Teva Pharma B.V. 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 hepatitis C viral ribonucleic acid HCV RNA (see section 4.4).

Children 3 years of age and older and adolescents: Ribavirin Teva Pharma B.V. is intended for use, 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 HCV RNA.
When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain.
The decision to treat should be made on a case by case basis (see section 4.4).

Previous treatment failure patients
Adult patients: Ribavirin Teva Pharma B.V. 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: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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 continues to be 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
03/07/2009 Centralised - Authorisation EMEA/H/C/1064 (2009)5426 of 01/07/2009
21/10/2009 Centralised - Variation EMEA/H/C/1064/II/1 (2009)8269 of 19/10/2009
22/10/2009 Centralised - Variation EMEA/H/C/1064/IA/2
13/01/2010 Centralised - Variation EMEA/H/C/1064/IA/3
31/07/2010 Centralised - Variation EMEA/H/C/1064/WS/4 (2010)5330 of 27/07/2010
05/10/2010 Centralised - Variation EMEA/H/C/1064/IB/4
24/02/2011 Centralised - Variation EMEA/H/C/1064/WS/81 (2011)1204 of 21/02/2011
21/11/2012 Centralised - Variation EMEA/H/C/1064/IB/8/G
Updated with Decision(2014)324 of 16/01/2014
11/12/2012 Referral EMEA/H/C/1064/A-20/7 (2012)9389 of 06/12/2012
19/07/2013 Centralised - Lift of suspension EMEA/H/C/1064/II/10 (2013)4698 of 17/07/2013
26/07/2013 Centralised - Variation EMEA/H/C/1064/IAin/11/G
Updated with Decision(2014)324 of 16/01/2014
22/01/2014 Centralised - Renewal EMEA/H/C/1064/R/12 (2014)324 of 16/01/2014
11/03/2014 Centralised - Variation EMEA/H/C/1064/IB/14