MIRVALA 28 TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DESOGESTREL; ETHINYL ESTRADIOL

Доступно од:

APOTEX INC

АТЦ код:

G03AA09

INN (Међународно име):

DESOGESTREL AND ESTROGEN

Дозирање:

0.1500MG; 0.0300MG

Фармацеутски облик:

TABLET

Састав:

DESOGESTREL 0.1500MG; ETHINYL ESTRADIOL 0.0300MG

Пут администрације:

ORAL

Јединице у пакету:

28 TABS

Тип рецептора:

Prescription

Терапеутска област:

CONTRACEPTIVES

Резиме производа:

Active ingredient group (AIG) number: 0224591001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2013-08-07

Карактеристике производа

_MIRVALA (Desogestrel and Ethinyl Estradiol Tablets) _
_ Page 1 of 67 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MIRVALA
® 21
PR
MIRVALA
®
28
Desogestrel and Ethinyl Estradiol Tablets
Tablets, 0.15 mg Desogestrel and 0.03 mg Ethinyl Estradiol, Oral
USP
Oral Contraceptive
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
AUG 07, 2013
Date of Revision:
JUL 25, 2023
Submission Control No: 272136
_MIRVALA (Desogestrel and Ethinyl Estradiol Tablets) _
_ Page 2 of 67 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
7 WARNINGS AND PRECAUTIONS
07/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
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
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administr