EMEA-003366-PIP01-22 - paediatric investigation plan

ciclosporin

Key facts

• Active substance:
  ciclosporin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0140/2023
• PIP number:
  EMEA-003366-PIP01-22
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of dry eye disease
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2023
• Compliance check done:
  No

Decision

P/0140/2023 : EMA decision of 14 April 2023 on the granting of a product specific waiver for ciclosporin (EMEA-003366-PIP01-22)

Reference Number: EMA/127645/2023