Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1436082
Name of medicinal product: JAVLOR
Active substances:
Vinflunine
Estonian, English, Latin
ATC code: L01CA05
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 25mg 1ml
Amount in package: 2ml 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with Performance Status >= 2.
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: Pierre Fabre Medicament 
Marketing authorization number: EU/1/09/550 
Marketing authorization issued on: September 21, 2009 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 22, 2014
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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