Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ACTIKERALL
Active substances:
Fluorouracil+Salicylic acid
Estonian, English, Latin
ATC code: L01BC82
Dosage form: cutaneous solution
Strength: 5mg+100mg 1g
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated November 24, 2023)
Package information leaflet (PIL): EST  (last updated November 24, 2023)
Labelling:  (last updated June 28, 2022)
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
Marketing authorization holder: ALMIRALL HERMAL GmbH 
Marketing authorization number: 808313 
Marketing authorization issued on: March 4, 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated December 27, 2013) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1552014  ACTIKERALL  cutaneous solution  5mg +100mg 1g 25ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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