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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/12/812|
|INN :||Meningococcal group B Vaccine (rDNA, component, adsorbed)|
|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: J07AH09 - Meningococcus B, multicomponent vaccine
(See WHO ATC Index)
|Indication:||Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.|
The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating. See section 5.1 for information on protection against specific group B strains.
The use of this vaccine should be in accordance with official recommendations.
|Marketing Authorisation Holder:||Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia
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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|18/01/2013||Centralised - Authorisation||EMEA/H/C/2333||(2013)218 of 14/01/2013|
|26/03/2013||Rectificative Decision||EMEA/H/C/2333||(2013)1849 of 22/03/2013|
|02/05/2013||Corrigendum||(2013)2651 of 29/04/2013|
|24/10/2013||Centralised - Variation||EMEA/H/C/2333/II/5|
|26/06/2014||Centralised - Variation||EMEA/H/C/2333/II/13|
|26/06/2014||Centralised - Variation||EMEA/H/C/2333/II/12|