Daronrix

Lapsed

This medicine's authorisation has lapsed

pandemic influenza vaccine (whole virion, inactivated, adjuvanted)

Overview

On 21 March 2007, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Daronrix (pandemic influenza vaccine (H5N1) (whole virion, inactivated, adsorbed)), indicated for the prophylaxis of influenza in an officially declared pandemic situation. The marketing authorisation holder was notified on the 23 March 2007. 

Daronrix (pandemic influenza vaccine (H5N1) (whole virion, inactivated, adsorbed)) has not been marketed in Europe since this initial marketing authorisation. In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation. 

Because of this, the marketing authorisation for Daronrix is no longer valid. The Marketing Authorisation Holder of Daronrix has confirmed that the product was not marketed due to lack of demand for this vaccine. 

Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Daronrix is updated to reflect that the marketing authorisation is no longer valid.

Daronrix : EPAR - Summary for the public

Product information

Daronrix : EPAR - Product Information

Daronrix : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Daronrix
• Active substance:
  Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs
• International non-proprietary name (INN) or common name:
  pandemic influenza vaccine (whole virion, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
• Anatomical therapeutic chemical (ATC) code:
  J07BB01

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/000706
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  GlaxoSmithKline Biologicals S.A.

  Rue de l'Institut, 89; B-1330 Rixensart; Belgium

• Marketing authorisation issued:
  21/03/2007
• Lapse of marketing authorisation:
  24/06/2013

Assessment history

Initial marketing authorisation documents

Daronrix : EPAR - Scientific Discussion

Daronrix : EPAR - Procedural steps taken before authorisation