Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Epivir   
Auth. number : EU/1/96/015
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: Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Marketing Authorisation Holder: ViiV Healthcare UK Limited
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
25/05/1996 Other procedure - Archives
09/08/1996 Centralised - Authorisation EMEA/H/C/107 (96)2379 of 08/08/1996
30/10/1996 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/1
30/10/1996 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/2
17/02/1997 Centralised - Variation EMEA/H/C/107/I/3 (97)449 of 14/02/1997
28/02/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/1/8
28/02/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/1/9
28/02/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/1/7
28/02/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/6
17/04/1997 Centralised - Variation EMEA/H/C/107/II/4 (97)1079 of 15/04/1997
23/05/1997 Centralised - Variation EMEA/H/C/107/II/5 (97)1425 of 22/05/1997
17/12/1997 Centralised - Variation EMEA/H/C/107/II/10, 12, 13 (97)4161 of 16/12/1997
08/01/1998 Centralised - Annual reassessment EMEA/H/C/107/S/11 (97)4311 of 07/01/1998
08/07/1998 Centralised - Variation EMEA/H/C/107/II/14, 15 (1998)1864 of 07/07/1998
08/07/1998 Centralised - Variation EMEA/H/C/107/I/16 (1998)1853 of 07/07/1998
25/10/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/19
10/11/1999 Centralised - Variation EMEA/H/C/107/II/18 (1999)3703 of 10/11/1999
07/08/2000 Centralised - Variation EMEA/H/C/107/I/20 (2000)2314 of 27/07/2000
23/01/2001 Centralised - Variation EMEA/H/C/107/II/21 (2001)47 of 22/01/2001
12/07/2001 Centralised - Variation EMEA/H/C/107/II/22 (2001)1999 of 11/07/2001
15/11/2001 Centralised - Renewal EMEA/H/C/107/R/24 (2001)3518 of 09/11/2001
16/11/2001 Centralised - Variation EMEA/H/C/107/X/23 (2001)3540 of 15/11/2001
15/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/26
23/08/2002 Centralised - Variation EMEA/H/C/107/II/25 (2002)3166 of 21/08/2002
24/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/29
24/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/27
21/10/2002 Centralised - Variation EMEA/H/C/107/I/28 (2002)4053 of 17/10/2002
14/11/2002 Centralised - Variation EMEA/H/C/107/I/30 (2002)4500 of 12/11/2002
25/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/31
16/05/2003 Centralised - Variation EMEA/H/C/107/II/32 (2003)1666 of 14/05/2003
15/07/2003 Centralised - Variation EMEA/H/C/107/II/33, 34 (2003)2536 of 09/07/2003
19/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/I/36
19/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/39
03/02/2004 Centralised - Variation EMEA/H/C/107/II/37 (2004)290 of 29/01/2004
10/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IB/40
02/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/42
07/06/2004 Centralised - Variation EMEA/H/C/107/II/41 (2004)2016 of 01/06/2004
02/08/2004 Centralised - Variation EMEA/H/C/107/IA/43
Updated with Decision(2004)4844 of 06/12/2004
07/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/46
08/12/2004 Centralised - Variation EMEA/H/C/107/II/44, 45 (2004)4844 of 06/12/2004
22/12/2004 Centralised - Variation EMEA/H/C/107/II/47 (2004)5383 of 17/12/2004
12/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/50
09/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IB/49
10/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IB/48
11/01/2006 Centralised - Variation EMEA/H/C/107/IA/51
Updated with Decision(2006)3528 of 28/07/2006
11/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/53
27/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/55
02/08/2006 Centralised - Renewal EMEA/H/C/107/R/52 (2006)3528 of 28/07/2006
02/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/56
08/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IB/54
16/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/59
16/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/57
20/10/2006 Centralised - Variation EMEA/H/C/107/IA/58
Updated with Decision(2007)268 of 25/01/2007
29/01/2007 Centralised - Variation EMEA/H/C/107/II/60 (2007)268 of 25/01/2007
20/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/62
05/03/2007 Centralised - Variation EMEA/H/C/107/II/61 (2007)758 of 01/03/2007
06/09/2007 Centralised - Variation EMEA/H/C/107/II/64 (2007)4194 of 31/08/2007
01/11/2007 Centralised - Variation EMEA/H/C/107/II/63 (2007)5390 of 30/10/2007
29/11/2007 Centralised - Variation EMEA/H/C/107/IA/66
Updated with Decision(2008)3440 of 02/07/2008
29/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/65
28/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/II/67
22/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/68
03/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/107/IA/70
04/07/2008 Centralised - Variation (2008)3440 of 02/07/2008
09/09/2008 Centralised - Variation EMEA/H/C/107/II/69 (2008)5015 of 05/09/2008
30/10/2009 Centralised - Variation EMEA/H/C/107/II/71 (2009)8506 of 28/10/2009
04/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/107/T/72 (2010)2946 of 29/04/2010
03/08/2010 Centralised - Notification EMEA/H/C/107/N/73
Updated with Decision(2010)7528 of 25/10/2010
27/10/2010 Centralised - Variation EMEA/H/C/107/II/74 (2010)7528 of 25/10/2010
14/04/2011 Centralised - Variation EMEA/H/C/107/IA/76
Updated with Decision(2012)4214 of 15/06/2012
29/11/2011 Centralised - Variation EMEA/H/C/107/IAin/77
Updated with Decision(2012)4214 of 15/06/2012
20/06/2012 Centralised - Variation (2012)4214 of 15/06/2012
27/07/2012 Centralised - Variation EMEA/H/C/107/WS/163 (2012)5353 of 23/07/2012
28/03/2013 Centralised - 2-Monthly update EMEA/H/C/107/WS/338 (2013)1904 of 26/03/2013
03/06/2013 Centralised - Variation EMEA/H/C/107/WS/361 (2013)3377 of 30/05/2013
03/12/2013 Centralised - Notification EMEA/H/C/107/N/82
25/04/2014 Centralised - Variation EMEA/H/C/107/WS/544
23/10/2014 Centralised - Variation EMEA/H/C/107/II/84