RIVA-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

OLANZAPINE

Tersedia dari:

LABORATOIRE RIVA INC.

Kode ATC:

N05AH03

INN (Nama Internasional):

OLANZAPINE

Dosis:

10MG

Bentuk farmasi:

TABLET (ORALLY DISINTEGRATING)

Komposisi:

OLANZAPINE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

ATYPICAL ANTIPSYCHOTICS

Ringkasan produk:

Active ingredient group (AIG) number: 0128783002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-07-04

Karakteristik produk

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