國藥現代(600420.SH):注射用頭孢曲松鈉獲得德國上市許可
格隆匯1月28日丨國藥現代(600420.SH)公佈,近日,公司控股孫公司DALIPharma GmbH (“DALI Pharma”)收到德國聯邦藥品和醫療器械機構(BfArM)核准簽發的注射用頭孢曲松鈉(250mg、500mg和1g)的上市許可。
適應症:頭孢曲松鈉為長效、廣譜的第三代頭孢菌素類抗生素,臨牀上一般用於治療敏感菌所致的細菌性腦膜炎、社區和醫院獲得性肺炎、急性中耳炎、腹部感染、併發性尿道感染(包括腎盂腎炎)、骨和關節感染、皮膚和軟組織感染、淋病、梅毒以及細菌性心內膜炎等。
此次DALI Pharma的注射用頭孢曲松鈉(250mg、500mg和1g)獲得德國上市許可,標誌着DALI Pharma具備了在德國市場銷售上述產品的資格,將對公司拓展歐盟市場帶來積極影響,公司後續將積極推進上述產品在歐盟市場上市銷售。
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