ACT BETAHISTINE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

BETAHISTINE HYDROCHLORIDE

Disponível em:

ACTAVIS PHARMA COMPANY

Código ATC:

N07CA01

DCI (Denominação Comum Internacional):

BETAHISTINE

Dosagem:

16MG

Forma farmacêutica:

TABLET

Composição:

BETAHISTINE HYDROCHLORIDE 16MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0103555003; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2018-06-12

Características técnicas

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_Product Monograph - _
ACT
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BETAHISTINE
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_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
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_Product Monograph - _
ACT
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BETAHISTINE
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_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
......................................................................................