Nazione: Canada
Lingua: inglese
Fonte: Health Canada
DONEPEZIL HYDROCHLORIDE
VANC PHARMACEUTICALS INC
N06DA02
DONEPEZIL
5MG
TABLET
DONEPEZIL HYDROCHLORIDE 5MG
ORAL
100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0131548001; AHFS:
CANCELLED POST MARKET
2019-08-07
_ _ VAN-Donepezil Page 1 of 43 _ _ PRODUCT MONOGRAPH PR VAN-DONEPEZIL DONEPEZIL HYDROCHLORIDE TABLETS USP 5 AND 10 MG CHOLINESTERASE INHIBITOR MANUFACTURER AND DISTRIBUTOR: Vanc Pharmaceuticals Inc. Date of Preparation: Building 152, 11782 River Road September 10, 2014 Richmond, BC V6X 1Z7 www.vancpharm.com SUBMISSION CONTROL NUMBER: 177490 _ _ VAN-Donepezil Page 2 of 43 _ _ 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................. Leggi il documento completo