GMPc Vietnam JSC
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      • Designing, Constructing, Ensured Certification
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Việt Nam tạm dừng 3 lô thuốc nghi nhiễm bệnh bò điên

18/09/2017 | 8093 | Tin tức Tổng hợp

Bộ Y tế yêu cầu tất cả các sở y tế và các công ty dược trên cả nước tạm dừng mua bán, sử dụng 3 lô sinh phẩm Human Albumin 20% vì nghi nhiễm bệnh bò điên.

Theo báo cáo, 3 lô sinh phẩm Human Albumin 20% (200g/l), lần lượt là: 29610616, 29700916, 29590616 đã được công ty CP dược phẩm TƯ CP1 phân phối tại Việt Nam, quy cách lọ 50ml.
 
Trước đó Ban Kinh tế thương mại của Phái đoàn Liên minh châu Âu tại Việt Nam đã có thông báo và cảnh báo nhanh với Cục Quản lý dược Italy, Viện Dinh dưỡng và Dược phẩm quốc gia Hungary đối với lô sinh phẩm y tế có nguồn gốc máu và huyết tương do công ty Kedrion SpA và công ty Human BioPlazma Kft. sản xuất do nghi ngờ về khả năng nhiễm bệnh Creutzfeld-Jakob (bệnh bò điên).
 
Việt Nam tạm dừng 3 lô thuốc nghi nhiễm bệnh bò điên
 
Để đảm bảo an toàn cho người sử dụng, trong khi chờ Cục Quản lý dược phối hợp với Viện Dinh dưỡng và Dược phẩm quốc gia Hungary kiểm tra, đánh giá tính an toàn của sản phẩm, Bộ Y tế yêu cầu tất cả Sở Y tế, bệnh viện và các công ty nhập khẩu, phân phối thuốc trên toàn quốc, tạm dừng mua bán và sử dụng 3 lô sinh phẩm nói trên.
 
Các cơ sở khám chữa bệnh trên cả nước tăng cường theo dõi, xử trí trường hợp phản ứng có hại của các thuốc trên (nếu có), báo cáo TT quốc gia về thông tin thuốc và theo dõi phản ứng có hại của thuốc hoặc TT khu vực tại TP.HCM.
 
Với các công ty nhập khẩu, phân phối, ngoài việc tạm dừng mua bán tiếp các lô thuốc nói trên, cần tiếp tục bảo quản các thuốc đã có trong kho theo đúng điều kiện ghi trên nhãn, thông báo cho các đơn vị đã phân phối biết, đồng thời phải tổng hợp số lượng sản phẩm còn tồn kho, báo cáo về Cục Quản lý dược trước ngày 20/9.
 
Human Albumin 20% là dịch truyền để điều chỉnh và duy trì thể tích máu tuần hoàn sau khi đã xét nghiệm bị thiếu thể tích, trong trường hợp cần sử dụng dạng keo.
Nguồn: kenh14.vn

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  • GMPc Vietnam JSC
  • Head Office: No. 18, Mang Cam 1 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
  • Business location : No. 32, Vi Cam 5 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
  • Tel: 0243.787.2242 | CEO hotline: 0982.866.668
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  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact
 
Hotline: 0982.866.668
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