ACH-DONEPEZIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DONEPEZIL HYDROCHLORIDE

Commercializzato da:

ACCORD HEALTHCARE INC

Codice ATC:

N06DA02

INN (Nome Internazionale):

DONEPEZIL

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

DONEPEZIL HYDROCHLORIDE 10MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-12-01

Scheda tecnica

_Donepezil Hydrochloride Product Monograph _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
ACH-DONEPEZIL
Donepezil Hydrochloride Tablets
5 mg and 10 mg
USP
CHOLINESTERASE INHIBITOR
Accord Healthcare Inc.
Date of Revision:
3535 boul. St. Charles suite 704
November 27, 2020
Kirkland, QC, H9H 5B9
Canada
Submission Control No: 241736
_ ACH-Donepezil Product Monograph _
_ _
_ _
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_ 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
......................................................................................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