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Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Lamivudine Teva Pharma B.V.   
Auth. number : EU/1/09/596
INN : Lamivudine
ATC: J - General antiinfectives for systemic use
J05 - Antivirals for systemic use
J05A - Agents affecting the virus directly
J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF05 - Lamivudine
(See WHO ATC Index)
Indication: Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  EPAR and active package presentations

Package presentations

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be 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
14/12/2009 Centralised - Authorisation EMEA/H/C/1111 (2009)10230 of 10/12/2009
13/01/2010 Centralised - Variation EMEA/H/C/1111/IA/1
01/03/2011 Centralised - Variation EMEA/H/C/1111/II/3/G
03/07/2012 Centralised - Variation EMEA/H/C/1111/IB/5/G
Updated with Decision(2012)4578 of 28/06/2012
03/07/2012 Centralised - Variation EMEA/H/C/1111/IA/6/G
Updated with Decision(2012)4578 of 28/06/2012
03/07/2012 Centralised - Variation - (2012)4578 of 28/06/2012
08/03/2013 Corrigendum