ACT SUMATRIPTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-10-2016
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
N02CC01
INN (International Name):
SUMATRIPTAN
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 50MG
Administration route:
ORAL
Units in package:
6/100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AGONISTS
Product summary:
Active ingredient group (AIG) number: 0123238002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-19
Summary of Product characteristics
_ _
ACT_ _SUMATRIPTAN_ _
_Page 1 of 35_
PRODUCT MONOGRAPH
PR
ACT SUMATRIPTAN
Sumatriptan Tablets BP
25 mg, 50mg and 100 mg Sumatriptan
(as sumatriptan succinate)
5-HT
1
Receptor Agonist
Migraine Therapy
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Preparation:
May 27, 2014
Control Number : 173493
_ _
ACT_ _SUMATRIPTAN_ _
_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
.............................................................................
13
OVERDOSAGE
...............................................................................................................
14
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
......................................................................................................
Read the complete document
