SEPTA-ZOLMITRIPTAN-ODT TABLET (ORALLY DISINTEGRATING)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ZOLMITRIPTAN

Disponible depuis:

SEPTA PHARMACEUTICALS INC

Code ATC:

N02CC03

DCI (Dénomination commune internationale):

ZOLMITRIPTAN

Dosage:

2.5MG

forme pharmaceutique:

TABLET (ORALLY DISINTEGRATING)

Composition:

ZOLMITRIPTAN 2.5MG

Mode d'administration:

ORAL

Unités en paquet:

2X3

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE SEROTONIN AGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-08-15

Résumé des caractéristiques du produit

_SEPTA ZOLMITRIPTAN-ODT _
_Page 1 of 32_
PRODUCT MONOGRAPH
PR
SEPTA ZOLMITRIPTAN-ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Septa Pharmaceuticals, Inc Date of Preparation:
7490 Pacific Circle, # 1, Mississauga
ON L5T 2A3
August 7, 2014
Canada
SUBMISSION CONTROL NO.: 176170
_SEPTA ZOLMITRIPTAN-ODT _
_Page 2 of 32_
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...........