TORRENT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

OLANZAPINE

Disponibbli minn:

TORRENT PHARMACEUTICALS LIMITED

Kodiċi ATC:

N05AH03

INN (Isem Internazzjonali):

OLANZAPINE

Dożaġġ:

15MG

Għamla farmaċewtika:

TABLET (ORALLY DISINTEGRATING)

Kompożizzjoni:

OLANZAPINE 15MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ATYPICAL ANTIPSYCHOTICS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED (UNRETURNED ANNUAL)

Data ta 'l-awtorizzazzjoni:

2021-12-20

Karatteristiċi tal-prodott

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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
..............................................................