Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Baraclude   
Auth. number : EU/1/06/343
INN : entecavir
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: J05AF10 - Entecavir
(See WHO ATC Index)
Indication: Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with:- compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. - decompensated liver disease (see section 4.4)For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, 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
28/06/2006 Centralised - Authorisation EMEA/H/C/623 (2006)3003 of 26/06/2006
14/07/2006 Centralised - Variation EMEA/H/C/623/IA/1
07/02/2007 Centralised - Variation EMEA/H/C/623/IA/4
06/03/2007 Centralised - Variation EMEA/H/C/623/N/3
Updated with Decision(2007)1935 of 26/04/2007
30/04/2007 Centralised - Variation EMEA/H/C/623/II/2 (2007)1935 of 26/04/2007
30/05/2007 Centralised - Variation EMEA/H/C/623/II/6
02/08/2007 Centralised - Variation EMEA/H/C/623/IA/8
02/08/2007 Centralised - Variation EMEA/H/C/623/IA/9
24/08/2007 Centralised - Variation EMEA/H/C/623/II/5 (2007)4038 of 22/08/2007
25/10/2007 Centralised - Variation EMEA/H/C/623/II/10
29/10/2007 Centralised - Variation EMEA/H/C/623/IA/11
Updated with Decision(2008)3293 of 25/06/2008
29/10/2007 Centralised - Variation EMEA/H/C/623/IA/12
Updated with Decision(2008)3293 of 25/06/2008
23/11/2007 Centralised - Variation EMEA/H/C/623/II/7 (2007)5787 of 21/11/2007
14/01/2008 Centralised - Variation EMEA/H/C/623/IA/15
31/01/2008 Centralised - Variation EMEA/H/C/623/IB/14
Updated with Decision(2008)3293 of 25/06/2008
31/01/2008 Centralised - Variation EMEA/H/C/623/IB/13
Updated with Decision(2008)3293 of 25/06/2008
19/02/2008 Centralised - Variation EMEA/H/C/623/IA/16
27/05/2008 Centralised - Variation EMEA/H/C/623/IB/18
27/06/2008 Centralised - Variation (2008)3293 of 25/06/2008
26/08/2008 Centralised - Variation EMEA/H/C/623/II/17 (2008)4651 of 22/08/2008
12/02/2009 Centralised - Variation EMEA/H/C/623/II/19 (2009)1025 of 10/02/2009
02/03/2009 Centralised - Variation EMEA/H/C/623/II/21 (2009)1468 of 26/02/2009
05/03/2009 Centralised - Variation EMEA/H/C/623/IA/23
05/03/2009 Centralised - Variation EMEA/H/C/623/IA/24
24/03/2009 Centralised - Variation EMEA/H/C/623/IB/22
10/06/2009 Centralised - Variation EMEA/H/C/623/II/20 (2009)4582 of 08/06/2009
08/07/2009 Centralised - Variation EMEA/H/C/623/II/26 (2009)5596 of 07/07/2009
05/08/2009 Centralised - Variation EMEA/H/C/623/II/26 (2009)6254 of 03/08/2009
21/09/2009 Centralised - Variation EMEA/H/C/623/IA/28
19/11/2009 Centralised - Variation EMEA/H/C/623/N/27
Updated with Decision(2010)5327 of 27/07/2010
15/03/2010 Centralised - Variation EMEA/H/C/623/IA/29/G
Updated with Decision(2010)5327 of 27/07/2010
29/07/2010 Centralised - Variation (2010)5327 of 27/07/2010
03/08/2010 Centralised - Variation EMEA/H/C/623/IA/31/G
19/08/2010 Centralised - Variation EMEA/H/C/623/IA/32
Updated with Decision(2010)7536 of 25/10/2010
31/08/2010 Centralised - Variation EMEA/H/C/623/II/30 (2010)6017 of 26/08/2010
27/10/2010 Centralised - Variation (2010)7536 of 25/10/2010
25/11/2010 Centralised - Variation EMEA/H/C/623/IA/34
Updated with Decision(2011)1215 of 21/02/2011
28/02/2011 Centralised - Variation (2011)1215 of 21/02/2011
03/03/2011 Centralised - Variation EMEA/H/C/623/II/33 (2011)1485 of 28/02/2011
28/03/2011 Centralised - Variation EMEA/H/C/623/IA/36
16/05/2011 Centralised - Renewal EMEA/H/C/623/R/35 (2011)3443 of 12/05/2011
26/10/2012 Centralised - Variation EMEA/H/C/623/II/38 (2012)7670 of 24/10/2012
23/01/2014 Centralised - Variation EMEA/H/C/623/II/42
12/06/2014 Centralised - Variation EMEA/H/C/623/IAIN/44