ACT BETAHISTINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BETAHISTINE HYDROCHLORIDE

Tersedia dari:

ACTAVIS PHARMA COMPANY

Kode ATC:

N07CA01

INN (Nama Internasional):

BETAHISTINE

Dosis:

16MG

Bentuk farmasi:

TABLET

Komposisi:

BETAHISTINE HYDROCHLORIDE 16MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-06-12

Karakteristik produk

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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
......................................................................................