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Sun Phamaceutical Industries Europe B.V.EU/1/11/697/003-004

Main Information

Active SubstancesTEMOZOLOMIDE
Dosage FormCapsule, hard
Licence HolderSun Phamaceutical Industries Europe B.V.
Licence NumberEU/1/11/697/003-004

Group Information

ATC CodeL01AX03 temozolomide


License statusAuthorised
Licence Issued13/07/2011
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceSubject 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 20mg Capsules
Interchangeable List CodeIC0080-003-001
Interchangeable List DocumentPDF of Interchangeable List
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