erlotinib
Tarceva · ATC code L01EB02
Brand names: Tarceva, Erlotev, Erlotinib Axiromed, Erlotinib Beta, Erlotinib Glenmark, Erlotinib Hexal, Erlotinib Ratiopharm, Erlotinib Stada, Erlotinib Zentiva, Binitol, Ertinob, Ertivec, Etinib, Lungerlo, Sevastra …
- Key facts
- Active substance
- erlotinib
- ATC code
- L01EB02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tarceva 25 mg film-coated tablets / Tarceva 100 mg film-coated tablets / Tarceva 150 mg film-coated tablets
- Marketing authorisation holder
- Cheplapharm Registration GmbH
- Information as of
- 2026-10-28
Key facts
Erlotinib is an EGFR tyrosine kinase inhibitor. It is used for advanced non-small cell lung cancer (NSCLC) and, together with gemcitabine, for metastatic pancreatic cancer.
What it is used for
- First-line treatment of locally advanced or metastatic NSCLC with EGFR activating mutations.
- Switch maintenance treatment in locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.
- NSCLC after failure of at least one prior chemotherapy (in tumours without EGFR activating mutations only when other options are not suitable).
- Metastatic pancreatic cancer in combination with gemcitabine.
Dosing
- Tarceva, NSCLC: 150 mg daily, at least one hour before or two hours after food.
- Tarceva, pancreatic cancer: 100 mg daily in combination with gemcitabine, also apart from food; if no rash develops within the first 4 – 8 weeks, further treatment should be re-assessed.
- When dose adjustment is necessary, reduce in 50 mg steps.
- Smokers: smoking reduces erlotinib exposure; current smokers should be advised to stop smoking.
- Caution in hepatic impairment, not recommended in severe hepatic dysfunction; not recommended in severe renal impairment. With a potent CYP3A4 inducer such as rifampicin, an increase to 300 mg should be considered.
Contraindications
- Hypersensitivity to erlotinib or to any of the excipients.
Important warnings
- Before first-line or maintenance use, EGFR mutation status must be determined with a validated test.
- Interstitial lung disease, including fatal cases, has been reported uncommonly; investigate new or worsening respiratory symptoms.
- Gastrointestinal perforation (uncommon, some fatal), especially with anti-angiogenic agents, corticosteroids, NSAIDs or a history of peptic ulceration.
- Bullous and exfoliative skin conditions including SJS/TEN; keratitis and, very rarely, corneal perforation.
- Monitor liver function periodically; hepatitis and hepatic failure have been reported – see the full text.
Side effects
- Most frequent: rash and diarrhoea, mostly Grade 1/2.
- Serious: interstitial lung disease, gastrointestinal perforation, severe skin reactions, keratitis.
Interactions
- Potent CYP3A4 inducers (e.g. rifampicin) markedly reduce levels – avoid; CYP1A2 inhibitors (ciprofloxacin, fluvoxamine) increase them.
- Avoid proton pump inhibitors; H2 antagonists and antacids may reduce absorption.
- Coumarin anticoagulants (e.g. warfarin): increased INR and bleeding, monitor INR regularly; statins: increased risk of myopathy.
Pregnancy and breastfeeding
- Women of childbearing potential should use adequate contraception during therapy and for at least 2 weeks after; continue in pregnancy only if the benefit to the mother outweighs the risk to the foetus.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
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)
- TarcevaCheplapharm Registration GmbH · EMEA/H/C/000618
Source: European Medicines Agency (EMA), product information
Germany
- ErlotevTad Pharma Gmbh · 1 register entry
- Erlotinib AxiromedMedical Valley Invest Ab · 1 register entry
- Erlotinib BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Erlotinib GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
- Erlotinib HexalHexal Ag · 1 register entry
- Erlotinib RatiopharmRatiopharm Gmbh · 1 register entry
- Erlotinib StadaStadapharm Gmbh · 1 register entry
- Erlotinib ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- BinitolDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 3 register entries
- ErtinobNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- ErtivecKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
- EtinibATABAY KİMYA SAN. VE TİC. A.Ş. · 1 register entry
- LungerloABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- SevastraTURGUT İLAÇLARI A.Ş. · 2 register entries
- TarcetinDEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- TarcevaBMED İLAÇ DANIŞMANLIK SAĞLIK ÜRÜN VE HİZMETLERİ TİCARET LİMİTED ŞİRKETİ, ROCHE MÜSTAHZARLARI SAN.A.Ş. · 3 register entries
- TarsinibDEVA HOLDİNG A.Ş. · 3 register entries
- TartadaWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 25 more European countries
- Belgium
- Erlotinib Sandoz
- Bulgaria
- Ерлотиниб Актавис, Ерлотиниб Крка, Ерлотиниб С Сандоз, Ерлотиниб Сандоз, Фоклерос
- Croatia
- Erlotinib Alpha-Medical, Erlotinib Krka, Erlotinib Teva, Erlotinib Viatris, Fokleros
- Cyprus
- Erlotinib Remedica
- Czechia
- Erlotinib Krka, Erlotinib Teva, Erlotinib Vipharm
- Denmark
- Erlotinib "stada", Erlotinib Krka, Erlotinib Sandoz, Erlotinib Teva, Erlotinib Viatris
- Estonia
- Erlotinib Viatris
- Finland
- Erlotinib Krka, Erlotinib Stada
- France
- Erlotinib Biogaran, Erlotinib Eg, Erlotinib Krka, Erlotinib Sandoz, Erlotinib Teva France, Erlotinib Viatris, Erlotinib Zentiva
- Greece
- Erlotinib Faran, Erlotinib Teva
- Hungary
- Erlotinib Actavis, Erlotinib Krka, Erlotinib Sandoz, Erlotinib Stada, Erlotinib Viatris, Erlotinib Vipharm, Varlota
- Iceland
- Erlotinib Krka, Erlotinib Teva, Erlotinib Wh, Tarceva
- Italy
- Erlotinib Mylan, Erlotinib Sandoz, Erlotinib Tillomed
- Latvia
- Erlotinib Sandoz, Erlotinib Viatris
- Liechtenstein
- Tarceva
- Lithuania
- Erlotinib Viatris, Varlota
- Netherlands
- Erlotinib Accordpharma, Erlotinib Amarox, Erlotinib Bioorganics, Erlotinib Sandoz, Erlotinib Sun, Erlotinib Synthon, Erlotinib Viatris, Erlotinib Vipharm, Erlotinib Zentiva, Fokleros
- Norway
- Erlotinib Krka, Tarceva
- Poland
- Erlotinib Zentiva
- Portugal
- Erlotinib Mylan, Erlotinib Qritou, Erlotinib Sandoz, Erlotinib Zentiva
- Romania
- Erlotinib Krka, Erlotinib Viatris, Erlotinib Zentiva, Fokleros
- Slovakia
- Erlotinib Sandoz, Erlotinib Stada, Erlotinib Teva, Erlotinib Vipharm
- Slovenia
- Erlotinib Krka, Erlotinib Teva, Fokleros
- Spain
- Erlotinib Sandoz, Erlotinib Tarbis, Erlotinib Teva Group
- Sweden
- Erlotinib Krka, Erlotinib Medical Valley, Erlotinib Sandoz, Erlotinib Stada
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- European Medicines Agency. Tarceva – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.