EMEA-000095-PIP02-21 - paediatric investigation plan

plitidepsin

Key facts

• Active substance:
  plitidepsin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0544/2021
• PIP number:
  EMEA-000095-PIP02-21
• Pharmaceutical form(s):
  Powder and solvent for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/12/2021
• Compliance check done:
  No

Decision

P/0544/2021 : EMA decision of 31 December 2021 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for plitidepsin (EMEA-000095-PIP02-21)

Reference Number: EMA/709690/2021