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Leydex 12.5 mg Orodispersible Tablets



Leyden Delta BVPA2241/001/001

Main Information

Trade NameLeydex 12.5 mg Orodispersible Tablets
Active SubstancesClozapine
Dosage FormOrodispersible tablet
Licence HolderLeyden Delta BV
Licence NumberPA2241/001/001

Group Information

ATC CodeN05AH Diazepines, oxazepines, thiazepines and oxepines
N05AH02 clozapine

Status

License statusAuthorised
Licence Issued12/04/2019
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceTo be dispensed under strict medical supervision in accordance with official recommendations. Use of clozapine is restricted to patients who are registered with a monitoring service to manage the risk of agranulocytosis associated with treatment. Both doctor and pharmacist concerned must be registered with this service. (See SmPC for full details).
Marketing StatusUnknown

Documents

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