OLANZAPINE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

OLANZAPINE

Tilgængelig fra:

JUBILANT GENERICS LIMITED

ATC-kode:

N05AH03

INN (International Name):

OLANZAPINE

Dosering:

2.5MG

Lægemiddelform:

TABLET

Sammensætning:

OLANZAPINE 2.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100/1000

Recept type:

Prescription

Terapeutisk område:

ATYPICAL ANTIPSYCHOTICS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2014-01-16

Produktets egenskaber

_Pr_
_Olanzapine _
_Page 1 of 55 _
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..........................................................................