Nevirapine Teva

Withdrawn

This medicine's authorisation has been withdrawn

nevirapine

Overview

The marketing authorisation for Nevirapine Teva has been withdrawn at the request of the marketing-authorisation holder.

Nevirapine Teva : EPAR - Summary for the public

Product information

Nevirapine Teva : EPAR - Product Information

Latest procedure affecting product information: N/0024

08/12/2021

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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