ACT PREGABALIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-04-2017
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Active ingredient:
PREGABALIN
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
N02BF02
INN (International Name):
PREGABALIN
Dosage:
75MG
Pharmaceutical form:
CAPSULE
Composition:
PREGABALIN 75MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0151121003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-07-09
Summary of Product characteristics
ACT PREGABALIN _ _
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PRODUCT MONOGRAPH
PR
ACT PREGABALIN
Pregabalin Capsules
25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
ANALGESIC AGENT
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
Canada, L5N 6J5
Date of Revision:
April 11, 2017
Submission Control No: 204334
ACT PREGABALIN _ _
_Page 2 of 54 _
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
....................................................................................................
13
DRUG INTERACTIONS
.....................................................................................................
29
DOSAGE AND ADMINISTRATION
.................................................................................
31
OVERDOSAGE
...................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 34
STORAGE AND STABILITY
.............................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 37
PART II: SCIENTIFIC INFORMATION
...................................................................................
40
PHARMACEUTICAL INFORMATION
............................................................................
40
CLINICAL TRIALS
.......................................................................
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