Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3049196
Name of medicinal product: FILSUVEZ
Active substances:
Birch bark extract
Estonian, English, Latin
ATC code: D03AX13
Dosage form: gel
Route of administration: cutaneous use
Strengh: 100mg 1g
Amount in package: 9.4g 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
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: Amryt Pharmaceuticals Designated Activity Company 
Marketing authorization number: EU/1/22/1652 
Marketing authorization issued on: June 21, 2022 
Marketing authorization expires on: June 23, 2027 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 20, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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