Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prepandemic Influenza   
Auth. number : EU/1/10/657
INN : Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
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: J07BB02 - Influenza, purified antigen
(See WHO ATC Index)
Indication: Active immunisation against H5N1 subtype of Influenza A virus.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be used in accordance with official recommendations.
Marketing Authorisation Holder: Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia

  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
03/12/2010 Centralised - Authorisation EMEA/H/C/2269 (2010)8659 of 29/11/2010
10/06/2011 Centralised - Variation EMEA/H/C/2269/IA/2
Updated with Decision(2012)900 of 09/02/2012
13/02/2012 Centralised - Variation EMEA/H/C/2269/II/3 (2012)898 of 09/02/2012
13/02/2012 Centralised - Variation (2012)900 of 09/02/2012