EMEA-002164-PIP01-17-M02 - paediatric investigation plan

(RS)-Bacoflen

D-Sorbitol (PXT3003)

naltrexone hydrochloride

Key facts

• Active substance:
  • (RS)-Bacoflen
  • D-Sorbitol (PXT3003)
  • naltrexone hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0030/2020
• PIP number:
  EMEA-002164-PIP01-17-M02
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of Charcot-Marie-Tooth disease Type 1A
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/01/2020
• Compliance check done:
  No

Decision

P/0030/2020: EMA decision of 29 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for (RS)-baclofen / Naltrexone HCl / D-Sorbitol (PXT3003) (EMEA-002164-PIP01-17-M02)

Adopted Reference Number: EMA/12127/2020