EMEA-000816-PIP02-10-M03 - paediatric investigation plan

magnesium sulfate heptahydrate (BLI800)

Sodium sulphate anhydrou

potassium sulfate

Key facts

• Invented name:
  Izinova (and associated names)
• Active Substance:
  • magnesium sulfate heptahydrate (BLI800)
  • Sodium sulphate anhydrou
  • potassium sulfate
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0159/2022
• PIP number:
  EMEA-000816-PIP02-10-M03
• Pharmaceutical form(s):
  Concentrate for oral solution
• Condition(s) / indication(s):
  Diagnostic of organic and/or functional bowel diseases
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022

Decision

P/0159/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for magnesium sulphate heptahydrate / potassium sulphate / sodium sulphate anhydrous... (EMEA-000816-PIP02-10-M03)

AdoptedReference Number: EMA/169200/2022