SANDOZ ALISKIREN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALISKIREN (ALISKIREN FUMARATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

C09XA02

INN (International Name):

ALISKIREN

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

ALISKIREN (ALISKIREN FUMARATE) 300MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

RENIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152352002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2017-12-06

Summary of Product characteristics

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_Sandoz Aliskiren Page 1 of 28_
PRODUCT MONOGRAPH
PR
SANDOZ ALISKIREN
aliskiren (as aliskiren fumarate)
Tablets, 150 and 300 mg
Renin inhibitor
Sandoz Canada Inc.
145 Jules-Léger
Boucherville (QC)
J4B 7K8
Date of Revision: August 31, 2016
Submission Control No: 197205
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_Sandoz Aliskiren Page 2 of 28_
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
.................................................................................................
8
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
........................................................................