ALEMBIC-LACOSAMIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

LACOSAMIDE

Mevcut itibaren:

ALEMBIC PHARMACEUTICALS LIMITED

ATC kodu:

N03AX18

INN (International Adı):

LACOSAMIDE

Doz:

100MG

Farmasötik formu:

TABLET

Kompozisyon:

LACOSAMIDE 100MG

Uygulama yolu:

ORAL

Paketteki üniteler:

60

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

Active ingredient group (AIG) number: 0152810002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-10-01

Ürün özellikleri

______________________________________________________________________________
_Alembic-Lacosamide Product Monograph_
_ Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALEMBIC-LACOSAMIDE
Lacosamide Tablets
Tablets; 50 mg, 100 mg, 150 mg and 200 mg, Oral
Ph.Eur.
Antiepileptic Agent
ATC Code: N03AX18
Manufactured by:
Date of Initial Authorization:
Alembic Pharmaceuticals Limited
December 19, 2018
Alembic Road,
Vadodara – 390003,
Gujarat, India
Canadian Importer and Distributor:
Date of Revision:
Alembic Pharmaceuticals Canada Ltd.
February 7, 2023
2680, Matheson Blvd. East, Unit 102
Mississauga, Ontario
L4W 0A5, Canada
Submission Control Number: 271051
______________________________________________________________________________
_Alembic-Lacosamide Product Monograph_
_ Page 2 of 43_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
02/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1.
INDICATIONS
................................................................................................................4
1.1 Pediatrics
................................................................................................................4
1.2
Geriatrics.................................................................................................................4
2.
CONTRAINDICATIONS
...................................................................................................4
4.
DOSAGE AND
ADMINISTRATION.....................................................................