EMEA-002839-PIP01-20-M01 - paediatric investigation plan

hydroxypropyl-β-cyclodextrin

Key facts

• Active Substance:
  hydroxypropyl-β-cyclodextrin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0095/2023
• PIP number:
  EMEA-002839-PIP01-20-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Niemann-Pick disease, type C
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Cyclo Therapeutics Inc.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0095/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for hydroxypropyl-β- cyclodextrin (EMEA-002839-PIP01-20-M01)

Reference Number: EMA/66794/2023