Details for: SIMPONI
Company: JANSSEN INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02417472 | SIMPONI I.V. | GOLIMUMAB | 50 MG / 4.0 ML | SOLUTION | INTRAVENOUS |
02324776 | SIMPONI | GOLIMUMAB | 50 MG / 0.5 ML | SOLUTION | SUBCUTANEOUS |
02324784 | SIMPONI | GOLIMUMAB | 50 MG / 0.5 ML | SOLUTION | SUBCUTANEOUS |
02413175 | SIMPONI | GOLIMUMAB | 100 MG / 1.0 ML | SOLUTION | SUBCUTANEOUS |
02413183 | SIMPONI | GOLIMUMAB | 100 MG / 1.0 ML | SOLUTION | SUBCUTANEOUS |
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)
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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