M-BETAHISTINE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

BETAHISTINE HYDROCHLORIDE

Verfügbar ab:

MANTRA PHARMA INC

ATC-Code:

N07CA01

INN (Internationale Bezeichnung):

BETAHISTINE

Dosierung:

8MG

Darreichungsform:

TABLET

Zusammensetzung:

BETAHISTINE HYDROCHLORIDE 8MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

MISCELLANEOUS THERAPEUTIC AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0103555002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2021-08-30

Fachinformation

_M-Betahistine Product Monograph_
Page 1 of 20
PRODUCT MONOGRAPH
PR
M-BETAHISTINE
BETAHISTINE DIHYDROCHLORIDE TABLETS BP
8 MG, 16 MG AND 24 MG
ANTI-VERTIGO AGENT
MANTRA PHARMA INC.
9150 Boulevard Leduc, Suite 201
Brossard, QC, Canada
J4Y 0E3
DATE OF PREPARATION:
August 25, 2021
SUBMISSION CONTROL NO: 254780
_M-Betahistine Product Monograph_
Page 2 of 20
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
.............................................................................................
13
DETAILED PHARMACOLOGY
........................................................................
13
TOXICOLOGY
............................................................................................