EMEA-003520-PIP01-23 - paediatric investigation plan

motugivatrep

Key facts

• Active substance:
  motugivatrep
• Therapeutic area:
  Eye disorders
• Decision number:
  P/0066/2024
• PIP number:
  EMEA-003520-PIP01-23
• Pharmaceutical form(s):
  Eye drops, suspension
• Condition(s) / indication(s):
  Treatment of dry eye disease
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/03/2024
• Compliance check done:
  No

Decision

P/0066/2024 : EMA decision of 8 March 2024 on the granting of a product specific waiver for motugivatrep, (EMEA-003520-PIP01-23)

Adopted Reference Number: EMA/87529/2024