TEVA-BUSPIRONE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BUSPIRONE HYDROCHLORIDE

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

N05BE01

INN (Nome Internazionale):

BUSPIRONE

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

BUSPIRONE HYDROCHLORIDE 10MG

Via di somministrazione:

ORAL

Confezione:

35/100/500/1000

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0116263001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-06-03

Scheda tecnica

_TEVA-BUSPIRONE (Buspirone Hydrochloride Tablets)_
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-BUSPIRONE
Buspirone Hydrochloride Tablets
Tablets, 10 mg, Oral
USP
Anxiolytic
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
June 18, 1997
Toronto, ON
M1B 2K9 Date of Revision:
Canada December 20, 2023
Submission Control Number: 277097
_TEVA-BUSPIRONE (Buspirone Hydrochloride Tablets)_
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
12/2023
2 Contraindications
12/2023
3 Serious warnings and precautions box
12/2023
4 Dosage and administration, 4.1 Dosing Considerations
12/2023
7 Warnings and precautions, General
12/2023
7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome
12/2023
7 Warnings and precautions, Dependence/Tolerance
12/2023
7 Warnings and precautions, Withdrawal
12/2023
7 Warnings and precautions, Falls and Fractures
12/2023
7 Warnings and precautions, 7.1.4 Geriatrics
12/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE OF
CONTENTS………………………………………………………………………………………………………………2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
........................................................................................................................
4
1.2
Geriatrics
.........................................................................................................................
4
2
CONTRAINDICATIONS
........................................................................................................
4
3
SERIOUS WARNINGS AND