EMEA-000420-PIP01-10 - paediatric investigation plan

duloxetine hydrochloride
PIPHuman

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
Contact for public enquiries

Eli Lilly & Company Limited

E-mail: eu_paediatric@lilly.com 
Tel. +44 (0)1276 483000

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

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