Human medicines European public assessment report (EPAR): Nintedanib Accord, nintedanib, Status: Opinion
Overview
On 22 February 2024, 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 Accord for the treatment of adults with idiopathic pulmonary fibrosis, other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis associated interstitial lung disease (SSc-ILD). The applicant for this medicinal product is Accord Healthcare S.L.U.
Nintedanib Accord will be available as 100 mg and 150 mg soft capsules. The active substance of Nintedanib Accord is nintedanib, a protein kinase inhibitor (ATC code: L01EX09). Nintedanib blocks the intracellular signalling cascades involved in the pathogenesis of fibrotic tissue remodelling in interstitial lung diseases.
Nintedanib Accord is a generic of Ofev, which has been authorised in the EU since 14 January 2015. Studies have demonstrated the satisfactory quality of Nintedanib Accord and its bioequivalence to the reference product Ofev. A question and answer document on generic medicines can be found here.
The full indication is:
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).
Nintedanib Accord should be prescribed by physicians experienced in the in the management of diseases for which Nintedanib Accord is approved.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
CHMP summary of positive opinion for Nintedanib Accord
AdoptedFirst published: Reference Number: EMA/CHMP/34939/2024
Product details
- Name of medicine
Nintedanib Accord
- Active substance
nintedanib
- International non-proprietary name (INN) or common name
nintedanib
- Therapeutic area (MeSH)
- Idiopathic Pulmonary Fibrosis
- Lung Diseases, Interstitial
- Scleroderma, Systemic
- Anatomical therapeutic chemical (ATC) code
L01EX09
- EMA product number
EMEA/H/C/006179
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
Accord Healthcare S.L.U.
- Opinion adopted
22/02/2024
- Opinion status
Positive
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