SANDOZ CLOZAPINE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CLOZAPINE

MAH:

SANDOZ CANADA INCORPORATED

ATC_code:

N05AH02

INN:

CLOZAPINE

dosage:

25MG

pharmaceutical_form:

TABLET

composition:

CLOZAPINE 25MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

ATYPICAL ANTIPSYCHOTICS

leaflet_short:

Active ingredient group (AIG) number: 0122583001; AHFS:

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2022-07-25

SPC

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_Sandoz Clozapine Page 1 of 53_
PRODUCT MONOGRAPH
PR
SANDOZ CLOZAPINE
Clozapine Tablets
25 mg and 100 mg tablets
Antipsychotic Agent
Sandoz Canada Inc.
Date of Revision:
110 rue de Lauzon
March 20, 2020
Boucherville, QC, Canada
J4B 1E6
Control No.: 237094
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_Sandoz Clozapine Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
20
DRUG INTERACTIONS
..................................................................................................
25
DOSAGE AND ADMINISTRATION
..............................................................................
27
OVERDOSAGE
................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 31
STORAGE AND STABILITY
..........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL
INFORMATION..........................................................................
33
CLINICAL TRIALS
..........................................................................................................
34
DETAILED PHARMACOLOGY
..................................................