Zerit

Withdrawn

This medicine's authorisation has been withdrawn

stavudine

Overview

On 24 June 2020, the European Commission withdrew the marketing authorisation for Zerit (stavudine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bristol-Myers Squibb Pharma EEIG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Zerit was granted marketing authorisation in the EU on 8 May 1996 for treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2006. It was then granted unlimited validity in 2011. The product had not been marketed in the EU since 2020. 

The European Public Assessment Report (EPAR) for Zerit is updated to indicate that the marketing authorisation is no longer valid.

Zerit : EPAR - Summary for the public

Product information

Zerit : EPAR - Product Information

Zerit : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zerit
• Active substance:
  stavudine
• International non-proprietary name (INN) or common name:
  stavudine
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AF04

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Hard capsules

Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.

Powder for oral solution

Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.

Authorisation details

• EMA product number:
  EMEA/H/C/000110
• Marketing authorisation holder:
  Bristol-Myers Squibb Pharma EEIG

  Plaza 254; Blanchardstown Corporate Park 2; Dublin 15; D15 T867; Ireland

• Marketing authorisation issued:
  08/05/1996
• Revision:
  31

Assessment history

Changes since initial authorisation of medicine

Zerit : EPAR - Procedural steps taken and scientific information after authorisation

Zerit-H-C-110-P46-0063 : EPAR - Assessment Report

AdoptedReference Number: EMA/CHMP/394445/2016

Zerit-H-C-110-P46-59 : EPAR - Assessment Report

AdoptedReference Number: EMA/539978/2013

Zerit-H-C-110-P45-51 : EPAR - Assessment Report

AdoptedReference Number: EMA/CHMP/533490/2012

Zerit-H-C-110-R-79 : EPAR - Assessment Report - Renewal

Adopted

Zerit : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Zerit : EPAR - Procedural steps taken before authorisation

Zerit : EPAR - Scientific Discussion