MHRA-100738-PIP01-22

Key Facts

Active Substance
Active Substance:
  • PEMIGATINIB
Invented Name
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
PIP Number MHRA-100738-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Tablet
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):PEMIGATINIB.pdf
Published Date 24/08/2023