EMEA-002370-PIP03-22 - paediatric investigation plan

pemigatinib

Key facts

• Invented name:
  Pemazyre
• Active Substance:
  pemigatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0472/2022
• PIP number:
  EMEA-002370-PIP03-22
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Incyte Biosciences Distribution B.V.

  E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2022

Decision

P/0472/2022 : EMA decision of 1 December 2022 on the granting of a product specific waiver for pemigatinib (Pemazyre), (EMEA-002370-PIP03-22)

Reference Number: EMA/897884/2022