Overview
The marketing authorisation for Zerit has been withdrawn at the request of the marketing authorisation holder.
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 |
Product information
13/02/2019 Zerit - EMEA/H/C/000110 - IAIN/0107
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).
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.