VYVANSE TABLET (CHEWABLE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LISDEXAMFETAMINE DIMESYLATE

Διαθέσιμο από:

TAKEDA CANADA INC

Φαρμακολογική κατηγορία (ATC):

N06BA12

INN (Διεθνής Όνομα):

LISDEXAMFETAMINE

Δοσολογία:

40MG

Φαρμακοτεχνική μορφή:

TABLET (CHEWABLE)

Σύνθεση:

LISDEXAMFETAMINE DIMESYLATE 40MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Schedule G (CDSA I)

Θεραπευτική περιοχή:

AMPHETAMINES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0152536004; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-07-08

Αρχείο Π.Χ.Π.

_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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