Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Celvapan   
Auth. number : EU/1/08/506
INN : Pandemic influenza vaccine (H1N1) (whole virion, Vero cell derived, inactivated) A/California/07/2009 (H1N1)v
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: J07BB01 - Influenza, inactivated, whole virus
(See WHO ATC Index)
Indication: Prophylaxis of influenza caused by A(H1N1)v 2009 virus.
Marketing Authorisation Holder: Baxter AG
Industriestraße 67, A-1221 Wien, Österreich

  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
06/03/2009 Centralised - Authorisation EMEA/H/C/982 (2009)1647 of 04/03/2009
01/09/2009 Centralised - Variation EMEA/H/C/982/II/1 (2009)6716 of 27/08/2009
08/10/2009 Centralised - Variation EMEA/H/C/982/PU/2 (2009)7784 of 06/10/2009
28/10/2009 Centralised - Variation EMEA/H/C/982/II/3, 4
12/11/2009 Centralised - Variation EMEA/H/C/982/II/6 (2009)8997 of 11/11/2009
23/12/2009 Centralised - Variation EMEA/H/C/982/II/9 (2009)10740 of 22/12/2009
11/02/2010 Centralised - Variation EMEA/H/C/982/II/11
05/03/2010 Centralised - Variation EMEA/H/C/982/II/10
01/04/2010 Centralised - Variation EMEA/H/C/982/II/8, 12 (2010)2269 of 30/03/2010
08/07/2010 Centralised - Variation EMEA/H/C/982/II/5, 7, 13 (2010)4792 of 05/07/2010
13/08/2010 Centralised - Variation EMEA/H/C/982/SW/14 (2010)5746 of 12/08/2010
20/05/2011 Centralised - Variation EMEA/H/C/982/II/17 (2011)3604 of 18/05/2011
22/06/2011 Centralised - Variation EMEA/H/C/982/IB/18
Updated with Decision(2012)487 of 24/01/2012
26/01/2012 Centralised - Variation (2012)487 of 24/01/2012
30/07/2012 Centralised - Variation EMEA/H/C/982/IB/20
Updated with Decision(2012)5472 of 26/07/2012
30/07/2012 Centralised - Variation EMEA/H/C/982/II/19/G (2012)5472 of 26/07/2012
21/06/2013 Centralised - Variation EMEA/H/C/982/IAin/26
Updated with Decision(2014)4264 of 19/06/2014
26/05/2014 Centralised - Variation EMEA/H/C/982/N/28
Updated with Decision(2014)4264 of 19/06/2014
23/06/2014 Centralised - Variation (2014)4264 of 19/06/2014