Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pandemrix   
Auth. number : EU/1/08/452
INN : Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)
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 caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary.
Pandemrix should be used in accordance with Official Guidance.
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique

  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
22/05/2008 Centralised - Authorisation EMEA/H/C/832 (2008)2156 of 20/05/2008
31/07/2008 Centralised - Variation EMEA/H/C/832/IA/2
Updated with Decision(2009)3133 of 21/04/2009
15/12/2008 Centralised - Variation EMEA/H/C/832/II/1
23/04/2009 Centralised - Variation (2009)3133 of 21/04/2009
01/07/2009 Centralised - Variation EMEA/H/C/832/II/10
01/07/2009 Centralised - Variation EMEA/H/C/832/II/9
14/07/2009 Centralised - Variation EMEA/H/C/832/II/4, 5, 6 (2009)5694 of 10/07/2009
04/09/2009 Centralised - Variation EMEA/H/C/832/II/11
04/09/2009 Centralised - Variation EMEA/H/C/832/II/12
14/09/2009 Centralised - Variation EMEA/H/C/832/IB/14
30/09/2009 Centralised - Variation EMEA/H/C/832/PU/17 (2009)7587 of 29/09/2009
05/10/2009 Centralised - Variation EMEA/H/C/832/II/8
05/10/2009 Centralised - Variation EMEA/H/C/832/II/15
13/10/2009 Centralised - Variation EMEA/H/C/832/IB/16
26/10/2009 Centralised - Variation EMEA/H/C/832/II/20
30/10/2009 Centralised - Variation EMEA/H/C/832/II/18
12/11/2009 Centralised - Variation EMEA/H/C/832/II/19 (2009)8999 of 11/11/2009
17/11/2009 Centralised - Variation EMEA/H/C/832/II/21
17/11/2009 Centralised - Variation EMEA/H/C/832/II/22
30/11/2009 Centralised - Variation EMEA/H/C/832/II/23, 24, 25, 26 (2009)9652 of 27/11/2009
04/12/2009 Centralised - Variation EMEA/H/C/832/II/27
11/12/2009 Centralised - Variation EMEA/H/C/832/II/28 (2009)10143 of 09/12/2009
18/12/2009 Centralised - Variation EMEA/H/C/832/II/30
23/12/2009 Centralised - Variation EMEA/H/C/832/II/32, 34 (2009)10741 of 22/12/2009
04/01/2010 Centralised - Variation EMEA/H/C/832/II/31
13/01/2010 Centralised - Variation EMEA/H/C/832/II/35
25/01/2010 Centralised - Variation EMEA/H/C/832/II/36
09/02/2010 Centralised - Variation EMEA/H/C/832/II/37
10/02/2010 Centralised - Variation EMEA/H/C/832/II/33 (2010)890 of 08/02/2010
13/08/2010 Centralised - Variation EMEA/H/C/832/SW/41 (2010)5745 of 12/08/2010
14/09/2010 Centralised - Variation EMEA/H/C/832/II/42, 43 (2010)6326 of 10/09/2010
28/10/2010 Centralised - Variation EMEA/H/C/832/II/44
06/12/2010 Centralised - Variation EMEA/H/C/832/IB/47
26/01/2011 Centralised - Variation EMEA/H/C/832/II/46 (2011)416 of 21/01/2011
02/03/2011 Centralised - Variation EMEA/H/C/832/IG/33/G
18/03/2011 Centralised - Variation EMEA/H/C/832/IG/52/G
31/03/2011 Centralised - Variation EMEA/H/C/832/II/48 (2011)2089 of 24/03/2011
23/06/2011 Referral EMEA/H/C/832/A-20/45, EMEA/H/C/832/II/50 (2011)4460 of 17/06/2011
22/08/2011 Centralised - Variation EMEA/H/C/832/II/51 (2011)6048 of 18/08/2011
21/09/2011 Referral EMEA/H/C/832/A-20/45 (2011)6593 of 16/09/2011
07/11/2011 Centralised - Variation EMEA/H/C/832/II/52 (2011)8059 of 03/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/832/WS/153 (2011)9959 of 19/12/2011
26/10/2012 Centralised - Variation EMEA/H/C/832/II/60 (2012)7667 of 24/10/2012
22/03/2013 Centralised - Variation EMEA/H/C/832/IB/64
Updated with Decision(2014)1860 of 14/03/2014
25/07/2013 Centralised - Variation EMEA/H/C/832/II/61
Updated with Decision(2014)1860 of 14/03/2014
18/03/2014 Centralised - Variation (2014)1860 of 14/03/2014
10/04/2014 Centralised - Variation EMEA/H/C/832/IB/71
Updated with Decision(2014)5494 of 28/07/2014
30/07/2014 Centralised - Variation EMEA/H/C/832/II/68, 69 (2014)5494 of 28/07/2014