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For the use of Denzapine® in a patient who does not meet the licensed indications or patient criteria as
stated in the Summary of Product Characteristics (SmPC).
The Summary of Product Characteristics for DENZAPINE (clozapine) states that
‘DENZAPINE is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who
have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical
Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate
doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for
DENZAPINE is also indicated in psychotic disorders occurring during the course of Parkinson's disease, in
cases where standard treatment has failed.'
The Summary of Product Characteristics for DENZAPINE (clozapine) also describes those patients in whom
Denzapine is not recommended or is contra-indicated (Please refer to SmPC for further guidance).
I, the undersigned, acknowledge and agree that Britannia Pharmaceuticals does not recommend the use of
DENZAPINE in the circumstances applicable to the patient set out below, and that the decision to treat is my
decision and clinical responsibility alone.
I hereby waive any rights I (or Hospital Name) may have against Britannia Pharmaceuticals, and release and
discharge Britannia Pharmaceuticals from any claims (or Hospital Name) may have against Britannia
Pharmaceuticals, arising in connection with the use of DENZAPINE in the circumstances applicable to the
patient set out below.
Please state the reason(s) why the above-named patient does not meet the patient criteria (described in the
SmPC for Denzapine®):