Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Intanza   
Auth. number : EU/1/08/505
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 INTANZA should be based on official recommendations.
Marketing Authorisation Holder: Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès, 69 007 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/957 (2009)1349 of 24/02/2009
14/04/2009 Centralised - Variation EMEA/H/C/957/N/1
Updated with Decision(2010)705 of 29/01/2010
03/02/2010 Centralised - Variation EMEA/H/C/957/II/3 (2010)705 of 29/01/2010
05/03/2010 Centralised - Variation EMEA/H/C/957/II/4
23/03/2010 Centralised - Variation EMEA/H/C/957/II/6
30/03/2010 Centralised - Variation EMEA/H/C/957/II/5 (2010)2173 of 26/03/2010
20/08/2010 Centralised - Variation EMEA/H/C/957/II/7 (2010)5852 of 18/08/2010
05/01/2011 Centralised - Variation EMEA/H/C/957/WS/67
23/02/2011 Centralised - Variation EMEA/H/C/957/WS/85 (2011)1183 of 21/02/2011
28/02/2011 Centralised - Variation EMEA/H/C/957/IB/WS/106
22/03/2011 Centralised - Variation EMEA/H/C/957/IB/8
05/04/2011 Centralised - Variation EMEA/H/C/957/WS/103/G
12/05/2011 Centralised - Variation EMEA/H/C/957/IB/9
Updated with Decision(2012)775 of 06/02/2012
08/02/2012 Centralised - Variation (2012)775 of 06/02/2012
21/03/2012 Centralised - Variation EMEA/H/C/957/II/WS/219 (2012)1911 of 19/03/2012
09/05/2012 Centralised - Variation EMEA/H/C/957/IB/WS/240 (2012)3144 of 07/05/2012
23/08/2012 Centralised - Variation EMEA/H/C/957/FU/21 (2012)5986 of 22/08/2012
10/09/2013 Centralised - Variation EMEA/H/C/957/II/24 (2013)5867 of 09/09/2013
26/09/2013 Centralised - Renewal EMEA/H/C/957/R/23 (2013)6311 of 24/09/2013
17/01/2014 Centralised - Variation EMEA/H/C/957/IB/26
Updated with Decision(2014)5783 of 06/08/2014
07/08/2014 Centralised - Variation EMEA/H/C/957/II/29 (2014)5783 of 06/08/2014