PRO-QUETIAPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

QUETIAPINE (QUETIAPINE FUMARATE)

Available from:

PRO DOC LIMITEE

ATC code:

N05AH04

INN (International Name):

QUETIAPINE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

QUETIAPINE (QUETIAPINE FUMARATE) 150MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

Active ingredient group (AIG) number: 0131858004; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-11-28

Summary of Product characteristics

_PRO-QUETIAPINE (Quetiapine Fumarate Immediate-Release Tablets) 25 mg,
100 mg, 150 mg, 200 mg & 300 mg _
_ _
_ _
_Page 1 of 69 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-QUETIAPINE
Quetiapine Tablets
Immediate-Release Tablets, 25 mg, 100 mg, 150 mg, 200 mg & 300 mg
quetiapine (as
quetiapine fumarate), Oral
Antipsychotic Agent
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
www.prodoc.qc.ca
Submission Control No:
261700
Date of Initial Authorization:
June 04, 2020
Date of
Revision:
March 07,
2022
_PRO-QUETIAPINE (Quetiapine Fumarate Immediate-Release Tablets) 25 mg,
100 mg, 150 mg, 200 mg & 300 mg _
_ _
_ _
_Page 2 of 69 _
RECENT MAJOR LABEL CHANGES
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TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1.
INDICATIONS
.....................................................................................................................
4
1.1 Pediatrics
.........................................................................................................................
4
1.2 Geriatrics
.........................................................................................................................
4
2.
CONTRAINDICATIONS
.......................................................................................................
5
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................. 5
4.
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1 Dosing Considerations
....................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
............................