RIVA-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

OLANZAPINE

Tilgjengelig fra:

LABORATOIRE RIVA INC.

ATC-kode:

N05AH03

INN (International Name):

OLANZAPINE

Dosering :

5MG

Legemiddelform:

TABLET (ORALLY DISINTEGRATING)

Sammensetning:

OLANZAPINE 5MG

Administreringsrute:

ORAL

Enheter i pakken:

30

Resept typen:

Prescription

Terapeutisk område:

ATYPICAL ANTIPSYCHOTICS

Produkt oppsummering:

Active ingredient group (AIG) number: 0128783003; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2019-05-27

Preparatomtale

RIVA-OLANZAPINE ODT _ _
Page 1 of 59
PRODUCT MONOGRAPH
PR RIVA-OLANZAPINE ODT
(Olanzapine Orally Disintegrating Tablets)
5 mg, 10 mg, 15 mg, 20 mg
Antipsychotic Agent
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
Submission Control No: 172770
Date of Preparation:
April 24, 2014
RIVA-OLANZAPINE ODT _ _
Page 2 of 59
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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
26
DOSAGE AND ADMINISTRATION
.............................................................................
28
OVERDOSAGE
...............................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 30
STORAGE AND STABILITY
.........................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
..............