Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AGARF
Active substances:
Nintedanib
Estonian, English, Latin
ATC code: L01EX09
Dosage form: capsule, soft
Strength: 100mg
Legal status for supply*: Subject to medicinal prescription
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)
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
Marketing authorization holder: Norameda UAB 
Marketing authorization number: 1142624 
Marketing authorization issued on: February 26, 2024 
Marketing authorization expires on: February 26, 2029 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
3011016  AGARF  capsule, soft  100mg 60TK  Prescription          üksikannuseline blister 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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