Lamivudine/Zidovudine Teva

Withdrawn

This medicine's authorisation has been withdrawn

lamivudine / zidovudine

Overview

The marketing authorisation for Lamivudine/Zidovudine Teva has been withdrawn at the request of the marketing-authorisation holder.

Lamivudine/Zidovudine Teva : EPAR - Summary for the public

Product information

Lamivudine/Zidovudine Teva : EPAR - Product Information

Latest procedure affecting product information: IB/0028

21/03/2022

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).

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

AdoptedReference Number: EMA/725978/2010