Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Eisai GmbH, Edmund-Rumpler-Straรe 3, 60549, Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
Fycompa 2 mg film-coated tablets.
Fycompa 4 mg film-coated tablets.
Fycompa 6 mg film-coated tablets.
Fycompa 8 mg film-coated tablets.
Fycompa 10 mg film-coated tablets.
Fycompa 12 mg film-coated tablets
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Fycompa 2 mg film-coated tablets: Orange, round, biconvex tablet, engraved with E275 on one side and ‘2’ on other side Fycompa 4 mg film-coated tablets: Red, round, biconvex tablet, engraved with E277 on one side and ‘4’ on other side Fycompa 6 mg film-coated tablets: Pink, round, biconvex tablet, engraved with E294 on one side and ‘6’ on other side Fycompa 8 mg film-coated tablets: Purple, round, biconvex tablet, engraved with E295 on one side and ‘8’ on other side Fycompa 10 mg film-coated tablets: Green, round, biconvex tablet, engraved with E296 on one side and ‘10’ on other side Fycompa 12 mg film-coated tablets: Blue, round, biconvex tablet, engraved with E297 on one side and ‘12’ on other side. |
Fycompa 2 mg film-coated tablets: Each film-coated tablet contains 2 mg perampanel.
Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Fycompa 4 mg film-coated tablets: Each film-coated tablet contains 4 mg perampanel.
Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Fycompa 6 mg film-coated tablets: Each film-coated tablet contains 6 mg perampanel.
Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Fycompa 8 mg film-coated tablets: Each film-coated tablet contains 8 mg perampanel.
Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Fycompa 10 mg film-coated tablets: Each film-coated tablet contains 10 mg perampanel.
Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Fycompa 12 mg film-coated tablets: Each film-coated tablet contains 12 mg perampanel.
Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Perampanel |
Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic ฮฑ-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal overexcitation. The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated. |
| List of Excipients |
|---|
Fycompa 2 mg, 4 mg film-coated tabletsCore: Lactose monohydrate Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tabletsCore: Lactose monohydrate Fycompa 2 mg film-coated tabletsFilm coating: Hypromellose 2910 Fycompa 4 mg film-coated tabletsFilm coating: Hypromellose 2910 Fycompa 6 mg film-coated tabletsFilm coating: Hypromellose 2910 Fycompa 8 mg film-coated tabletsFilm coating: Hypromellose 2910 Fycompa 10 mg film-coated tabletsFilm coating: Hypromellose 2910 Fycompa 12 mg film-coated tabletsFilm coating: Hypromellose 2910 |
PVC/aluminium blisters.
Fycompa 2 mg film-coated tablets: Pack of 7 only for first week of dosing, 28 and 98
Fycompa 4 mg film-coated tablets: 4 mg – packs of 7, 28, 84 and 98
Fycompa 6 mg film-coated tablets: 6 mg – packs of 7, 28, 84 and 98
Fycompa 8 mg film-coated tablets: 8 mg – packs of 7, 28, 84 and 98
Fycompa 10 mg film-coated tablets: 10 mg – packs of 7, 28, 84 and 98
Fycompa 12 mg film-coated tablets: 12 mg – packs of 7, 28, 84 and 98
Not all pack sizes may be marketed.
Eisai GmbH, Edmund-Rumpler-Straรe 3, 60549, Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
EU/1/12/776/001-023
Date of first authorisation: 23/07/2012
Date of latest renewal: 6 April 2017
| Drug | Countries | |
|---|---|---|
| FYCOMPA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa |
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