Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Optaflu   
Auth. number : EU/1/07/394
INN : Influenza vaccine (surface antigen, inactivated, prepared in cell culture)
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 for adults, especially in those who run an increased risk of associated complications.
Marketing Authorisation Holder: Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

  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 continues to be 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
05/06/2007 Centralised - Authorisation EMEA/H/C/758 (2007)2424 of 01/06/2007
16/01/2008 Centralised - Variation EMEA/H/C/758/SU/2 (2008)231 of 14/01/2008
14/02/2008 Centralised - Variation EMEA/H/C/758/IA/4
20/02/2008 Centralised - Variation EMEA/H/C/758/IA/6
26/02/2008 Centralised - Variation EMEA/H/C/758/II/3
05/03/2008 Centralised - Variation EMEA/H/C/758/IA/9
05/03/2008 Centralised - Variation EMEA/H/C/758/IA/10
06/03/2008 Centralised - Variation EMEA/H/C/758/IB/7
29/05/2008 Centralised - Variation EMEA/H/C/758/IA/13
03/07/2008 Centralised - Variation EMEA/H/C/758/II/8
14/07/2008 Centralised - Variation EMEA/H/C/758/II/11 (2008)3660 of 10/07/2008
25/09/2008 Centralised - Variation EMEA/H/C/758/IA/14
02/10/2008 Centralised - Variation EMEA/H/C/758/II/12
13/02/2009 Centralised - Variation EMEA/H/C/758/IA/15
25/03/2009 Centralised - Variation EMEA/H/C/758/IA/20
28/04/2009 Centralised - Variation EMEA/H/C/758/N/19
Updated with Decision(2011)1156 of 18/02/2011
28/04/2009 Centralised - Variation EMEA/H/C/758/II/18
28/04/2009 Centralised - Variation EMEA/H/C/758/II/16
16/06/2009 Centralised - Variation EMEA/H/C/758/II/17
15/10/2010 Centralised - Variation EMEA/H/C/758/IA/22/G
14/12/2010 Centralised - Variation EMEA/H/C/758/IA/21
Updated with Decision(2011)1156 of 18/02/2011
14/12/2010 Centralised - Variation EMEA/H/C/758/IA/24/G
Updated with Decision(2011)1156 of 18/02/2011
04/02/2011 Centralised - Variation EMEA/H/C/758/N/23
Updated with Decision(2011)5151 of 11/07/2011
22/02/2011 Centralised - Variation (2011)1156 of 18/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/758/IB/25
23/03/2011 Centralised - Variation EMEA/H/C/758/IB/26/G
13/05/2011 Centralised - Variation EMEA/H/C/758/IA/27/G
Updated with Decision(2011)5151 of 11/07/2011
13/07/2011 Centralised - Variation (2011)5151 of 11/07/2011
24/11/2011 Centralised - Variation EMEA/H/C/758/II/31 (2011)8684 of 22/11/2011
31/05/2012 Centralised - Renewal EMEA/H/C/758/R/33 (2012)3586 of 25/05/2012
24/09/2012 Centralised - Variation EMEA/H/C/758/FU/40 (2012)6708 of 20/09/2012
25/04/2013 Centralised - Variation EMEA/H/C/758/II/49
Updated with Decision(2013)7204 of 24/10/2013
20/06/2013 Centralised - Variation EMEA/H/C/758/IAin/55/G
Updated with Decision(2013)7204 of 24/10/2013
28/10/2013 Centralised - Variation EMEA/H/C/758/II/56 (2013)7204 of 24/10/2013
20/02/2014 Centralised - Variation EMEA/H/C/758/II/60