Penbraya

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Withdrawn

This medicine's authorisation has been withdrawn

meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)
MedicineHumanWithdrawn
  • 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The European Public Assessment Report (EPAR) for Penbraya is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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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).

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dansk (DA) (86.3 KB - PDF)

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slovenščina (SL) (85.44 KB - PDF)

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Suomi (FI) (100.7 KB - PDF)

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svenska (SV) (95.37 KB - PDF)

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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 vaccines 

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/006165
Marketing authorisation holder
Pfizer Europe MA EEIG 

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Opinion adopted
19/09/2024
Marketing authorisation issued
14/11/2024
Withdrawal of marketing authorisation
20/01/2025

Assessment history

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