EMEA-002696-PIP02-21 - paediatric investigation plan

Parsaclisib (as hydrochloride)

Key facts

• Active Substance:
  Parsaclisib (as hydrochloride)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0085/2022
• PIP number:
  EMEA-002696-PIP02-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of autoimmune haemolytic anaemia
• 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:
  11/03/2022

Decision

P/0085/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for parsaclisib (as hydrochloride) (EMEA-002696-PIP02-21)

AdoptedReference Number: EMA/99627/2022