Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sebivo   
Auth. number : EU/1/07/388
Active substance : telbivudine
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: J05AF11 - Telbivudine
(See WHO ATC Index)
Indication: Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

Initiation of Sebivo 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 for details of the study and specific patient characteristics on which this indication is based.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, 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
26/04/2007 Centralised - Authorisation EMEA/H/C/713 (2007)1890 of 24/04/2007
29/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/713/IA/2
26/06/2007 Centralised - Variation EMEA/H/C/713/IB/1
Updated with Decision(2008)532 of 06/02/2008
08/02/2008 Centralised - Variation (2008)532 of 06/02/2008
03/03/2008 Centralised - Variation EMEA/H/C/713/II/3 (2008)841 of 28/02/2008
31/10/2008 Centralised - Variation EMEA/H/C/713/II/5 (2008)6652 of 31/10/2008
22/01/2009 Centralised - Variation EMEA/H/C/713/X/4 (2009)421 of 20/01/2009
20/03/2009 Centralised - Variation EMEA/H/C/713/IA/7
Updated with Decision(2009)6903 of 07/09/2009
09/09/2009 Centralised - Variation EMEA/H/C/713/II/6 (2009)6903 of 07/09/2009
02/11/2009 Centralised - Variation EMEA/H/C/713/II/8 (2009)8575 of 29/10/2009
27/01/2010 Centralised - Variation EMEA/H/C/713/II/9 (2010)528 of 25/01/2010
11/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/713/IB/12
17/03/2010 Centralised - Variation EMEA/H/C/713/II/10 (2010)1763 of 15/03/2010
17/03/2010 Centralised - Variation EMEA/H/C/713/II/11 (2010)1834 of 15/03/2010
22/06/2010 Centralised - Variation EMEA/H/C/713/IB/14/G
Updated with Decision(2010)8644 of 29/11/2010
08/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/713/IA/16/G
13/07/2010 Centralised - Variation EMEA/H/C/713/IB/15
Updated with Decision(2010)8644 of 29/11/2010
26/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/713/IB/17
21/10/2010 Centralised - Variation EMEA/H/C/713/IB/19
Updated with Decision(2010)8644 of 29/11/2010
06/12/2010 Centralised - Variation EMEA/H/C/713/II/13 (2010)8644 of 29/11/2010
13/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/713/IG/32
31/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/713/II/20/G
01/02/2011 Centralised - Variation EMEA/H/C/713/II/18 (2011)572 of 27/01/2011
19/05/2011 Centralised - Variation (refusal) EMEA/H/C/713/IG/65
09/06/2011 Centralised - Variation EMEA/H/C/713/IA/21/G
Updated with Decision(2011)6233 of 26/08/2011
06/07/2011 Centralised - Variation EMEA/H/C/713/IA/22/G
Updated with Decision(2011)6233 of 26/08/2011
31/08/2011 Centralised - Variation (2011)6233 of 26/08/2011
26/04/2012 Centralised - Renewal EMEA/H/C/713/R/23 (2012)2852 of 20/04/2012
20/11/2013 Centralised - Notification EMEA/H/C/713/N/35
Updated with Decision(2015)6542 of 18/09/2015
23/10/2014 Centralised - Variation EMEA/H/C/713/II/39/G
Updated with Decision(2015)6542 of 18/09/2015
22/09/2015 Centralised - Yearly update (2015)6542 of 18/09/2015
20/12/2016 Centralised - Renewal EMEA/H/C/000713/R/0045 (2016)8890 of 16/12/2016
27/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/00002880/201608 (2017)4483 of 23/06/2017