MedeliX
Start asking

temozolomide

Temodal · ATC code L01AX03

Also known as: Temozolomid · Brand names: Temodal, Temozo-Cell, Temozolomid Cipla, Temozolomid Devatis, Temozolomid Fair-Med Healthcare, Temozolomid Ratiopharm, Temozolomid Ribosepharm, Midizol, Temomid, Temotu, Temozolid

Key facts
Active substance
temozolomide
Drug class
Alkylating antineoplastic agent
ATC code
L01AX03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Temodal 5 mg hard capsules / Temodal 20 mg hard capsules / Temodal 100 mg hard capsules · Temodal 2.5 mg/ml powder for solution for infusion
Marketing authorisation holder
Merck Sharp & Dohme B.V.
Information as of
2026-10-27

Key facts

Temozolomide (Temodal) is an alkylating cytotoxic agent used to treat glioblastoma and other malignant gliomas.

What it is used for

  • Newly diagnosed glioblastoma multiforme in adults, concomitantly with radiotherapy and then as monotherapy
  • Malignant glioma (e.g. glioblastoma, anaplastic astrocytoma) recurring or progressing after standard therapy in children from three years, adolescents and adults

Dosing

  • Glioblastoma, concomitant phase: 75 mg/m2 daily for 42 days with focal radiotherapy; weekly blood count
  • Then up to 6 cycles of monotherapy (150 - 200 mg/m2 on days 1 - 5 of every 28-day cycle), starting 4 weeks after the end of radiotherapy
  • Recurrent or progressive glioma: regimen in full text; lowest recommended dose 100 mg/m2
  • Capsules taken without food; anti-emetics may be given
  • Interruption or discontinuation based on neutrophils, platelets and non-haematological toxicity

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Hypersensitivity to dacarbazine
  • Severe myelosuppression

Important warnings

  • Pneumocystis jirovecii pneumonia: prophylaxis required during the 42-day combination with radiotherapy
  • Opportunistic infections and reactivation of HBV and CMV; herpetic meningoencephalitis
  • Myelosuppression up to aplastic anaemia, sometimes fatal; elderly at higher risk
  • Hepatic injury including fatal hepatic failure; liver tests before treatment and after each cycle
  • Very rare myelodysplastic syndrome and secondary malignancies

Side effects

  • Most common: nausea, vomiting, constipation, anorexia, headache, fatigue, convulsions, rash
  • Myelosuppression (neutropenia, thrombocytopenia)

Interactions

  • Food lowers peak concentration; therefore take without food
  • Valproic acid: small decrease in clearance
  • Other myelosuppressive medicines may increase myelosuppression

Pregnancy and breastfeeding

  • Should not be given to pregnant women; breast-feeding should be discontinued during treatment
  • Effective contraception for women for at least 6 months and for men at least 3 months after treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • TemodalMerck Sharp & Dohme B.V. · EMEA/H/C/000229
  • Temomedac · genericmedac Gesellschaft für klinische Spezialpräparate mbH · EMEA/H/C/001124
  • Temozolomide Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/001125
  • Temozolomide Sun · genericSun Pharmaceutical Industries Europe B.V. · EMEA/H/C/002198
  • Temozolomide Teva · genericTeva B.V. · EMEA/H/C/001126

Source: European Medicines Agency (EMA), product information

Germany

  • Temozo-CellStadapharm Gmbh · 1 register entry
  • Temozolomid CiplaCipla Europe Nv · 1 register entry
  • Temozolomid DevatisDevatis Gmbh · 1 register entry
  • Temozolomid Fair-Med HealthcareFairmed Healthcare Gmbh · 1 register entry
  • Temozolomid RatiopharmRatiopharm Gmbh · 1 register entry
  • Temozolomid RibosepharmHikma Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • MidizolDEVA HOLDİNG A.Ş. · 6 register entries
  • TemodalMERCK SHARP DOHME İLAÇLARI LTD. ŞTİ. · 6 register entries
  • TemomidKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 8 register entries
  • TemotuONKO İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • TemozolidDEM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 22 more European countries
Croatia
Temazol, Temozolomid Pgf Pharma
Cyprus
Advecit, Ridoca
Czechia
Temozolomide Glenmark
Denmark
Temozolomid Fair-Med, Temozolomid Stada
Estonia
Blastomat
Finland
Temozolomid Ratiopharm
France
Kimozo, Temozolomide Viatris
Greece
Ridoca
Hungary
Temozolomide Pharmacenter
Iceland
Temodal, Temomedac, Temozolomid Ratiopharm, Temozolomide Accord, Temozolomide Sun, Temozolomide Teva
Ireland
Temozolomide Clonmel, Temozolomide Fair-Med
Latvia
Blastomat
Liechtenstein
Temodal, Temomedac, Temozolomide Accord, Temozolomide Teva
Lithuania
Blastomat
Malta
Temozolomide Clonmel
Netherlands
Blastomat, Nogron, Ridoca, Temozolomide Amarox, Temozolomide Devatis, Temozolomide Fair-Med, Temozolomide Glenmark, Temozolomide Koanaa, Temozolomide Lotus, Temozolomide Ratiopharm
Norway
Temodal, Temomedac, Temozolomide Accord, Temozolomide Pgf Pharma, Temozolomide Sun, Temozolomide Teva
Poland
Temozolomide Fair-Med, Temozolomide Glenmark
Portugal
Temozolomida, Temozolomide
Romania
Temozolomidă Hf
Slovakia
Temostad
Sweden
Temozolomid Stada, Temozolomide Pgf Pharma

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Temodal – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/temodal-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC L01AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.