Overview
The marketing authorisation for Vitrasert Implant has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Vitrasert Implant
|
| Agency product number |
EMEA/H/C/000120
|
| Active substance |
ganciclovir
|
| International non-proprietary name (INN) or common name |
ganciclovir
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J05AB06
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH..
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
18/03/1997
|
| Contact address |
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbuetteler Damm 165-173 D-13581Berlin (Spandau) Germany |
Product information
02/04/2002 Vitrasert Implant - EMEA/H/C/000120 -
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
The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).