LYRICA CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-05-2020
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Active ingredient:
PREGABALIN
Available from:
UPJOHN CANADA ULC
ATC code:
N02BF02
INN (International Name):
PREGABALIN
Dosage:
100MG
Pharmaceutical form:
CAPSULE
Composition:
PREGABALIN 100MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0151121004; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2021-09-09
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
LYRICA
®
Pregabalin capsules
25, 50, 75, 100, 150, 200, 225, 300 mg
ANALGESIC AGENT
Upjohn Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Revision:
May 11, 2020
Submission Control No.: 237599
®
C.P. Pharmaceuticals International C.V.
Upjohn Canada ULC, Licensee
© Upjohn Canada ULC, 2020
_LYRICA (pregabalin) – Product Monograph _
_Page 2 of 62_
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
..................................................................................................16
DRUG INTERACTIONS
..................................................................................................34
DOSAGE AND ADMINISTRATION
..............................................................................36
OVERDOSAGE
................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
............................................................40
STORAGE AND STABILITY
..........................................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIENTIFIC INFORMATION
...............................................................................45
PHARMACEUTICAL INFORMATION
..........................................................................45
CLINICAL TRIALS
............................................................................................
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