Overview
The marketing authorisation for Vitravene has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Vitravene
|
| Agency product number |
EMEA/H/C/000244
|
| Active substance |
fomivirsen
|
| International non-proprietary name (INN) or common name |
fomivirsen
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
S01AD08
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Novartis Ophthalmics Europe Ltd.
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
29/07/1999
|
| Contact address |
Delta House, Southwood Crescent
Southwood, Farnborough Hants, GU14 0NL United Kingdom |
Product information
30/07/2002 Vitravene - EMEA/H/C/000244 -
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
Ophthalmologicals
Therapeutic indication
For the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immuno-deficiency syndrome (AIDS).
Until further experience is gained, fomivirsen should be used only when other therapy has been ineffective or is considered unsuitable.