BEXSERO Suspension for injection Ref.[50804] Active ingredients: Neisseria meningitidis OMPC

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy

Product name and form

Bexsero suspension for injection in pre-filled syringe.

Meningococcal group B Vaccine (rDNA, component, adsorbed).

Pharmaceutical Form

Suspension for injection.

White opalescent liquid suspension.

Qualitative and quantitative composition

One dose (0.5 ml) contains:

Recombinant Neisseria meningitidis group B NHBA fusion protein1,2,3: 50 micrograms

Recombinant Neisseria meningitidis group B NadA protein1,2,3: 50 micrograms

Recombinant Neisseria meningitidis group B fHbp fusion protein1,2,3: 50 micrograms

Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.42: 25 micrograms

1 produced in E. coli cells by recombinant DNA technology
2 adsorbed on aluminium hydroxide (0.5 mg Al3+)
3 NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp
(factor H binding protein)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Neisseria meningitidis OMPC
List of Excipients

Sodium chloride
Histidine
Sucrose
Water for injections

For adsorbent see section 2.

Pack sizes and marketing

0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.

The tip cap and rubber plunger stopper of the pre-filled syringe are made with synthetic rubber.

Pack sizes of 1 and 10, with or without needles.

Not all pack sizes may be marketed.

Marketing authorization holder

GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy

Marketing authorization dates and numbers

EU/1/12/812/001
EU/1/12/812/002
EU/1/12/812/003
EU/1/12/812/004

Date of first authorisation: 14 January 2013
Date of latest renewal: 18 September 2017

Drugs

Drug Countries
BEXSERO Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States
 
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