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Denzapine 200 mg Tablets



Clonmel Healthcare LtdPA0126/235/004

Main Information

Trade NameDenzapine 200 mg Tablets
Active SubstancesClozapine
Dosage FormTablet
Licence HolderClonmel Healthcare Ltd
Licence NumberPA0126/235/004

Group Information

ATC CodeN05AH Diazepines, oxazepines, thiazepines and oxepines
N05AH02 clozapine

Status

License statusAuthorised
Licence Issued03/04/2009
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceDENZAPINE 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 StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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