Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: IDflu   
Auth. number : EU/1/08/507
INN : Influenza Vaccine (split virion, inactivated)
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 adults up to 59 years of age, especially in those who run an increased risk of associated complications.
The use of IDflu should be based on official recommendations.
Marketing Authorisation Holder: Sanofi Pasteur SA
2 avenue Pont Pasteur, F-69007 Lyon, France

  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
26/02/2009 Centralised - Authorisation EMEA/H/C/966 (2009)1348 of 24/02/2009
14/04/2009 Centralised - Variation EMEA/H/C/966/N/1
Updated with Decision(2010)2024 of 23/03/2010
03/03/2010 Centralised - Variation EMEA/H/C/966/II/3
24/03/2010 Centralised - Variation EMEA/H/C/966/II/5
25/03/2010 Centralised - Variation EMEA/H/C/966/II/4 (2010)2024 of 23/03/2010
20/08/2010 Centralised - Variation EMEA/H/C/966/II/6 (2010)5853 of 18/08/2010
16/11/2010 Centralised - Variation EMEA/H/C/966/IA/7/G
Updated with Decision(2011)1491 of 28/02/2011
03/01/2011 Centralised - Variation EMEA/H/C/966/WS/67
03/03/2011 Centralised - Variation EMEA/H/C/966/WS/85 (2011)1491 of 28/02/2011
07/03/2011 Centralised - Variation EMEA/H/C/966/WS/106
18/04/2011 Centralised - Variation EMEA/H/C/966/WS/103/G
18/04/2011 Centralised - Variation EMEA/H/C/966/IB/8
10/06/2011 Centralised - Variation EMEA/H/C/966/IB/9
Updated with Decision(2012)597 of 30/01/2012
01/02/2012 Centralised - Variation (2012)597 of 30/01/2012
22/03/2012 Centralised - Variation EMEA/H/C/966/WS/219 (2012)1929 of 19/03/2012
25/05/2012 Centralised - Variation EMEA/H/C/966/WS/240 (2012)3465 of 22/05/2012
23/08/2012 Centralised - Variation EMEA/H/C/966/FU/20 (2012)5987 of 22/08/2012
10/09/2013 Centralised - Variation EMEA/H/C/966/II/23 (2013)5866 of 09/09/2013
27/09/2013 Centralised - Renewal EMEA/H/C/966/R/22 (2013)6340 of 25/09/2013
17/01/2014 Centralised - Variation EMEA/H/C/966/IB/25