EMEA-002198-PIP01-21-M01 - paediatric investigation plan

alisitol

retinyl palmitate

zinc gluconate

Key facts

• Active substance:
  • alisitol
  • retinyl palmitate
  • zinc gluconate
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0511/2023
• PIP number:
  EMEA-002198-PIP01-21-M01
• Pharmaceutical form(s):
  Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of microvillus inclusion disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0511/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for zinc gluconate / alisitol / retinyl palmitate (EMEA-002198-PIP01-21-M01)

Reference Number: EMA/554245/2023