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

Temozolomide Accord

140 milligram(s) Capsule, hard

Accord Healthcare S.L.U.EU/1/10/615/013-014

Main Information

Trade NameTemozolomide Accord
Active SubstancesTemozolomide
Strength140 milligram(s)
Dosage FormCapsule, hard
Licence HolderAccord Healthcare S.L.U.
Licence NumberEU/1/10/615/013-014

Group Information

ATC CodeL01AX Other alkylating agents
L01AX03 temozolomide


Licence Issued15/03/2010
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 140 mg Capsules
Interchangeable List CodeIC0080-134-001
Interchangeable List DocumentPDF of Interchangeable List
« Back