ZARAH 28 TABLET

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

DROSPIRENONE; ETHINYL ESTRADIOL

Available from:

COBALT PHARMACEUTICALS COMPANY

ATC code:

G03AA12

INN (International Name):

DROSPIRENONE AND ESTROGEN

Dosage:

3MG; 0.03MG

Pharmaceutical form:

TABLET

Composition:

DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG

Administration route:

ORAL

Units in package:

28 (7 HORMONE FREE)

Prescription type:

Prescription

Therapeutic area:

CONTRACEPTIVES

Product summary:

Active ingredient group (AIG) number: 0250430001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-11-12

Summary of Product characteristics

                                _ZARAH_
_TM_
_ Product Monograph _
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_Page 1 of 58_
PRODUCT MONOGRAPH
PR
ZARAH
™ 21
PR
ZARAH
™ 28
(3.0 mg drospirenone and 0.030 mg ethinyl estradiol tablets)
Oral Contraceptive
Acne Therapy
Cobalt Pharmaceuticals Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
July 03, 2015
Submission Control No.: 181396
_ZARAH_
_TM_
_ Product Monograph _
_ _
_ _
_ _
_ _
_ _
_ _
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_Page 2 of 58_
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
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
......................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
......................
                                
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