SANDOZ SAXAGLIPTIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-02-2019
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Active ingredient:
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
A10BH03
INN (International Name):
SAXAGLIPTIN
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 2.5MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152653002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-03-08
Summary of Product characteristics
_Sandoz Saxagliptin _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
SANDOZ SAXAGLIPTIN
Saxagliptin Tablets
Saxagliptin (as saxagliptin hydrochloride dihydrate)
2.5 mg and 5 mg
Oral Antihyperglycemic Agent
DPP-4 inhibitor
Incretin Enhancer
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Québec
J4B 1E6
Date of Revision:
February 25, 2019
Submission Control No: 224039
_Sandoz Saxagliptin _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................
4
ADVERSE REACTIONS
........................................................................................................
7
DRUG INTERACTIONS
......................................................................................................
15
DOSAGE AND ADMINISTRATION
..................................................................................
19
OVERDOSAGE
....................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 20
STORAGE AND STABILITY
..............................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 24
PART II: SCIENTIFIC INFORMATION
....................................................................................
25
PHARMACEUTICAL INFORMATION
..............................................................................
25
CLINICAL TRIALS
................
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