OPTION 2 TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

LEVONORGESTREL

Fáanlegur frá:

PERRIGO INTERNATIONAL

ATC númer:

G03AD01

INN (Alþjóðlegt nafn):

LEVONORGESTREL

Skammtar:

0.75MG

Lyfjaform:

TABLET

Samsetning:

LEVONORGESTREL 0.75MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

2

Gerð lyfseðils:

OTC

Lækningarsvæði:

CONTRACEPTIVES

Vörulýsing:

Active ingredient group (AIG) number: 0125218002; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2021-07-22

Vara einkenni

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_Product Monograph _
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PRODUCT MONOGRAPH
OPTION 2
®
Levonorgestrel Tablets 0.75 mg
Manufacturer’s Standard
EMERGENCY CONTRACEPTION
Manufactured by:
Perrigo
®
International
DATE OF REVISION:
Allegan Michigan USA 49010
September 3, 2014
Imported by:
Teva Canada Limited
Toronto Ontario Canada M1B 2K9
Control Number: 171559
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_Product Monograph _
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_ Page 2 of 36 _
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TABLE OF CONTENTS
PART I: HEALTH CARE PROVIDER INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 15
STORAGE AND STABILITY
.................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 17
PART II: SCIENTIFIC INFORMATION
...............................................................................
18
PHARMACEUTICAL INFORMATION
.....................................................................