EMEA-002696-PIP03-22 - paediatric investigation plan

Parsaclisib (hydrochloride)

Key facts

• Active Substance:
  Parsaclisib (hydrochloride)
• Therapeutic area:
  Oncology
• Decision number:
  P/0240/2022
• PIP number:
  EMEA-002696-PIP03-22
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of myelofibrosis
• 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:
  08/07/2022

Decision

P/0240/2022: EMA decision of 8 July 2022 on the granting of a product specific waiver for parsaclisib (hydrochloride) (EMEA-002696-PIP03-22)

Reference Number: EMA/602335/2022