Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only).
Vimpat 50 mg film-coated tablets.
Vimpat 100 mg film-coated tablets.
Vimpat 150 mg film-coated tablets.
Vimpat 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Vimpat 50 mg film-coated tablets: Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed with ‘SP’ on one side and ‘50’ on the other side. Vimpat 100 mg film-coated tablets: Dark yellow, oval film-coated tablets with approximate dimensions of 13.2 mm x 6.1 mm, and debossed with ‘SP’ on one side and ‘100’ on the other side. Vimpat 150 mg film-coated tablets: Salmon, oval film-coated tablets with approximate dimensions of 15.1 mm x 7.0 mm, and debossed with ‘SP’ on one side and ‘150’ on the other side. Vimpat 200 mg film-coated tablets: Blue, oval film-coated tablets with approximate dimensions of 16.6 mm x 7.8 mm, and debossed with ‘SP’ on one side and ‘200’ on the other side. |
Vimpat 50 mg film-coated tablets: Each film-coated tablet contains 50 mg lacosamide.
Vimpat 100 mg film-coated tablets: Each film-coated tablet contains 100 mg lacosamide.
Vimpat 150 mg film-coated tablets: Each film-coated tablet contains 150 mg lacosamide.
Vimpat 200 mg film-coated tablets: Each film-coated tablet contains 200 mg lacosamide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lacosamide |
Lacosamide is a functionalised amino acid. The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be fully elucidated. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Tablet coat: Polyvinyl alcohol Vimpat 50 mg film-coated tablets: Red iron oxide (E172) Vimpat 100 mg film-coated tablets: Yellow iron oxide (E172) Vimpat 150 mg film-coated tablets: Yellow iron oxide (E172) Vimpat 200 mg film-coated tablets: Indigo carmine aluminium lake (E132) |
PVC/PVDC blister sealed with an aluminium foil.
The treatment initiation pack contains 4 cartons, each carton with 14 Vimpat film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
EU/1/08/470/013
Date of first authorisation: 29 August 2008
Date of latest renewal: 31 July 2013
| Drug | Countries | |
|---|---|---|
| VIMPAT | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
