Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Imvanex   
Auth. number : EU/1/13/855
Active substance : 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
The use of this vaccine should be in accordance with official recommendations.
Marketing Authorisation Holder: Bavarian Nordic A/S
Hejreskovvej 10a, 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 PSUSA - 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
Updated with Decision(2015)6534 of 18/09/2015
20/11/2014 Centralised - Annual reassessment EMEA/H/C/2596/S/10
03/08/2015 Centralised - Variation EMEA/H/C/2596/IB/16
Updated with Decision(2015)6534 of 18/09/2015
22/09/2015 Centralised - Yearly update (2015)6534 of 18/09/2015
28/01/2016 Centralised - Annual reassessment EMEA/H/C/2596/S/7
21/04/2016 Centralised - Variation EMEA/H/C/2596/II/20
Updated with Decision(2016)5368 of 12/08/2016
26/05/2016 Centralised - Variation EMEA/H/C/2596/II/18
Updated with Decision(2016)5368 of 12/08/2016
17/08/2016 Centralised - Yearly update (2016)5368 of 12/08/2016
23/11/2016 Centralised - Variation EMEA/H/C/2596/IB/24
Updated with Decision(2017)7739 of 15/11/2017
08/02/2017 Centralised - Annual reassessment EMEA/H/C/2596/S/22 (2017)790 of 06/02/2017
11/04/2017 Centralised - Variation EMEA/H/C/2596/IB/26
Updated with Decision(2017)7739 of 15/11/2017
14/09/2017 Centralised - Variation EMEA/H/C/2596/II/27
Updated with Decision(2017)7739 of 15/11/2017
17/11/2017 Centralised - Yearly update (2017)7739 of 15/11/2017