Vitrasert Implant

Withdrawn

This medicine's authorisation has been withdrawn

ganciclovir

Overview

On 18 March 1997, the European Commission granted a marketing authorisation for the whole European Union to Chiron B.V. for Vitrasert Implant (Ganciclovir), indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). This marketing authorisation was transferred on 24 February 2000 to Dr. Gerhard Mann Chem. Pharm. Fabrik GmbH.

On 21 November 2001, the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Vitrasert implant.

On 2 April 2002, the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use “Vitrasert Implant”. Pursuant to this decision, the European Public Assessment Report for Vitrasert implant has been removed from this website.

Product information

Product details

• Name of medicine:
  Vitrasert Implant
• Active substance:
  ganciclovir
• International non-proprietary name (INN) or common name:
  ganciclovir
• Therapeutic area (MeSH):
  • Cytomegalovirus Retinitis
  • HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AB06

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000120
• Marketing authorisation holder:
  Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH..

  Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH; Brunsbuetteler Damm 165-173; D-13581Berlin (Spandau); Germany

• Marketing authorisation issued:
  18/03/1997
• Withdrawal of marketing authorisation:
  02/04/2002