常山藥業(300255.SZ):依諾肝素鈉注射液的生產設施首次通過歐盟GMP認證
格隆匯9月20日丨常山藥業(300255.SZ)公佈,公司於近日收到克羅地亞藥品及醫療器械管理局(Republic of Croatia Agency For Medicinal Products AndMedical Devices)依據歐洲藥品管理局相關法規頒發的《藥品 GMP 證書》(《Certificate Of GMP Compliance Of A Manufacturer》)。
依諾肝素鈉注射液用於預防靜脈血栓栓塞性疾病(預防靜脈內血栓形成),特別是與骨科或普外手術有關的血栓形成;治療已形成的深靜脈栓塞,伴或不伴有肺栓塞,臨牀症狀不嚴重,不包括需要外科手術或溶栓劑治療的肺栓塞;與阿司匹林合用,治療不穩定性心絞痛及非Q波心肌梗死;用於血液透析體外循環中,防止血栓形成。
本次系公司依諾肝素鈉注射液的生產設施首次通過歐盟GMP認證。根據歐盟成員國之間的GMP互認制度,本次通過GMP認證表明本次接受認證的生產線已符合歐盟GMP標準,公司依諾肝素鈉注射液產品具備歐盟市場準入資格。本次通過GMP認證後,依諾肝素鈉注射液於歐盟上市前尚需獲得歐盟上市許可申請批准。
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