EMA/PE/0000241152 - paediatric investigation plan

chloroprocaine hydrochloride

Key facts

• Invented name:
  Ampres
• Active substance:
  chloroprocaine hydrochloride
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000241152
• PIP number:
  EMA/PE/0000241152
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Peripheral nerve block (local anaesthesia by perineural injection)
• Route(s) of administration:
  Perineural use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/04/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000241152 : EMA decision of 24 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for chloroprocaine hydrochloride (Ampres, associated names: Clorotekal, Decelex)

Adopted Reference Number: EMADOC-1700519818-2068697