TEVA-DABIGATRAN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-04-2017
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Active ingredient:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)
Available from:
TEVA CANADA LIMITED
ATC code:
B01AE07
INN (International Name):
DABIGATRAN ETEXILATE
Dosage:
150MG
Pharmaceutical form:
CAPSULE
Composition:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG
Administration route:
ORAL
Units in package:
60
Prescription type:
Prescription
Therapeutic area:
DIRECT THROMBIN INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152467003; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-02-19
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
TEVA-DABIGATRAN
Dabigatran Etexilate
Capsule
s
Capsules 75 mg and 150 mg Dabigatran Etexilate,
(as Dabigatran Etexilate Me
silate)
Anticoagulant
Teva Canada Limited.
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Date of Preparation
APRIL 26, 2017
Control Number:
184807
2
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
.....................................................................................................
11
DRUG
INTERACTIONS.....................................................................................................
21
DOSAGE AND ADMINISTRATION
................................................................................
27
OVERDOSAGE
....................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 34
STORAGE AND STABILITY
............................................................................................
38
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 38
PART II: SCIENTIFIC INFORMATION
....................................................................................
40
PHARMACEUTICAL INFORMATION
...........................................................................
40
CLINICAL
TRIALS.............................................................................................................
42
DETAILED PHARMACOLOGY
............
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