APO-QUETIAPINE FUMARATE TABLET (IMMEDIATE RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

QUETIAPINE (QUETIAPINE FUMARATE)

Disponível em:

APOTEX INC

Código ATC:

N05AH04

DCI (Denominação Comum Internacional):

QUETIAPINE

Dosagem:

300MG

Forma farmacêutica:

TABLET (IMMEDIATE RELEASE)

Composição:

QUETIAPINE (QUETIAPINE FUMARATE) 300MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

ATYPICAL ANTIPSYCHOTICS

Resumo do produto:

Active ingredient group (AIG) number: 0131858005; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2020-07-31

Características técnicas

_APO-QUETIAPINE FUMARATE (Quetiapine tablets)_
_Page 1 of 71_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-QUETIAPINE FUMARATE
Quetiapine tablets
Immediate-Release Tablets, 25 mg, 100 mg, 200 mg and 300 mg quetiapine
(as quetiapine
fumarate), Oral
USP
Antipsychotic Agent
Apotex Inc.
150 Signet Drive
Toronto, Ontario M9L 1T9
Canada
Date of Initial Authorization:
July 31, 2020 Date of Revision:
December 6, 2022
Submission Control No: 265729
_APO-QUETIAPINE FUMARATE (Quetiapine tablets)_
_Page 2 of 71_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS - Musculoskeletal -
Rhabdomyolysis
12/2022
7 WARNINGS AND PRECAUTIONS - Psychiatric
12/2022
1 INDICATIONS, 1.1 Pediatrics
12/2022
2 CONTRAINDICATIONS
12/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
12/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment, Dosing Considerations in Special
Populations, Pediatric Use
12/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
12/2022
7 WARNINGS AND PRECAUTIONS, Weight Gain
12/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2022
7 WARNINGS AND PRECAUTIONS, 7.3 Pediatrics
12/2022
7 WARNINGS AND PRECAUTIONS, Use in Geriatric Patients with
Dementia
12/2022
7 WARNINGS AND PRECAUTIONS, Skin
12/2022
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
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics....................................................................................................................
4
2
CONTRAINDICATIONS
....