BO YTE CUC QUAN LY DUOC CONG HOA XA HOI CHU NGHIA VIET NAM Doc lap - Tu1 do - Hanh phuc S6: /QD-QLD Ha Noi, ngay/q thang nam 2019 QUYET DINH Ve viec b

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1 BO YTE CUC QUAN LY DUOC CONG HOA XA HOI CHU NGHIA VIET NAM Doc lap - Tu1 do - Hanh phuc S6: /QD-QLD Ha Noi, ngay/q nam 2019 QUYET DINH Ve viec ban hanh danh muc 07 thuoc san xuat trong nuoc duoc cap giay dang ky liru hanh tai Viet Nam co hieu lire den het ngay 30/06/2019 Dot 164 (bo sung) CUC TRUONG CUC QUAN LY DUOC Can cu Luat Dupe ngay 06 4 nam 2016; Can cu Nghi dinh so 75/2017/ND-CP ngay 20/6/2017 cua Chinh phu quy dinh chuc nang, nhiem vu, quyen han va co cau to chuc cua Bo Y te; Can cu Quyet dinh so 7868/QD-BYT ngay 28/12/2018 cua Bo truung Bo Y te quy dinh chuc nang, nhiem vu, quyen han va co cau to chuc cua Cue Quan ly Duqc thuoc Bo Y te; Can cu Thong tu so 32/2018/TT-BYT ngay 12/11/2018 cua Bo Y t6 quy dinh viec dang ky luu hanh thuoc, nguyen lieu lam thuoc, Can cu y kien cua Hoi dong tu van cap giay dang ky luu hanh thuoc, nguyen lieu lam thuoc - Bo Y te; Xet de nghi cua Truong phong Dang ky thuoc - Cue Quan ly Dupe, QUYET DINH: Dieu 1. Ban hanh kern theo Quyet dinh nay danh muc 07 thuoc san xuat trong nude dupe cap giay dang ky luu hanh tai Viet Nam co hieu luc den het ngay 30/6/ Dot 164 (bo sung). Dieu 2. Cong ty san xuat va cong ty dang ky co thuoc luu hanh phai in so dang ky dupe Bo Y te cap len nhan thuoc va phai chap hanh dung cac quy dinh co lien quan tdi san xuat va luu hanh thuoc. Cac so dang ky co ky hieu V...-H06-19 co gia tri den het ngay 30/06/2019. Dieu 3. Quyet dinh nay co hieu luc ke tu ngay ky ban hanh. Dieu 4. Giam doc So Y te cac tinh, thanh pho true thuoc trung uong va giam doc cong ty san xuat va cong ty dang ky co thuoc tai Dieu 1 chiu trach nhiem thi hanh Quyet dinh nay. Noi nhan: - Nhu1 Dieu 4; - BT. Nguyen Thi Kim Tien (de b/c); - TT. Truong Quoc Cuong (de b/c); - Cue Quan y - Bo Quoc phong, Cue Y te - Bo CA; - Cue Y te giao ng van tai- Bo GTVT; - Tong Cue Hai Quan- Bo Tai Chinh; - Bao hiem xa hoi Viet Nam; - Vu Phap, Cue Quan ly Y Duoc co truyen, Cue Qua Kham, chira benh - Bo Y te; Thanh tra Bo Y te; - Vien KN thubc TU va VKN thuoc TP.HCM; - Tong Cong ty Duoc VN - CTCP; - Cac benh vien, Vien co giuong benh true thuoc BYT; - Website cua Cue QLD, Tap chi Dupe My pham - Cue QLD; -Luu: VT, KDD, DKT(15b). CUC TRUONG u Tuan Cuong k

2 BO YTE CUC QUAN LY DUOC CONG HOA XA HOI CHU NGH1A VIET NAM Doc lap - Tur do - Hanh phuc DANH MUC 07 THUOC SAN XUAT TRONG NUCiC DUOC CAP GIAY DANG KY LU U HANH TAI VIET NAM CO HIEU LU C DEN NGAY 30/06/ DOT 164 (BO SUNG) Ban hanh kem theo quyet dinh sd:^2'^./qd-qld, ngay/^(2./.. /...^'/5 1. Cong ty dang ky: Co* so san xuat Dong Nam duoc Trung An (D/c: 43/1A Khu pho Trung Luang, P 10, My Tho, Tien Giang- Viet Nam) 1.1 Nha san xuat: Co so san xuat Dong Nam duroc Trung An (D/c: 43/1A Khu pho Trung Luang, P 10, My Tho, Tien Giang - Viet Nam) Ham lurong 1 Bo than duong Moi chai 45g chua hon hop: Bot duoc lieu (tuong duong vdi: Thue dia 8,7g; Son thu 4,3g; Hoai Son 4,3g; Mau don bi: 3,5g; Trach ta 3,5g; Phuc linh 3,5g; Phu tu 1,15g; Que chi l,15g) 30,lg; Cao long dupe lieu (tuong duong vdi: Thue dia 9,3g Son thu 4,7g; Hoai son 4,7g; Mau don bi 3,7g; Trach ta 3,7g; Phuc linh 3,7g; Phu tu,25g; Que chi l,25g) 32,4ml 24 TCCS Hop 1 chai 45g V191-H Te thap phong hoan Moi 45g hoan chua hon hop tuong duong vdi Ma tien 1,17 g; Huong phu 8,55 g ; Hac chi ma 8,55 g; Bach chi 6,75 g; Doc hoat 6,75 g; Khuong hoat 6,75 g; Xuyen khung 24 TCCS Hop lchai 45 gam hoan V192-H06-19 Trang 1

3 6,75 g 2. Cong ty dang ky: Co1 so san xuat thuoc dong nam duoc Nhuan Due Dirong (D/c: So 997, duemg so 879 Ap Long Hda, xa Dao Thanh, My Tho, Tien Giang - Viet Nam) 2.1 Nha san xuat: Co so san xuat thuoc dong nam duoc Nhuan Due DiroTig (D/c: So 997, during so 879 Ap Long Hda, xa Dao Thanh, My Tho, Tien Giang - Viet Nam) 3 Hau khoa ngoc dich do-n Moi chai 2g thuoc bot chua: Hoang lien 0,16g; Thanh dai 0,1 g; Bac ha 0,06g; Nhon trung bach 0,06g; Cat canh 0,16g; Re quat 0,16g; Mot thach tu 0,16g; Hoang ba 0,16g; Thach cao 0,06g; Phuc linh 0,12g; Cam thao 0,144g; Bach chi 0,16g; Ke noi kirn 0,12g; Kha tu 0,16g; Bang phien 0,02g; Bang sa 0,06g; Tran chau 0,008g; Phen chua 0,12g; Nguu hoang 0,008g Thuoc bot 24 TCCS Hop 10 chai x 2g V193-H Cong ty dang ky: Co so san xuat thuoc dong y Duoc pham PQA (D/c: Xa Tan Thanh, huyen Vu Ban, tinh Nam Dinh - Viet Nam) 3.1 Nha san xuat: Co so san xuat thuoc dong y "Diroc pham PQA (D/c: Xa Tan Thanh, huyen Vu Ban, tinh Nam dinh - Viet Nam) 4 Hoan cu ng xuong khdp Moi lo 32g hoan hon hop cao kho tuong duong: Doc hoat 48g; Que nhuc 32 g; Phong phong 32 g; Duong quy 32 g; Te tan TCCS Hop 1 lo 32g V194-H06-19 Trang 2

4 g; Xuyen khung 32 g; Tan giao 32 g; Bach thuoc 32 g; Tang ky sinh 32 g; Can dia hoang 32 g; Do trong 32 g; Nhan sam 32 g; Nguu tat 32 g; Phuc linh 32 g; Cam thao 32 g 5 Hoan quy ty Moi 5g hoan cu ng chua hon hop: Dang Sam 0,3g; Bach truat 0,61 g; Hoang ky 0.6 lg; Cam thao chich mat 0,15g; Bach linh 0,61 g; Vien chi 0,06g; Toan tao nhan 0,6lg; Long nhan 0,6lg; Ducmg quy 0,06g; Moc huo ng 0,3g; Dai tao 0,15g 36 TCCS Hop 10 goi 5g hoan; Hop 1 lo 40g hoan. V195-H Vien sang mat Moi lo 32g hoan chua hon hop: Thue dia 4 g; Son thu 2 g; Mau don bi 1,5 g; Hoai son 2 g; Phuc linh 1,5 g; Trach ta 1,5 g; Cau <y tu 1,5 g; Cue hoa vang 1,5 g; Duong quy 1,5 g; Bach thuoc 1,5 g; Bach tat le 1,5 g; Thach quyet minh 2 g 36 TCCS Hop 1 lo 32g V196-H06-19 A hl 4. Cong ty dang ky: Co so san xuat thuoc YIICT Bong Sen Vang (D/c: Thon Da Ban - Hung An - Bac Quang - Ha Giang - Viet Nam) 4.1 Nha san xuat: Co so san xuat thuoc YHCT Bong Sen Vang (D/c: Thdn Da Ban - Hung An - Bac Quang - Ha Giang - Viet Nam) Trang 3

5 7 Thap toan dai bo BSV Cao dac hon hop duoc lieu 430 mg tuo'ng duong vdi cac diroc lieu: Dang sam 0,75g; Bach truat 0,5g; Phuc Linh 0,4g; Cam Thao 0,4g; Duong Quy 0,5g; Xuyen khung 0,4g; Bach thuoc 0,5g; Thue dia 0,75g: Hoang Ky 0,75g; Que nhuc 0,5g 36 TCCS Hop 01 lo 36 vien hoan V197-H06-19 Prang 4