JAMP-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ZOLMITRIPTAN

Disponible desde:

JAMP PHARMA CORPORATION

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:

APPROVED

Fecha de autorización:

2014-08-12

Ficha técnica

_JAMP-ZOLMITRIPTAN ODT _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
JAMP-ZOLMITRIPTAN ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
JAMP Pharma Corporation
1380-203 newton
Boucherville, Québec
J4B 5H2
DATE OF PREPARATION:
August 1, 2014
SUBMISSION CONTROL NO.: 176028
_JAMP-ZOLMITRIPTAN ODT _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................. 3
SUMMARY PRODUCT
INFORMATION.....................................................................
3
INDICATIONS AND CLINICAL
USE............................................................................
3
CONTRAINDICATIONS..................................................................................................
3
WARNINGS AND
PRECAUTIONS................................................................................
4
ADVERSE
REACTIONS..................................................................................................
10
DRUG
INTERACTIONS..................................................................................................
15
DOSAGE AND
ADMINISTRATION..............................................................................
16
OVERDOSAGE.................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY.............................................................
18
STORAGE AND
STABILITY..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................
20
PART II: SCIENTIFIC
INFORMATION.........................................................................
21
PHARMACEUTICAL
INFORMATION..........................................................................
21
CLINICAL
TRIALS..........................................................................................................
21
DETAILED
PHARMACOLOGY...........................