Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3074464
Name of medicinal product: APREMILAST ACCORD
Active substances:
Apremilast
Estonian, English, Latin
ATC code: L04AA32
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 10mg/20mg/30mg
Amount in package: 4TK / 4TK / 19TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1). Psoriasis Apremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Beh?et’s disease Apremilast Accord is indicated for the treatment of adult patients with oral ulcers associated with Beh?et’s disease (BD) who are candidates for systemic therapy.
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: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/24/1796 
Marketing authorization issued on: April 23, 2024 
Marketing authorization expires on: April 23, 2029 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: June 13, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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