Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP, Badhoevedorp, The Netherlands
Fampyra 10 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. An off-white, film coated, oval biconvex 13 × 8 mm tablet with flat edge debossed with A10 on one side. |
Each prolonged-release tablet contains 10 mg of fampridine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fampridine |
Fampridine is a potassium channel blocker. By blocking potassium channels, fampridine reduces the leakage of ionic current through these channels, thereby prolonging repolarization and thus enhancing action potential formation in demyelinated axons and neurological function. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose Film-coat: Hypromellose |
Fampyra is supplied in either bottles or blister packs.
Bottles:
HDPE (high-density polyethylene) bottle with polypropylene caps, each bottle contains 14 tablets and a silica gel desiccant.
Pack size of 28 (2 bottles of 14) tablets.
Pack size of 56 (4 bottles of 14) tablets.
Blister packs:
Foil blisters (aluminium/aluminium), each blister tray contains 14 tablets.
Pack size of 28 (2 blisters of 14) tablets.
Pack size of 56 (4 blisters of 14) tablets.
Not all pack sizes may be marketed.
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP, Badhoevedorp, The Netherlands
EU/1/11/699/001
EU/1/11/699/002
EU/1/11/699/003
EU/1/11/699/004
Date of first authorisation: 20 July 2011
Date of latest renewal: 18 May 2017
| Drug | Countries | |
|---|---|---|
| FAMPYRA | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey |
© 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.
