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Community Register of medicinal products
Community list of not active medicinal products for human use |
SUSPENDED |
Product information |
| Invented name: | Ribavirin Teva
|
| Auth. number : | EU/1/09/509 |
| INN : | Ribavirin |
| ATC: | J - General antiinfectives for systemic use J05 - Antivirals for systemic use J05A - Agents affecting the virus directly J05AB - Nucleosides 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 or older), and adolescents). Ribavirin monotherapy must not be used. |
| Marketing Authorisation Holder: | Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland |
EPAR and active package presentations
Package presentations
|
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. |
European Commission procedures
| 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 | |||
| 20/05/2009 | Corrigendum | - | ||||
| 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 | |||
| 26/11/2012 | 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 |