Human medicines European public assessment report (EPAR): Nintedanib Viatris, nintedanib, Status: Opinion
On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nintedanib Viatris, intended for the treatment of adults with idiopathic pulmonary fibrosis (IPF), adults and children aged 6 years and above with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and adults and children aged 6 years and older with systemic sclerosis associated interstitial lung disease (SSc-ILD).
The applicant for this medicinal product is Viatris Limited.
Nintedanib Viatris will be available as 100 mg and 150 mg soft capsules. The active substance of Nintedanib Viatris is nintedanib, a protein kinase inhibitor (ATC code: L01EX09). By binding to several protein kinases, nintedanib inhibits intracellular signalling cascades involved in the pathogenesis of fibrotic tissue remodelling in interstitial lung diseases.
Nintedanib Viatris is a generic of Ofev, which has been authorised in the EU since 14 January 2015. Studies have demonstrated the satisfactory quality of Nintedanib Viatris, and its bioequivalence to the reference product Ofev.
The full indication is:
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 (see section 5.1).
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) (see section 4.2 and 5.1).
Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
For adults, treatment with Nintedanib Viatris should be initiated by physicians experienced in the in the management of diseases for which nintedanib is approved.
For children, treatment with Nintedanib Viatris should be initiated only after involvement of a multidisciplinary team (physicians, radiologists, pathologists) experienced in the diagnosis and treatment of ILDs.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Name of medicine
Nintedanib Viatris
Active substance
nintedanib esylate
International non-proprietary name (INN) or common name
nintedanib
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
L01EX09
EMA product number
EMEA/H/C/006486
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Marketing authorisation applicant
Viatris Limited
Opinion adopted
19/06/2025
Opinion status
Positive
