GMPc Vietnam JSC
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Đình chỉ thuốc dạ dày Esalep của Dược phẩm Phú Long nhập

17/03/2017 | 2371 | Tin tức Tổng hợp

Do không đảm bảo yêu cầu chất lượng, thuốc viên nén chữa dạ dày của Công ty Dược phẩm Phú Long nhập khẩu vừa bị thu hồi đình chỉ.

Theo đó, thuốc bị đình chỉ lưu hành là thuốc Viên nén bao tan Esalep (Esomeprazole 40mg), Lô SX: 0416, NSX 19/02/2016, HD 18/02/2018, SĐK: VN-12168-11 do Công ty Reman Drug Laboratories Ltd. (Bangladesh) sản xuất, Công ty Cổ phần Xuất nhập khẩu thương mại Dược phẩm Phú Long có trụ sở tại FF5 Đường Ba Vì, Phường 15, Quận 10, TP Hồ Chí Minh nhập khẩu.
 
 
Đình chỉ thuốc dạ dày Esalep của Dược phẩm Phú Long nhập
 Thuốc Viên nén bao tan Esalep bị đình chỉ lưu hành
 
Nguyên nhân loại thuốc dạ dày Esalep bị đình chỉ lưu hành là do không đạt tiêu chuẩn chất lượng về chỉ tiêu độ hòa tan.
Cục Quản lý Dược đã yêu cầu Công ty Cổ phần Xuất nhập khẩu thương mại Dược phẩm Phú Long phối hợp với nhà cung cấp và phân phối thuốc, phải gửi thông báo thu hồi tới những nơi phân phối, sử dụng thuốc viên nén trên và tiến hành thu hồi toàn bộ lô thuốc không đạt tiêu chuẩn chất lượng nêu trên, báo cáo thu hồi về Cục Quản lý Dược trong ngày 9/4/2017.
Cục Quản lý Dược cũng đề nghị Sở Y tế các tỉnh thành phố, Y tế các ngành thông báo cho các cơ sở kinh doanh, sử dụng thuốc thu hồi lô thuốc không đạt chất lượng nêu trên, kiểm tra và giám sát các đơn vị thực hiện thông báo này; xử lý những đơn vị vi phạm theo quy định hiện hành; báo cáo về Cục Quản lý Dược và các cơ quan chức năng có liên quan.
Thuốc Viên nén bao tan Esalep bị đình chỉ là loại thuốc dùng điều trị & dự phòng tái phát loét dạ dày, loét tá tràng, viêm thực quản trào ngược.
 

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  • GMPc Vietnam JSC
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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
 
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