Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ixiaro   
Auth. number : EU/1/08/501
INN : Japanese Encephalitis vaccine (inactivated, adsorbed)
Orphan status based on designation EU/3/05/348 added on 02/04/2009
Orphan status based on designation EU/3/05/348 removed or expired on 02/04/2009
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BA - Encephalitis vaccines
Chemical substance: J07BA02 - Encephalitis, japanese, inactivated, whole virus
(See WHO ATC Index)
Indication: IXIARO is indicated for active immunization against Japanese encephalitis for adults. Extension of indication of Ixiaro to the paediatric segment (2 months of age and older).
Marketing Authorisation Holder: Valneva Austria GmbH
Campus Vienna Biocenter 3, A-1030 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
02/04/2009 Centralised - (orphan status)
02/04/2009 Centralised - Authorisation EMEA/H/C/963 (2009)2604 of 31/03/2009
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/II/3
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/II/4
30/10/2009 Centralised - Variation EMEA/H/C/963/II/1, 2 (2009)8505 of 28/10/2009
25/03/2010 Centralised - Variation EMEA/H/C/963/II/5 (2010)2023 of 23/03/2010
27/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IB/9/G
03/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/II/6/G
03/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IB/10/G
04/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/II/7
31/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/II/8
21/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IA/12
16/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/II/11/G
30/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IB/15
03/12/2010 Centralised - Variation EMEA/H/C/963/IB/14/G
Updated with Decision(2011)6937 of 22/09/2011
09/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IB/13/G
14/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IB/17/G
03/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/II/16
10/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IB/19/G
18/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/963/IB/20
31/08/2011 Centralised - Notification EMEA/H/C/963/N/18
Updated with Decision(2011)6937 of 22/09/2011
26/09/2011 Centralised - Variation (2011)6937 of 22/09/2011
06/02/2012 Centralised - Notification EMEA/H/C/963/N/33
Updated with Decision(2012)3584 of 25/05/2012
31/05/2012 Referral EMEA/H/C/963/A-20/29 (2012)3584 of 25/05/2012
05/02/2013 Centralised - Variation EMEA/H/C/963/II/39/G (2013)645 of 01/02/2013
29/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/963/T/52 (2013)3229 of 27/05/2013
25/10/2013 Centralised - Variation EMEA/H/C/963/IAin/58/G
Updated with Decision(2014)1481 of 28/02/2014
04/03/2014 Centralised - Renewal EMEA/H/C/963/R/55 (2014)1481 of 28/02/2014