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Community register of medicinal products for human use


Product information

Invented name: Nevirapine Teva   
Auth. number : EU/1/09/598
Active substance : nevirapine
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: J05AG01 - papillomavirus (human types 16, 18)
(See WHO ATC Index)
Indication: Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.
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
02/12/2009 Centralised - Authorisation EMEA/H/C/1119 (2009)9783 of 30/11/2009
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1119/IA/1
07/10/2011 Centralised - Variation EMEA/H/C/1119/IB/3
Updated with Decision(2012)3565 of 25/05/2012
30/05/2012 Centralised - Variation (2012)3565 of 25/05/2012
21/02/2013 Centralised - Variation EMEA/H/C/1119/IB/5/G
Updated with Decision(2014)1247 of 20/02/2014
11/10/2013 Centralised - Variation EMEA/H/C/1119/IB/7/G
Updated with Decision(2014)1247 of 20/02/2014
25/02/2014 Centralised - Yearly update (2014)1247 of 20/02/2014
03/04/2014 Centralised - Variation EMEA/H/C/1119/IB/9/G
Updated with Decision(2014)6176 of 26/08/2014
28/08/2014 Centralised - Renewal EMEA/H/C/1119/R/10 (2014)6176 of 26/08/2014
24/10/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1119/T/11 (2014)7936 of 22/10/2014
25/04/2016 Centralised - Variation EMEA/H/C/1119/IA/13
Updated with Decision(2017)2133 of 24/03/2017
27/04/2016 Centralised - Notification EMEA/H/C/1119/N/12
Updated with Decision(2017)2133 of 24/03/2017
22/08/2016 Centralised - Variation EMEA/H/C/1119/IB/14
Updated with Decision(2017)2133 of 24/03/2017
28/03/2017 Centralised - Yearly update (2017)2133 of 24/03/2017