VYVANSE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LISDEXAMFETAMINE DIMESYLATE

Available from:

TAKEDA CANADA INC

ATC code:

N06BA12

INN (International Name):

LISDEXAMFETAMINE

Dosage:

50MG

Pharmaceutical form:

CAPSULE

Composition:

LISDEXAMFETAMINE DIMESYLATE 50MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Schedule G (CDSA I)

Therapeutic area:

AMPHETAMINES

Product summary:

Active ingredient group (AIG) number: 0152536002; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-02-12

Summary of Product characteristics

_VYVANSE_
_®_
_ (lisdexamfetamine dimesylate) _
_Page 1 of 67_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VYVANSE®
lisdexamfetamine dimesylate capsules
Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg, oral
lisdexamfetamine dimesylate chewable tablets
Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg, oral
Central Nervous System Stimulant
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto, Ontario
M5H 4E3
Date of Initial Authorization:
19 February 2009
Date of Revision:
MAR 20, 2024
Submission Control Number: 280611
VYVANSE® and the VYVANSE Logo® are registered trademarks of Takeda
Pharmaceuticals U.S.A.,
Inc.
TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda
Pharmaceutical Company
Limited, used under license.
_VYVANSE_
_®_
_ (lisdexamfetamine dimesylate) _
_Page 2 of 67_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular, QTc Prolongation
03/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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