Basic Information
Nintedanib Accord
Regulatory Information
EMEA/H/C/006179
April 19, 2024
February 22, 2024
2
December 18, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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. Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Overview Summary
Nintedanib Accord is a medicine used to treat adults with: - idiopathic pulmonary fibrosis (IPF), a disease of unknown cause in which fibrous tissue forms in the lungs; - systemic sclerosis associated interstitial lung disease, a disease in which the immune system (the body’s natural defences) is overactive, causing production of fibrous tissue and progressive scarring of the lungs; - other chronic fibrosing interstitial lung diseases which are progressive. Nintedanib Accord contains the active substance nintedanib and is a ‘generic medicine’. This means that Nintedanib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Nintedanib Accord is Ofev. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).