Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Efavirenz Teva   
Auth. number : EU/1/11/742
INN : efavirenz
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: J05AG - Non-nucleoside reverse transcriptase inhibitors
Chemical substance: J05AG03 - Efavirenz
(See WHO ATC Index)
Indication: Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus 1 (HIV 1) infected adults, adolescents and children 3 years of age and older.
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
11/01/2012 Centralised - Authorisation EMEA/H/C/2352 (2011)10093 of 09/01/2012
12/09/2012 Centralised - Variation EMEA/H/C/2352/IB/1
Updated with Decision(2012)7758 of 25/10/2012
12/11/2012 Centralised - Variation (2012)7758 of 25/10/2012
01/07/2013 Centralised - Variation EMEA/H/C/2352/IB/3
Updated with Decision(2014)4853 of 04/07/2014
27/08/2013 Centralised - Variation EMEA/H/C/2352/IAin/6/G
Updated with Decision(2014)4853 of 04/07/2014
13/06/2014 Centralised - Variation EMEA/H/C/2352/IAin/10/G
Updated with Decision(2014)4853 of 04/07/2014
09/07/2014 Centralised - Variation (2014)4853 of 04/07/2014