Denzapine ®50 mg Tablets

Licence information

ATC code

N05AH Diazepines, oxazepines, thiazepines and oxepines, N05AH02 clozapine

Legal supply status

Product subject to prescription which may not be renewed (A)

Place of sale

Supply through pharmacies only

Conditions of Licence

DENZAPINE Official Recommendations: DENZAPINE is associated with a specific risk of agranulocytosis. Any adverse haematological effects should be notified to the Irish Medicines Board. Intrinsic to Denzapine therapy is enrolment with and monitoring by the DENZAPINE Monitoring Service (DMS), based at: Denzapine Monitoring Service Merz Pharma UK Ltd., 260 Centennial Park, Elstree South, Elstree, Hertfordshire WD6 3SR, UK. The DMS database embodies tightly controlled post-marketing surveillance and ensures the safe use of DENZAPINE in registered patients. Features of the DMS which are of fundamental importance to patient safety include the following: Psychiatrists who wish to prescribe DENZAPINE must be registered with the DMS. Pharmacists dispensing DENZAPINE must be registered with the DMS. Patients to receive DENZAPINE must be enrolled with the DMS. They must undergo pre-treatment screening, as well as subsequent haematological tests. These will be weekly initially, then may become fortnightly after a perio

Marketing availability

Marketed

Advertising conditions

Advertising to healthcare professionals only

Licence issued

03/04/2009