ZOLMITRIPTAN-ODT TABLET (ORALLY DISINTEGRATING)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ZOLMITRIPTAN

MAH:

JUBILANT GENERICS LIMITED

ATC_code:

N02CC03

INN:

ZOLMITRIPTAN

dosage:

2.5MG

pharmaceutical_form:

TABLET (ORALLY DISINTEGRATING)

composition:

ZOLMITRIPTAN 2.5MG

administration_route:

ORAL

units_in_package:

6

prescription_type:

Prescription

therapeutic_area:

SELECTIVE SEROTONIN AGONISTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2014-01-20

SPC

_ZOLMITRIPTAN-ODT _
_Page 1 of 31 _
PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN-ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
SPONSOR: DATE OF REVISION:
Jubilant Generics Limited
April 1, 2020
1A- Sector 16A, Institutional Area,
Noida, Uttar Pradesh, India, 201301
DISTRIBUTOR:
Pharmapar Inc.,
1565 Boul. Lionel- Boulet, Varennes QC
J3X 1P7
SUBMISSION CONTROL NO.: 237423
_ZOLMITRIPTAN-ODT _
_Page 2 of 31 _
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..............................................................................
17
OVERDOSAGE.................................................................................................................
18
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..............................................................