EMEA-002012-PIP01-16-M05 - paediatric investigation plan

Mexiletine hydrochloride

Key facts

• Invented name:
  Namuscla
• Active substance:
  Mexiletine hydrochloride
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0227/2024
• PIP number:
  EMEA-002012-PIP01-16-M05
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral solution
• Condition(s) / indication(s):
  Treatment of myotonic disorders
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2024
• Compliance check done:
  Ne

Decision

P/0227/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mexiletine (hydrochloride) (Namuscla), (EMEA-002012-PIP01-16-M05)

Adopted Reference Number: EMA/291493/2024