Zerit

Withdrawn

This medicine's authorisation has been withdrawn

stavudine

Overview

The marketing authorisation for Zerit has been withdrawn at the request of the marketing authorisation holder.

Zerit : EPAR - Summary for the public

Product information

Zerit : EPAR - Product Information

Latest procedure affecting product information: IAIN/0107

13/02/2019

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

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