MINT-DONEPEZIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DONEPEZIL HYDROCHLORIDE

Commercializzato da:

MINT PHARMACEUTICALS INC

Codice ATC:

N06DA02

INN (Nome Internazionale):

DONEPEZIL

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

DONEPEZIL HYDROCHLORIDE 10MG

Via di somministrazione:

ORAL

Confezione:

30/500

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:

2013-12-24

Scheda tecnica

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Page 1 of 51
F
PRODUCT MONOGRAPH
PR
MINT-DONEPEZIL
(donepezil hydrochloride USP as donepezil hydrochloride monohydrate)
5 mg and 10 mg tablets
In-House
CHOLINESTERASE INHIBITOR
MINT Pharmaceuticals Inc.
Date of Revision:
1093 Meyerside Drive, Unit 1
March 05, 2015
Mississauga, Ontario
Canada L5T 1J6
Submission Control No: 182010
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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
.......................................