ACH-LACOSAMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LACOSAMIDE

Available from:

ACCORD HEALTHCARE INC

ATC code:

N03AX18

INN (International Name):

LACOSAMIDE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

LACOSAMIDE 200MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0152810004; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-06-10

Summary of Product characteristics

_Product Monograph_
_-ACH-LACOSAMIDE _
_ Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-LACOSAMIDE
lacosamide tablets
Tablets, 50 mg, 100 mg, 150 mg, 200 mg, Oral
Antiepileptic
ATC Code: N03AX18
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
June 10, 2019
Date of Revision:
January 24, 2023
Submission Control Number: 269505
_Product Monograph_
_-ACH-LACOSAMIDE _
_ Page 2 of 42_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
12/2022
7 Warnings and Precautions, 7.1.2 Breast-feeding
12/2022
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
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
....................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.4
Administration
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