Details for: IMBRUVICA
Company: JANSSEN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02434407 | IMBRUVICA | IBRUTINIB | 140 MG | CAPSULE | ORAL |
Summary Reports
Summary Basis of Decision
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Summary Safety Review - IMBRUVICA (ibrutinib) - Assessing the potential risk of a serious and life-threatening abnormal heart rhythm (ventricular tachyarrhythmia)
Summary Safety Review - Imbruvica (ibrutinib) - Assessing the Potential Risk of Hemophagocytic Lymphohistiocytosis
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Summary Safety Review - IMBRUVICA (ibrutinib) - Assessing the potential risk of a serious and life-threatening abnormal heart rhythm (ventricular tachyarrhythmia)
Summary Safety Review - Imbruvica (ibrutinib) - Assessing the Potential Risk of Hemophagocytic Lymphohistiocytosis
Consumer Information
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