MHRA-101028-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)
Invented Name
Vaxchora
PIP Number MHRA-101028-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Powder for oral suspension
  • Age-appropriate oral liquid dosage form
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of cholera
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR).pdf
Published Date 19/12/2023