RIVA-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

OLANZAPINE

Fáanlegur frá:

LABORATOIRE RIVA INC.

ATC númer:

N05AH03

INN (Alþjóðlegt nafn):

OLANZAPINE

Skammtar:

10MG

Lyfjaform:

TABLET (ORALLY DISINTEGRATING)

Samsetning:

OLANZAPINE 10MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ATYPICAL ANTIPSYCHOTICS

Vörulýsing:

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

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2018-07-04

Vara einkenni

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