Dexamethasone - paediatric investigation plan

dexamethasone

Key facts

• Active substance:
  dexamethasone
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/68/2008
• PIP number:
  Dexamethasone
• Pharmaceutical form(s):
  Intravitreal implant in an applicator
• Condition(s) / indication(s):
  Other retinal vascular occlusion
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/08/2008
• Compliance check done:
  No

Decision

P/68/2008: European medicines agency decision of 15 August 2008 on the application for product specific waiver for dexamethasone (EMEA-000198 PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parl...

Adopted Reference Number: EMEA/423051/2008