EMA/PE/0000225592 - paediatric investigation plan

ulixacaltamide (hydrochloride)

Key facts

• Active substance:
  ulixacaltamide (hydrochloride)
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000225592
• PIP number:
  EMA/PE/0000225592
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of essential tremor
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000225592 : EMA decision of 3 January 2025 on the granting of a product specific waiver for ulixacaltamide hydrochloride

Adopted Reference Number: EMADOC-1700519818-1799922