天士力(600535.SH):逍遙片獲得荷蘭藥物評審委員會註冊批准
格隆匯9月8日丨天士力(600535.SH)公佈,近日,公司收到荷蘭藥品審評委員會簽發的關於公司產品逍遙片通過藥品註冊(傳統植物藥註冊,Traditional Use Registration)批准的通知。
截至公吿日,公司對該項目的累計研發投入為1090.80萬元人民幣。
逍遙片在中國藥典中所記載的適應症為疏肝健脾、養血調經,用於肝鬱脾虛所致的胸悶不舒、胸脅脹痛、頭暈目眩、食慾減退、月經不調。公司以現代醫學研究和歐盟傳統植物藥上市許可要求為基礎,對逍遙片進行了處方化裁,經藥效學研究表明處方化裁後效果明顯,產品質量可控性得以提升,劑型與用法設計符合歐盟患者的用藥特點和習慣。植物藥產品在荷蘭及其它歐盟國家被廣泛使用,且中藥(植物藥)具有多靶點、標本兼治等特點,使該藥在批准的適應症相關治療領域易於得到當地患者認同,有利於市場拓展。
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