LYRICA CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PREGABALIN

Tersedia dari:

UPJOHN CANADA ULC

Kode ATC:

N02BF02

INN (Nama Internasional):

PREGABALIN

Dosis:

100MG

Bentuk farmasi:

CAPSULE

Komposisi:

PREGABALIN 100MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2021-09-09

Karakteristik produk

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