MHRA-100119-PIP01-21-M01 (update)

Key Facts

Active Substance
  • TEZACAFTOR
  • IVACAFTOR
Invented Name
  • Symkevi
  • Symkevi
  • Symkevi
PIP Number MHRA-100119-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Therapeutic area
  • Pneumology - Allergology
  • Other: Congenital, hereditary and neonatal diseases and abnormalities
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 +18776348789
  • 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TEZACAFTOR;IVACAFTOR.pdf
Published Date 18/03/2022