Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1552799
Name of medicinal product: AMELUZ
Active substances:
Aminolevulinic acid
Estonian, English, Latin
ATC code: L01XD04
Dosage form: gel
Route of administration: cutaneous use
Strengh: 78mg 1g
Amount in package: 2g 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of actinic keratosis of mild to moderate severity (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults. Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome 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: Biofrontera Bioscience GmbH 
Marketing authorization number: EU/1/11/740 
Marketing authorization issued on: December 14, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 19, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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