Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Imvanex   
Auth. number : EU/1/13/855
INN : modified vaccinia ankara virus
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BX - Other viral vaccines
Chemical substance: J07BX - Other viral vaccines
(See WHO ATC Index)
Indication: Active immunisation against smallpox in adults
Marketing Authorisation Holder: Bavarian Nordic A/S
Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark
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
05/08/2013 Centralised - Authorisation EMEA/H/C/2596 (2013)5144 of 31/07/2013
19/12/2013 Rectificative Decision (2013)9659 of 17/12/2013
26/06/2014 Centralised - Variation EMEA/H/C/2596/II/4
Updated with Decision(2014)6087 of 22/08/2014
26/08/2014 Centralised - Modification EMEA/H/C/2596/PSUV/7 (2014)6087 of 22/08/2014
25/09/2014 Centralised - Variation EMEA/H/C/2596/II/8/G
20/11/2014 Centralised - Annual reassessment EMEA/H/C/2596/S/10