MINT-BETAHISTINE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
17-05-2023
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Aktiv bestanddel:
BETAHISTINE HYDROCHLORIDE
Tilgængelig fra:
MINT PHARMACEUTICALS INC
ATC-kode:
N07CA01
INN (International Name):
BETAHISTINE
Dosering:
16MG
Lægemiddelform:
TABLET
Sammensætning:
BETAHISTINE HYDROCHLORIDE 16MG
Indgivelsesvej:
ORAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Produkt oversigt:
Active ingredient group (AIG) number: 0103555003; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2023-06-01
Produktets egenskaber
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
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