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Dalvance for injection
儿科标签批准日期
2021/7/22 0:00:00
特定指示/秒
Acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms to include pediatric patients from birth to less than 18 years
标签更改摘要
- Safety and effectiveness for the treatment of ABSSSI has been established in pediatric patients aged birth to less than 18 years.
- Use for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged birth to less than 18 years.
- Information on dosing, PK parameters, and clinical trials.
- Postmarketing study.
- New active ingredient.