OLANZAPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLANZAPINE

Available from:

JUBILANT GENERICS LIMITED

ATC code:

N05AH03

INN (International Name):

OLANZAPINE

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

OLANZAPINE 2.5MG

Administration route:

ORAL

Units in package:

30/100/1000

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

Active ingredient group (AIG) number: 0128783001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-01-16

Summary of Product characteristics

_Pr_
_Olanzapine _
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PRODUCT MONOGRAPH
PR
OLANZAPINE
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg
Manufacturer Standard
Antipsychotic Agent
MANUFACTURER:
Jubilant Generics Limited
1-A, Sector -16A, Institutional Area,
Noida -201301, Uttar Pradesh, India
DATE OF REVISION: April 7, 2020
IMPORTER AND DISTRIBUTOR:
Pharmapar Inc.
1565 boul. Lionel-Boulet,
Varennes QC J3X 1P7
SUBMISSION CONTROL NO: 237756
_Pr_
_Olanzapine _
_Page 2 of 55 _
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...............................................................................................13
DRUG INTERACTIONS
...............................................................................................26
DOSAGE AND
ADMINISTRATION............................................................................28
OVERDOSAGE
.............................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
.........................................................30
STORAGE AND
STABILITY.......................................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................32
PART II: SCIENTIFIC INFORMATION
........................................................................33
PHARMACEUTICAL
INFORMATION.....................................................................33
CLINICAL
TRIALS..........................................................................