EMEA-000420-PIP01-10 - paediatric investigation plan

duloxetine hydrochloride

Key facts

• Invented name:
  • • Cymbalta
    • Xeristar
    • Yentreve
    • Ariclaim
  • • Ariclaim
    • Yentreve
    • Nodetrip (previously Xeristar)
    • Cymbalta
• Active Substance:
  duloxetine hydrochloride
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/268/2010
• PIP number:
  EMEA-000420-PIP01-10
• Pharmaceutical form(s):
  • Capsule, hard
  • Gastro-resistant capsule
• Condition(s) / indication(s):
  • Treatment of chronic pain
  • Treatment of diabetic neuropathic pain
  • Treatment of generalised anxiety disorder
  • Treatment of major depressive disorder
  • Treatment of stress urinary incontinence
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/11/2010

Decision

P/268/2010: EMA decision of 17 November 2010 on review of a granted waiver for duloxetine hydrochloride (Cymbalta/Xeristar/Yentreve/Ariclaim)(EMEA-000420-PIP01-10)

AdoptedReference Number: EMA/704354/2010