EMA/PE/0000222352 - paediatric investigation plan

clostridium botulinum a, strain pm-12759 hall-a, botulin a conjugated to protein ntnh, hemagglutinin ha17, hemagglutinin ha34, hemagglutinin ha23 and hemagglutinin ha48

Key facts

• Active substance:
  clostridium botulinum a, strain pm-12759 hall-a, botulin a conjugated to protein ntnh, hemagglutinin ha17, hemagglutinin ha34, hemagglutinin ha23 and hemagglutinin ha48
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000222352
• PIP number:
  EMA/PE/0000222352
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of upper limb essential tremor
• Route(s) of administration:
  • Intramuscular use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000222352 : EMA decision of 16 May 2025 on granting of product specific waiver for Clostridium botulinum A, strain PM-12759 Hall-A, botulin A conjugated to protein NTNH, hemagglutinin HA17, hemagglutinin HA34, hemagglutinin HA23 and HA48

Adopted Reference Number: EMADOC-1700519818-2113227