LYRICA CAPSULE

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

PREGABALIN

Disponibbli minn:

UPJOHN CANADA ULC

Kodiċi ATC:

N02BF02

INN (Isem Internazzjonali):

PREGABALIN

Dożaġġ:

100MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

PREGABALIN 100MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0151121004; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2021-09-09

Karatteristiċi tal-prodott

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
............................................................................................