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Pharmaceuticals - Community Register
Community register of orphan medicinal products | GRANTED |
Product information |
Rufinamide
| EU orphan designation number: | EU/3/04/240
|
| Active ingredient: | Rufinamide |
| Indication: | Treatment of Lennox-Gastaut syndrome |
| Sponsor: | Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
| EU Centralised marketing authorisation: | A centralised EU marketing authorisation has been obtained under the name Inovelon on 16/01/2007 with the number EU/1/06/378 |
Public summary of scientific opinion
EPAR
European Commission procedures |
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 22/10/2004 | Orphan designation | EMEA/OD/047/04 | (2004)4188 of 20/10/2004 |


