ANZUPGO Cream Ref.[114507] Active ingredients: Delgocitinib

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Product name and form

Anzupgo 20 mg/g cream.

Pharmaceutical Form

Cream.

White to slightly brown cream.

Qualitative and quantitative composition

Each gram of cream contains 20 mg of delgocitinib.

Excipients with known effect: Each gram of cream contains 10 mg of benzyl alcohol (E1519), 0.2 mg of butylhydroxyanisole (E320), and 72 mg of cetostearyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Delgocitinib

Delgocitinib is a pan Janus kinase (JAK) inhibitor that targets the activity of all four members of the JAK family of enzymes consisting of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2) in a concentration dependent manner.

List of Excipients

Benzyl alcohol (E1519)
Butylhydroxyanisole (E320)
Cetostearyl alcohol
Citric acid monohydrate (E330)
Disodium edetate
Hydrochloric acid (E507) (for pH-adjustment)
Liquid paraffin
Macrogol cetostearyl ether
Purified water

Pack sizes and marketing

Laminate tube with an aluminium barrier layer and an inner layer of low-density polyethylene fitted with a polypropylene flip-top cap.

Package sizes: 1 tube of 15 g or 60 g.

Not all pack sizes may be marketed.

Marketing authorization holder

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Marketing authorization dates and numbers

EU/1/24/1851/001
EU/1/24/1851/002

Drugs

Drug Countries
ANZUPGO Cyprus, Estonia, France, Italy, Lithuania

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.