M-DONEPEZIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DONEPEZIL HYDROCHLORIDE

Disponible depuis:

MANTRA PHARMA INC

Code ATC:

N06DA02

DCI (Dénomination commune internationale):

DONEPEZIL

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

DONEPEZIL HYDROCHLORIDE 10MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0131548002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-08-17

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
Pr
M-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std
5 and 10 mg
CHOLINESTERASE INHIBITOR
J4Y 0E3
Brossard, Quebec
9150 Boulevard Leduc, Suite 201
Mantra Pharma
Inc.
March
24,
2020
Date of Revision:
Submission Control No.:
236845
Pr
M-DONEPEZIL (Donepezil Hydrochloride Tablets) Product Monograph
Page 2 of 53
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
............................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
..................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 22
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
..................................................................................
24
CLINICAL TRIALS
..................................................................................................................
25
DETAILED PHARMACOLOGY
....................................