GEN-CLOZAPINE SUSPENSION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
16-04-2019
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Aktiva substanser:
CLOZAPINE
Tillgänglig från:
MYLAN PHARMACEUTICALS ULC
ATC-kod:
N05AH02
INN (International namn):
CLOZAPINE
Dos:
50MG
Läkemedelsform:
SUSPENSION
Sammansättning:
CLOZAPINE 50MG
Administreringssätt:
ORAL
Enheter i paketet:
125ML
Receptbelagda typ:
Prescription
Terapiområde:
ATYPICAL ANTIPSYCHOTICS
Produktsammanfattning:
Active ingredient group (AIG) number: 0122583003; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2019-09-30
Produktens egenskaper
_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
..........................................................
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