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UTEKNIX (Cipla Australia Pty Ltd)
Product name
UTEKNIX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
185 (255 working days)
Active ingredients
Ustekinumab
Registration type
New biosimilar medicine
Indication
Plaque psoriasis
UTEKNIX is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Psoriatic arthritis (PsA)
UTEKNIX, alone or in combination with ethotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological DMARD therapy has been inadequate.
UTEKNIX has not been approved for use in children or adolescents under the age of 18 years.
UTEKNIX has not been approved for use in patients with Crohn’s disease or ulcerative colitis.