Product class: Authorized package
Medicinal product class: For human use
Package code: 1552014
Name of medicinal product: ACTIKERALL
Active substances:
Fluorouracil+Salicylic acid
Estonian, English, Latin
ATC code: L01BC82
Dosage form: cutaneous solution
Route of administration: cutaneous use
Strengh: 5mg+100mg 1g
Amount in package: 25ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Actikerall-Almirall is indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in immunocompetent adult patients. Grade I/II intensity based on the 4-point scale of Olsen et al. (1991), see section 5.1
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 24 November 2023)
Package information leaflet (PIL): EST  (last updated 24 November 2023)
Labelling:  (last updated 28 June 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: ALMIRALL HERMAL GmbH 
Marketing authorization number: 808313 
Marketing authorization issued on: 04 March 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 12 December 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription