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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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.
|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|