AURO-LEVETIRACETAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LEVETIRACETAM

Available from:

AURO PHARMA INC

ATC code:

N03AX14

INN (International Name):

LEVETIRACETAM

Dosage:

750MG

Pharmaceutical form:

TABLET

Composition:

LEVETIRACETAM 750MG

Administration route:

ORAL

Units in package:

30/100/250/500

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0148843003; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-10-26

Summary of Product characteristics

Auro-Levetiracetam Product Monograph
Page 1 of 40
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-LEVETIRACETAM
Levetiracetam Tablets
Film-coated tablets, 250 mg, 500 mg, and 750 mg, Oral
Manufacturer Standard
Antiepileptic
ATC Code: N03AX14
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial
Authorization: October 25,
2011
Date of Revision:
December 12, 2023
Submission Control Number: 276354
Auro-Levetiracetam Product Monograph
Page 2 of 40
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
12/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric
12/2023
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
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
........................................................................................
4
4.1 Dosing Considerations
......................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
................................................................. 4
4.4 Administration
.........