智通财经APP讯,甘李药业(603087.SH)发布公告,公司及其欧洲全资子公司甘李药业欧洲有限责任公司(Gan&LeePharmaceuticalsEuropeGmbH,以下简称“甘李欧洲”)于近日收到欧洲药品管理局(EuropeanMedicinesAgency, EMA)的通知,甘精胰岛素注射液(商品名:Ondibta®)获得EMA人用药品委员会(Committee for Medicinal Products for Human Use,CHMP)积极意见。CHMP 建议欧盟委员会(EuropeanCommission,EC)批准甘精胰岛素注射液(商品名: Ondibta®)作为 Lantus SoloStar 的生物类似药上市,用于治疗成人、青少年和2岁及以上儿童的糖尿病。CHMP的建议将进入EC审查阶段,以获得Ondibta®在欧盟、冰岛、列支敦士登和挪威的上市许可,最终决定预计将于明年初做出。
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