AG-QUETIAPINE TABLET (IMMEDIATE RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

QUETIAPINE (QUETIAPINE FUMARATE)

Disponível em:

ANGITA PHARMA INC.

Código ATC:

N05AH04

DCI (Denominação Comum Internacional):

QUETIAPINE

Dosagem:

100MG

Forma farmacêutica:

TABLET (IMMEDIATE RELEASE)

Composição:

QUETIAPINE (QUETIAPINE FUMARATE) 100MG

Via de administração:

ORAL

Unidades em pacote:

100/500

Tipo de prescrição:

Prescription

Área terapêutica:

ATYPICAL ANTIPSYCHOTICS

Resumo do produto:

Active ingredient group (AIG) number: 0131858002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2018-05-22

Características técnicas

AG-Quetiapine (Quetiapine Tablets)
Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-QUETIAPINE
Quetiapine Tablets
Immediate-Release Tablets, 25, 100, 200 and 300 mg (as quetiapine
fumarate), Oral Use
USP
Antipsychotic Agent
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
MAY 22, 2018
Date of Revision:
FEB 02, 2023
Submission Control No: 270866
AG-Quetiapine (Quetiapine Tablets)
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS- Musculoskeletal- Rhabdomyolysis
01/2023
7 WARNINGS AND PRECAUTIONS – Psychiatric
01/2023
7 WARNINGS AND PRECAUTIONS - Skin
04/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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
4.4
Administration
........................................................................................................
7
4.5
Missed
Dose...................................................................................................................
7
5.
OVERDOSAGE
...........................