GMPc Vietnam JSC
  • 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

    News

  1. Home
  2. News
  3. Tin tức Tổng hợp

News category

  • GMPC News
    • Notification
    • Activities & Cooperation
    • Internal News
  • Field News
    • Exhibition & Conference
    • News
    • Typical GMP enterprise
  • GMP Projects News
    • GMPc contract
    • Project Progress Updates

Thuốc viên nén Misoprostol không đạt chất lượng bị đình chỉ lưu hành

02/04/2018 | 1854 | Tin tức Tổng hợp

Thuốc viên nén Misoprostol 200mcg được chỉ định dùng trong điều trị viêm loét dạ dày tá tràng vừa bị đình chỉ lưu hành trên toàn quốc

Sở Y tế TP Hà Nội đã có văn bản chỉ đạo các đơn vị y tế trực thuộc ngành, phòng y tế quận, huyện, thị xã trên địa bàn về việc đình chỉ lưu hành thuốc viên nén Misoprostol không đạt tiêu chuẩn chất lượng.
 
Thuốc bị đình chỉ lưu hành là thuốc viên nén Misoprostol 200mcg, SĐK: VD-20509-14, số lô: 0207, HD: 20/3/2018, do Công ty Cổ phần sinh học Dược phẩm Ba Đình sản xuất. Mẫu lấy tại Bệnh viện Từ Dũ, thành phố Hồ Chí Minh. Thuốc không đạt tiêu chuẩn chất lượng về chỉ tiêu độ đồng đều hàm lượng, độ hòa tan, định lượng.
 
Trước đó, Cục Quản lý Dược (Bộ Y tế) cũng đã có công văn số 4764/QLD-CL  gửi Sở Y tế các tỉnh, thành phố trong cả nước thông báo quyết định đình chỉ lưu hành trên toàn quốc loại thuốc Misoprostol 200mcg có số lô nói trên.
 
Thuốc viên nén Misoprostol không đạt chất lượng bị đình chỉ lưu hành
 
 
Sở Y tế TP Hà Nội yêu cầu các cơ sở y tế công lập trực thuộc ngành, các cơ sở y tế ngoài công lập, các doanh nghiệp kinh doanh thuốc, các cơ sở bán lẻ thuốc trên địa bàn thành phố khẩn trương rà soát, thu hồi lô thuốc không đạt tiêu chuẩn chất lượng nêu trên.
 
Phòng Y tế các quận, huyện, thị xã thông báo đến các cơ sở hành nghề trên địa bàn quản lý, đồng thời tiến hành kiểm tra, giám sát việc thực hiện thu hồi của cơ sở nếu có kinh doanh, sử dụng lô thuốc  không đạt chất lượng nói trên.
 
Thuốc viên nén Misoprostol 200mcg có tác dụng ức chế tiết acid dịch vị và bảo vệ niêm mạc dạ dày và được chỉ định dùng trong điều trị bệnh viêm loét dạ dày tá tràng.
 
Nguồn: suckhoedoisong.vn

Related news

Ground - Breaking ceremony of HSC - HOSTEP stem cell technology complex

Ground - Breaking ceremony of HSC - HOSTEP stem cell technology complex

09/01/2025 | 355

Hòa Lạc Stem Cell Technology Joint Stock Company (HSC) begins construction of the HSC HOSTEP Stem Cell Technology Complex according to...

What is quality risk management in pharmaceutical?

What is quality risk management in pharmaceutical?

07/12/2023 | 60

Quality risk management in pharmaceutical is a systematic process for the assessment, control, communication and review of risks to the quality of...

The Guide to creating a GMP Training Program

The Guide to creating a GMP Training Program

04/12/2023 | 50

GMP training is an informational program that covers the required guidelines for your industry. Your GMP training will be required to cover...

GMP training for employees – essential steps

GMP training for employees – essential steps

04/12/2023 | 20

In principle, the GMP training program can be built around the following steps with clear objective and deliverables. The training program should...

How to conduct GMP training for employee

How to conduct GMP training for employee

04/12/2023 | 38

A successful GMP training for employee ensures that all staff will receive adequate, relevant and documented training to enable them to perform...

Internal audits, Complaints, Product Recalls in GMP

Internal audits, Complaints, Product Recalls in GMP

06/11/2023 | 32

Pharmaceutical manufacturers regularly conduct internal audits which is a way of verifying that all quality related activities comply with the code of...

  • 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
  • Email: contact@gmp.com.vn
  • Representative Office: 156/1/1, Cong Hoa Street - Ward 12 - Tan Binh District - Ho Chi Minh City
  • Tel: 0283.811.7383 
  • Quick link
  • About Us
  • Services
  • Project
  • GMP-Handbook
  • Video
  • Consulting for cosmetic facility
  • Consulting for health supplement facility
  • Consulting for GSP warehouse
  • Fanpage
Facebook

Copyright © 2020 GMPc. All rights reserved.

  • 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
Nhắn tin Facebook Zalo: 0982.866.668