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Fycompa
儿科标签批准日期
2018/9/27 0:00:00
特定指示/秒
Treatment of partial onset seizures (POS), with or without secondarily generalized seizures in patients 4 years and older
标签更改摘要
- Expanded the POS indication to include pediatric patients 4 to less than 12 years; previously approved for use in pediatric patients 12 years and older.
- Safety and effectiveness for the POS indication have been not been established in pediatric patients less than 4 years.
- Postmarketing study.
研究年龄
4 YEARS - 11 YEARS
2 YEARS - 11 YEARS
研究设计
Multicenter,Open-Label,Phase 3,Single Arm
Multicenter,Open-Label,Phase 2,Multiple Dose,Long Term Extension