Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1534687
Name of medicinal product: BLASTOMAT 100 MG
Active substances:
Temozolomide
Estonian, English, Latin
ATC code: L01AX03
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 100mg
Amount in package: 20TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: is indicated for the treatment of: - Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. - Children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated April 29, 2021)
Package information leaflet (PIL): EST  (last updated April 29, 2021)
Labelling:  (last updated September 12, 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Zentiva k.s. 
Marketing authorization number: 799612 
Marketing authorization issued on: October 29, 2012 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 7, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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