EMEA-003255-PIP01-22 - paediatric investigation plan

lidocaine hydrochloride

Key facts

• Active substance:
  lidocaine hydrochloride
• Therapeutic area:
  Pain
• Decision number:
  P/0419/2022
• PIP number:
  EMEA-003255-PIP01-22
• Pharmaceutical form(s):
  Dental gel
• Condition(s) / indication(s):
  Local anaesthesia
• Route(s) of administration:
  Oromucosal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0419/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for lidocaine (hydrochloride monohydrate) (EMEA-003255- PIP01-22)

Adopted Reference Number: EMA/824709/2022