NAT-DONEPEZIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DONEPEZIL HYDROCHLORIDE

Disponible depuis:

NATCO PHARMA (CANADA) INC

Code ATC:

N06DA02

DCI (Dénomination commune internationale):

DONEPEZIL

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

DONEPEZIL HYDROCHLORIDE 5MG

Mode d'administration:

ORAL

Unités en paquet:

7/14/28/30/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0131548001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-05-27

Résumé des caractéristiques du produit

_NAT-Donepezil Product Monograph _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
NAT-DONEPEZIL
Donepezil Hydrochloride Tablets
5 mg and 10 mg
USP
CHOLINESTERASE INHIBITOR
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, suite 200
Mississauga, Ontario
L5N 1P7
Date of Revision:
February 17, 2021
Submission Control No.: 248208
_ NAT-Donepezil Product Monograph _
_ _
_ _
_ _
_ Page_
_2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................3
INDICATIONS AND CLINICAL USE
......................................................................................3
CONTRAINDICATIONS
...........................................................................................................3
WARNINGS AND PRECAUTIONS
..........................................................................................3
ADVERSE REACTIONS
............................................................................................................7
DRUG INTERACTIONS
..........................................................................................................15
DOSAGE AND ADMINISTRATION
......................................................................................17
OVERDOSAGE
........................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
..................................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
..................................................................................22
CLINICAL TRIAL