VAN-RIZATRIPTAN ODT TABLET (ORALLY DISINTEGRATING)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-11-2015
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Active ingredient:
RIZATRIPTAN (RIZATRIPTAN BENZOATE)
Available from:
VANC PHARMACEUTICALS INC
ATC code:
N02CC04
INN (International Name):
RIZATRIPTAN
Dosage:
10MG
Pharmaceutical form:
TABLET (ORALLY DISINTEGRATING)
Composition:
RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG
Administration route:
ORAL
Units in package:
6
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AGONISTS
Product summary:
Active ingredient group (AIG) number: 0137841002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-08-07
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
VAN-RIZATRIPTAN ODT
Rizatriptan Benzoate Orally Disintegrating Tablets
5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate)
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Vanc Pharmaceuticals Inc.
Date of Preparation:
210-2639, Viking way 9 November, 2015
Richmond, BC V6V3B7
www.vancpharm.com
Submission Control No: 188668
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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
..............................................................................................................
12
DRUG INTERACTIONS
...............................................................................................................
18
DOSAGE AND ADMINISTRATION
...........................................................................................
20
OVERDOSAGE
.............................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
22
STORAGE AND STABILITY
......................................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 26
PART II: SCIENTIFIC INFORMATION
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