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Công văn 20918/QLD-CL của Cục Quản lý Dược về việc tạm ngưng sử dụng lô thuốc Tatumcef 2g

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Công văn 20918/QLD-CL của Cục Quản lý Dược về việc tạm ngưng sử dụng lô thuốc Tatumcef 2g đã được chúng tôi chia sẻ trong bài viết này. Các bạn cần nắm được cho bản thân những kiến thức cơ bản nhất để bảo vệ sức khỏe của bản thân và những người thân yêu. Cùng theo dõi nhé!

BỘ Y TẾ
CỤC QUẢN LÝ DƯỢC
——-
Số: 20918/QLD-CL
V/v: Tạm ngưng sử dụng lô thuốc Tatumcef 2g
CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
Độc lập – Tự do – Hạnh phúc
—————
Hà Nội, ngày 11 tháng 12 năm 2013
 
 
Kính gửi:
– Sở Y tế thành phố Hà Nội;
– Sở Y tế tỉnh Đắk Lắk;
– Công ty Cổ phần Xuất nhập khẩu y tế Việt Nam
(138 Giảng Võ, Ba Đình, Hà Nội);
– Công ty TNHH Dược phẩm Châu Á Thái Bình Dương 
(113 Đường Y Ngông, phường Tân Thanh, thành phố Buôn Ma Thuột, tỉnh Đăk Lăk).
 
Cục Quản lý dược nhận được công văn số 94/TTT ngày 02/12/2013 của Trung tâm DI & ADR Quốc gia về các báo cáo ADR từ Bệnh viện Trung ương Huế liên quan đến các phản ứng có hại của thuốc Tatumcef 2g (Ceftazidim), SĐK: VN-5654-10, Số lô: T2005, do Công ty China Chemical & Pharmaceutical Co., Ltd. (Hsinfong Plant (Taiwan) sản xuất, Công ty Sunward Pharmaceutical Pte., Ltd. đăng ký, Công ty Cổ phần Xuất nhập khẩu y tế Việt Nam nhập ủy thác cho Công ty TNHH Dược phẩm Châu Á Thái Bình Dương.
Để đảm bảo an toàn cho người sử dụng, Cục Quản lý dược thông báo:
1. Tạm ngừng việc sử dụng đối với lô thuốc Tatumcef 2g (Ceftazidim), SĐK: VN-5654-10, Số lô: T2005, do Công ty China Chemical & Pharmaceutical Co., Ltd. (Hsinfong Plant (Taiwan) sản xuất, Công ty Sunward Pharmaceutical Pte., Ltd. đăng ký, Công ty Cổ phần Xuất nhập khẩu y tế Việt Nam nhập ủy thác cho Công ty TNHH Dược phẩm Châu Á Thái Bình Dương.
2. Yêu cầu Công ty Cổ phần Xuất nhập khẩu y tế Việt Nam phối hợp với Công ty TNHH Dược phẩm Châu Á Thái Bình Dương:
– Gửi thông báo tạm ngừng sử dụng tới những nơi phân phối, sử dụng đối với thuốc Tatumcef 2g (Ceftazidim), SĐK: VN-5654-10, Số lô: T2005, do Công ty China Chemical & Pharmaceutical Co., Ltd. (Hsinfong Plant (Taiwan) sản xuất và bảo quản lô thuốc này theo đúng điều kiện quy định ghi trên nhãn thuốc.
– Phối hợp với Cơ quan kiểm nghiệm nhà nước tiến hành lấy mẫu và gửi đến Viện Kiểm nghiệm thuốc Trung ương hoặc Viện Kiểm nghiệm thuốc thành phố Hồ Chí Minh để kiểm tra chất lượng đối với thuốc Tatumcef 2g (Ceftazidim), SĐK: VN-5654-10, Số lô: T2005, do Công ty China Chemical & Pharmaceutical Co., Ltd. (Hsinfong Plant (Taiwan) sản xuất.
– Báo cáo tình hình nhập khẩu, phân phối và sử dụng (số lượng, thời gian nhập khẩu, tình hình phân phối, sử dụng), kết quả kiểm tra chất lượng lô thuốc nêu trên và các trường hợp về phản ứng có hại (nếu có) về Cục Quản lý dược trước ngày 16/12/2013.
3. Đề nghị Sở Y tế thành phố Hà Nội, Sở Y tế tỉnh Đắk Lắk kiểm tra, xử lý các đơn vị vi phạm theo quy định hiện hành./.
 
 Nơi nhận:
– Như trên;
– Sở Y tế các tỉnh, thành phố trực thuộc TW;
– VKN thuốc TW, VKN thuốc Tp. HCM (để phối hợp);
– Bệnh viện Trung ương Huế;
– Trung tâm DI & ADR Quốc gia;
– Phòng TT-QC thuốc, Cục QLD;
– Website Cục QLD;
– Lưu: VT, CL.
CỤC TRƯỞNG

Trương Quốc Cường

Công văn 20918/QLD-CL của Cục Quản lý Dược về việc tạm ngưng sử dụng lô thuốc Tatumcef 2g đã được chúng tôi chia sẻ trong bài viết này. Đồng hành cùng elead.com.vn để theo dõi những bài viết đặc sắc nhất nhé các bạn. Thân Ái!

Y Tế – Tags: Công văn 20918/QLD-CL

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