Country: Canada
Language: English
Source: Health Canada
ALISKIREN (ALISKIREN FUMARATE)
NODEN PHARMA DAC
C09XA02
ALISKIREN
300MG
TABLET
ALISKIREN (ALISKIREN FUMARATE) 300MG
ORAL
28
Prescription
RENIN INHIBITORS
Active ingredient group (AIG) number: 0152352002; AHFS:
APPROVED
2018-01-12
_ _ _ _ _Page 1 of 29_ PRODUCT MONOGRAPH PR RASILEZ ® ALISKIREN (AS ALISKIREN FUMARATE) Tablets, 150 and 300 mg Renin inhibitor Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street Dublin 2, Ireland Date of revision: April 26, 2021 Control No. 246712 RASILEZ is a registered trademark _ _ _ _ _Page 2 of 29_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION.................................................................3 INDICATIONS AND CLINICAL USE ......................................................................3 CONTRAINDICATIONS ...........................................................................................3 WARNINGS AND PRECAUTIONS...........................................................................4 ADVERSE REACTIONS............................................................................................7 DRUG INTERACTIONS .......................................................................................... 12 DOSAGE AND ADMINISTRATION ....................................................................... 15 OVERDOSAGE ........................................................................................................ 16 ACTION AND CLINICAL PHARMACOLOGY..................................................... 16 STORAGE AND STABILITY .................................................................................. 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................... 19 PART II: SCIENTIFIC INFORMATION ......................................................................... 20 PHARMACEUTICAL INFORMATION ................................................................. 20 CLINICAL TRIALS ................................................................................................. 21 DETAILED PHARMACOLOGY ............................................................................. 22 TOXICOLOGY............................................................ Read the complete document