NRA-ZOLMITRIPTAN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ZOLMITRIPTAN

זמין מ:

NORA 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:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

SELECTIVE SEROTONIN AGONISTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2019-06-27

מאפייני מוצר

1 of 36
PRODUCT MONOGRAPH
PR
NRA-ZOLMITRIPTAN
ZOLMITRIPTAN TABLETS
2.5 MG
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Nora Pharma Inc.
205-2900 Boul Cote-Vertu
Saint-Laurent, Quebec
H4R 3E8
DATE OF PREPERATION:
June 27, 2019
CONTROL# 228042
2 of 36
TABLE OF CONTENTS
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
....................................................................................................
17
DOSAGE AND ADMINISTRATION
................................................................................
18
OVERDOSAGE
...................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 20
STORAGE AND STABILITY
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 22
PART II: SCIENTIFIC INFORMATION
................................................................................
23
PHARMACEUTICAL INFORMATION
............................................................................
23
CLINICAL TRIALS
............................................................................................................
23
TOXICOLOGY
............................................................................