Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vepacel   
Auth. number : EU/1/12/752
Active substance : Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated)
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: Active immunisation against H5N1 subtype of influenza A virus.
This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains.
Marketing Authorisation Holder: Nanotherapeutics Bohumil, s.r.o.
Bohumil 138, 28163 Jevany, Česká republika
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
21/02/2012 Centralised - Authorisation EMEA/H/C/2089 (2012)1177 of 17/02/2012
08/10/2012 Centralised - Variation EMEA/H/C/2089/II/2 (2012)7107 of 04/10/2012
13/08/2013 Centralised - Variation EMEA/H/C/2089/IB/8
Updated with Decision(2013)8507 of 25/11/2013
27/11/2013 Centralised - 2-Monthly update EMEA/H/C/2089/II/7 (2013)8507 of 25/11/2013
02/06/2015 Centralised - Variation EMEA/H/C/2089/IAin/12
Updated with Decision(2015)8638 of 30/11/2015
02/12/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2089/T/13 (2015)8638 of 30/11/2015