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🇪🇺EU · EMAAuthorisedATC: L04AC05

Fymskina(ustekinumab)

Crohn Disease;Psoriasis;Arthritis, Psoriatic

Marketing Authorisation Holder: Formycon AG

EMA Authorisation: 25/09/2024

INN: ustekinumab

Indication

Plaque psoriasisFymskina is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).Paediatric plaque psoriasisFymskina is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Fymskina, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Crohn’s DiseaseFymskina is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.