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Community register of medicinal products for human use


Product information

Invented name: Pandemic influenza vaccine H5N1 BAXTER   
Auth. number : EU/1/09/571
Active substance : 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: Nanotherapeutics UK Limited
10 Chiswell Street, 2nd Floor, London EC1Y 4UQ, United Kingdom
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
20/10/2009 Centralised - Authorisation EMEA/H/C/1200 (2009)8132 of 16/10/2009
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1200/II/2
09/02/2010 Centralised - Variation (no change in Commission Decision) 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 - 2-Monthly update EMEA/H/C/1200/II/15 (2013)8504 of 25/11/2013
16/05/2014 Centralised - Renewal EMEA/H/C/1200/R/16 (2014)3367 of 14/05/2014
01/12/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1200/T/21 (2015)8595 of 27/11/2015
28/03/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1200/T/24 (2017)2122 of 24/03/2017