MHRA-100978-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Genetically detoxified Pertussis Toxin (PTgen) and Pertussis Filamentous Haemagglutinin (FHA)
Invented Name
  • Pertagen
  • Pertagen
  • Pertagen
  • Pertagen aPgen
PIP Number MHRA-100978-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of Pertussis disease
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Genetically detoxified Pertussis Toxin (PTgen) andPertussis Filamentous Haemagglutinin (FHA).pdf
Published Date 30/01/2024