EMEA-002759-PIP01-19 - paediatric investigation plan

olinciguat

Key facts

• Active substance:
  olinciguat
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0501/2020
• PIP number:
  EMEA-002759-PIP01-19
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/12/2020
• Compliance check done:
  No

Decision

P/0501/2020 : EMA decision of 22 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for olinciguat (EMEA-002759-PIP01-19)

Adopted Reference Number: EMA/628660/2020