EMEA-002618-PIP04-23 - paediatric investigation plan | European Medicines Agency (EMA)
Skip to main content
EMEA-002618-PIP04-23 - paediatric investigation plan
Ruxolitinib (phosphate)
PIPHuman
Key facts
Invented name
Jakavi
Opzelura
Active Substance
Ruxolitinib (phosphate)
Therapeutic area
Skin and subcutaneous tissue disorders
Decision number
P/0034/2024
PIP number
EMEA-002618-PIP04-23
Pharmaceutical form(s)
Cream
Condition(s) / indication(s)
Treatment of prurigo nodularis
Route(s) of administration
Cutaneous use
Contact for public enquiries
Incyte Biosciences Distribution B.V. E-mail: RA@incyte.com Tel. +1 3024252734
Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date
Decision
P/0034/2024 : EMA decision of 31 January 2024 on the granting of a product-specific waiver for ruxolitinib (phosphate) (Jakavi, Opzelura), (EMEA- 002618-PIP04-23)