VIIBRYD KIT

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

VILAZODONE HYDROCHLORIDE; VILAZODONE HYDROCHLORIDE

Dostupné s:

ABBVIE CORPORATION

ATC kód:

N06AX24

INN (Mezinárodní Name):

VILAZODONE

Dávkování:

10MG; 20MG

Léková forma:

KIT

Složení:

VILAZODONE HYDROCHLORIDE 10MG; VILAZODONE HYDROCHLORIDE 20MG

Podání:

ORAL

Jednotky v balení:

7X10MG-7X20MG-16X40MG

Druh předpisu:

Prescription

Terapeutické oblasti:

SEROTONIN MODULATORS

Přehled produktů:

Active ingredient group (AIG) number: 0257130001; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2023-07-20

Charakteristika produktu

_VIIBRYD (vilazodone hydrochloride, tablets) _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
VIIBRYD®
vilazodone hydrochloride tablets
Tablets, 10 mg, 20 mg, and 40 mg, Oral
Antidepressant
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Date of Initial Authorization:
JUL 15, 2015
Date of Revision:
NOV 17, 2022
Submission Control Number: 268750
_ _
_VIIBRYD (vilazodone hydrochloride, tablets) _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
03/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
03/2021
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 PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.2.1
Initiating treatment
........