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Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pandemic influenza vaccine H5N1 BAXTER   
Auth. number : EU/1/09/571
INN : Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated)
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. Pandemic influenza vaccine should be used in accordance with official guidance.
Marketing Authorisation Holder: Baxter AG
Industriestraße 67, A-1221 Wien, Österreich

  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 continues to be 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
20/10/2009 Centralised - Authorisation EMEA/H/C/1200 (2009)8132 of 16/10/2009
09/02/2010 Centralised - Variation EMEA/H/C/1200/II/2
09/02/2010 Centralised - Variation EMEA/H/C/1200/II/1
21/12/2011 Centralised - Variation EMEA/H/C/1200/II/3/G (2011)9956 of 19/12/2011
28/03/2012 Centralised - Variation EMEA/H/C/1200/II/6 (2012)2169 of 26/03/2012
27/11/2013 Centralised - Variation EMEA/H/C/1200/II/15 (2013)8504 of 25/11/2013