Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: INOVELON
Active substances:
Rufinamide
Estonian, English, Latin
ATC code: N03AF03
Dosage form: film-coated tablet
Strength: 400mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 year of age and older.
Safety features: Yes
Marketing authorization holder: Eisai GmbH 
Marketing authorization number: EU/1/06/378 
Marketing authorization issued on: January 16, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1280269  INOVELON  film-coated tablet  400mg 10TK  Prescription           
1280270  INOVELON  film-coated tablet  400mg 30TK  Prescription           
1280281  INOVELON  film-coated tablet  400mg 50TK  Prescription           
1280292  INOVELON  film-coated tablet  400mg 60TK  Prescription           
1280304  INOVELON  film-coated tablet  400mg 100TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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