Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zeffix   
Auth. number : EU/1/99/114
INN : Lamivudine
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: J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
Chemical substance: 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
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

  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 is 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
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
20/05/2001 Centralised - Annual reassessment EMEA/H/C/242/S/3 (2001)1241 of 18/05/2001
04/04/2002 Centralised - Variation EMEA/H/C/242/II/4 (2002)1376 of 02/04/2002
17/05/2002 Centralised - Variation (no change in Commission Decision) 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 - Notification EMEA/H/C/242/N/12 (2003)611 of 17/02/2003
19/08/2003 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/242/IA/23
28/06/2004 Centralised - Notification EMEA/H/C/242/N/25
Updated with Decision(2004)4185 of 20/10/2004
07/09/2004 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/242/IA/32
15/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/242/IB/31
15/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/242/IB/30
31/03/2006 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/242/IA/37
27/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/242/IA/39
08/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/242/IB/38
13/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/242/IA/41
20/02/2007 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 - Notification EMEA/H/C/242/N/52
Updated with Decision(2014)137 of 10/01/2014
17/01/2013 Centralised - Variation EMEA/H/C/242/II/53
Updated with Decision(2014)137 of 10/01/2014
18/04/2013 Centralised - Variation EMEA/H/C/242/IG/279
Updated with Decision(2014)137 of 10/01/2014
04/10/2013 Centralised - Notification EMEA/H/C/242/N/61
Updated with Decision(2014)137 of 10/01/2014
14/01/2014 Centralised - Yearly update (2014)137 of 10/01/2014
25/06/2014 Centralised - Renewal EMEA/H/C/242/R/62 (2014)4356 of 23/06/2014