AG-QUETIAPINE XR TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-09-2021
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Active ingredient:
QUETIAPINE (QUETIAPINE FUMARATE)
Available from:
ANGITA PHARMA INC.
ATC code:
N05AH04
INN (International Name):
QUETIAPINE
Dosage:
50MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
QUETIAPINE (QUETIAPINE FUMARATE) 50MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ATYPICAL ANTIPSYCHOTICS
Product summary:
Active ingredient group (AIG) number: 0131858006; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-09-21
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
AG-QUETIAPINE XR
Quetiapine Fumarate Extended-Release Tablets
50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as quetiapine
fumarate)
House Standard
Antipsychotic / Antidepressant Agent
Angita Pharma Inc.
Date of Preparation:
1310 rue Nobel
September 20, 2021
Boucherville, Québec
J4B 5H3, Canada
Submission Control No: 255711
Product Monograph of AG-Quetiapine XR
Page 2 of 79
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
17
DRUG INTERACTIONS
.........................................................................................................
37
DOSAGE AND ADMINISTRATION
.....................................................................................
39
OVERDOSAGE
........................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
44
STORAGE AND STABILITY
.................................................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 47
PART II: SCIENTIFIC INFORMATION
...............................................................................48
PHARMACEUTICAL INFORMATION
.................................................................................
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