NEXT CHOICE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LEVONORGESTREL

Disponible desde:

ACTAVIS PHARMA COMPANY

Código ATC:

G03AD01

Designación común internacional (DCI):

LEVONORGESTREL

Dosis:

0.75MG

formulario farmacéutico:

TABLET

Composición:

LEVONORGESTREL 0.75MG

Vía de administración:

ORAL

Unidades en paquete:

2

tipo de receta:

OTC

Área terapéutica:

CONTRACEPTIVES

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-03-05

Ficha técnica

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_Next Choice™ - Product Monograph _
_Page 1 of 32 _
PRODUCT MONOGRAPH
NEXT CHOICE™
Levonorgestrel Tablets 0.75 mg
House Standard
EMERGENCY CONTRACEPTION
ACTAVIS PHARMA COMPANY
6733 Mississauga Road, Unit 400
Mississauga, ON, Canada, L5N 6J5
Date of Preparation:
June 26, 2014
Submission Control No: 174352
_ _
_Next Choice™ - Product Monograph _
_Page 2 of 32 _
TABLE OF CONTENTS
PART I: HEALTH CARE PROVIDER INFORMATION
.......................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
CLINICAL TRIALS
..........................................................................................................18
DETAIL