TEVA-RIZATRIPTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-01-2012
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Active ingredient:
RIZATRIPTAN (RIZATRIPTAN BENZOATE)
Available from:
TEVA CANADA LIMITED
ATC code:
N02CC04
INN (International Name):
RIZATRIPTAN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AGONISTS
Product summary:
Active ingredient group (AIG) number: 0137841002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2015-10-16
Summary of Product characteristics
1
PRODUCT MONOGRAPH
Pr
TEVA-RIZATRIPTAN
rizatriptan benzoate tablets
5 mg and 10 mg rizatriptan (as rizatriptan benzoate)
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Teva Canada Limited
Date of Revision:
30 Novopharm Court
November 30, 2011
Toronto, Ontario
M1B 2K9
Control Number: 127063, 150938
2
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
................................................................... 19
STORAGE AND
STABILITY.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC
INFORMATION....................................................................................
22
PHARMACEUTICAL
INFORMATION.................................................................................
22
CLINICAL
TRIALS............................................................................................
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