ACT DONEPEZIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Disponible depuis:

ACTAVIS PHARMA COMPANY

Code ATC:

N06DA02

DCI (Dénomination commune internationale):

DONEPEZIL

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 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:

2018-06-12

Résumé des caractéristiques du produit

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ACT
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DONEPEZIL
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_Page 1 of 49_
PRODUCT MONOGRAPH
Pr
ACT_ _DONEPEZIL
(donepezil hydrochloride as donepezil hydrochloride monohydrate)
Donepezil Hydrochloride Tablets USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Submission Control No: 181946
Date of Revision:
February 26, 2015
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ACT
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DONEPEZIL
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_Page 2 of 49_
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
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
16
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 TRIALS
..........................................................................