ACCEL-DONEPEZIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DONEPEZIL HYDROCHLORIDE

Disponible depuis:

ACCEL PHARMA 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:

30/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2019-10-28

Résumé des caractéristiques du produit

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Page 1 of 51
PRODUCT MONOGRAPH
PR
ACCEL-DONEPEZIL
(donepezil hydrochloride USP as donepezil hydrochloride monohydrate)
5 mg and 10 mg tablets
In-House
CHOLINESTERASE INHIBITOR
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, Quebec
H9R 4Z7
Date of Revision:
March 19, 2015
Submission Control No: 182956
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Page 2 of 51
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
......................................................................................................
8
DRUG INTERACTIONS
.....................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................
18
OVERDOSAGE
....................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 20
STORAGE AND STABILITY
..............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 22
PART II: SCIENTIFIC INFORMATION
...................................................................................
23
PHARMACEUTICAL INFORMATION
..............................................................................
23
CLINICAL TRIALS
................................................................