EMEA-003431-PIP01-23 - paediatric investigation plan

clotrimazole

Key facts

• Active substance:
  clotrimazole
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0332/2023
• PIP number:
  EMEA-003431-PIP01-23
• Pharmaceutical form(s):
  Ear drops, solution
• Condition(s) / indication(s):
  Treatment of acute otitis externa
• Route(s) of administration:
  Auricular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2023
• Compliance check done:
  No

Decision

P/0332/2023 : EMA decision of 9 August 2023 on the granting of a product specific waiver for clotrimazole (EMEA-003431-PIP01-23)

Reference Number: EMA/347894/2023