AG-QUETIAPINE TABLET (IMMEDIATE RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

QUETIAPINE (QUETIAPINE FUMARATE)

Available from:

ANGITA PHARMA INC.

ATC code:

N05AH04

INN (International Name):

QUETIAPINE

Dosage:

100MG

Pharmaceutical form:

TABLET (IMMEDIATE RELEASE)

Composition:

QUETIAPINE (QUETIAPINE FUMARATE) 100MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-05-22

Summary of Product characteristics

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
...........................