Product Name 産(chǎn)品名(míng)稱 | Budesonide Capsule 布地奈德(dé)膠囊 |
Strength 規格 | 3mg |
Product License | A209041 |
Indications 适應症 | • Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older. • Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. •治療8歲及以上患者中(zhōng)涉及回腸和/或升結腸的輕度至中(zhōng)度活動性克羅恩病。 •在成人中(zhōng)，涉及回腸和/或升結腸的輕度至中(zhōng)度克羅恩病的臨床緩解期長(cháng)達3個月。 |
Approved Date 批準日期 | 09/28/2017 |
Market Authorization Holder 持有(yǒu)人 | Sciecure Pharma Inc. |