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TOFACITINIB SANDOZ (Sandoz Pty Ltd)

Product name
TOFACITINIB SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
139 (255 working days)
Active ingredients
Tofacitinib citrate
Registration type
New generic medicine
Indication

Rheumatoid Arthritis (RA)

Tofacitinib Sandoz is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. Tofacitinib Sandoz can be used alone or in combination with conventional synthetic diseasemodifying antirheumatic drugs (DMARDs), including methotrexate.

Psoriatic Arthritis (PsA)

Tofacitinib Sandoz in combination with conventional synthetic DMARDs is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response to a prior DMARD therapy.

Ulcerative Colitis (UC)

Tofacitinib Sandoz is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

Ankylosing Spondylitis (AS)

Tofacitinib Sandoz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.

Juvenile Idiopathic Arthritis (JIA)

Tofacitinib Sandoz 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.