ZOLMITRIPTAN-ODT TABLET (ORALLY DISINTEGRATING)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-04-2020
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Active ingredient:
ZOLMITRIPTAN
Available from:
JUBILANT GENERICS LIMITED
ATC code:
N02CC03
INN (International Name):
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
Product summary:
Active ingredient group (AIG) number: 0134381001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-01-20
Summary of Product characteristics
_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..............................................................
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