| Document Date: 2013-11-15 13:27:29
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City Reference / / Company Janssen Biotech Inc. / / Country United States / / Currency pence / / Event FDA Phase / Product Issues / / IndustryTerm dry natural rubber / biological product / healthcare / leftover product / organ systems / biologic products / treatment of hepatitis B / / MedicalCondition Demyelinating Disease / TB / primary sclerosing cholangitis / COPD / viral infection / severe fungal infection / Lymphoma / HBV / active infection / Rheumatoid Arthritis SIMPONI / heumatoid Arthritis / severe persistent asthma / Ankylosing Spondylitis / leukopenia / serious systemic illness / viral and other infections / lcerative Colitis / Rheumatoid Arthritis / Crohn's disease / skin cancer / pneumocystosis / cellulitis / Demyelinating Disorders / thrombocytopenia / anaphylaxis / chronic exposure / Serious infections / non-melanoma skin cancer / hepatitis B / colon cancer / C ongestive Heart Failure / tuberculosis infection / systemic illness / Melanoma / erious Infections / severely active rheumatoid arthritis / multiple sclerosis / mycoses / extrapulmonary disease / aspergillosis / endemic tuberculosis / Severely Active Ulcerative Colitis / Ankylosing Spondylitis SIMPONI / blastomycosis / hepatosplenic T-cell lymphoma / MS / bacterial sepsis / endemic mycoses / severe Ulcerative colitis / infections / central demyelination / Psoriatic Arthritis / sepsis / severe systemic illness / upper respiratory tract infection / leukemia / colon carcinoma / nonmelanoma skin cancer / congestive heart failure / pneumonia / latent tuberculosis infection / Ulcerative Colitis SIMPONI / very aggressive disease / HBV infection / peripheral demyelinating disorders / opportunistic infections / recurrent infection / disease / Active ankylosing spondylitis / active HBV infection / nasopharyngitis / peripheral nervous system demyelinating disorders / Guillain-Barré syndrome / Carcinogenesis / optic neuritis / tuberculosis infections / neutropenia / aplastic anemia / acute and chronic leukemia / neutropenia / candidiasis / Active tuberculosis / chronic inflammatory diseases / histoplasmosis / active TB / legionellosis / localized disease / clinically important localized infections / lymphomas / MALIGNANCY Lymphoma / Psoriatic Arthritis SIMPONI / Serious systemic hypersensitivity / Ulcerative Colitis / Live vaccines/therapeutic infectious agents / latent tuberculosis / opportunistic infection / tumor necrosis factor / latent infection / Heart Failure / Reported infections / coccidioidomycosis / highly active disease / infection / Invasive Fungal Infections / peripheral demyelinating polyneuropathy / T-cell lymphoma / chronic hepatitis B / Active psoriatic arthritis / abscess / serious infection / disorders / invasive fungal infection / pancytopenia / tuberculosis / Merkel cell carcinoma / / MedicalTreatment anti-fungal therapy / antiviral therapy / anti-viral therapy / immunosuppression / antifungal therapy / Vaccinations / / Organization Anakinra Concurrent administration / DOSAGE AND ADMINISTRATION / FDA / / / Position general U.S. population / MP / physician / / Product cyclophosphamide / mercaptopurine / azathioprine / SIMPONI / RA / response / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SIMPONI safely and effectively. See full prescribing information for SIMPONI. SIMPONI (golimumab) injection, for sub