DONEPEZIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DONEPEZIL HYDROCHLORIDE

Disponible depuis:

RANBAXY PHARMACEUTICALS CANADA 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:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2022-08-19

Résumé des caractéristiques du produit

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_DONEPEZIL (Donepezil Hydrochloride Tablets, USP) Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
DONEPEZIL
Donepezil Hydrochloride Tablets, USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
DATE OF PREPARATION:
March 7, 2014
Submission Control No: 171793
Trademark owned by Ranbaxy Laboratories Limited
_ _
_DONEPEZIL (Donepezil Hydrochloride Tablets USP) Product Monograph _
_Page 2 of 47_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL