Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Nimenrix   
Auth. number : EU/1/12/767
Active substance : 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 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
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 PSUSA - Modification EMEA/H/C/2226/PSUV/20 (2014)5255 of 18/07/2014
20/08/2014 Centralised - Variation EMEA/H/C/2226/IB/28
Updated with Decision(2015)5458 of 28/07/2015
26/03/2015 Centralised - Variation EMEA/H/C/2226/II/38
Updated with Decision(2015)5458 of 28/07/2015
26/03/2015 Centralised - Variation EMEA/H/C/2226/II/40
Updated with Decision(2015)5458 of 28/07/2015
31/07/2015 Centralised - Yearly update (2015)5458 of 28/07/2015
18/12/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2226/T/47 (2015)9635 of 16/12/2015
15/01/2016 Centralised - Variation EMEA/H/C/2226/IA/52
Updated with Decision(2016)5088 of 29/07/2016
03/08/2016 Centralised - 2-Monthly update EMEA/H/C/2226/II/45 (2016)5088 of 29/07/2016
24/08/2016 Centralised - 2-Monthly update EMEA/H/C/2226/II/53 (2016)5484 of 22/08/2016
15/09/2016 Centralised - Variation EMEA/H/C/2226/II/58
Updated with Decision(2016)8653 of 12/12/2016
14/12/2016 Centralised - 2-Monthly update EMEA/H/C/2226/II/49 (2016)8653 of 12/12/2016
20/02/2017 Centralised - Renewal EMEA/H/C/2226/R/59 (2017)1216 of 16/02/2017
17/08/2017 Centralised - Notification EMEA/H/C/2226/N/68