Country: Canada
Language: English
Source: Health Canada
OLANZAPINE
JUBILANT GENERICS LIMITED
N05AH03
OLANZAPINE
7.5MG
TABLET
OLANZAPINE 7.5MG
ORAL
30/100/1000
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0128783004; AHFS:
APPROVED
2014-01-16
_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.......................................................................... Read the complete document