Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lamivudine Teva   
Auth. number : EU/1/09/566
Active substance : 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: Lamivudine Teva 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
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
27/10/2009 Centralised - Authorisation EMEA/H/C/1113 (2009)8397 of 23/10/2009
23/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1113/IA/1
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1113/II/3/G
18/11/2011 Centralised - Variation EMEA/H/C/1113/IB/5/G
Updated with Decision(2012)3712 of 31/05/2012
13/04/2012 Centralised - Variation EMEA/H/C/1113/IA/6/G
Updated with Decision(2012)3712 of 31/05/2012
04/06/2012 Centralised - Variation (2012)3712 of 31/05/2012
10/02/2014 Centralised - Variation EMEA/H/C/1113/IB/8
Updated with Decision(2014)6479 of 09/09/2014
09/06/2014 Centralised - Variation EMEA/H/C/1113/IAin/10
Updated with Decision(2014)6479 of 09/09/2014
12/09/2014 Centralised - Renewal EMEA/H/C/1113/R/9 (2014)6479 of 09/09/2014
18/12/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1113/T/11 (2014)10095 of 16/12/2014