Lamivudine/Zidovudine Teva

Withdrawn

This medicine's authorisation has been withdrawn

lamivudine / zidovudine

Overview

On 9 March 2023, the European Commission withdrew the marketing authorisation for Lamivudine / Zidovudine Teva (lamivudine / zidovudine) 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 not to market the product in the EU for commercial reasons. 

Lamivudine / Zidovudine Teva was granted marketing authorisation in the EU on 28 February 2011 for treatment of HIV infection. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2015. The product had not been marketed in the EU since 2021. 

Lamivudine / Zidovudine Teva is a generic medicine of Combivir. 

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Assessment Report (EPAR) for Lamivudine / Zidovudine Teva is updated to indicate that the marketing authorisation is no longer valid.

Lamivudine/Zidovudine Teva : EPAR - Summary for the public

Product information

Lamivudine/Zidovudine Teva : EPAR - Product Information

Lamivudine/Zidovudine Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Lamivudine/Zidovudine Teva
• Active substance:
  • lamivudine
  • zidovudine
• International non-proprietary name (INN) or common name:
  • lamivudine
  • zidovudine
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AR01

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.

Authorisation details

• EMA product number:
  EMEA/H/C/001236
• 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 Pharma B.V.

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

• Opinion adopted:
  18/11/2010
• Marketing authorisation issued:
  28/02/2011
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

Lamivudine/Zidovudine Teva : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Lamivudine/Zidovudine Teva : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Lamivudine/Zidovudine Teva

Adopted Reference Number: EMA/725978/2010