LINESSA 21 TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DESOGESTREL; ETHINYL ESTRADIOL; DESOGESTREL; ETHINYL ESTRADIOL; DESOGESTREL; ETHINYL ESTRADIOL

Доступно од:

ASPEN PHARMACARE CANADA INC.

АТЦ код:

G03AB05

INN (Међународно име):

DESOGESTREL AND ESTROGEN

Дозирање:

0.1MG; 0.025MG; 0.125MG; 0.025MG; 0.15MG; 0.025MG

Фармацеутски облик:

TABLET

Састав:

DESOGESTREL 0.1MG; ETHINYL ESTRADIOL 0.025MG; DESOGESTREL 0.125MG; ETHINYL ESTRADIOL 0.025MG; DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.025MG

Пут администрације:

ORAL

Јединице у пакету:

21

Тип рецептора:

Prescription

Терапеутска област:

CONTRACEPTIVES

Резиме производа:

Active ingredient group (AIG) number: 0650285001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2018-02-01

Карактеристике производа

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LINESSA
® 21 AND
PR
LINESSA
® 28
desogestrel and ethinyl estradiol tablets USP
0.100 mg, 0.025 mg
0.125 mg, 0.025 mg
0.150 mg, 0.025 mg
Oral Contraceptive
G03AB05
Aspen Pharmacare Canada Inc.
8 – 1155 North Service Road West
Oakville, ON
L6M 3E3
Date of Initial Approval:
June 13, 2006
Date of Preparation:
September 12, 2023
Trademarks are owned by or licensed to the Aspen Group of companies.
©
2023 Aspen Group of companies or its licensor. All rights reserved.
Submission Control No: 273119
_ _
LINESSA
®
21 and LINESSA
®
28 (desogestrel and ethinyl estradiol tablets)
© 2023 Aspen Group of companies or its licensor. All rights reserved.
_ _
_Page 2 of 72_
RECENT MAJOR LABEL CHANGES
Contraindications (2)
09/2023
Warnings and Precautions (7)
09/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
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