Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Hepsera   
Auth. number : EU/1/03/251
INN : adefovir dipivoxil
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: J05AF08 - Adefovir dipivoxil
(See WHO ATC Index)
Indication: Hepsera 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 fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1).

• decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.
Marketing Authorisation Holder: Gilead Sciences International Limited
Cambridge CB21 6GT, 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
10/03/2003 Centralised - Authorisation EMEA/H/C/485 (2003)775 of 06/03/2003
02/05/2003 Centralised - Variation EMEA/H/C/485/I/1
03/02/2004 Centralised - Variation EMEA/H/C/485/N/3 (2004)295 of 29/01/2004
08/03/2004 Centralised - Variation EMEA/H/C/485/II/2 (2004)748 of 02/03/2004
27/05/2004 Centralised - Variation EMEA/H/C/485/II/4 (2004)1968 of 25/05/2004
17/08/2004 Centralised - Variation EMEA/H/C/485/N/5
Updated with Decision(2005)3584 of 15/09/2005
09/09/2004 Centralised - Variation EMEA/H/C/485/IB/6
10/09/2004 Centralised - Variation EMEA/H/C/485/IA/7
24/11/2004 Centralised - Variation EMEA/H/C/485/IA/8
24/11/2004 Centralised - Variation EMEA/H/C/485/IA/9
14/04/2005 Centralised - Variation EMEA/H/C/485/N/10
Updated with Decision(2005)3584 of 15/09/2005
27/04/2005 Centralised - Variation EMEA/H/C/485/IA/12
10/08/2005 Centralised - Variation EMEA/H/C/485/IA/15
10/08/2005 Centralised - Variation EMEA/H/C/485/IA/14
15/09/2005 Centralised - Variation EMEA/H/C/485/II/13 (2005)3537 of 13/09/2005
20/09/2005 Centralised - Variation EMEA/H/C/485/II/11 (2005)3584 of 15/09/2005
23/01/2006 Centralised - Variation EMEA/H/C/485/N/17
Updated with Decision(2006)1338 of 29/03/2006
31/03/2006 Centralised - Variation EMEA/H/C/485/II/16 (2006)1338 of 29/03/2006
19/04/2006 Centralised - Variation EMEA/H/C/485/IB/20
19/04/2006 Centralised - Variation EMEA/H/C/485/IB/19
19/04/2006 Centralised - Variation EMEA/H/C/485/IB/18
08/08/2006 Centralised - Variation EMEA/H/C/485/II/21 (2006)3635 of 04/08/2006
31/08/2006 Centralised - Variation EMEA/H/C/485/II/22, 23 (2006)3938 of 28/08/2006
22/09/2006 Centralised - Variation EMEA/H/C/485/IB/25
Updated with Decision(2007)2143 of 14/05/2007
02/02/2007 Centralised - Variation EMEA/H/C/485/N/26
Updated with Decision(2007)2143 of 14/05/2007
24/04/2007 Centralised - Variation EMEA/H/C/485/IA/29
25/04/2007 Centralised - Variation EMEA/H/C/485/IB/28
16/05/2007 Centralised - Variation (2007)2143 of 14/05/2007
25/10/2007 Centralised - Variation EMEA/H/C/485/IA/32
25/10/2007 Centralised - Variation EMEA/H/C/485/II/27 (2007)5267 of 23/10/2007
03/03/2008 Centralised - Variation EMEA/H/C/485/II/30 (2008)836 of 28/02/2008
20/03/2008 Centralised - Renewal EMEA/H/C/485/R/31 (2008)1171 of 18/03/2008
01/04/2008 Centralised - Variation EMEA/H/C/485/IA/36
04/04/2008 Centralised - Variation EMEA/H/C/485/II/33 (2008)1307 of 01/04/2008
09/04/2008 Centralised - Variation EMEA/H/C/485/IB/35
23/04/2008 Centralised - Variation EMEA/H/C/485/II/34 (2008)1661 of 21/04/2008
18/07/2008 Centralised - Variation EMEA/H/C/485/IA/38
15/08/2008 Centralised - Variation EMEA/H/C/485/II/37 (2008)4533 of 13/08/2008
11/11/2008 Centralised - Variation EMEA/H/C/485/IA/44
Updated with Decision(2008)8817 of 17/12/2008
25/11/2008 Centralised - Variation EMEA/H/C/485/IB/42
25/11/2008 Centralised - Variation EMEA/H/C/485/IB/41
22/12/2008 Centralised - Variation EMEA/H/C/485/II/40 (2008)8817 of 17/12/2008
29/01/2009 Centralised - Variation EMEA/H/C/485/II/39, 43 (2009)591 of 27/01/2009
23/03/2009 Centralised - Variation EMEA/H/C/485/IA/46
02/07/2009 Centralised - Variation EMEA/H/C/485/II/47 (2009)5392 of 30/06/2009
08/07/2009 Centralised - Variation EMEA/H/C/485/IA/48
09/04/2010 Centralised - Variation EMEA/H/C/485/IA/49
19/07/2010 Centralised - Variation EMEA/H/C/485/IA/50
Updated with Decision(2011)3596 of 18/05/2011
30/03/2011 Centralised - Variation EMEA/H/C/485/IG/47/G
Updated with Decision(2011)5830 of 05/08/2011
20/05/2011 Centralised - Variation (2011)3596 of 18/05/2011
20/06/2011 Centralised - Variation EMEA/H/C/485/N/51
Updated with Decision(2011)9961 of 19/12/2011
10/08/2011 Centralised - Variation (2011)5830 of 05/08/2011
21/12/2011 Centralised - Variation EMEA/H/C/485/II/52/G (2011)9961 of 19/12/2011
28/08/2012 Centralised - Variation EMEA/H/C/485/II/59 (2012)6036 of 23/08/2012
16/05/2013 Centralised - Variation EMEA/H/C/485/IB/61 (2013)2894 of 14/05/2013
20/03/2014 Centralised - Variation EMEA/H/C/485/II/64