EMEA-001729-PIP02-18 - paediatric investigation plan

cenegermin

Key facts

• Invented name:
  Oxervate
• Active substance:
  cenegermin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0118/2019
• PIP number:
  EMEA-001729-PIP02-18
• 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:
  17/04/2019
• Compliance check done:
  Ei

Decision

P/0118/2019: EMA decision of 17 April 2019 on the granting of a product-specific waiver for cenegermin (Oxervate), (EMEA-001729-PIP02-18)

Adopted Reference Number: EMA/182620/2019