PRIVA-DONEPEZIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DONEPEZIL HYDROCHLORIDE

Commercializzato da:

PHARMAPAR INC

Codice ATC:

N06DA02

INN (Nome Internazionale):

DONEPEZIL

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

DONEPEZIL HYDROCHLORIDE 10MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2022-07-29

Scheda tecnica

PRODUCT MONOGRAPH
PR
PRIVA-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std.
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
PHARMAPAR INC.
DATE OF REVISION:
1565 boul. Lionel-Boulet
September 21, 2020
Varennes, Quebec
J3X 1P7
SUBMISSION CONTROL NO.: 242839
_Priva-DONEPEZIL _
_Page 2 of 49 _
TABLE OF CONTENTS
PAR
T 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
........................................................................................17
OVERDOSAGE
..........................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
......................................................................18
STORAGE AND STABILITY
...................................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................21
PAR
T II: SCIENTIFIC INFORMATION ...........................................................................22
PHARMACEUTICAL INFORMATION
...................................................................................22
CLINICAL TRIALS
........................................................................................