MINESTRIN 1/20 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-07-2020
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Active ingredient:
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Available from:
ALLERGAN INC
ATC code:
G03AA05
INN (International Name):
NORETHISTERONE AND ESTROGEN
Dosage:
1MG; 20MCG
Pharmaceutical form:
TABLET
Composition:
NORETHINDRONE ACETATE 1MG; ETHINYL ESTRADIOL 20MCG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0206375002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-04-26
Summary of Product characteristics
_Minestrin 1/20 Product Monograph _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINESTRIN
® 1/20
(NORETHINDRONE ACETATE [NA] AND ETHINYL ESTRADIOL [EE] TABLETS, USP)
1 MG NA AND 20 MCG EE TABLETS
ORAL CONTRACEPTIVE
Allergan Inc.
85 Enterprise Blvd., Suite 500
Markham, Ontario
L6G 0B5
www.allergan.ca
Date of Initial Approval:
August 20, 1974
Date of Revision:
July 23, 2020
Submission Control No: 230974
_ _
_MINESTRIN_
®
_ 1/20 Product Monograph _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
CONTRAINDICATIONS (2)
12-2019
DRUG INTERACTIONS, Drug Interactions (9.2)
12-2019
WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic (7)
12-2019
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................
2
1
INDICATIONS
......................................................................................................
4
1.1
Pediatrics
.....................................................................................................
4
1.2
Geriatrics
.....................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................ 5
4
DOSAGE AND ADMINISTRATION
.....................................................................
5
4.1
Recommended Dose and Dosage Adjustment
............................................ 5
4.2
Missed Dose
................................................................................................
5
5
OVERDOSAGE
....................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 6
7
WARNINGS AND PRECAUTIONS
......................................................................
6
7.1
Special Populations
...................................................................................
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