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WHO 药品预认证与检查动态·· 14 小时前AI 评分50

WHO预认证部门第11次邀请生殖健康产品生产商提交产品评估意向书(EOI)

11th Invitation to Manufacturers of Reproductive Health Products to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit

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WHO预认证部门第11次邀请生殖健康产品生产商提交产品评估意向书(EOI),此次更新系应WHO生命周期健康与生殖部门请求作出。清单涵盖妊娠期高血压疾病管理用药(甲基多巴250 mg片剂、硝苯地平10、20 mg片剂、拉贝洛尔100 mg片剂及10 mg注射剂、肼屈嗪5 mg注射剂)和妊娠期重度缺铁性贫血用药(羧基麦芽糖铁50mg/ml铁、蔗糖铁20mg/ml铁,均为10 ml瓶)。

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29 October, 2026 - 00:12 (CET)

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The Invitation Manufacturers of Reproductive Health Products to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit was recently updated following a request by the WHO Lifecourse Health and Reproduction Department.

  • Under Management of hypertensive disorders of pregnancy:
  • Alpha Methyl dopa 250 mg tablet
  • Nifedipine 10, 20 mg tablet
  • Labetalol 100 mg tablet
  • Labetalol 10 mg Injection (5mg/ml in 2ml ampoule)
  • Hydralazine 5 mg Injection (5 mg/ml in 2ml ampoule)

-    Under Management of severe iron deficiency anemia during pregnancy:

  • Ferric carboxymaltose50mg/ml iron, 10 ml vial
  • Iron sucrose 20mg/ml iron, 10ml vial    

The UN maternal mortality estimates, about 260000 women died due to maternal causes in 2023. Hypertensive disorders of pregnancy remained a leading cause of mortality worldwide. Similarly, anemia affects approximately 37% of pregnant women globally (WHO Global Anemia Estimates, 2021 Edition). Women in low-resource countries are at a higher risk of developing both anemia and pre-eclampsia compared to those in high-resource countries. Thus, improving the availability and quality of medicines for prevention and treatment of PE/E and anemia is necessary to help reduce the risk of adverse outcomes to a mother and to a baby as well as maximize health equities. 
 

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来源:WHO 药品预认证与检查动态 · extranet.who.int