九典制藥(300705.SZ):公司獲得藥品補充申請批准通知書
格隆匯5月11日丨九典制藥(300705.SZ)公吿,湖南九典制藥股份有限公司(以下簡稱“公司”)於近日收到國家藥品監督管理局下發的《藥品補充申請批准通知書》。申請內容:藥品上市許可持有人變更,申請將右酮洛芬氨丁三醇片的藥品上市許可持有人由“湖南諾納醫藥科技有限公司”變更為“湖南九典制藥股份有限公司”,生產場地保持不變。審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品此次申請事項符合藥品註冊的有關要求,同意本品上市許可持有人變更。
右酮洛芬氨丁三醇由Menarini(梅納里尼實驗室)開發,最早於1996年4月在西班牙上市,目前有片劑、顆粒劑、膠囊劑、注射劑等多種劑型在國內外上市。右酮洛芬氨丁三醇片屬於非甾體抗炎藥,適用於治療不同病因的輕中度疼痛,如類風濕性關節炎、骨性關節炎、強直性脊柱炎、痛風性關節炎等的關節痛,以及痛經、牙痛、手術後痛、癌性疼痛、急性扭傷或軟組織挫傷疼痛和感冒發熱引起的全身疼痛等各種急慢性疼痛。摩熵數據顯示,2021年、2022年和2023年,全國醫院終端及藥店終端總銷售額分別為4,201.02萬元、5,599.19萬元以及4,106.54萬元。
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