Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SERB S.A., Avenue Louise 480, 1050 Bruxelles, Belgium
FIRDAPSE 10 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White, round tablet, flat-faced on one side and scored on the other side. The tablets can be divided into equal halves. |
Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Amifampridine |
Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell membrane depolarisation. Prolonging the action potential enhances the transport of calcium into the nerve ending. The resulting increase in intra-cellular calcium concentrations facilitates exocytosis of acetylcholine-containing vesicles, which in turn enhances neuromuscular transmission. |
| List of Excipients |
|---|
|
Microcrystalline cellulose |
Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
One box contains 100 tablets comprising 10 strips with 10 tablets each.
SERB S.A., Avenue Louise 480, 1050 Bruxelles, Belgium
EU/1/09/601/001
Date of first authorisation: 23 December 2009
Date of latest renewal: 23 August 2019
| Drug | Countries | |
|---|---|---|
| FIRDAPSE | Austria, Canada, Estonia, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom, United States |
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