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
Yes
Compliance Check Decision Date
Compliance opinion date
10/04/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100116-PIP01-21-M03-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IVACAFTORTEZACAFTORELEXACAFTOR.pdf
Published Date 14/04/2026