Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Focetria   
Auth. number : EU/1/07/385
INN : Pandemic influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-181)
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.
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
04/05/2007 Centralised - Authorisation EMEA/H/C/710 (2007)2025 of 02/05/2007
02/07/2009 Centralised - Variation EMEA/H/C/710/IA/2
02/07/2009 Centralised - Variation EMEA/H/C/710/IA/3
12/08/2009 Centralised - Variation EMEA/H/C/710/II/1
08/09/2009 Centralised - Variation EMEA/H/C/710/IA/4
Updated with Decision(2009)7585 of 29/09/2009
30/09/2009 Centralised - Variation EMEA/H/C/710/PU/5 (2009)7585 of 29/09/2009
20/10/2009 Centralised - Variation EMEA/H/C/710/II/7
20/10/2009 Centralised - Variation EMEA/H/C/710/II/6
12/11/2009 Centralised - Variation EMEA/H/C/710/II/8, 9, 10, 11 (2009)8998 of 11/11/2009
30/11/2009 Centralised - Variation EMEA/H/C/710/II/13, 15 (2009)9653 of 27/11/2009
28/12/2009 Centralised - Variation EMEA/H/C/710/II/16, 18 (2009)10781 of 23/12/2009
03/03/2010 Centralised - Variation EMEA/H/C/710/II/14
29/04/2010 Centralised - Variation EMEA/H/C/710/II/20 (2010)2831 of 27/04/2010
03/05/2010 Centralised - Variation EMEA/H/C/710/II/17 (2010)2937 of 29/04/2010
07/05/2010 Centralised - Variation EMEA/H/C/710/IA/22
17/05/2010 Centralised - Variation EMEA/H/C/710/IA/23/G
Updated with Decision(2010)5744 of 12/08/2010
14/07/2010 Centralised - Variation EMEA/H/C/710/IB/21
13/08/2010 Centralised - Variation EMEA/H/C/710/SW/24 (2010)5744 of 12/08/2010
21/10/2010 Centralised - Variation EMEA/H/C/710/IA/25
10/05/2011 Centralised - Variation EMEA/H/C/710/IA/27/G
Updated with Decision(2011)5828 of 05/08/2011
10/08/2011 Centralised - Variation (2011)5828 of 05/08/2011
26/04/2012 Centralised - Variation EMEA/H/C/710/II/30 (2012)2818 of 20/04/2012