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

Artenimol
piperaquine phosphate anhydride
PIPHuman

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
Contact for public enquiries

Alfasigma SpA

Tel. +39 0691393657
E-mail: giulia.bruno@alfasigma.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000153-PIP01-07-M05
Compliance opinion date
Compliance outcome
Positive

Decision

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