国家: 加拿大
语言: 英文
来源: Health Canada
BETAHISTINE HYDROCHLORIDE
ACTAVIS PHARMA COMPANY
N07CA01
BETAHISTINE
16MG
TABLET
BETAHISTINE HYDROCHLORIDE 16MG
ORAL
100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0103555003; AHFS:
CANCELLED POST MARKET
2018-06-12
_ _ _Product Monograph - _ ACT _ _ BETAHISTINE _ _ _Page 1 of 21_ PRODUCT MONOGRAPH PR ACT BETAHISTINE Betahistine dihydrochloride tablets, BP 16 MG AND 24 MG ANTI-VERTIGO AGENT Actavis Pharma Company 6733 Mississauga Road, Suite 400 Mississauga, Ontario L5N 6J5 Date of Revision: November 6, 2017 Submission Control No.: 210611 _ _ _Product Monograph - _ ACT _ _ BETAHISTINE _ _ _Page 2 of 21_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................5 DRUG INTERACTIONS ....................................................................................................6 DOSAGE AND ADMINISTRATION ................................................................................7 OVERDOSAGE ..................................................................................................................8 ACTION AND CLINICAL PHARMACOLOGY ..............................................................8 STORAGE AND STABILITY ..........................................................................................11 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................11 PART II: SCIENTIFIC INFORMATION ................................................................................12 PHARMACEUTICAL INFORMATION ..........................................................................12 CLINICAL TRIALS ...................................................................................... 阅读完整的文件