通用名称

clindamycin phosphate

儿科标签批准日期

2021/12/7 0:00:00

特定指示/秒

Bacterial vaginosis in female patients 12 years and older

标签更改摘要

- Safety and effectiveness have been established in females aged 12 years and older for the treatment of bacterial vaginosis. - Use for this indication is supported by the extrapolation of clinical trial data from adequate and well controlled clinical studies in adult women. - Safety and effectiveness have not been established in pediatric patients younger than 12 years for the treatment of bacterial vaginosis. - Information on application, adverse reactions, and clinical trial. - New dosage form.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接