EMEA-002710-PIP01-19 - paediatric investigation plan

artesunate

Key facts

• Active Substance:
  artesunate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0328/2020
• PIP number:
  EMEA-002710-PIP01-19
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of malaria
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Amivas Ireland Ltd

  E-mail: [e-mail]; Tel.: + 353 51 347 322

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/08/2020
• Compliance procedure number:
  EMEA-C-002710-PIP01-19
• Compliance opinion date:
  09/09/2022
• Compliance outcome:
  Positive

Decision

P/0328/2020 : EMA decision of 14 August 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for artesunate (EMEA-002710-PIP01-19)

AdoptedReference Number: EMA/420938/2020