EMEA-002198-PIP01-21 - paediatric investigation plan

Alisitol

Retinyl Palmitate

zinc gluconate

Key facts

• Active Substance:
  • Alisitol
  • Retinyl Palmitate
  • zinc gluconate
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0171/2022
• PIP number:
  EMEA-002198-PIP01-21
• Pharmaceutical form(s):
  Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of microvillus inclusion disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Vanessa Research Magyarorszag Kft/Vanessa Research Hungary ltd

  Email: [e-mail] ; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/05/2022

Decision

P/0171/2022 : EMA decision of 13 May 2022 on the agreement of a paediatric investigation plan for zinc gluconate / alisitol / retinyl palmitate (EMEA-002198-PIP01-21)

AdoptedReference Number: EMA/204214/2022