EMEA-002423-PIP01-18 - paediatric investigation plan

dexamethasone

Key facts

• Active substance:
  dexamethasone
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0210/2019
• PIP number:
  EMEA-002423-PIP01-18
• Pharmaceutical form(s):
  Ophthalmic insert
• Condition(s) / indication(s):
  Treatment of postoperative pain and inflammation associated with ophthalmic surgery
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  12/06/2019
• Compliance check done:
  No

Decision

P/0210/2019: EMA decision of 12 June 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for dexamethasone (EMEA-002423-PIP01-18)

Adopted Reference Number: EMA/288637/2019