AURO-ZOLMITRIPTAN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ZOLMITRIPTAN

זמין מ:

AURO PHARMA INC

קוד ATC:

N02CC03

INN (שם בינלאומי):

ZOLMITRIPTAN

כמות:

2.5MG

טופס פרצבטיות:

TABLET

הרכב:

ZOLMITRIPTAN 2.5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

6/30

סוג מרשם:

Prescription

איזור תרפויטי:

SELECTIVE SEROTONIN AGONISTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2018-09-21

מאפייני מוצר

Page 1 of 36
PRODUCT MONOGRAPH
Pr
AURO-ZOLMITRIPTAN
Zolmitriptan Tablets, 2.5 mg
House Standard
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of revision:
February 6, 2020
SUBMISSION CONTROL NO: 235669
Page 2 of 36
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................................................................................................
16
DOSAGE AND ADMINISTRATION
...........................................................................
17
OVERDOSAGE
..............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 19
STORAGE AND STABILITY
.......................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 21
PART II: SCIENTIFIC INFORMATION
............................................................................
22
PHARMACEUTICAL INFORMATION
.......................................................................
22
CLINICAL TRIALS
.......................................................................................................
23
DETAILED PHARMACOLOGY
.........................................................................