EMEA-000365-PIP01-08-M12 - paediatric investigation plan

oseltamivir (phosphate)

Key facts

• Invented name:
  • Tamiflu
  • Tamiflu
• Active substance:
  oseltamivir (phosphate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0241/2021
• PIP number:
  EMEA-000365-PIP01-08-M12
• Pharmaceutical form(s):
  • Capsule, hard
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment and prevention of influenza
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/06/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000365-PIP01-08-M12
• Compliance opinion date:
  15/10/2021
• Compliance outcome:
  Positive

Decision

P/0241/2021 : EMA decision of 25 June 2021 on the acceptance of a modification of an agreed paediatric investigation plan for oseltamivir (phosphate) (Tamiflu) (EMEA-000365-PIP01-08-M12)

Adopted Reference Number: EMA/342337/2021