EMEA-003246-PIP01-22 - paediatric investigation plan

Golidocitinib

Key facts

• Active Substance:
  Golidocitinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0386/2022
• PIP number:
  EMEA-003246-PIP01-22
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of peripheral T cell lymphoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2022

Decision

P/0386/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for golidocitinib (EMEA-003246-PIP01-22)

AdoptedReference Number: EMA/675794/2022