EMEA-000639-PIP03-16-M02 - paediatric investigation plan

Chloroprocaine hydrochloride

Key facts

• Invented name:
  Ampres
• Active Substance:
  Chloroprocaine hydrochloride
• Therapeutic area:
  Anaesthesiology
• Decision number:
  P/0334/2022
• PIP number:
  EMEA-000639-PIP03-16-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Peripheral nerve block (local anaesthesia by perineural injection)
• Route(s) of administration:
  Perineural use
• Contact for public enquiries:

  Sintetica GmbH

  Tel. [phone]; E-mail: [e-mail], [e-mail]

• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  11/08/2022

Decision

P/0334/2022 : EMA decision of 10 August 2022 on the refusal of a modification of an agreed paediatric investigation plan for chloroprocaine (hydrochloride) (Ampres), (EMEA-000639-PIP03-16-M02)

AdoptedReference Number: EMA/671995/2022