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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Zeffix
|
| Auth. number : | EU/1/99/114 |
| INN : | Lamivudine |
| 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 J05AF05 - Lamivudine (See WHO ATC Index) |
| Indication: | Zeffix is indicated for the treatment of chronic hepatitis B in adults with: - compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and/or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate. - decompensated liver disease in combination with a second agent without cross-resistance to lamivudine. |
| Marketing Authorisation Holder: | Glaxo Group Ltd
Greenford Road, Greenford, Middlesex UB6 0NN, 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 |
| 05/08/1999 | Centralised - Authorisation | EMEA/H/C/242 | (1999)2503 of 29/07/1999 | |||
| 25/04/2001 | Centralised - Variation | EMEA/H/C/242/II/2 | (2001)852 of 23/04/2001 | |||
| 04/04/2002 | Centralised - Variation | EMEA/H/C/242/II/4 | (2002)1376 of 02/04/2002 | |||
| 17/05/2002 | Centralised - Variation | EMEA/H/C/242/I/5 | ||||
| 10/09/2002 | Centralised - Variation | EMEA/H/C/242/I/8 | (2002)3374 of 09/09/2002 | |||
| 23/12/2002 | Centralised - Variation | EMEA/H/C/242/II/6 | (2002)5503 of 19/12/2002 | |||
| 19/02/2003 | Centralised - Variation | EMEA/H/C/242/N/12 | (2003)611 of 17/02/2003 | |||
| 19/08/2003 | Centralised - Variation | EMEA/H/C/242/I/14 | ||||
| 20/01/2004 | Centralised - Variation | EMEA/H/C/242/II/15 | (2004)138 of 20/01/2004 | |||
| 02/03/2004 | Centralised - Variation | EMEA/H/C/242/IA/23 | ||||
| 28/06/2004 | Centralised - Variation | EMEA/H/C/242/N/25 | ||||
| Updated with Decision(2004)4185 of 20/10/2004 | ||||||
| 07/09/2004 | Centralised - Variation | EMEA/H/C/242/IA/26 | ||||
| 22/10/2004 | Centralised - Renewal | EMEA/H/C/242/R/24 | (2004)4185 of 20/10/2004 | |||
| 31/03/2005 | Centralised - Variation | EMEA/H/C/242/II/27 | (2005)1068 of 29/03/2005 | |||
| 27/04/2005 | Centralised - Variation | EMEA/H/C/242/II/28, 29 | (2005)1344 of 25/04/2005 | |||
| 18/01/2006 | Centralised - Variation | EMEA/H/C/242/IA/32 | ||||
| 15/02/2006 | Centralised - Variation | EMEA/H/C/242/IB/30 | ||||
| 15/02/2006 | Centralised - Variation | EMEA/H/C/242/IB/31 | ||||
| 31/03/2006 | Centralised - Variation | EMEA/H/C/242/IA/33 | ||||
| 31/03/2006 | Centralised - Variation | EMEA/H/C/242/IA/34 | ||||
| Updated with Decision(2006)3140 of 04/07/2006 | ||||||
| 03/04/2006 | Centralised - Variation | EMEA/H/C/242/IA/36 | ||||
| 06/07/2006 | Centralised - Variation | EMEA/H/C/242/II/35 | (2006)3140 of 04/07/2006 | |||
| 11/07/2006 | Centralised - Variation | EMEA/H/C/242/IA/37 | ||||
| 27/07/2006 | Centralised - Variation | EMEA/H/C/242/IA/39 | ||||
| 08/08/2006 | Centralised - Variation | EMEA/H/C/242/IB/38 | ||||
| 13/11/2006 | Centralised - Variation | EMEA/H/C/242/IA/41 | ||||
| 20/02/2007 | Centralised - Variation | EMEA/H/C/242/IA/42 | ||||
| 01/03/2007 | Centralised - Variation | EMEA/H/C/242/II/40 | (2007)717 of 27/02/2007 | |||
| 18/12/2007 | Centralised - Variation | EMEA/H/C/242/IA/43 | ||||
| Updated with Decision(2008)4099 of 25/07/2008 | ||||||
| 18/12/2007 | Centralised - Variation | EMEA/H/C/242/IA/44 | ||||
| Updated with Decision(2008)4099 of 25/07/2008 | ||||||
| 28/01/2008 | Centralised - Variation | EMEA/H/C/242/II/45 | ||||
| 29/07/2008 | Centralised - Variation | - | (2008)4099 of 25/07/2008 | |||
| 01/09/2009 | Centralised - Renewal | EMEA/H/C/242/R/46 | (2009)6713 of 27/08/2009 | |||
| 08/07/2010 | Centralised - Variation | EMEA/H/C/242/II/47 | (2010)4720 of 02/07/2010 | |||
| 01/12/2010 | Centralised - Variation | EMEA/H/C/242/II/49 | (2010)8543 of 26/11/2010 | |||
| 27/04/2011 | Centralised - Variation | EMEA/H/C/242/IA/50 | ||||
| Updated with Decision(2011)9434 of 09/12/2011 | ||||||
| 24/11/2011 | Centralised - Variation | EMEA/H/C/242/IA/51 | ||||
| Updated with Decision(2012)4502 of 27/06/2012 | ||||||
| 13/12/2011 | Centralised - Variation | - | (2011)9434 of 09/12/2011 | |||
| 02/07/2012 | Centralised - Variation | - | (2012)4502 of 27/06/2012 | |||
| 14/12/2012 | Centralised - Variation | EMEA/H/C/242/N/52 | ||||
| 17/01/2013 | Centralised - Variation | EMEA/H/C/242/II/53 | ||||