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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Efavirenz Teva   
Auth. number : EU/1/11/742
Active substance : 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 - nevirapine
(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.
Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens.
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of
regimens containing efavirenz.
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
11/01/2012 Centralised - Authorisation EMEA/H/C/2352 (2011)10093 of 9/01/2012
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
1/07/2013 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
9/07/2014 Centralised - Yearly update (2014)4853 of 4/07/2014
15/12/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2352/T/13 (2014)9829 of 11/12/2014
23/03/2015 Centralised - Variation EMEA/H/C/2352/IB/14/G
Updated with Decision(2016)1444 of 02/03/2016
4/03/2016 Centralised - Yearly update (2016)1444 of 2/03/2016
14/04/2016 Centralised - Variation EMEA/H/C/2352/IB/17
Updated with Decision(2016)5860 of 09/09/2016
19/04/2016 Centralised - Variation EMEA/H/C/2352/IA/16
Updated with Decision(2016)5860 of 09/09/2016
13/09/2016 Centralised - Renewal EMEA/H/C/2352/R/18 (2016)5860 of 9/09/2016