EMEA-002883-PIP02-22 - paediatric investigation plan

trimodulin

Key facts

• Active substance:
  trimodulin
• Therapeutic area:
  • Infectious diseases
  • Neonatology-Paediatric Intensive Care
• Decision number:
  P/0372/2023
• PIP number:
  EMEA-002883-PIP02-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0372/2023 : EMA decision of 8 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for trimodulin (EMEA-002883-PIP02-22)

Reference Number: EMA/384196/2023