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

Key Facts

PIPS Key Facts
Active Substance
Invented Name
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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IVACAFTORTEZACAFTORELEXACAFTOR.pdf
Published Date 24/06/2024