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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Ribavirin Teva|
|Auth. number :||EU/1/09/509|
|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 is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and 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).
Adult patients: Ribavirin Teva 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 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 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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|02/04/2009||Centralised - Authorisation||EMEA/H/C/1018||(2009)2609 of 31/03/2009|
|03/08/2009||Centralised - Variation||EMEA/H/C/1018/N/2|
|Updated with Decision(2009)7137 of 17/09/2009|
|21/09/2009||Centralised - Variation||EMEA/H/C/1018/II/1||(2009)7137 of 17/09/2009|
|18/01/2010||Centralised - Variation||EMEA/H/C/1018/IA/3|
|18/02/2010||Centralised - Variation||EMEA/H/C/1018/IA/4|
|18/02/2010||Centralised - Variation||EMEA/H/C/1018/IA/5|
|30/07/2010||Centralised - Variation||EMEA/H/C/1018/WS/4||(2010)5329 of 27/07/2010|
|24/02/2011||Centralised - Variation||EMEA/H/C/1018/WS/81||(2011)1205 of 21/02/2011|
|21/11/2012||Centralised - Variation||EMEA/H/C/1018/IB/9/G|
|11/12/2012||Referral||EMEA/H/C/1018/A-20/8||(2012)9387 of 06/12/2012|
|19/07/2013||Centralised - Lift of suspension||EMEA/H/C/1018/II/11||(2013)4697 of 17/07/2013|
|26/07/2013||Centralised - Variation||EMEA/H/C/1018/IAin/12/G|