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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Sebivo
|
| Auth. number : | EU/1/07/388 |
| INN : | telbivudine |
| ATC: | J - General antiinfectives for systemic use J05 - Antivirals for systemic use J05A - Agents affecting the virus directly J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors J05AF11 - Telbivudine (See WHO ATC Index) |
| Indication: | Treatment of chronic hepatitis B in adult patients. |
| Marketing Authorisation Holder: | Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
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 |
| 26/04/2007 | Centralised - Authorisation | EMEA/H/C/713 | (2007)1890 of 24/04/2007 | |||
| 29/05/2007 | Centralised - Variation | EMEA/H/C/713/IA/2 | ||||
| 26/06/2007 | Centralised - Variation | EMEA/H/C/713/IB/1 | ||||
| Updated with Decision(2008)532 of 06/02/2008 | ||||||
| 08/02/2008 | Centralised - Variation | - | (2008)532 of 06/02/2008 | |||
| 03/03/2008 | Centralised - Variation | EMEA/H/C/713/II/3 | (2008)841 of 28/02/2008 | |||
| 31/10/2008 | Centralised - Variation | EMEA/H/C/713/II/5 | (2008)6652 of 31/10/2008 | |||
| 22/01/2009 | Centralised - Variation | EMEA/H/C/713/X/4 | (2009)421 of 20/01/2009 | |||
| 20/03/2009 | Centralised - Variation | EMEA/H/C/713/IA/7 | ||||
| Updated with Decision(2009)6903 of 07/09/2009 | ||||||
| 09/09/2009 | Centralised - Variation | EMEA/H/C/713/II/6 | (2009)6903 of 07/09/2009 | |||
| 02/11/2009 | Centralised - Variation | EMEA/H/C/713/II/8 | (2009)8575 of 29/10/2009 | |||
| 27/01/2010 | Centralised - Variation | EMEA/H/C/713/II/9 | (2010)528 of 25/01/2010 | |||
| 11/03/2010 | Centralised - Variation | EMEA/H/C/713/IB/12 | ||||
| 17/03/2010 | Centralised - Variation | EMEA/H/C/713/II/10 | (2010)1763 of 15/03/2010 | |||
| 17/03/2010 | Centralised - Variation | EMEA/H/C/713/II/11 | (2010)1834 of 15/03/2010 | |||
| 22/06/2010 | Centralised - Variation | EMEA/H/C/713/IB/14/G | ||||
| Updated with Decision(2010)8644 of 29/11/2010 | ||||||
| 08/07/2010 | Centralised - Variation | EMEA/H/C/713/IA/16/G | ||||
| 13/07/2010 | Centralised - Variation | EMEA/H/C/713/IB/15 | ||||
| Updated with Decision(2010)8644 of 29/11/2010 | ||||||
| 26/07/2010 | Centralised - Variation | EMEA/H/C/713/IB/17 | ||||
| 21/10/2010 | Centralised - Variation | EMEA/H/C/713/IB/19 | ||||
| Updated with Decision(2010)8644 of 29/11/2010 | ||||||
| 06/12/2010 | Centralised - Variation | EMEA/H/C/713/II/13 | (2010)8644 of 29/11/2010 | |||
| 13/01/2011 | Centralised - Variation | EMEA/H/C/713/IG/32 | ||||
| 31/01/2011 | Centralised - Variation | EMEA/H/C/713/II/20/G | ||||
| 01/02/2011 | Centralised - Variation | EMEA/H/C/713/II/18 | (2011)572 of 27/01/2011 | |||
| 19/05/2011 | Centralised - Variation | EMEA/H/C/713/IG/65 | ||||
| 09/06/2011 | Centralised - Variation | EMEA/H/C/713/IA/21/G | ||||
| Updated with Decision(2011)6233 of 26/08/2011 | ||||||
| 06/07/2011 | Centralised - Variation | EMEA/H/C/713/IA/22/G | ||||
| Updated with Decision(2011)6233 of 26/08/2011 | ||||||
| 31/08/2011 | Centralised - Variation | - | (2011)6233 of 26/08/2011 | |||
| 26/04/2012 | Centralised - Renewal | EMEA/H/C/713/R/23 | (2012)2852 of 20/04/2012 |