TORRENT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLANZAPINE

Available from:

TORRENT PHARMACEUTICALS LIMITED

ATC code:

N05AH03

INN (International Name):

OLANZAPINE

Dosage:

15MG

Pharmaceutical form:

TABLET (ORALLY DISINTEGRATING)

Composition:

OLANZAPINE 15MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

Active ingredient group (AIG) number: 0128783005; AHFS:

Authorization status:

CANCELLED (UNRETURNED ANNUAL)

Authorization date:

2021-12-20

Summary of Product characteristics

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_Page 1 of 62_
PRODUCT MONOGRAPH
PR
TORRENT-OLANZAPINE ODT
Olanzapine
Orally Disintegrating Tablets
5 mg, 10 mg, 15 mg, 20 mg
Antipsychotic Agent
Torrent Pharmaceuticals Ltd.
Ahmedabad-Mehsana Highway
Taluka - Kadi, Dist. Mehsana
Indrad-382 721, Gujarat, India
Distributed by:
Torrent Pharma Canada Inc.
Woodbridge, ON, L4H 1Y6
Date of Revision :
February 07, 2014
Submission Control No: 166045
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_Page 2 of 62_
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
..................................................................................................27
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................36
PHARMACEUTICAL INFORMATION
..........................................................................36
CLINICAL TRIALS
..............................................................