Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Vitrasert implant
Auth. number : EU/1/97/034
Active substance : ganciclovir
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AB - Nucleosides
Chemical substance: J05AB06 - Ganciclovir
(See WHO ATC Index)
Indication: Treatment of CMV renititis in patient with AIDS
Marketing Authorisation Holder: Dr Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbuetteler Damm 165-173, 13581 Berlin (Spandau), Deutschland
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
19/03/1997 Centralised - Authorisation EMEA/H/C/120 (97)784 of 18/03/1997
28/02/2000 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/120/T/1 (2000)451 of 24/02/2000
27/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/120/I/2
29/12/2000 Centralised - Variation EMEA/H/C/120/I/3 (2000)3987 of 27/12/2000
04/04/2002 Centralised - Withdrawal (2002)1371 of 02/04/2002