Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Foclivia   
Auth. number : EU/1/09/577
Active substance : A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen
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: Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
Marketing Authorisation Holder: Novartis Vaccines Influenza 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
21/10/2009 Centralised - Authorisation EMEA/H/C/1208 (2009)8264 of 19/10/2009
28/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1208/IA/2
15/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1208/IB/1
10/08/2010 Centralised - Variation EMEA/H/C/1208/IA/3/G
Updated with Decision(2011)3230 of 06/05/2011
12/05/2011 Centralised - Variation (2011)3230 of 6/05/2011
13/05/2011 Centralised - Variation (refusal) EMEA/H/C/1208/IA/4/G
7/11/2011 Centralised - Variation (refusal) EMEA/H/C/1208/IA/5/G
26/03/2012 Centralised - Variation EMEA/H/C/1208/II/6, 7 (2012)2039 of 21/03/2012
25/04/2014 Centralised - Variation EMEA/H/C/1208/II/11G
Updated with Decision(2014)4511 of 27/06/2014
22/05/2014 Centralised - Variation EMEA/H/C/1208/II/8/G
Updated with Decision(2015)3643 of 27/05/2015
1/07/2014 Centralised - Renewal EMEA/H/C/1208/R/12 (2014)4511 of 27/06/2014
29/05/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1208/T/17 (2015)3643 of 27/05/2015
5/02/2016 Centralised - Variation EMEA/H/C/1208/IAIN/21/G
Updated with Decision(2017)105 of 09/01/2017
3/11/2016 Centralised - Variation EMEA/H/C/1208/IAIN/24/G
Updated with Decision(2017)105 of 09/01/2017
11/01/2017 Centralised - Yearly update (2017)105 of 9/01/2017