BOY TE CONG HOA XA HOI CHU NGHIA VIET NAM CUC QUAN LY DUQC De lip - Ty do - Hanh phic +4 /QLD-CL Ha N6i, ngay 09 thang 5 nam 2017 8 so cBng bd thude e6 chimg minh TDSH Kinh giti: . Can cit Thong tu sé 08/2010/TT-BYT ngiy 26/4/2010 ciia BO Y té hudng din bao cao sé ligu nghién ctu sinh kha dyng/tuong duong sinh hoc trong dang ky thude; Can cir Quyét dinh s6 2962/QD-BYT ngay 22/8/2012 ciia BO truéng BO Y 16 vé vige ban hanh Quy dinh tam thai vé ede tai ligu cn cung cép dé cing b6 ee danh muc thuéc biét duge géc, thud tong durong diéu tri véi thudc bigt durgc géc, thude c6 tai ligu chimg minh twong duong sinh hoc va Quyét dinh s6.1545/QD- BYT ngay 08/5/2013 cia BO Y té vé vige sita déi, bd sung Quyét dinh sé 2962/QD-BYT ngay 22/08/2012 cia BO Y té vé viée ban hanh Quy dinh tam thoi vé céc tai ligu cdn cung cap d& céng bd cdc danh muc thude bigt durge gdc, thude tuong duong diéu tr] vdi thude biét duge géc, thudc cé tai Tigu chimg minh tuong duong sinh hoc; Can ctr ¥ kién cia H6i déng xét duyét danh muc thudc biét durge gdc, thude cé tuong duong dieu tri véi thudc biét duge géc va thudc ¢6 chimg minh tuong duong sinh hoc cia BO Y té tai budi hop ngay 27/4/2017, Cuc Quan ly Duge théng bao vé vige xem xét hd so dé nghi céng bé thude 6 tai ligu chimg minh tuong duong sinh hoc cia doanh nghiép nhu sau Phu luc 1: Danh myc hé so céng bé thude cé tai ligu ching minh tuong duong sinh hge can bé sung, gidi trinh; Phu luc 2: Danh myc hd so cong b6 thuéc cé tai ligu chimg minh tong duong sinh hoc khéng dat yéu cau. Dé nghi céc doanh nghigp can cit cdc ¥ kién yéu cau bé sung va/hode giai trinh tai Phy luc 1 kém theo céng van nay dé bé sung hé so dé nghi céng bé danh muc thud theo quy dinh. (Céc Phy lye duge ding tai trén trang thong tin dign tir ca Cue Quan ly Durge, dia chi: http:/Avww.dav.gov.vn - Myc Quan ly gid thude/Théng tin dau thau). Cue Quan ly Duge théng bio dé cde doanh nghigp biét va thyte hién/. KT. CUC TRUONG PHO CYC TRUONG - That trudng Trrong Quée Curie (dé bve); = Website Cue Quan ly Duges = Lamu: VP, CL Qb)(Ban hank kem th wy PHY LUC 1. HO SO DE NGH] BO SUNG, GIAI TRINH /QLD-CL ngay 09 /§ /2017 ctta Cuc Quan by Duge) eo Cong vin sé £444 Mi hd so | Tén thude, SDK | Ham lugng. quy eich Cos6 sin walt Thude doi ching | Noi thir nghigm ¥ kign To chuyén gia B0S/BE-13. [Fudcefu S00mg, |Cefuroxim S00me. [Cong ty © phan duge phim [Zinnat 500mg, [Vien KN thudc [Khong dng ¥ vOi gai trinh vé vige noi ong ngutmg Cl Ivp-10336-10 [Hp 1 vi, 2 vi, 3 vi, 6 vi, 10|Phiong Dong Glaxo Operations |Tp. HCM 190% cho Cmax 75 - 133% vat edng.thit tinh e& mau. hi, 30 vi, 50 vix 10 vign; }L6 s6 7, duomg s62, KCN. UK Lid G5 Vigt Nam da 6 nhigu nghién ctu tuong dong sinh hoc Fiép 2 vi, 4 vi,6 vi, 10 vi, [Tan Tao A, quin Binh Tle, abi véi vien nén chita Cefuroxim va két qué Cmax dat 80 - 30 vi, 0 vix Sign; Tp. HO Chi Minh, 125% voi ngudng CI 90%. [Chai 30 vign, 60 vign, 100 [bE nghj thyc hign nghién ciru bé sung hod ting ed mu dé lien, 250 vién, 500 vien |dap img nguémg Cl 90% cho Cmax 80 - 125%. bo phim loa7BE-17 _[Riteptid, [Risperidone Ting. gis Pharmaceuticals Risperdal Img, [Hungarian [Bd sung ban dich tng Anh ban chip thudn eta Hoi dong IN-16749-13 | Hop 6 vix 10 vién nén bao [Private Limited Company, [Janssen Cilag, UK |Railways hospital, }4go dite; phim 1165, Budapest, Hungary |- Bé sung bao cio so sinh két qua thir twong dong d6 hoa Bokényfoldi at 118-120, lan pita thude thi va thubec 46i chimg; [Hungary |- Bé sung hé so liy mau, theo d0i im sing géc trong qua rn nghign cieu (20% ben nn; JovBE-17 [Rileptid, [Risperidone 2mg, gis Pharmaceuticals Risperdal Tg, [Hungarian Hb so miga thi hm hagng 2 mg dua ten nghién era thube IN-16750-13 |HOp 6 vix 10 vien nén bao [Private Limited Company, [Janssen Cilag, UK Railways hospital, thir him Izong Risperidone | me phim 1165, Budapest, Hungary - Bd sung ban dich tiéng Anh ban chép thudn cia Hi déng Bokényfoldi dt 118-120, Hungary tao dit; -Bé sung bio cio so sinh tong dong. hoa tan gta ce ham lugng khéc nhau, bang so sdnh cng thite bao ché theo se, thong tin v8 ti chun chit lagged thin phn dra vio cng thir bao ché cia cham lung Kh nau; |. 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