Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1493030
Name of medicinal product: ADENURIC
Active substances:
Febuxostat
Estonian, English, Latin
ATC code: M04AA03
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 120mg
Amount in package: 98TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: ADENURIC is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). ADENURIC is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). ADENURIC is indicated in adults.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Menarini International Operations Luxembourg S.A. 
Marketing authorization number: EU/1/08/447 
Marketing authorization issued on: April 21, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 27, 2015
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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