MINT-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ZOLMITRIPTAN

Disponible desde:

MINT PHARMACEUTICALS INC

Código ATC:

N02CC03

Designación común internacional (DCI):

ZOLMITRIPTAN

Dosis:

2.5MG

formulario farmacéutico:

TABLET (ORALLY DISINTEGRATING)

Composición:

ZOLMITRIPTAN 2.5MG

Vía de administración:

ORAL

Unidades en paquete:

6

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE SEROTONIN AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0134381001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2017-06-19

Ficha técnica

Page 1 of 45
PRODUCT MONOGRAPH
PR
MINT-ZOLMITRIPTAN
Zolmitriptan T
ablets
2.5
m
g
PR
MINT-ZOLMITRIPTAN ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Mint Pharmaceuticals Inc.,
DATE OF PREPARATION:
1093 Meyerside Drive, Unit 1,
16 JANUARY 2014
Mississauga, Ontario
L5T 1J6
SUBMISSION CONTROL NO: 163326, 163327
Page 2 of 45
TABLE OF
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................3
SUMMARY PRODUCT
INFORMATION......................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS.................................................................................................4
WARNINGS AND PRECAUTIONS
...............................................................................4
ADVERSE REACTIONS
...............................................................................................11
DRUG
INTERACTIONS................................................................................................17
DOSAGE AND ADMINISTRATION
...........................................................................18
OVERDOSAGE
..............................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
..........................................................20
STORAGE AND STABILITY
.......................................................................................23
DOSAGE FORMS, COMPOSITION AND
PACKAGING...........................................23
PART II: SCIENTIFIC
INFORMATION.............................................................................24
PHARMACEUTICAL INFORMATION
.......................................................................24
CLINICAL TRIALS
.......................................................................................................25
DETAILED PHARMACOLOGY
...........................