Product class: Authorized package
Medicinal product class: For human use
Package code: 1280269
Name of medicinal product: INOVELON
Active substances:
Estonian, English, Latin
ATC code: N03AF03
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 400mg
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Eisai GmbH 
Marketing authorization number: EU/1/06/378 
Marketing authorization issued on: 16 January 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 03 October 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription