AG-QUETIAPINE FUMARATE TABLET (IMMEDIATE RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-06-2021
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Active ingredient:
QUETIAPINE (QUETIAPINE FUMARATE)
Available from:
ANGITA PHARMA INC.
ATC code:
N05AH04
INN (International Name):
QUETIAPINE
Dosage:
200MG
Pharmaceutical form:
TABLET (IMMEDIATE RELEASE)
Composition:
QUETIAPINE (QUETIAPINE FUMARATE) 200MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ATYPICAL ANTIPSYCHOTICS
Product summary:
Active ingredient group (AIG) number: 0131858003; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-06-14
Summary of Product characteristics
Page 1 of 59
PRODUCT MONOGRAPH
PR
AG-QUETIAPINE FUMARATE
Quetiapine Tablets USP
25 mg, 100 mg, 200 mg and 300 mg
quetiapine (as quetiapine fumarate)
Antipsychotic Agent
_ANGITA PHARMA INC. _
_DATE OF REVISION:_
1310 rue Nobel
June 11, 2021
Boucherville, Québec
J4B 5H3
Submission Control No.: 252148
Page 2 of 59
TABLE OF CONTENTS
PRODUCT MONOGRAPH
....................................................................................................
1
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
...............................................................................................
15
DRUG INTERACTIONS
...............................................................................................
31
DOSAGE AND ADMINISTRATION
...........................................................................
33
OVERDOSAGE
.............................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 36
STORAGE AND STABILITY
.......................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 38
PART II: SCIENTIFIC INFORMATION
.............................................................................
39
PHARMACEUTICAL INFORMATION
.......................................................................
39
CLINICAL TRIALS
..........................................................................
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