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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lamivudine Teva Pharma B.V.   
Auth. number : EU/1/09/596
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 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 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
14/12/2009 Centralised - Authorisation EMEA/H/C/1111 (2009)10230 of 10/12/2009
13/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1111/IA/1
01/03/2011 Centralised - Variation (no change in Commission Decision) 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 (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
08/03/2013 Corrigendum (2012)4578 cor of 28/06/2012
10/02/2014 Centralised - Variation EMEA/H/C/1111/IB/8/G
Updated with Decision(2014)6507 of 11/09/2014
15/04/2014 Centralised - Variation EMEA/H/C/1111/IA/10/G
Updated with Decision(2014)6507 of 11/09/2014
15/09/2014 Centralised - Renewal EMEA/H/C/1111/R/9 (2014)6507 of 11/09/2014
20/11/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1111/T/11 (2014)8726 of 17/11/2014
06/02/2015 Centralised - Variation EMEA/H/C/1111/IB/12
Updated with Decision(2016)1132 of 18/02/2016
01/07/2015 Centralised - Variation EMEA/H/C/1111/IB/13
Updated with Decision(2016)1132 of 18/02/2016
06/01/2016 Centralised - Variation EMEA/H/C/1111/IB/15
Updated with Decision(2016)1132 of 18/02/2016
22/02/2016 Centralised - Yearly update (2016)1132 of 18/02/2016
29/03/2016 Centralised - Variation EMEA/H/C/1111/IA/16
Updated with Decision(2016)5989 of 16/09/2016
20/09/2016 Centralised - 2-Monthly update EMEA/H/C/1111/IB/17/G (2016)5989 of 16/09/2016