ORTHO 1/35 TABLETS (28 DAY)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-03-2017
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Active ingredient:
NORETHINDRONE; ETHINYL ESTRADIOL
Available from:
JANSSEN INC
ATC code:
G03AA05
INN (International Name):
NORETHISTERONE AND ESTROGEN
Dosage:
1MG; .035MG
Pharmaceutical form:
TABLET
Composition:
NORETHINDRONE 1MG; ETHINYL ESTRADIOL .035MG
Administration route:
ORAL
Units in package:
12X1/28
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0210010002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-09-01
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
ORTHO
® 1/35
norethindrone and ethinyl estradiol Tablets, USP
1.0 mg norethindrone and 0.035 mg ethinyl estradiol Tablets
Oral Contraceptive
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 14, 2017
SUBMISSION CONTROL NO.: 201117
© 2017 Janssen Inc.
All trademarks used under license.
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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
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
....................................................................................
30
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