SEPTA-ZOLMITRIPTAN-ODT TABLET (ORALLY DISINTEGRATING)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ZOLMITRIPTAN

Доступно од:

SEPTA PHARMACEUTICALS INC

АТЦ код:

N02CC03

INN (Међународно име):

ZOLMITRIPTAN

Дозирање:

2.5MG

Фармацеутски облик:

TABLET (ORALLY DISINTEGRATING)

Састав:

ZOLMITRIPTAN 2.5MG

Пут администрације:

ORAL

Јединице у пакету:

2X3

Тип рецептора:

Prescription

Терапеутска област:

SELECTIVE SEROTONIN AGONISTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2014-08-15

Карактеристике производа

_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...........