NU-QUETIAPINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-09-2009
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Active ingredient:
QUETIAPINE (QUETIAPINE FUMARATE)
Available from:
NU-PHARM INC
ATC code:
N05AH04
INN (International Name):
QUETIAPINE
Dosage:
300MG
Pharmaceutical form:
TABLET
Composition:
QUETIAPINE (QUETIAPINE FUMARATE) 300MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
ATYPICAL ANTIPSYCHOTICS
Product summary:
Active ingredient group (AIG) number: 0131858005; AHFS:
Authorization status:
CANCELLED (UNRETURNED ANNUAL)
Authorization date:
2018-03-28
Summary of Product characteristics
Page 1 of 42
PRODUCT MONOGRAPH
Pr
NU-QUETIAPINE
QUETIAPINE AS QUETIAPINE FUMARATE
TABLETS 25 MG, 100 MG, 200 MG AND 300 MG
ANTIPSYCHOTIC AGENT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1 & 2
RICHMOND HILL, ON
SEPTEMBER 2, 2009
L4B 1E4
Control#: 132324
Page 2 of 42
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.......................................................................................................
11
DRUG INTERACTIONS
.......................................................................................................
18
DOSAGE AND ADMINISTRATION
...................................................................................
20
OVERDOSAGE......................................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
22
STORAGE AND
STABILITY...............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 24
PART II: SCIENTIFIC INFORMATION
.............................................................................
25
PHARMACEUTICAL
INFORMATION...............................................................................
25
CLINICAL TRIALS
...............................................................................................................
26
DETAILED PHARMACOLOGY
.....
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