BO Y TECUC QUAN LY DUGC

CONG HOA XA HOI CHU NGHIA VIET NAM Doc lap - Tir do - Hanh phuc

/QLD-DK Ha Noi, ngay gjO-thdng Q nam2018V/v cong bo danh muc nguyen lieu dugc chat lam thuoc phai kiem soat

dac biet phai thirc hien cap phep nhap khau cua thuoc trong nuoc da dugc

cip SDK.

Kinh gui: Cac ca sa dang ky, san xuat thuoc trong nuoc.

-Can cu* Luat dugc so 105/2016/QH13 ngay 06/4/2016;

Can cu Nghi dinh 54/2017/ND-CP ngay 08/5/2017;

Can cu cac ho so thay doi, bo sung thuoc trong nuoc da co giay dang ky luu hanh da dugc Cue Quan ly Dugc phe duyet noi dung thay doi, bo sung;

Theo de nghi cong bo nguyen lieu tai van thu so 1025/CV-DK/DMC ngay 11/09/2018 cua Cong ty co phan xuat nhap khau y te Domesco,

Cue Quan ly Dugc thong bao:r r r ? r r

Cong bo Danh muc nguyen lieu dugc chat lam thuoc de san xuat thuoc theo ho so dang ky thuoc da co giay dang ky luu hanh tai Viet Nam phai kiem soat dac biet phai cap giay phep nhap khau theo Danh muc dinh kem cong van nay.

Danh muc nguyen lieu lam thuoc dugc cong bo neu tren dang tai tren trang thong tin dien tu cua Cue Quan ly Dugc tai dia chi: www.dav.gov.vn.

Cue Quan ly Dugc thong bao de cac cong ty san xuat biet va thuc hien.Noi nhan:- Nlur tren;- CT. Vu Tuan Cndng (de b/c);- Tong Cue Hai Quan (de phoi hop);- Phong Quan ly kinli doanh du'gc;- Website Cue QLD; /- Luu: VT, DK (Bi).

TRUONG DANG KY THUOC

DANH MUCNGUYEN LIEU DUOC CHAT DE SAN XUAT THEO HO SO DANG KY THUOC

DA CO GlAY DANG KY LUU HANH TAI VIET NAM PHAI KIEM SOAT DAC BIETPHAI THUC HIEN CAP PHEP NHAP KHAU

(Ban hanh kern theo cong van sdyjg/lQQ /QLD-DK ngay thdng Cj nam 2018 cua Cue Quan ly Duo’c)

STT Ten thuoc

So giay dang ky luu hanh thuoc

Ngay het hieu luc cua giay dang ky

luu hanh

Ten co' so1 san xuat thuoc

Ten nguyen lieu lam thuoc

Tieu chuan chat luong cua nguyen

lieu

Ten co’ so1 san xuat nguyen lieu

Bia chi co1 so1 san xuat nguyen lieu

Ten nude san xuat nguyen

lieu

1 .Dorociplo 500mg (1)

VD-26465-17 06/02/2022

Cong ty Co phan Xuat nhap khau

Y ta DOMESCO

Ciprofloxacinhydrochloride USP35

Shangyu Jingxin Pharmaceutical Co.,Ltd

No.31 Weisan Road, Hangzhou Bay Shangyu Economic and Technological Development Area, Shangyu, Zhejiang Province, China - 312369

r W:'"WPiV

CHINA

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(1) Thay doi each ghi dia chi co sd san xuat dugc chat theo ho so thay doi nho chi can thong bao, ma tiep nhan: 2315/TDTN ngay 05/07/2018