infliximab Lyophilized Concentrate
for Injection, for Intravenous Use Initial U.S. Approval: 1998

Facts about infliximab Lyophilized Concentrate

Approval Date: 1998
Proprietary Name: On Request
Active Ingredient(s): infliximab
Dosage Forms And Strengths: For injection: 100 mg of infliximab as a lyophilized powder in a single-dose vial for reconstitution and dilution.
Company: Johnson & Johnson
Diseases: Chron’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis
Medicine Approved By: –
European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)

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