Details for: SAPHRIS
Company: ORGANON CANADA INC.
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02374803 | SAPHRIS | ASENAPINE (ASENAPINE MALEATE) | 5 MG | TABLET | SUBLINGUAL |
02374811 | SAPHRIS | ASENAPINE (ASENAPINE MALEATE) | 10 MG | TABLET | SUBLINGUAL |
Summary Reports
Summary Basis of Decision
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Sleep Apnoea
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Urinary Retention
Summary Safety Review - Atypical Antipsychotics - Liver failure
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of sleep walking and sleep-related eating disorder
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Sleep Apnoea
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Urinary Retention
Summary Safety Review - Atypical Antipsychotics - Liver failure
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of sleep walking and sleep-related eating disorder
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Consumer Information
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