Zerit

RSS

stavudine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zerit has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 13/10/2020

Authorisation details

Product details
Name
Zerit
Agency product number
EMEA/H/C/000110
Active substance
stavudine
International non-proprietary name (INN) or common name
stavudine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AF04
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
08/05/1996
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

13/02/2019 Zerit - EMEA/H/C/000110 - IAIN/0107

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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