AURO-CLOZAPINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CLOZAPINE

Διαθέσιμο από:

AURO PHARMA INC

Φαρμακολογική κατηγορία (ATC):

N05AH02

INN (Διεθνής Όνομα):

CLOZAPINE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CLOZAPINE 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ATYPICAL ANTIPSYCHOTICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0122583002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-05-26

Αρχείο Π.Χ.Π.

_AURO-CLOZAPINE PRODUCT MONOGRAPH _Page 1 of 52
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-CLOZAPINE
Clozapine Tablets, USP
25 mg, 50 mg, 100 mg and 200 mg
Antipsychotic Agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
CANADA.
Date of Initial Authorization:
April 06, 2016
Date of Revision:
September 28, 2022
Submission Control No.: 266744
_AURO-CLOZAPINE PRODUCT MONOGRAPH _Page 2 of 52
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
09/2022
7 WARNINGS AND PRECAUTIONS, General, Anticholinergic Activity
03/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES...............................................................................................
2
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1
INDICATIONS..........................................................................................................................
4
1.1 Pediatrics
.................................................................................................................
5
1.2
Geriatrics..................................................................................................................
5
2 CONTRAINDICATIONS
............................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX........................................................................
6
4 DOSAGE AND ADMINISTRATION
............................................................................................
7
4.1 Dosing Considerations
..............................................................................................
7
4.2 Recommended Dose and Dos