Publicado 05/12/2016 19:02
- Comunicado -

Results Presented for Pivotal Phase III Clinical Trial of Adjunctive Rufinamide in Children With Inadequately Controlled

2. Inovelon(R) (rufinamide) SPC - Inovelon Tablets and Oral Suspension.  Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_...  Accessed November 2016

3. Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs (NCT01405053). Available at: https://clinicaltrials.gov/ct2/show/reco... November 2016

4. Tyagi S, et al. Pharmacological management of Lennox-Gastaut Syndrome-a difficult-to-treat form of childhood-onset epilepsy: an overview. International Journal of Pharma and Bio Sciences. 2010:1(3).  Available at: http://www.ijpbs.net/issue-3/82.pdf . Accessed August 2016

5. Wier H et al. Rufinamide for Pediatric Patients with Lennox-Gastaut Syndrome. Pediatric Drugs 2011;13(2):97-106

6. Xu M et al. Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects. European Journal of Drug Metabolism and Pharmacokinetics 2016;41(5):541-548

7. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510... June 2016)

December 2016

Inovelon-EU0029

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