Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Vitravene
Auth. number : EU/1/99/115
Active substance : Fomivirsen
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01A - Antiinfectives
Chemical subgroup: S01AD - Antivirals
Chemical substance: S01AD08 - fomivirsen
(See WHO ATC Index)
Indication: local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immuno-deficiency syndrome (AIDS)
Marketing Authorisation Holder: Novartis Ophtalmics Europe Ltd
Delta House, Southwood Crescent, Southwood, Farnborough, Hants, GU 14 0NL, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
05/08/1999 Centralised - Authorisation EMEA/H/C/244 (1999)2547 of 29/07/1999
07/10/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/244/I/1
28/04/2000 Centralised - Variation EMEA/H/C/244/II/2 (2000)987 of 25/04/2000
01/09/2000 Centralised - Notification EMEA/H/C/244/N/4 (2000)2541 of 28/08/2000
21/09/2000 Centralised - Annual reassessment EMEA/H/C/244/S/6
25/10/2000 Centralised - Notification EMEA/H/C/244/N/5 (2000)2850 of 23/10/2000
07/03/2001 Centralised - Variation EMEA/H/C/244/I/8 (2001)308 of 05/03/2001
25/04/2001 Centralised - Variation EMEA/H/C/244/I/7 (2001)842 of 23/04/2001
12/04/2002 Centralised - Annual reassessment EMEA/H/C/244/S/9 (2002)1440 of 10/04/2002
01/08/2002 Centralised - Withdrawal (2002)3021 of 30/07/2002