MHRA-100844-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • IVACAFTOR
Invented Name
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
PIP Number MHRA-100844-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Granules in sachet
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
  • Vertex Pharmaceuticals (Europe) Limited
  • Country United Kingdom
  • Tel 0018776348789
  • Email medicalinfo@vrtx.com
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
07/06/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100844-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IVACAFTOR.pdf
Published Date 24/08/2023