EMEA-000198-PIP04-10 - paediatric investigation plan

dexamethasone

Key facts

• Active Substance:
  dexamethasone
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/139/2010
• PIP number:
  EMEA-000198-PIP04-10
• Pharmaceutical form(s):
  Intravitreal implant in applicator
• Condition(s) / indication(s):
  Treatment of diabetic macular oedema
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/07/2010

Decision

P/139/2010: European Medicines Agency decision of 30 July 2010 on the granting of a product specific waiver for dexamethasone (EMEA-000198-PIP04-10) in accordance with Regulation (EC) No 1901/2006 of the European Parlia...

AdoptedReference Number: EMA/425487/2010