MHRA-100116-PIP01-21-M03 (update)

Key Facts

Active Substance
  • IVACAFTOR
  • TEZACAFTOR
  • ELEXACAFTOR
Invented Name
Kaftrio
PIP Number MHRA-100116-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet Age-appropriate solid dosage form (Granules)
Therapeutic area
Therapeutic area:
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Conditions / Indications
Conditions / Indications:
  • Treatment of Cystic Fibrosis
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):IVACAFTORTEZACAFTORELEXACAFTOR.pdf
Published Date 24/06/2024