EMEA-000153-PIP01-07-M05

Key facts

Invented name
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
Compliance procedure number
EMEA-C-000153-PIP01-07-M05
Compliance opinion date
26/01/2018
Compliance outcome
positive

Decision

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