ALEMBIC-LACOSAMIDE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LACOSAMIDE

Dostępny od:

ALEMBIC PHARMACEUTICALS LIMITED

Kod ATC:

N03AX18

INN (International Nazwa):

LACOSAMIDE

Dawkowanie:

50MG

Forma farmaceutyczna:

TABLET

Skład:

LACOSAMIDE 50MG

Droga podania:

ORAL

Sztuk w opakowaniu:

60

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTICONVULSANTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0152810001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-10-01

Charakterystyka produktu

______________________________________________________________________________
_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.....................................................................