TRI-CIRA 21 TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL

Предлага се от:

APOTEX INC

АТС код:

G03AB09

INN (Международно Name):

NORGESTIMATE AND ETHINYLESTRADIOL

дозиране:

0.18MG; 0.035MG; 0.215MG; 0.035MG; 0.25MG; 0.035MG

Лекарствена форма:

TABLET

Композиция:

NORGESTIMATE 0.18MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

CONTRACEPTIVES

Каталог на резюме:

Active ingredient group (AIG) number: 0636783002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2020-11-18

Данни за продукта

PRODUCT MONOGRAPH
PR
TRI-CIRA 21
PR
TRI-CIRA 28
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS
0.18 mg norgestimate and 0.035 mg ethinyl estradiol
0.215 mg norgestimate and 0.035 mg ethinyl estradiol
0.25 mg norgestimate and 0.035 mg ethinyl estradiol
Apotex Standard
Oral Contraceptive
Apotex. Inc.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Preparation:
November 17, 2020
SUBMISSION CONTROL NO.: 230304
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
............................................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................................
4
CONTRAINDICATIONS
.......................................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................................
5
ADVERSE
REACTIONS......................................................................................................................
12
DRUG INTERACTIONS
......................................................................................................................
18
DOSAGE AND ADMINISTRATION
..................................................................................................
27
OVERDOSAGE
....................................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
................................................................................
33
STORAGE AND STABILITY
..............................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................. 35
PART II: SCIENTIFIC INFORMATION
...........................