Details for: ZEPATIER
Company: MERCK CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02451131 | ZEPATIER | ELBASVIR; GRAZOPREVIR | 50 MG; 100 MG | TABLET | ORAL |
Summary Reports
Summary Basis of Decision
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
Summary Safety Review - Direct-acting antiviral products containing a Protease Inhibitor - Assessing the Potential Risks of Hepatic Decompensation and Hepatic Failure
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
Summary Safety Review - Direct-acting antiviral products containing a Protease Inhibitor - Assessing the Potential Risks of Hepatic Decompensation and Hepatic Failure
Consumer Information
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