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Nintedanib Accord (nintedanib)

Generic
Region
🇪🇺 EU
Active substance
nintedanib
Company
Accord Healthcare S.L.U.
Status
Authorised
Therapeutic area
Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Scleroderma, Systemic; Pulmonary Fibrosis
CHMP opinion
Thu 22 Feb 2024
EU approval
Fri 19 Apr 2024
Designations
Generic
Application
EMEA/H/C/006179
ATC
L01EX09
Official record
www.ema.europa.eu

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 interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Accord 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 Accord is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).

Regulatory milestones

No milestones recorded in the last year.

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