JAMP-DONEPEZIL TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
23-12-2013
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Aktiv ingrediens:
DONEPEZIL HYDROCHLORIDE
Tilgjengelig fra:
JAMP PHARMA CORPORATION
ATC-kode:
N06DA02
INN (International Name):
DONEPEZIL
Dosering :
10MG
Legemiddelform:
TABLET
Sammensetning:
DONEPEZIL HYDROCHLORIDE 10MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100
Resept typen:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0131548002; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2017-07-31
Preparatomtale
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PRODUCT MONOGRAPH
PR JAMP-DONEPEZIL
DONEPEZIL HYDROCHLORIDE TABLETS USP
5 AND 10 MG
CHOLINESTERASE INHIBITOR
Jamp Pharma Corporation
Date of Preparation:
1380-203 Newton
December 20th, 2013
Boucherville, Québec
Canada J4B 5H2
Submission Control No: 163283
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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……………………............................................................................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.................................................................................20
PHARMACEUTICAL
INFORMATION...................................................................................20
CLINICAL
TRIALS........................................................
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