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Temodal

5 milligram(s) Capsule, hard

Merck Sharp & Dohme BVEU/1/98/096/001-002

Main Information

Trade NameTemodal
Active SubstancesTemozolomide
Strength5 milligram(s)
Dosage FormCapsule, hard
Licence HolderMerck Sharp & Dohme BV
Licence NumberEU/1/98/096/001-002

Group Information

ATC CodeL01AX Other alkylating agents
L01AX03 temozolomide

Status

Authorised/WithdrawnAuthorised
Licence Issued26/01/1999
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 5mg Capsules
Interchangeable List CodeIC0080-001-001
Interchangeable List DocumentPDF of Interchangeable List
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