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賽隆藥業(002898.SZ)子公司獲注射用胸腺法新、阿加曲班注射液藥品註冊批件
格隆匯 12-27 15:59

格隆匯12月27日丨賽隆藥業(002898.SZ)公佈,公司全資子公司湖南賽隆藥業有限公司於近日獲得國家藥品監督管理局核准簽發的注射用胸腺法新、阿加曲班注射液《藥品註冊批件》。

1、注射用胸腺法新基本信息

藥品名稱:注射用胸腺法新;劑型:注射劑;規格:1.6mg;藥品批件號:2019S00688;註冊分類:原化學藥品第6類;藥品批准文號:國藥準字H20193385;藥品批准文號有效期:至2024年12月17日。

2、阿加曲班注射液基本信息

藥品名稱:阿加曲班注射液;劑型:注射劑;規格:20ml:10mg;藥品批件號:2019S00672;註冊分類:原化學藥品第6類;藥品批准文號:國藥準字H20193374;藥品批准文號有效期:至2024年12月17日。

注射用胸腺法新作為一種免疫調節劑,適用於:(1)慢性乙型肝炎;(2)作為免疫損害病者的疫苗免疫應答增強劑。免疫系統功能受到抑制者,包括接受慢性血液透析和老年病患者,本品可增強患者對病毒性疫苗,例如流感疫苗或乙肝疫苗的免疫應答。

阿加曲班為合成的精氨酸衍生物,能抑制凝血酶的活性從而產生抗凝作用,具有起效快、作用時間短、出血傾向小、無免疫原性等優勢。適用於:(1)發病48小時內的缺血性腦梗死急性期病人的神經症狀(運動麻痺)、日常活動(步行、起立、坐位保持、飲食)的改善;(2)對慢性動脈閉塞症(血栓閉塞性脈管炎,閉塞性動脈硬化症)患者的四肢潰瘍,靜息痛及冷感等的改善。

上述藥品的獲批進一步豐富了公司產品的種類,將對公司業績產生積極的影響。

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