SUMATRIPTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-02-2010
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Active ingredient:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
Available from:
COBALT PHARMACEUTICALS COMPANY
ATC code:
N02CC01
INN (International Name):
SUMATRIPTAN
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 100MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AGONISTS
Product summary:
Active ingredient group (AIG) number: 0123238001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-09-01
Summary of Product characteristics
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SUMATRIPTAN
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_Page 1 of 35_
PRODUCT MONOGRAPH
PR
SUMATRIPTAN
Sumatriptan Tablets BP
25 mg, 50mg and 100 mg Sumatriptan
(as sumatriptan succinate)
5-HT
1
Receptor Agonist
Migraine Therapy
Manufactured by:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Preparation:
February 22, 2010
Control #: 136519
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SUMATRIPTAN
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_Page 2 of 35_
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
.................................................................................................
13
DOSAGE AND
ADMINISTRATION.............................................................................
14
OVERDOSAGE
...............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND
STABILITY.........................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL
INFORMATION.........................................................................
18
CLINICAL
TRIALS.........................................................................................................
19
DETAILED
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