EMEA-003458-PIP01-23 - paediatric investigation plan

clobetasol propionate

Key facts

• Active substance:
  clobetasol propionate
• Therapeutic area:
  Eye disorders
• Decision number:
  P/0042/2024
• PIP number:
  EMEA-003458-PIP01-23
• Pharmaceutical form(s):
  Eye drops, emulsion
• Condition(s) / indication(s):
  Treatment of ocular inflammations and manifestations associated with ocular surgery
• Route(s) of administration:
  Ocular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/02/2024
• Compliance check done:
  No

Decision

P/0042/2024 : EMA decision of 9 February 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for clobetasol propionate, (EMEA-003458-PIP01-23)

Adopted Reference Number: EMA/53064/2024