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Nuvessa
儿科标签批准日期
2018/8/3 0:00:00
特定指示/秒
Bacterial vaginosis
标签更改摘要
- Safety and effectiveness have been established in pediatric patients 12 years and older.
- Use in this age grouppatients 12 to less than 18 years is supported by evidence from a multicenter, open-label safety and tolerability study in 60 pediatric patients with bacterial vaginosis and, evidence from adequate and well-controlled studies in adult women.
- Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
- Safety was similar to that observed in adults.
- Information on adverse reactions and clinical trial
- Postmarketing study.