Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Nimenrix   
Auth. number : EU/1/12/767
INN : Meningococcal group A, C, W-135 and Y conjugate vaccine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07A - Bacterial vaccines
Chemical subgroup: J07AH - Meningococcal vaccines
Chemical substance: J07AH08 - Meningococcus, tetravalent purified polysaccharides antigen conjugated
(See WHO ATC Index)
Indication: Nimenrix is indicated for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135 and Y
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique

  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
25/04/2012 Centralised - Authorisation EMEA/H/C/2226 (2012)2813 of 20/04/2012
17/05/2013 Centralised - Variation EMEA/H/C/2226/IG/304
Updated with Decision(2014)2823 of 23/04/2014
24/10/2013 Centralised - Variation EMEA/H/C/2226/II/14
Updated with Decision(2014)2823 of 23/04/2014
18/12/2013 Centralised - Variation EMEA/H/C/2226/IA/19/G
Updated with Decision(2014)2823 of 23/04/2014
20/02/2014 Centralised - Variation EMEA/H/C/2226/II/9
Updated with Decision(2014)2823 of 23/04/2014
25/04/2014 Centralised - Yearly update (2014)2823 of 23/04/2014
22/07/2014 Centralised - Modification EMEA/H/C/2226/PSUV/20 (2014)5255 of 18/07/2014
20/08/2014 Centralised - Variation EMEA/H/C/2226/IB/28