The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


TEMOMEDAC



Medac Gesellschaft fur Klinische Spezialpraparate mbHEU/1/09/605/5-6

Main Information

Trade NameTEMOMEDAC
Active SubstancesTEMOZOLOMIDE
Dosage FormCapsule, hard
Licence HolderMedac Gesellschaft fur Klinische Spezialpraparate mbH
Licence NumberEU/1/09/605/5-6

Group Information

ATC CodeL01AX03 temozolomide

Status

License statusAuthorised
Licence Issued25/01/2010
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing Status

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Generics Information

Interchangeable ListTemozolomide 100mg Capsules
Interchangeable List CodeIC0080-024-001
Interchangeable List DocumentPDF of Interchangeable List
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