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Product information

Invented name: Aflunov   
Auth. number : EU/1/10/658
Active substance : 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/turkey/Turkey/1/05 (H5N1)-like strain (see section 5.1).
AFLUNOV should be used in accordance with official recommendations.
Marketing Authorisation Holder: Seqirus S.r.l.
Via Fiorentina 1, 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/2094 (2010)8660 of 29/11/2010
06/05/2011 Centralised - Variation EMEA/H/C/2094/IA/2/G
Updated with Decision(2011)6368 of 05/09/2011
07/09/2011 Centralised - Variation (2011)6368 of 05/09/2011
09/02/2012 Centralised - Variation EMEA/H/C/2094/II/3 (2012)760 of 06/02/2012
26/04/2012 Centralised - Variation EMEA/H/C/2094/II/1 (2012)2859 of 20/04/2012
13/12/2012 Centralised - Variation EMEA/H/C/2094/II/5/G
Updated with Decision(2013)9725 of 18/12/2013
12/02/2013 Centralised - 2-Monthly update EMEA/H/C/2094/II/7/G (2013)799 of 08/02/2013
30/10/2013 Centralised - Variation EMEA/H/C/2094/IB/13
Updated with Decision(2013)9725 of 18/12/2013
20/12/2013 Centralised - Yearly update (2013)9725 of 18/12/2013
29/05/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2094/T/23 (2015)3684 of 27/05/2015
22/07/2015 Centralised - Renewal EMEA/H/C/2094/PSUSA/10008/201410, EMEA/H/C/2094/R/21 (2015)5152 of 17/07/2015
12/08/2015 Centralised - Variation EMEA/H/C/2094/IA/24
Updated with Decision(2016)5405 of 16/08/2016
13/05/2016 Centralised - Variation EMEA/H/C/2094/IA/28
Updated with Decision(2016)5405 of 16/08/2016
18/08/2016 Centralised - Yearly update (2016)5405 of 16/08/2016
19/05/2017 Centralised - Variation EMEA/H/C/2094/IA/37
Updated with Decision(2018)3066 of 08/05/2018
15/05/2018 Centralised - Yearly update (2018)3066 of 08/05/2018