Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eisai GmbH, Lyoner Straße 36, 60528, Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
Inovelon 100 mg film-coated tablets.
Inovelon 200 mg film-coated tablets.
Inovelon 400 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. 100 mg: Pink, ‘ovaloid’, slightly convex, approximately 10.2 mm in length, scored on both sides, embossed ‘Є261’ on one side and blank on the other side. The tablet can be divided into equal halves. 200 mg: Pink, ‘ovaloid’, slightly convex, approximately 15.2 mm in length, scored on both sides, embossed ‘Є262’ on one side and blank on the other side. The tablet can be divided into equal halves. 400 mg: Pink, ‘ovaloid’, slightly convex, approximately 18.2 mm in length, scored on both sides, embossed ‘Є263’ on one side and blank on the other side. The tablet can be divided into equal doses. |
Oral Tablet:
Each film-coated tablet contains 100 mg rufinamide.
Each film-coated tablet contains 200 mg rufinamide.
Each film-coated tablet contains 400 mg rufinamide.
Excipients with known effect:
Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate).
Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate).
Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rufinamide |
Rufinamide is an anticonvulsant medication. Rufinamide modulates the activity of sodium channels, prolonging their inactive state. |
| List of Excipients |
|---|
|
Core: Lactose monohydrate Film coating: Hypromellose |
Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Eisai GmbH, Lyoner Straße 36, 60528, Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
EU/1/06/378/001-005
EU/1/06/378/006-010
EU/1/06/378/011-016
Date of first authorisation: 16 January 2007
Date of latest renewal: 09 January 2012
| Drug | Countries | |
|---|---|---|
| INOVELON | Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom |
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