NORLEVO TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-05-2014
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Active ingredient:
LEVONORGESTREL
Available from:
LABORATOIRE HRA PHARMA
ATC code:
G03AD01
INN (International Name):
LEVONORGESTREL
Dosage:
0.75MG
Pharmaceutical form:
TABLET
Composition:
LEVONORGESTREL 0.75MG
Administration route:
ORAL
Units in package:
2
Prescription type:
OTC
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0125218002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-01-31
Summary of Product characteristics
_ _
_Appendix E - Product Monograph Template - Standard _
_Page 1 of 35_
PRODUCT MONOGRAPH
NORLEVO
®
LEVONORGESTREL TABLETS
0.75 MG
MANUFACTURER’S STANDARD
EMERGENCY CONTRACEPTION
Manufacturer :
Laboratoire HRA Pharma
15, rue Béranger
75003, Paris, France
Date of Revision:
March 14, 2014
Distributor :
Bayer Inc
77 Belfield Road
Toronto, Ontario, M9W 1G6
Canada
Date of Approval:
March 19, 2014
_ _
Submission Control No: 170655
_ _
_Appendix E - Product Monograph Template - Standard _
_Page 2 of 35_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL INFORMATION
........................................................................
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