Nevirapine Teva

Withdrawn

This medicine's authorisation has been withdrawn

nevirapine

Overview

On 6 March 2023 the European Commission withdrew the marketing authorisation for Nevirapine Teva (nevirapine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Nevirapine Teva was granted marketing authorisation in the EU on 30 November 2009 for treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. Nevirapine Teva is a generic medicine of Viramune. 

The European Public Assessment Report (EPAR) for Nevirapine Teva is updated to indicate that the marketing authorisation is no longer valid.

Nevirapine Teva : EPAR - Summary for the public

Product information

Nevirapine Teva : EPAR - Product Information

Nevirapine Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nevirapine Teva
• Active substance:
  nevirapine
• International non-proprietary name (INN) or common name:
  nevirapine
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AG01

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/001119
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Teva B.V.

  Teva B.V.; Swensweg 5; 2031 GA Haarlem; The Netherlands

• Opinion adopted:
  24/09/2009
• Marketing authorisation issued:
  30/11/2009
• Revision:
  11

Assessment history

Changes since initial authorisation of medicine

Nevirapine Teva : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Nevirapine Teva : EPAR - Public assessment report

CHMP summary of positive opinion for Nevirapine Teva

Reference Number: EMEA/CHMP/578510/2009