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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lamivudine / Zidovudine Teva   
Auth. number : EU/1/10/663
Active substance : Lamivudine / Zidovudine
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: J05AR - Antivirals for treatment of hiv infections, combinations
Chemical substance: J05AR01 - Zidovudine and lamivudine
(See WHO ATC Index)
Indication: Antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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
02/03/2011 Centralised - Authorisation EMEA/H/C/1236 (2011)1465 of 28/02/2011
15/09/2011 Centralised - Variation EMEA/H/C/1236/IB/2/G
Updated with Decision(2012)3639 of 25/05/2012
01/06/2012 Centralised - Variation (2012)3639 of 25/05/2012
25/10/2012 Centralised - Variation EMEA/H/C/1236/IAin/3/G
Updated with Decision(2012)7990 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7990 of 31/10/2012
13/05/2013 Centralised - Notification EMEA/H/C/1236/N/5
Updated with Decision(2014)8515 of 11/11/2014
12/03/2014 Centralised - Variation EMEA/H/C/1236/IB/8
Updated with Decision(2014)8515 of 11/11/2014
13/11/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1236/T/9 (2014)8515 of 11/11/2014