Details for: EPCLUSA
Company: GILEAD SCIENCES CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02456370 | EPCLUSA | SOFOSBUVIR; VELPATASVIR | 400 MG; 100 MG | TABLET | ORAL |
Summary Reports
Summary Basis of Decision
Regulatory Decision Summary
Regulatory Decision Summary
Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of Liver Cancer Recurrence
Summary Safety Review - Direct-acting antivirals - Assessing the Potential Risk of Hepatitis B Virus Reactivation
Summary Safety Review - Direct-acting antivirals - Assessing the potential risk of abnormal blood sugar levels (dysglycemia)
Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of New or Returning Liver Cancer named Hepatocellular Carcinoma
Regulatory Decision Summary
Regulatory Decision Summary
Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of Liver Cancer Recurrence
Summary Safety Review - Direct-acting antivirals - Assessing the Potential Risk of Hepatitis B Virus Reactivation
Summary Safety Review - Direct-acting antivirals - Assessing the potential risk of abnormal blood sugar levels (dysglycemia)
Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of New or Returning Liver Cancer named Hepatocellular Carcinoma
Consumer Information
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