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Medac Gesellschaft fur Klinische Spezialpraparate mbHEU/1/09/605/9-10

Main Information

Active SubstancesTEMOZOLOMIDE
Dosage FormCapsule, hard
Licence HolderMedac Gesellschaft fur Klinische Spezialpraparate mbH
Licence NumberEU/1/09/605/9-10

Group Information

ATC CodeL01AX03 temozolomide


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


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

Generics Information

Interchangeable ListTemozolomide 180 mg Capsules
Interchangeable List CodeIC0080-135-001
Interchangeable List DocumentPDF of Interchangeable List
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