EMEA-000153-PIP01-07-M05 - paediatric investigation plan

artenimol

piperaquine phosphate anhydride

Key facts

• Invented name:
  • Eurartesim
  • Eurartesim
• Active substance:
  • artenimol
  • piperaquine phosphate anhydride
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0002/2018
• PIP number:
  EMEA-000153-PIP01-07-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  Treatment of uncomplicated malaria caused by Plasmodium falciparum
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/01/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000153-PIP01-07-M05
• Compliance opinion date:
  26/01/2018
• Compliance outcome:
  Positive

Decision

P/0002/2018: EMA decision of 4 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for artenimol / piperaquine phosphate anhydride (Eurartesim), (EMEA-000153-PIP01-07-M05)

Reference Number: EMA/517/2018