DUAVIVE TABLET (IMMEDIATE AND EXTENDED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-01-2019
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Active ingredient:
CONJUGATED ESTROGENS; BAZEDOXIFENE (BAZEDOXIFENE ACETATE)
Available from:
PFIZER CANADA ULC
ATC code:
G03CC07
INN (International Name):
CONJUGATED ESTROGENS AND BAZEDOXIFENE
Dosage:
0.45MG; 20MG
Pharmaceutical form:
TABLET (IMMEDIATE AND EXTENDED RELEASE)
Composition:
CONJUGATED ESTROGENS 0.45MG; BAZEDOXIFENE (BAZEDOXIFENE ACETATE) 20MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
ESTROGEN AGONIST-ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0256130001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-10-23
Summary of Product characteristics
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_DUAVIVE (conjugated estrogens/bazedoxifene) _
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PRODUCT MONOGRAPH
Pr
DUAVIVE
™
(conjugated estrogens and bazedoxifene modified release tablets)
0.45 mg conjugated estrogens / 20 mg bazedoxifene as bazedoxifene
acetate
Estrogenic Hormones and Selective Estrogen Receptor Modulator
Pfizer Canada Inc.
17,300 Trans Canada Highway
Kirkland, QC H9J 2M5
TM
Wyeth LLC
Pfizer Canada Inc., Licensee
© Pfizer Canada Inc. 2019
Date of Revision:
January 16, 2019
Submission Control No: 210469
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_DUAVIVE (conjugated estrogens/bazedoxifene) _
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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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
..................
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