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Details for: SIMPONI

Company: JANSSEN INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02417472SIMPONI I.V.GOLIMUMAB50 MG / 4.0 MLSOLUTIONINTRAVENOUS
02324776SIMPONIGOLIMUMAB50 MG / 0.5 MLSOLUTIONSUBCUTANEOUS
02324784SIMPONIGOLIMUMAB50 MG / 0.5 MLSOLUTIONSUBCUTANEOUS
02413175SIMPONIGOLIMUMAB100 MG / 1.0 MLSOLUTIONSUBCUTANEOUS
02413183SIMPONIGOLIMUMAB100 MG / 1.0 MLSOLUTIONSUBCUTANEOUS
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Summary Reports

Summary Basis of Decision
Regulatory Decision Summary
Summary Safety Review - Tumour Necrosis Factor (TNF) alpha blockers (SIMPONI and CIMZIA) - Assessing the Potential Risk of Liver Inflammation (Autoimmune Hepatitis)
Summary Safety Review - Tumour necrosis factor (TNF) blockers - Glioblastoma (brain tumour)

Consumer Information

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