GEN-CLOZAPINE SUSPENSION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CLOZAPINE

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

N05AH02

INN (Medzinárodný Name):

CLOZAPINE

Dávkovanie:

50MG

Forma lieku:

SUSPENSION

Zloženie:

CLOZAPINE 50MG

Spôsob podávania:

ORAL

Počet v balení:

125ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ATYPICAL ANTIPSYCHOTICS

Prehľad produktov:

Active ingredient group (AIG) number: 0122583003; AHFS:

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2019-09-30

Súhrn charakteristických

_Page 1 of 58_
PRODUCT MONOGRAPH
PR GEN-CLOZAPINE
Clozapine Tablets
25 mg, 50 mg, 100 mg and 200 mg
Pharmaceutical Standard: Mylan Std.
Clozapine Oral Suspension
50 mg/ml
Antipsychotic Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: April 16, 2019
Submission Control No.: 226604
_Page 2 of 58_
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................
3
SUMMARY PRODUCT INFORMATION
..................................................................................................
3
INDICATIONS AND CLINICAL USE
.......................................................................................................
4
CONTRAINDICATIONS
.............................................................................................................................
5
WARNINGS AND PRECAUTIONS
...........................................................................................................
6
ADVERSE REACTIONS
...........................................................................................................................
20
DRUG
INTERACTIONS............................................................................................................................
27
DOSAGE AND ADMINISTRATION
.......................................................................................................
28
OVERDOSAGE
..........................................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................
32
STORAGE AND STABILITY
...................................................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................................
34
PART II: SCIENTIFIC INFORMATION
..........................................................