Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Daronrix
Auth. number : EU/1/06/381
Active substance : A/Viet Nam/1194/2004 (H5N1) whole virus inactivated antigen
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BB - Influenza vaccines
Chemical substance: J07BB01 - influenza, inactivated, whole virus
(See WHO ATC Index)
Indication: Prophylaxis of influenza in an officially declared pandemic situation.
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique
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
23/03/2007 Centralised - Authorisation EMEA/H/C/706 (2007)1353 of 21/03/2007
07/11/2012 Centralised - Withdrawal (sunset clause)