Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1857337
Name of medicinal product: AREGALU
Active substances:
Estonian, English, Latin
ATC code: L04AK02
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 14mg
Amount in package: 14TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated January 4, 2023)
Package information leaflet (PIL): EST  (last updated January 4, 2023)
Labelling:  (last updated January 4, 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 1090522 
Marketing authorization issued on: January 4, 2023 
Marketing authorization expires on: January 4, 2028 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 6, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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