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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Fycompa
|
| Auth. number : | EU/1/12/776 |
| INN : | Perampanel |
| ATC: | N - Nervous system N03 - Antiepileptics N03A - Antiepileptics N03AX - Other antiepileptics N03AX22 - Perampanel (See WHO ATC Index) |
| Indication: | Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. |
| Marketing Authorisation Holder: | Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information". Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 25/07/2012 | Centralised - Authorisation | EMEA/H/C/2434 | (2012)5340 of 23/07/2012 | |||
| 27/09/2012 | Centralised - Variation | EMEA/H/C/2434/IB/3/G | ||||
| Updated with Decision(2012)7854 of 29/10/2012 | ||||||
| 31/10/2012 | Centralised - Variation | - | (2012)7854 of 29/10/2012 | |||
| 14/11/2012 | Centralised - Variation | EMEA/H/C/2434/IB/4 | ||||