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Việt Nam thu hồi thuốc ho gây hại tim bị cấm ở Pháp

20/02/2019 | 1560 | Tin tức Tổng hợp

Cục Quản lý Dược (Bộ Y tế) vừa có công văn thu hồi thuốc ho Pneumorel, do có nguy cơ gây rối loạn nhịp tim cho người sử dụng.
 
Văn phòng đại diện Les Laboratories Servier có thư về việc đề nghị thu hồi thuốc Pneumorel do có nguy cơ gây rối loạn nhịp tim của người sử dụng. Để đảm bảo an toàn cho người sử dụng, Cục Quản lý Dược (Bộ Y tế) thông báo đình chỉ lưu hành toàn quốc tất cả lô thuốc Pneumorel (Fenspiride hydrochloride 80mg) do Công ty Les Laboratoires sản xuất, Công ty cổ phần dược liệu Trung ương 2 (Phytopharma) nhập khẩu.
 
Ngoài ra, cơ quan này yêu cầu Công ty Cổ phần Dược liệu Trung ương 2 (Phytopharma) phối hợp với nhà phân phối trong thời hạn 48 giờ kể từ ngày ký công văn, gửi thông báo thu hồi tới các cơ sở bán buôn, bán lẻ, sử dụng và tiến hành thu hồi toàn bộ các lô thuốc nêu trên.
 
 
Việt Nam thu hồi thuốc ho gây hại tim bị cấm ở Pháp
 

Cục Quản lý Dược cũng đề nghị sở y tế các tỉnh, thành phố, y tế các ngành thông báo việc thu hồi tất cả các lô thuốc Pneumorel tới các cơ sở kinh doanh, sử dụng thuốc trên địa bàn; công bố thông tin việc thu hồi thuốc trên trang thông tin điện tử của sở.
 
Trước đó, cơ quan Quản lý dược phẩm và sản phẩm y tế Pháp ANSM cho biết loại thuốc ho phổ biến Pneumorel có chứa hoạt chất fenspiride có thể gây rối loạn nhịp tim. Hiện thuốc đã bị cấm lưu hành và không còn được sử dụng ở Pháp. Tất cả lô thuốc có mặt tại các hiệu thuốc, cơ sở y tế và nhà phân phối bán buôn đều bị thu hồi.
 
Nguồn: news.zing.vn

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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
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