AVIANE 21 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-03-2019
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Active ingredient:
LEVONORGESTREL; ETHINYL ESTRADIOL
Available from:
TEVA CANADA LIMITED
ATC code:
G03AA07
INN (International Name):
LEVONORGESTREL AND ESTROGEN
Dosage:
100MCG; 20MCG
Pharmaceutical form:
TABLET
Composition:
LEVONORGESTREL 100MCG; ETHINYL ESTRADIOL 20MCG
Administration route:
ORAL
Units in package:
21
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0220415005; AHFS:
Authorization status:
APPROVED
Authorization date:
2007-08-17
Summary of Product characteristics
PRODUCT
MONOGRAPH
Pr
AVIANE
® 21 AND
Pr
AVIANE
® 28
Levonorgestrel and Ethinyl Estradiol
Tablets, 0.10 mg levonorgestrel, 0.02 mg ethinyl estradiol
USP
Oral Contraceptive
G03AA07
Teva Canada Limited
30 Novopharm Court
Toronto, ON M1B 2K9
Date of Revision:
March 15, 2019
Submission Control No: 225099
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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
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 29
STORAGE AND STABILITY
.........................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
......................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
.........................................................................................................
33
ORAL CONTRACEPTION
.............................................................................................
34
DETAILED PHARMACOLOGY
......................................................
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