RASILEZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALISKIREN (ALISKIREN FUMARATE)

Available from:

NODEN PHARMA DAC

ATC code:

C09XA02

INN (International Name):

ALISKIREN

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

ALISKIREN (ALISKIREN FUMARATE) 150MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

RENIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152352001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-01-12

Summary of Product characteristics

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_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
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_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............................................................