MINT-BETAHISTINE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

BETAHISTINE HYDROCHLORIDE

Verfügbar ab:

MINT PHARMACEUTICALS INC

ATC-Code:

N07CA01

INN (Internationale Bezeichnung):

BETAHISTINE

Dosierung:

24MG

Darreichungsform:

TABLET

Zusammensetzung:

BETAHISTINE HYDROCHLORIDE 24MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Produktbesonderheiten:

Active ingredient group (AIG) number: 0103555004; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-06-01

Fachinformation

PRODUCT MONOGRAPH
PR
MINT-BETAHISTINE
Betahistine Dihydrochloride Tablets
(8 mg, 16 mg and 24 mg)
Manufacture’s Standard
Anti-vertigo Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Preparation:
May 17, 2023
Submission Control No: 257693
_MINT-BETAHISTINE Product Monograph _
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_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
...........................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 11
PART II: SCIENTIFIC INFORMATION
...............................................................................
12
PHARMACEUTICAL INFORMATION
...........................................................................
12
CLINICAL TRIALS
............................................................................................