LYRICA CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
11-05-2020
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Werkstoffen:
PREGABALIN
Beschikbaar vanaf:
UPJOHN CANADA ULC
ATC-code:
N02BF02
INN (Algemene Internationale Benaming):
PREGABALIN
Dosering:
100MG
farmaceutische vorm:
CAPSULE
Samenstelling:
PREGABALIN 100MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
MISCELLANEOUS ANTICONVULSANTS
Product samenvatting:
Active ingredient group (AIG) number: 0151121004; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2021-09-09
Productkenmerken
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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