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PRODUCT DETAIL

Opzelura 15 mg/g krém

Code 3577E
MA number EU/1/23/1726/001
Product Form: crm 1x100 mg (tuba Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Incyte Biosciences Distribution B.V., Netherland
Therapeutic Class: 46 - DERMATOLOGICA
ATC:
D DERMATOLOGICALS
D11 OTHER DERMATOLOGICAL PREPARATIONS
D11A OTHER DERMATOLOGICAL PREPARATIONS
D11AH Agents for dermatitis, excluding corticosteroids
D11AH09 Ruxolitinib
Shelf life: 21
Container: tube Al
Route of admin.: Cutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 19.04.2023
Validity: 19.04.2028
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 27.04.2023
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