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XELJANZ/XELJANZ XR (Pfizer Australia Pty Ltd)
Product name
XELJANZ/XELJANZ XR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
228 (255 working days)
Active ingredients
Tofacitinib citrate
Registration type
EOI
Indication
Ankylosing Spondylitis (AS)
XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.
Juvenile Idiopathic Arthritis (JIA)
XELJANZ is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, extended oligoarthritis and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.