Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
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: Vimpat 50 mg film-coated tablets: Polyvinyl alcohol Vimpat 100 mg film-coated tablets: Polyvinyl alcohol Vimpat 150 mg film-coated tablets: Polyvinyl alcohol Vimpat 200 mg film-coated tablets: Polyvinyl alcohol |
Vimpat 50 mg film-coated tablets:
Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Packs of 14 × 1 and 56 × 1 film-coated tablets in PVC/PVDC perforated unit dose blisters sealed with an aluminium foil.
Packs of 60 film-coated tablets in HDPE bottle with a child-resistant closure.
Vimpat 100 mg film-coated tablets:
Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Packs of 14 × 1 and 56 × 1 film-coated tablets in PVC/PVDC perforated unit dose blisters sealed with an aluminium foil.
Packs of 60 film-coated tablets in HDPE bottle with a child-resistant closure.
Vimpat 150 mg film-coated tablets:
Packs of 14, 28 and 56 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Multipacks containing 168 (3 packs of 56 tablets) film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Packs of 14 × 1 and 56 × 1 film-coated tablets in PVC/PVDC perforated unit dose blisters sealed with an aluminium foil.
Packs of 60 film-coated tablets in HDPE bottle with a child-resistant closure.
Vimpat 200 mg film-coated tablets:
Packs of 14, 28 and 56 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Multipacks containing 168 (3 packs of 56 tablets) film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Packs of 14 × 1 and 56 × 1 film-coated tablets in PVC/PVDC perforated unit dose blisters sealed with an aluminium foil.
Packs of 60 film-coated tablets in HDPE bottle with a child-resistant closure.
Not all pack sizes may be marketed.
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
EU/1/08/470/001
EU/1/08/470/002
EU/1/08/470/003
EU/1/08/470/004
EU/1/08/470/005
EU/1/08/470/006
EU/1/08/470/007
EU/1/08/470/008
EU/1/08/470/009
EU/1/08/470/010
EU/1/08/470/011
EU/1/08/470/012
EU/1/08/470/020
EU/1/08/470/021
EU/1/08/470/022
EU/1/08/470/023
EU/1/08/470/024
EU/1/08/470/025
EU/1/08/470/026
EU/1/08/470/027
EU/1/08/470/028
EU/1/08/470/029
EU/1/08/470/030
EU/1/08/470/031
EU/1/08/470/032
EU/1/08/470/033
EU/1/08/470/034
EU/1/08/470/035
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 |
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