LYRICA CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PREGABALIN

可用日期:

UPJOHN CANADA ULC

ATC代码:

N02BF02

INN（国际名称）:

PREGABALIN

剂量:

100MG

药物剂型:

CAPSULE

组成:

PREGABALIN 100MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANTICONVULSANTS

產品總結:

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

授权状态:

CANCELLED PRE MARKET

授权日期:

2021-09-09

产品特点

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