Zartra

Withdrawn

This medicine's authorisation has been withdrawn

imiquimod

Overview

On 18 September 1998, the European Commission granted a marketing authorisation for the whole European Union to Laboratoires 3M Santé for the medicinal products Aldara and Zartra (both containing the active substance, imiquimod), indicated for the topical treatment of external genital and perianal warts (condyloma acuminata) in adult patients.

On 12 April 2002, the Marketing Authorisation Holder notified the European Commission of his decision to voluntarily withdraw the Marketing Authorisation for Zartra for commercial reasons. Zartra has never been marketed in the European Union. Aldara continues to be available and is marketed in all European Member States.

On 11 June 2002, the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use “Zartra”. Pursuant to this decision, the European Public Assessment Report for Zartra has been removed from this website.

Product information

Product details

• Name of medicine:
  Zartra
• Active substance:
  imiquimod
• International non-proprietary name (INN) or common name:
  imiquimod
• Therapeutic area (MeSH):
  Condylomata Acuminata
• Anatomical therapeutic chemical (ATC) code:
  L03AX

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Imiquimod cream is indicated for the topical treatment of external genital and perianal warts (condyloma acuminata) in adult patients.

Authorisation details

• EMA product number:
  EMEA/H/C/000180
• Marketing authorisation holder:
  Laboratoires 3M Santé

  Laboratories 3M Sante; Boulevard de l'Oise; F-95029 Cergy Pontoise Cedex; France

• Marketing authorisation issued:
  18/09/1998
• Withdrawal of marketing authorisation:
  11/06/2002