Penbraya
Withdrawn
This medicine's authorisation has been withdrawn
meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 20 January 2025, the European Commission withdrew the marketing authorisation for Penbraya (meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)) in the European Union (EU).
The withdrawal was at the request of the marketing authorisation holder, Pfizer Europe MA EEIG, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Penbraya was granted marketing authorisation in the EU on 14 November 2024 for the “active immunisation of individuals 10 years of age and older to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y. The use of this vaccine should be in accordance with official recommendations.” The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Penbraya is updated to indicate that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Penbraya
- Active substance
- Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
- Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
- Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid
- Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid
- Neisseria meningitidis group B fHBP protein subfamily A
- Neisseria meningitidis group B fHBP protein subfamily B
- International non-proprietary name (INN) or common name
- meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)
- Therapeutic area (MeSH)
- Meningitis, Meningococcal
- Anatomical therapeutic chemical (ATC) code
- J07AH11
Pharmacotherapeutic group
Vaccines, meningococcal vaccinesTherapeutic indication
Penbraya is indicated for active immunisation of individuals 10 years of age and older to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y.
The use of this vaccine should be in accordance with official recommendations.
News on Penbraya
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