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AKM CLOZAPINE, CLOZITOR, PHARMACOR CLOZAPINE (Pharmacor Pty Ltd)

Product name
AKM CLOZAPINE, CLOZITOR, PHARMACOR CLOZAPINE
Date registered
Evaluation commenced
Decision date
Approval time
161 (255 working days)
Active ingredients
clozapine
Registration type
New generic medicine
Indication

Treatment with AKM CLOZAPINE, CLOZITOR, PHARMACOR CLOZAPINE (uncoated tablet) is indicated only in people with treatment resistant schizophrenia, i.e. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs.

Non-responsiveness is defined as lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations.

Intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse effects (extrapyramidal side effects or tardive dyskinesia).

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