AURO-LURASIDONE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-03-2021
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Active ingredient:
LURASIDONE HYDROCHLORIDE
Available from:
AURO PHARMA INC
ATC code:
N05AE05
INN (International Name):
LURASIDONE
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
LURASIDONE HYDROCHLORIDE 40MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0153185001; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-11-15
Summary of Product characteristics
Page 1 of 67
PRODUCT MONOGRAPH
PR
AURO-LURASIDONE
Lurasidone Hydrochloride Tablets
20 mg, 40 mg, 60 mg, 80 mg and 120 mg film-coated tablets
HOUSE STANDARD
Antipsychotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation:
March 17, 2021
Submission Control No: 204040
Page 2 of 67
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
.............................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................
5
ADVERSE
REACTIONS............................................................................................
17
DRUG INTERACTIONS
............................................................................................
40
DOSAGE AND ADMINISTRATION
.........................................................................
42
OVERDOSAGE
.........................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 46
STORAGE AND STABILITY
....................................................................................
48
SPECIAL HANDLING INSTRUCTIONS
................................................................... 48
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 48
PART II: SCIENTIFIC INFORMATION
...........................................................................49
PHARMACEUTICAL INFORMATION
.....................................................................
49
CLINICAL TRIALS
...................................................................................................
50
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