🇪🇺 vargatef in European Union

EMA authorised vargatef on 21 November 2014

Marketing authorisations

EMA — authorised 21 November 2014

  • Application: EMEA/H/C/002569
  • Marketing authorisation holder: Boehringer Ingelheim International GmbH
  • Local brand name: Vargatef
  • Indication: Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.
  • Status: approved

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EMA — authorised 19 April 2024

  • Application: EMEA/H/C/006179
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Nintedanib Accord
  • Indication: Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing
  • Status: approved

The European Medicines Agency (EMA) approved vargatef, marketed as Nintedanib Accord, on 19 April 2024. This approval allows Accord Healthcare S.L.U. to market the medicine in the European Union for the treatment of idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis associated interstitial lung disease (SSc-ILD) in adults. Additionally, Nintedanib Accord is approved for children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs).

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EMA — authorised 22 August 2025

  • Application: EMEA/H/C/006486
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Nintedanib Viatris
  • Indication: Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Viatris is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung
  • Status: approved

The European Medicines Agency (EMA) approved Nintedanib Viatris (vargatef) on 22 August 2025. This medication is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. It is also approved for treating other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults, and for children and adolescents from 6 to 17 years old. Additionally, Nintedanib Viatris is approved for treating systemic sclerosis associated interstitial lung disease (SSc-ILD) in adults, adolescents, and children aged 6 years and older. The marketing authorisation holder is Viatris Limited, and the local brand name is Nintedanib Viatris.

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Other Oncology approved in European Union

Frequently asked questions

Is vargatef approved in European Union?

Yes. EMA authorised it on 21 November 2014; EMA authorised it on 19 April 2024; EMA authorised it on 22 August 2025.

Who is the marketing authorisation holder for vargatef in European Union?

Boehringer Ingelheim International GmbH holds the EU marketing authorisation.