Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3011038
Name of medicinal product: AGARF
Active substances:
Nintedanib
Estonian, English, Latin
ATC code: L01EX09
Dosage form: capsule, soft
Route of administration: oral use
Strengh: 150mg
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: üksikannuseline blister
Indication: [Product Name] is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). [Product Name] is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). [Product Name] is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated February 26, 2024)
Package information leaflet (PIL): EST  (last updated February 26, 2024)
Labelling:  (last updated February 26, 2024)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Norameda UAB 
Marketing authorization number: 1142724 
Marketing authorization issued on: February 26, 2024 
Marketing authorization expires on: February 26, 2029 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 26, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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