EMEA-000777-PIP01-09-M05 - paediatric investigation plan

Artemether

lumefantrine

Key facts

• Invented name:
  Riamet
• Active Substance:
  • Artemether
  • lumefantrine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0118/2015
• PIP number:
  EMEA-000777-PIP01-09-M05
• Pharmaceutical form(s):
  • Tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  Treatment of Plasmodium falciparum malaria
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

  United Kingdom; Tel. [phone]; Fax [phone]; Email: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/06/2015
• Compliance procedure number:
  EMEA-C-000777-PIP01-09-M05
• Compliance opinion date:
  09/10/2015
• Compliance outcome:
  Positive

Decision

P/0118/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for artemether / lumefantrine (Riamet), (EMEA-000777-PIP01-09-M05)

AdoptedReference Number: EMA/300785/2015