TEVA-ZOLMITRIPTAN OD TABLET (ORALLY DISINTEGRATING)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ZOLMITRIPTAN

Предлага се от:

TEVA CANADA LIMITED

АТС код:

N02CC03

INN (Международно Name):

ZOLMITRIPTAN

дозиране:

1MG

Лекарствена форма:

TABLET (ORALLY DISINTEGRATING)

Композиция:

ZOLMITRIPTAN 1MG

Начин на приложение:

ORAL

Броя в опаковка:

2/6

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE SEROTONIN AGONISTS

Каталог на резюме:

Active ingredient group (AIG) number: 0134381003; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2015-10-16

Данни за продукта

PRODUCT MONOGRAPH
PR
TEVA-ZOLMITRIPTAN
(zolmitriptan) tablets
1 mg and 2.5 mg
PR
TEVA-ZOLMITRIPTAN OD
(zolmitriptan) orally disintegrating tablets
1 mg and 2.5 mg
Professed Standard
Migraine Therapy
5-HT
1
Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 176520
Date of Revision:
July 31, 2014
2
TABLE OF CONTENTS
PRODUCT MONOGRAPH
........................................................................................................
1
TABLE OF CONTENTS
.............................................................................................................
2
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
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
19
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 21
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: