FLUVOXAMINE-100 TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FLUVOXAMINE MALEATE

Disponible depuis:

PRO DOC LIMITEE

Code ATC:

N06AB08

DCI (Dénomination commune internationale):

FLUVOXAMINE

Dosage:

100MG

forme pharmaceutique:

TABLET

Composition:

FLUVOXAMINE MALEATE 100MG

Mode d'administration:

ORAL

Unités en paquet:

50/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0122450001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2023-07-10

Résumé des caractéristiques du produit

Page 1 of 50
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
FLUVOXAMINE-50
PR
FLUVOXAMINE-100
Fluvoxamine Maleate Tablets
Tablets, 50 mg and 100 mg, Oral
BP
Antidepressant, Antiobsessional Agent
_ _
CONTROL NUMBER:_ 261511 _
_ _
_ _
PRO DOC LTÉE
2925, BOUL. INDUSTRIEL
LAVAL, QUÉBEC
H7L 3W9 DATE OF INITIAL AUTHORIZATION:
October 29, 1997 DATE OF REVISION:
March 8, 2022
Page 2 of 50
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
03/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
03/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
03/2022
7 WARNINGS AND PRECAUTIONS,
Serotonin Toxicity/Neuroleptic Malignant
Syndrome
03/2022
7 WARNINGS AND PRECAUTIONS,
Reproductive Health: Male and Female Potential
03/2022
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
4 DOSAGE AND ADMINISTRATION
..................................................................................................5
4.1 Dosing Considerations
...........................................................