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Glycerol Phenylbutyrate (Ravicti) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Apr.
Drug | Glycerol phenylbutyrate (Ravicti) |
---|---|
Indication | Use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders who cannot be managed by dietary protein restriction and/or amino acid supplementation alone |
Reimbursement request | As per indication |
Dosage form(s) | Oral liquid, 1.1 g/mL |
NOC Date | March 18, 2016 |
Manufacturer | Horizon Therapeutics Canada |
Contents
- ABBREVIATIONS
- EXECUTIVE SUMMARY
- 1. INTRODUCTION
- 2. OBJECTIVES AND METHODS
- 3. RESULTS
- 4. DISCUSSION
- 5. CONCLUSIONS
- APPENDIX 1. PATIENT INPUT SUMMARY
- APPENDIX 2. LITERATURE SEARCH STRATEGY
- APPENDIX 3. EXCLUDED STUDIES
- APPENDIX 4. DETAILED OUTCOME DATA
- APPENDIX 5. VALIDITY OF OUTCOME MEASURES
- APPENDIX 6. SUMMARY OF EFFICACY AND SAFETY RESULTS IN THREE SHORT-TERM, NON-RANDOMIZED STUDIES: UP 1204-003, HPN-100-005, AND HPN-100-012
- APPENDIX 7. SUMMARY OF EFFICACY AND SAFETY RESULTS IN THREE LONG-TERM, NON-RANDOMIZED STUDIES: HPN-100-005, HPN-100-007, AND HPN-100-012
- REFERENCES
- Clinical Review Report - Glycerol Phenylbutyrate (Ravicti)Clinical Review Report - Glycerol Phenylbutyrate (Ravicti)
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