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CONG TY CP DUOC PHAM CONG HOA XA HOI CHU NGHIA YIET NAM

KHANH HOA

S6: /CP-DP

Poc lap - Tir do - Hanh phuc

Nha Trang, ngay 02 thdng 02 ndm 2020V/v: Xin thay doi so dang ky

«--------- :----------mat-hang (rung thanV'U Tr:J4^ '

lKinh gui ; So’ Y te Ninh Thuan

ifv ' Caffcir Quyet dinh so 3000/QD-SYT, ngay 06 thang 08 nam 2019 va Quyet.....'dinli"s6"3U08/QD-SYT ngay 07 thang 08 nam 2019 cua Chu dau tir (Giam doc So

' YlellifirNinh Thuan ) ve viec phe duyet ket qua lira chon nha thau goi thau so 1-Thuoc generic nam 2019.

Cong ty co phan dugc pham Khanh Hoa da trung thau mat hang Acetylcystein* f f r * r

do Cong ty san xuat den nay da het so dang ky va da dugc Cue Quan ly Dugc cap so dang ky moi theo Quyet dinh so 652/QB-QLD ngay 23/10/2019 cu the nhu sau:

Ten boat chat, ham lirong

So dang kyTen thuoc So dang ky moiMa hang cu

Acetylcystein200mgG10755 VD-16381-12Acetylcystein VD-33456-19

(Dinh kem:-Ban sao Quyet dmh cap so dang ky cua Cue Quan ly Dugc;

\ f f

-Ho so ke khai gia kem phieu tiep nhan cua Cue Quan ly Dugc).

Chinh vi vay, Cong ty co phan dugc pham Khanh Hoa kinh de nghi Quy So Y te cho phep Cong ty chung toi dugc cung ung cac mat hang tren theo so dang ky moi vai cac tieu chuan khac khong doi so voi ho so du thau.

Tran trong kinh chao.A

/t'1 TONG GIAM DOC/PHO TONG GIAM BOC

Xw jw/ CONG TY VvV /CO YUAN

*1 DUgCPHAM/iw1 ^SKHANH^O^W

Nai nhdn:- Nhu tren.- Luu TC, KD

BS.Lpfum.' J/fco $hb

_ . , ''IXaiidaMzlnCONG HOA XA HOI CHU NGHIA VlET NAM

Boc lap - Ty do - Hanh phucBp YTE

CUC QUAN LY orfQC

S6: 65Z Ha Noi, ngay^ thdngndm 2019

rpt --------- ------------^ve:dd^at)ailjhanh danh muc 775 thuoc san xuat trong nudes( ^6,5,^dp\gmy dang ky lu'u hanh tai Viet Nam - Dot 166 *\ oUOc pham /*]! ----- -------------------- -- * “*---------

: TRI/ONG eye QUAN LY DUOC

*3 *

1CONG TY CP DUQC PHAM KH )S^KHANH HOAaS

fiJiSDen so: Ngay:....JiQ|tDj.^airlCan cit Luat Dube so 105/2016/QH13 ngay 06/4/2016;

Can cu Nghi diuh s6 75/2017/ND-CP ngay 20/6/2017 cua Chinli phu quy dinhchuc nang, nhiem viij (}uyen han va ca can to chuc cua Bp Y te;

Can cu Thong tu so 32/2018/TT-BYT ngay 12/11/2018. cua Bp trirong Bp Y te

quy dinh viec dang ley lim hanh thuoc, nguyen lieu lam thuoc; jCan cu Quyet dinh so 7868/QD-BYT ngay 28/12/2018 cua Bp trudng Bp Y te

quy dinh chuc nang, rhiem vu, quyen han va ca cau to chuc eua Cue Quan ly Dugc

thuoc Bp Yte;Can cu y kien cua-Hoi dong tu van cap giay dang ky luu hanh tliuoc, nguyen

lieu lam thuoc - Bp Y te;Xet de nghi cua Trudng phohg Dang ky thuoc, Cue Quan ly Dugc,

QUYET DINH:11 i BiSu 1. Ban hanh kem theo QuySt dinh nay danh muc 775 thude san xuat trong

nude dupe cap giay dang^cy luu hanh tai Viet Nam - Dpt 166, cu the:1. Danh muc 748 thude san xuit trong nude dupe cip gi4y dang ley luu hanh

! tai Viet Nam hieu luc 05 nam (Phu luc I kem theo). Cac thude tai Danh muc nay co 1 sd dang ky vdi ky hiei VD-.. .-19 va hieu luc 05 nam ki tu ngay ky ban hanh Quyet

dinh nay.2. Danh muc 17 thuoc san xuit trong nude quan ly dac biet dupe ca^i giay dang

ley luu hanh tai Viet Nam hieu luc 03 nam (Phu hie IIkem theo). Cac thuoc tai Danh

muc nay co sd dang ky vdi ky hieu QLBB-...-19 va hieu luc 03 nam ke tu ngay ky

ban hanh Quyet dinh ray. ^ !3. Danh muc 03 thude san xuit trong nude dupe cap giay dang ky luu hanh tai

Viet Nam hieu luc 03 nam (Phu luc III kem theo). Cac thude tai Danh muc nay co sd dang ky vdi ky hieu ATH-...-19. vadiieu luc 03 nam ke tir ngay ky ban h^nh Quyet dinh nay. i* i .

, ; v ^ /4. Danh muc 07 thuoc san xuat gia edng trong nude dupe cap giay dang ky luu

hanh tai Viet Nam hieu luc 05-ham (Phu hie IV kem theo). Cac thude tai Danh muc nay co sd dang ky vdi ley hi'eu''GC-rV.-.-19 va hieu luc 05 nam k! tir ngay ky ban hanh Quyet djnh nay.

Dieu 2. Ca sd san xuat va ca sd dang ley thude co trach nhiem:1. Chap hanh dung'cac quy, dinh co lien quan tdi san xuit, luu hanh thude va

phai in sd dang ky dupe Bd Y te cap len nhan thude.2. Chi dupe san xuat, dua ra luu hanh cac thude kidm soat dac biet khi co Giiy

chung nhan du dieu k|en leinh doanh dupe pham vi kinh doanh thude phai kidm soat dac biet phii hop vdi p

II

ham vi boat dong cua ca sd dap ting quy dinh tai khoan 5 Bidu

v'l?*14j Nghi dinh so 54/2017/N©-CP ngay 08/5/2017 cua Chinh phu quy dinh chi tiSt mot so dieu va biei phap thi hanh Luat Dugc.

3. Thuc hien viec cap rdiat tieu chain chat Jirong cua thuhc tlieo quy dinh tai Thong tir so 11/2018/TT-BYT ngay 04/5/2018 cua Bo truong Bo Y te quy dinh chat Jirong thuoc, nguyen lieu lain thuoc.

--------4T^hucTiden7q3h4i^pp-vd-i-c0-sa-nhap4diau-thu:c4hen- theo ddng quy dinh taicong van so 5853/QLD-CL ngay 19/4/2019 cua Cue Quan ly Dugc ve viec Idem tra chat iugng nguyen; lieu lam thuoc nhom saitan doi vdi cac thuoc thuoc danh muc tai Dieu 1 co chua dugc chat thuoc nhom s art an.

5. Cap nhat jnhan thude, to huang din su dung thuoc theo quy dinh tai Thong tir s6 OI/2618/TT-BYT ngay 18/01/2018 cua Bo truemg Bo Y tS quy dinh ghi nhan

thuoc, nguyen lieu lam thuoc va td huang dan su dung thuoc theo hinh thuc thay doi, b6 sung gidy dang ky luu hanh thu6c qu>; dinh tai Thong tu s6 32/2018/TT-BYT ngay 12/11/2018 caa Bo tmdng B6 Y t6 d6i vdi thude chjua ctp nhat noi dung nlian

thuoc, td huong dan su dung thuoc theo quy dinh tai Thcng tu so 01/2018/TT-BYT ngay 18/01/2018 c laBo trudngBo Y te, cu jhe nhu.sau:

a) D6i vdi tl.uoc thuoc danh muc thuoc doc va nguyen lieu doc lam thuoc theo quy dinh tai Thdng tu so 06/2017/TT-BYT ngay 03/5/2017 cua Bo trudng Bo Y te Ve viec ban hanh Danh muc thuoc doc va nguyen lieu doc lam thuoc: chi dugc dua thuoc ra luu hanh tren thi trudng sau khi dugc Cue Quan ly Dugc phe duyet ngi dung cap

nhat nay. ...

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S •ve

:

b) Ddi vdi cac thuoc khac phai thuc hien viec cap nhat nay trong thdi ban 06 thang Ice tu ngay dugc cap giay dang ky luu hanh.

6. Phoi hop vdi cac ca sd dieu tri de thuc hien theo dung cac quy dinh hien hanh ve thuoc ke dan, tlieo doi an toan, hieu qua, tac dung khong mong muon cua

/ * * f**

thuoc tren ngudi \fiet Nam va tong hop, bao cao theo dung quy dinh hien hanh moi 06 thang mot lan ve Cue Quan ly Dugc - Bo Y te Viet Nam doi vdi cac thuoc thuocPhu luc II ban hanh kem theo Quyet dinh nay (sd dang ky co ky hieu QLDB-.....-19).

Dieu 3. Quyet dinh nay co hieu lire ke tu ngay ky ban hanh.Dieu 4. Gian doc Sd Y te cac tlnh, thanh pho true thuoc Trung uong va giam

doc co set san xua: va ca sd dang ky co thuoc tai Dieu lichiu trach nhiem thi hanh Quyet dinh nay./.

n

4Noi nhan: CUC TRITONG- Nhir Bi4u 4; # ■-BT. Ngtiyen Thj Kim Tien ((?eb/c); ’ &- TT. Trirong Qu6c Circmg (d€ b/c); - 1 ^- Cue Quan y - Bp Qufic phong, Cue Yt6-B6 Cong an; f fe, ; '- Cue Y te GTVT - Bp Giao thong van tai; L: \ 3 —- T6ng Cue Hai quan - Bp Tai chinh; ; : V'- Bao hiemxahpi Viet Nam; 1- Bp Y tl: Vu PC, Cue QLYDCT, Cue QLKCB, ThanJi tra Tuan Cu’O'ng- V if n KN thuoc TLT, Vien KN thufic TP. HCM;- T6ng Cong ty Dirge Viet Nam;- Cac Benh vien, Vien c6 gitrotig benh trirc thuoc Bo Y tl;- Cue QLD: P.QLKDD, JP.QLCLT, P.PCTTra, Website;- Liru: VT, DKT(15b).

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BO YTECyC.QUANLY Dirge

CONG HOA XA HOI CHU NGHIA VI$T NAMDoc lap - Tu' do ~ Hanh phuc

i

' PByp-LUe“IrBA^HiVIUe~743 ralJGG^SAN-XlJAT^TRGNG-NirG’e-BXrgc-CAp-GIAY-BANICY LUtJ HANH BDCfrU Lgc 5 NAM - BQT 166

Ban hanh kerr theo Quyet dinh s6:^-i?Z./QD-QLD, ng&yJ3.J./{Q.J

T/'i

I

nhanh cong ty co phan Armephaco- Xi n^hiep du-o'c pham 150 (B/c: ong Pham Ngu Lao, Quart 1, TP. Ho CM Mirth - Viet Nam)

1. Cong ty dang Icy: Chi 112 Tran HtmgBqo, phu1.1 Nha s:in xuSt: Chi nhanh cong ty co phan Armephaco- Xi nghiep du-o’c pham 150 (£)/c: 112

Trdrt Hung Dqo, phu&ng Pham Ngu Ldo, Quqn 1, TP. Ho CM Minh - Viet Nam)

Tu6iHoat chat chmh - Ham lu-ang

Quy each dong goi

Tieuchuan

Dang bao So dang kyTen thuocSTT die tho

VD-33234-19Hop 10 vi x 10 vien. Chai 100 vien"Hop lO v7x"l6 vien. Chai 100 vienHop 10vTx 10

vien. Chai 100 vienH6p 10 vi x 10 vien. Chai 100

Vien nen bao phim

36 TCCSDexibuprofen200mg

Amrfen 20011 thang

VD-33235-19Vien nen bao phim

36 TCCSDexibuprofen300mg

2 Amrfen 300thang

VD-33236-19Vien nen bao phim

36 TCCSDexibuprofen400mg

3 Amrfen 400thang

tVD-33237-1936 TCCSVien nang

cungFregabaiin 150mg4 Armbalin 150

thangien

Hop 10 vl x 10 vien (Al-PVC). Chai HD PE 100 vien

H6p 1 vi x 8 vien, hop 1 vi x 10 vien nang cung, vi bam Al/Al v& vi Al/PVC

rVien nen bao phim

36 TCCS thang

VD-33238-19Nabumeton 750mg5 Armeton 750■7

Ceftibuten (dudi dang Ceftibuten hydrat) 200mg

Vi6n nang cung

36 VD-33239-19TCCS6 Armten 200th^ng

1M6i goi 1,5 g'chua: Cleftibuten (dudi dang Ceftibuten dihydrat) 90mg

Bromhexin h^droclorid 8mg

Bot pha hon dich uong

7 Armten 90 36 TCCS thang

Hop 10 goi x TSgbptpha hon dich udng

VD-33240-19

8 Bromhexin 8mg Vien nang cung

36 TCCS thang

Hop 20 vi x 10 vien. Chai 200^___ _____

VD-33241-19

f

i

ILanam DT 200mg/2S,5mg

220 Amoxicilin (dual dang Amoxicilin trihydrat compacted) 2(0mg; AcidC avdianic-fdiroi----dang KaliC avulanat - Avicel (1:1)) 28,5mg

A Tioxicilin (duoi dmg Amoxicilin' tr. hydrat compacted) 4o0mg; Acid C avulanic (dirai dang KaliClavulanat - Avicel (1:1)) 57mg

Amoxicilin (dutfi dang Amoxicilin trihydrat) 600mg; Acid Clavulanic (du6i dang Kali Clavulanat ket hgp voi Avicel 1:1) 42,9mg

Vi§n nen phan tan

BP20124 Hop 1 tui x 2 vi x 7 vien

VD-33453-19thang 8

jJ____ ..I^op 1 tui chua 2 vi x 7 vien

24 BP201 thang 8

VD-33454-19Vien nen ph§n tan

221 Lanam DT 400mg/57mg

Vien nen phan tan

VD-33455-19Hop I tui nhom chira 02 vi, 03 vi, 04 vi x 7 vien

24 BP201 thang 8

222 Niflad ESI

38. CQng ty dang ley: Cong ty co phan duo'c pham Klianh Hoa (D/q: 74 Budiig ThongNhat, P. Van Thang, TP. Nha Tran38.1 Nha san xu^t: Con^ tyc6 phSn du’ffc phSm Khanh Hoa (B/c: Buang 2 thang 4, Khom

DongBac, P. YinhHoa, TP. Nha Trang, Khanh Hoa - Viet Nam)

g, Tinh Khanh Hoa - Viet Nam)*i

ccu

Tu6ithp

Hoat chat chirth - luong

Tieuchuan

Quy each d6ng goi

Dang bao che

So dang kyTen thuocSTT

VD-33456-19DDVN Hpp 10 vi, 50 vi x 10 vien; Chai 100 vien, 190 vien, 300 vien

36Acetylcystein 200 Vien nang cung

Acetylcystein223IVthangmg

USP Hop 3 vi, 6 vi, 10 vi x 10 vien; Chai 300 vien, 200 vien, 500 vien, 1.000 vien

Vien nen 36 VD-33457-19Calcium lactate pentahydrate (tuang dirong calcium (£a+) 39 mg) 300

224 Calciumthang 41

n>g

Sop 2 viTlO vi x 10 vien; Chai 1-00 vien

225 Esomeprazol 20mg Esomeprazol (dang v hat bao tan trong nipt chua

Vien nang cung (mau' tlm - tfm)

24 TCCS VD-33458-19i

thang

Esomeprazole magnesium (dudi dang Esomeprazole magnesium trihydrate) 22,5%) 20 mg ■

Moxifloxacin (dudi dang Moxifloxacin hydroclorid 436,8 mg) 400 mg

Levofloxacin (dudi dang Levofloxacin jhemihydrat 512,46 mg) 500 mgOmeprazol (dudi dang Omeprazol pellet 8,5%) 20 mg

Vien nen bao phim

36226 TCCS: Hop 1 vi, 10 vi x 5 vi6n

VD-33459-19Kacifloxi-thang

VD-33460-1936 TCCS tiling

Hop 1 vi, 10 vi x 5 vien

Vien nen bao phim

Caflovo227

VD-33461-19H6p2 vi, 10 vi x 10 vien; Chai 200 vien, 500 vien, 1.000 vien

36 DBVN thang 4

Vien nang cung

228 vagasdine

VD-33462-1936 DDVNHop 10 vi x 10 thang IV vien~"36"' TCCS~ Hop 10 vT, 20

thang vi, 50vixl0vien; Chai 100 vien, 200 vien, 500 vien, 1.000 vien

Vi6n nang cungVien nen

Sulpirid 50 mg-229 Kanpo

VD-33463-19Methylprednisolone 4 mg

230 vlethylprednisolone

j

Moi 1,5 g bpt chua: Thu6c b6t Paracetamol 150 mg sui bot

36 TCCS th^ng

Hpp 12 gdi, 24 gdi, 48 gdi x

231 Panactol 150 mg VD-33464-19s

1,5 gThuoc bot sui bpt

I}/f6i-l,5 g bpt chua: Paracetamol 250

232 ^anactol 250 mg 36 TCCS Hppi2 gdi, 24 gdi, 48 gdi x 1.5 g

VD-33465-19 Odthing

mg>■

39. Cong ty dang ky: Cong ty c6 phan duo-c phim IChanh Hoa (B/c: 74 Dirdmg ThdngNhdt, P, Van Thang, TP. Nha Trang, tinh Khdnh Hoa - Viet Nam)

39.1 Nha san xudt: C6ng ty c6 phan du-ffc phim Idianh Hoa (B/c: Bu&ng2 thang 4, khom Dong

Bac, phitdng VTnh Hoa, TP. Nha Trang, tinh Khdnh Hda - Viet Nam)

i/-1

TuoiHoat chat chinh - Ham lirung

Dang bao ro • alieuchuan

Quy each dong gdi

Ten thuocSTT So dang kyche tho233 Celecoxib C elecoxib 200mg Vien nang

cung36 TCCS Hop 3 vi x 10

vien, 10 vl x 10 vien. Chai 100 irien, chai 200 vien, chai

VD-33466-19thing

i

Trang 32

ItI■ (

I

|5Q0 yjen

40. Cong ty dang ky; Co: ig ty co phan' dirge pharn Khanli Hoa (£)/c: So 74 ThongNhat, TP. J\ha_ Trang, tinh Khdnh Hda - Viet Nam) -

40.1 Nha san xuat: Conj ty co pkan dirge pham Khanh Hoa (D/c: Budng 2 thdng 4, Ichom Bong Bde, phu&ng Vinh Hda, 7 P. Nha Trang, tinh Khdnh Hoa - Viet Nam)

\ loat chat chinh - Ham Iirgng

Tuoi Quy each dong goi

Tieuchuan

Dang bao chi

So dang kyTen thuocSTT tho

VD-33467-19Hop 3 vi x 10 vien, h6p 10 vi x 10 vienH6p 2 vi x 5 vien, hop 10 vi x 5 vien

36 TCCSVien nen nhai

Natri picosulfate 5mg

Pruzitin234thang

VD-33468-19DHVN36Vien nen bao phim

Spiramycin 3.000.000 IU

Spiramycin235thang 4

i

41. C6ng ty dang ky: Co’ng ty c6 pliSri du-gc pham Me Hi Sun (D/c: 521 khu pho An Led, phudng Hoa Lpi, thi xa Ben Cat, knh Binh Duong - Viet Nam)

41.1 Nha san xu^t: C6n;; ty c6 phan du-gc phim Me Hi Sun (D/c: 521 khuphd An Lpi, phudng

Hod Lpi, thj xa Bin Cat, tinh Binh Duong - Viet Nam)

Tu6iBoat chat chinh - Hhm Iirgng •

Quy each dong goi

Tieuchuan

Dang bao che

So dang kyTen thuicSTT thp

Hop 3 vi x 10 vien; Lo 50 vien, 100 vienHop 10 vl x 10 vienH6p rOgbiTio goi x 4,4g

36 VD-33469-i9Vien n6n bao phim

TCCSRivaroxaban 15 mg236 Abmuzathang

.v36 VD.33470-19Vien nang

ciingThuoc bpt pha h6n djeh uong

USPRamipril 2,5mgBeynit 2.5237thang 40 tn Moi g6i 4,4g chua:

Cefiiroxim (dirdi dang Cefuroxim axetil) 250 mgDexketoprofen (duo! dang Dexketoprofen b'ometamol 36,91 nig) 25 mg

1 icagrelor 90,00mg

36 TCCS VD-33471-19238 Febgas 250thang

5

Vien nen bao phim

36 TCCS Hop 3 vi, 6 vi x 10 vien

VD-33472-] 9239 Feleifenthang

240 Feleilor Vien nen bao phim

36 TCCS Hop 3 vi, 6 vien k 10 vien."fep 3 vi, 10 vi x 10 vien; Chai l00 vien

Hop 3 vi, 6 vi,9 vi x 10 vien.

VD-33473-19thang

241 Fistlow C lomifene citrat 50 Vien nen 36 TCCS VD-33474-I9i

thangmg .

242 Gacoba >yifuzosin HC1 2,5mg

Vien nen bao phim

36 TCCS thaiig

VD-33475-19

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153.1 Nha san xuat: Cor g ty TNHH Van Xu an (£>/c: Du&ng so 3, cum cong nghiep Lien Hung, dp BinhTien 2, xa Due Boa Ha, huyenBuc Hda, Long An - Viet Nani);

I-7“;r

Tuol!ioat chat chinh - Ham lirpiig.

Dang bao che

Tieu•%chuan

Quy each dong goi

So dang leySTT Ten thude tho

24Vien nen bao phim

Hop 1 chai 40 vien

VD-33980-19Cao kho ngu vi tir (ttrang irng 3g ngu vj tu) 300 mgCao kho hon hap dupe lieu 390 mg (tuang ung vdi : Doc hoat 330 mg; Phdn'g phong 330 nig; Tang ky sinh 330 nig; T&n giao 330 mg; Bach thugc 3io mg; Nguu tat *

’330 mg; Sinh dia ■ 3i0 mg; Cam thao; 330 mg; D6 trong. 3|0 mg; T^tan 60 mg; Que nhuc 60 mg; Nhan sam 60 mb; Duang quy 60 mg; Xuyen khung

TCCS747 Hepaschisthang

i

VD-3398I -19Hop 1 chai 40 viSn; Hop 10 vi x 10 vien

24 TCCSVien nen bao phim

748 V.phontethang

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i11

II

30 mg

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f-BO Y^Ecue ouaniIy-Dirac

56; /()LD-GTV/v cong'bo'llTOng^ir ve-gia-thuoc-ke -

khai, ke khai lai; thong tin bo sung, thay doi cua thuoc da ke khai

CONG HOA XA HOI GHU NGHlA VIET NAM Hoc lap - Ttf co- Hanh phuc

Ha Noi, ngay>j^thdng / nam20I9i

i

Kmh gui: ,- Cac Sa Y te tinhythanh pho true thuoc Trung irang;- Cac Benh vien, Vien co giuang berth true thuoc Bp Y te;- Cac ca sa san xuat va kinh doanh dupfe.

(Sau day gqi tat la Dan vi)

,11

Ngay 20/3/2319, Cue Quart ly Dupe co Cong van so 3583/QLD-GT thong bao cac dan vi v£ viec Cue Quan ly Dupe triin khai He thing dich vu cong cip

dp 4 vi ke khai, ke khai lai gia thuoc theo quy dinh tai Nghi dinh si

155/2018/ND-CP ngay 12/11/2018 di tiip nhan va giai 'f\uyei 03 thu tuc: Tiep nhan hi sa ke khai,gia thuic nuac ngoai va thuoc san xult trong nuoc; Tiep

nhan h6 sa ke khu lai gia thuoc nuac ngoai; Tiep nhan 16 sa thay doi, bo sung thong tin doi vai' huoc da ke khai, ke khai lai.

Sau qua trinl giay, Cue Quan ly

1. Kl tu ngay 01/5/2019, sau khi tiep nhan va xu ly ho sa Cue Quan ly* r • * ' •Dupe cong bo gia thuoc ke Ichai, ke kliai lai; thong tin bo sung, thay doi cua

thuic tren C6ng thong tin dien tu cua Cue tai dia chi:https://dichvucong.dav.sov.vn/con2bo2iathuoc/index.

2. Thong tin.gia thuoc' ke khai, ke khai lai; thong tin bo sung, thay doi cua/ j ' s f

thuoc da ke khai dupe cong bo tai dia chi tren va Thong tin ve gia thuoc ke Ichai, ke khai lai tai cac File cong bo cu dang co tren trang thong tin dien tu cua Cue co gia tri phap ly nhu nhau. ■

Cue Quan ly Dupe thong bao, gui tai cac Don vi duemg din tren dk tra cuu thong tin ve gia th joc.ke khai phuc vu cac tac nghiep lien quan.

Tran trong dm cm sit hap.tac cua Quy Dan vi.

11

f

true tuyen va ho sa ban9 *

trien khai song song hai hinh thuc: ho soDupe thong bao tai cac dan vi nhu sau: i

1

1

1

I

GUC TRUONGTRlTdNG

r. y-: . 3'^

^y.^N’guyen Tat Bat

Nffi nhan:- Nhu1 tren;- Thir tnrang Truong 3uoc Cu6'ng (de b/c);- Cue truang (de b/c);- T6ng CT Dupe VN - CTCP;- Hiep hoi Doanh nghiep dupe Viet Nam;- Trang thong tin dien tu cua Cue QLD;- Luu: VT, GT (C.H). :

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Uuan ly Dltq'c -.Bp Y te* L,l

Defauit\4200562765 (Den Crng dyng) (/Application) £>AN6 ky (/DANGKY)

V. 844.37366483 Q cqldvn@moh.gov.vn

(/)

TRACLTU GIATHUOC

TAT CA - : vd-33456-19

QTIMKIEM COAT LAI

vAnTRANG BANTHAI KIEN

NGHj

S(5 QUY CACH DONG G6}

NUtSfCNGAY Kg KHAI

PHANDANGGPLH/GPNK. BAOCH^ gia casdsxTEN THUfiC TEN HC ND/HL DVT DON VI KKSX LOAI

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HpplOvi, 50 vi x TO vien; Chai TOOvien, 190 vien. 300 vien

Cong ty co Congty co pliandvoc Viet phanjduoc pham Nam phani

Acetylcystein 200 mg

VD-33456- Vien nang oi’ng

KK trong nude

vienAcetylcystein 680200 mg07/11/201919

Khanh Hoa Khanh Hoa

https://dlchvucong.dav.gov.vn/congbogiathuoc/index 1/2

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So Nong do, Ham luong

Quy cadi dong goi so- san xuat - Nmrc san xuatTen thuoc Co-GPLE/GPNK

Cong ty co phan duac pham Khanh Hoa - Viet Nam

VD-3345'6-19 200 mg Hop 10 vi3 50 vi x 10 vien; Chai 100 vien, 190 vien, 300 vien

Acetylcystein

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Tai lieu khac (Ghi ro):Ghi chu: - ,- Phi£u ti6p nhan nay chi co ^ia tri xac nhan. co so da ti6n hanli thu tuc ke khai gia thuoc theo quy djnh tai Nghi dinli s6 155/2018/ND-OP ngay 12/11/2018- Giatliubc ke khai, ke khai h i va thong tin thay doi, bo sung se dugc cong bo tren trang thong tin dien tur cua Bp Y te theo quy dinh.

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V/v ke khai gia thuocKhanhHoa, ngay 01 thang 11 nain2019

bAng ke khai giA thuoc sAn xuAt trong Nl/OcKinh giri: Cue Quan ly Dugc - Bo Y te

Ten thuoc, dang bao che, guv cach dong goi

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Don vi tinh-------thi

Gia Gia ban buon du '~en(VND)

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Acetylcystein, Vien nang cung, Hop 10 vi, 50 vi x 10 vien; Chai 100 vien, 190 vi§n, 300 vien

Acetylcystein 200 200 mg vien 565VD-33456-191 680mg

Co sg cam ket va chiu trach nhiem impc phap luat ye tinh'chinh xac cua cac thong tin da ke khai." Ghi chi:- Bon vi tinh: Tinh thco quy each dong goi nho nhat.- Gia ban buon, ban le du kicn da bao gom thue gia trj gia t3ng v& gia thanh tinh theo VNB.

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Aciwe »iftfwd^nv A utyLTystilns.. ^OOn*9 LsfijpiA^u....„.q4. ....... luer'ACfl©»iM

INCWCiliOMS; D0S4 E • AOUIK^STRAIIOH:cotiTFiei!.uic*mw: rstcaunott aov-meEfHCT wiDOlHEfl WPOfll'allOfi: M}»* s« rxb^ikrtl STORAGE: Bilun 39C. bi O'v c«tcb, pro'tct bun bgN SPEOFlCATlO-Hr'Vrff SOK/Rfs.Na:

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COMPOSITION:AciKie Ifigrcciicnt: Acotyicysicino..^00mg Exerplonts...........o.s........... ‘or one capsule

l.’IDICAIIOJIS; DOSAGE • AOUIFtlSTRATIQH; C0IITRAIH01CATI0HS: PRECAUTICKI: ADVERSE EFFECT AMO OTHER IKFORMATIOM: PKaM see ffxlascd teanst

STORAGE: Bclsw 30’C, In dry place, pioiecl lipm ligm SPECIFICATIOHS: VP IV SOKFR

THANH PHAN CdllG THlJC:THlnh ppfin difpc ch/5i: Acelyicysifllr. .200 mg Thinh tjh^n id duoc__ vd.....1 vlin n. ng eiing

CHI Of-’H; UEU OlWS - CACH DUKS: CH&C CHl OffiU TKAH TROVC; rtc WKG KKdffS tone WJ( V vi ck THftlG TUI KKi.C; XS4xr:fgl3 Dis ii Inj ndt

BAG QUAN: OUdi 30 *C. ndi khft rA >,Hdnli onhsAng.

TIED CHOAII: 09VH IVoIXATAHTAYTREEU

DOC KV HUOMQ Oitl Sil 0V»C TRUiC K IIOUNG.' Sift tuft 1)1.CONG TY CG PH/M Owe Pk/m KHA IK HijA Ouin; UJ. P. VWi H:». TP. MhaT.tftj.T, I -jm Hij HSVU!g.ds;e :Sil&fUBattfiNa.:HWEipijl! :

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READ CAREfUUY ITSTFAJCTIOHS BEFORE USE1 .

IWHO-GMPIT- . • Manutncli ■cd tr,:Khanh Ha 1 phaimaceihica) javii slack company 2/4 sheet. Voih Koa ward, Nha Ttang city. Khanh Has province

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Aclive Ingredient: Acetylcysteine:..200irig Excipients.:.’:.. C).s......... tor one capsule

IIIDICATiOIIS; DOSAGE - ADMIIIISTRATIOII; CfflirBABfflKAIBSftPRECAUTKWiADVfflSE EFFECT AIIO OTHER IHFORI.IATIQI!: Fjease S68 end used Isail;;

THANH PHAN CONG THOC:Thanh phen duo: chat: Ace!ytcystein...200 mg Thinh phgn ti dUdc....vd... 1 viSn nang edng

CHi DpIH; LIEU OUHG • CACH OU.NG; CHONG CHi OINK: THAN TRQH6: fiC C(WG KHOW HONG HUON M CAC THONG TIN KHAC: Xis Jot umg td hJSng da'i wetn: tiftfe.

BAO QUAN: DUdi 30 °C, ndi khO rio. tiinh anh sing.

TIEUCHUAN: ODVN IV

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STORAGE: Selow 30‘C. in dry place, protect irom light SPECIFICATIONS: VP IV SDK/Reg.No:

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OEXATAUTAY TREEM DOC KY HlfSNG DAN SI/DUNG TRl/SC KHI DUNG

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Indicationsqossgs ■ Administration:Oonlreindfcitlons ;P cciutlons :A Iverse effects A td other Informations :)

/KEEP OUT OF REACH O* CHILOREN

headcakefuuv i:tsrituctio>/s BEFORE USE _____Ptsasesee

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Td hudng din su' dung 'xJLI/ i*^j^con Kh6ng c6dCrii6u v4 vi$c thuficcd b&i ti^t vSo sOanhi/ng do d$c llnh th5p. rul ro :i§m cho ir6 Id khdng ddng kd'.

th^diing cho phy nO cho con b i.^NH HUONG CUA THUfic L&N KHA f^NG LAI XE VA VAN HANH MAY M6C:Thufic gdy tdc dyng kh6ng mong muii bu6n ngu, nhtic dSu, u lei nen khOngsildyng dupe cho nguPi Idixevd vdnhdnhmdy m6c.TUONG TAC, Tl/ONG KY CUATHU6C:|Acetylcystein Id mil chdt khtl ndn khong dupe dung chung vdi cac thuoc c6 tlnh oxy • h6a.KhPng dupe diing d<5ng ihdi vpi ede thufic ho khde ho$c bdt cif ihu£c ndo Idm gidm bdi tf£t ph£ qudn trong (hpf gian di£u trj bdng acetylcystein.Do kh&ng cd ede nghlen cUu v§ tinh tuong ky cua Ihud'c, khfing Irpn l3n thufic ndy vdl Ihufic khde.TAC DUNG KHONG MONG MUON:Acetylcystein cd gidi hpn an todn f£ng. Tuy hi£m r&ng trong Idm sdng do acetylcystein, nhung v§n dang Ihud’c chUe acetylcystein.Itgfa I/iOOO<AOfl< t/tOO:HP mlSn d|ch: qud min. Thin kinh: daudiu Tal: 0 tat. Tim: nhfp tlm nhanh Machmiu: hahuyitip Da v& t6 chUc dUdi da: ngUa, phat ban. miy i TI6u h6a: vl6m da diy, dau bung, bufin nPn, n To£nthin:s£t.

\Zi£n nana ctlng

ACETYLCCYSTE J^VG - iOE THUfic XA TAM TAY EM.

DOC KY HLfONG DAN SLl DU, IG TRUOC KHI DUNG.THONG SAO NGAY CHO 6A< SY HOAC DUOC SY

NHONG TAC dung KHONG MONG Mu6 GAP PHAl KHI SLl DUNG THU6c. N^U CAN THfM THONG TIN, )||N HOI ’f KIEN BAC SYI

THANH PHAN C6NG THLfC: 1 viin.200 mg

Thinh phin ti dupe gdm: Tlnh bpt ml, lactose, arbocel M80, povidon K30, .viiadu

Thinh phin dupe chit: Acetylcystein.

1 viinnangcUngmagnesistearat...........................DANG BAD CHE: viin nang cUng.Md TA SAN PHAM: Win nang cting. nang $6 f. mit/ xanh la dim - xanh li nhat, bin trong chUa bpt thu£c miu tring.CHIOINH:Ti6u chit nhSy trong bpnh nhiy nhdt. b^nh ly h<5 hip cd ddm nhSy quint) nhu trong viim phi quin cipvd man tlnh vi lim sach Ihudngquy trong md khlquin.CACH DUNG VA LIEU LlfQNG:Cich dung: dung dUdng u6ng. jLiiu lupng: ngUdi I6n vi tri em trin 7 tu£l: 200 mg x 3 tin/ ngiyKhfing cd yiu ciu dpc dipt v4 xtrly thuSc sau khi silrdyng.ch6ng chIdinh: IOui min vdl acetylcystein hay bit kY thigh phin nio cua thude.Tri emdudiS tu£i. Tidn si/lodfdpdiyti tring. TiinsCrhen.CANHBADVATHANTRQNG KHI DUNGTHUdC:Ho li yi’u td cpbin d4 bio v$ phi quin-p^di ndn cin phat dupe tin frpng. Vi<Jc kit hpp thude lim lliu chit nhiy vdi thude chdng ho vi/hofic lim khd sU li£t chit nhiy (tic dgng gidng atropine) l& khdng hpp ly.Phii glim sit chit che ngUdl b$nh id nguy cd phit hen niu dung acetylcysteine cho ngud/ cd tlfin sii dj Ung; niu cd co thit phi quin, phii diing thude phun mu giin phi quin nhu salbutamol ho$c ipratropium vi phi! ngirng acetylcysteine ngay,Kht dl6u trj vdl acetylcysteine, cd thl ^uit hldn nhliu ddm loSng d phi quin, cinphii hut diliy raniu ngudibd Thltn trpng 6 nhOng b$nh nhin vidm toil da diy ti tring, die bi$t khl phdl hpp vdl tiiu hda. Niu cd ndn dtr dpi khl udng thude thi cin theo doi chiy miu da diy hope giin thpc quin, loit dp diy.Phin Ung da nghiem trpng nhu hpi chUrjg Stevens-Johnson vi hpi chUng Lyell da dupe bio cio rSt hlim khi xiy ra kh) dung acetylcysteine. Trong hiu hit cic trudng hpp bio cio, diu do dung acetylcysteine ding thdi vdl It nhit mpt loai thude khic cd khi ning kfch thich niim mac. Oi phdng ngUa, n£u tdnthuOngdahoicniimmac xuSlhipn, ndn ngUngdiiu trj ngay IpptUc vihoiy kiinbacsl.Trong cic nghidn cUu In vitrocho thiy acetylcysteine cd thi giy kit tip tiiu ciu. Y nghTa lim sing edn chUa rd. Thin trpng d nhOng b$nh nhin cd nguy edehiy mducao.Thude cd thi giy tic nghin dudng hd hip d tri em dUdl 2 tudi, do die llnh sinh ly dudng hd hip d nhdm tudl niy. Khi ning ho tdng ddm ra ngoii edn hanchi. Dodd, khdngninsCr dpng thude dtri emdudi2tudi.Thude cd chUa lactose nin b$nh nhin mic cic rdi loan di truyin hiim g$p vi dung nap galactose, chOng thfi'u hut lactose Lapp fio$c rdi loan hip thu glucose-galactose khdng ndn sir dyng thjidc niy.Thude niy cdcbOa 103,5 mg tinh bpt ml (iS 10,35 pg gluten) cho 1 vldn nang cUng acetylcystein 200mg. Tinh bpt ml trong thude eh? chUa ning d$ rSt thip gluten vi hiu nhU khdng giy v£n di n£u b$nh nhin friic bpnh coeliac.Thudc cd chda tinh bpt ml nin k^idng dung dupe cho b§nh nhin di Ung liia mi (khic binhcoelfac).THfll KV MANG THAI VA CHOCON BU:• Thdi ky mang thai: Nghiin cdu trin ddr g vpt cho thiy khdng cd khi ning giy qui/ thai, tuy nhlin eht/a cd nghiin cdu chdng mirth acetylcystein an loin trin phg nd cd thai. Do dd, chi dim i acetylcystein cho phy no cd thai khi thit cSn thiit.

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Hi&mgip. 1/IOOOO<ADR cl/1000:Tieu hda: khd tiiu. Hd hip: khd thd, co thit phd quin.RSt hiSm g&p: ADR < 1/10 000:H$ mi6n djeh: sdephin vi. phin Ungohan vp.Mach miu: xuit huyi't.TSnsuStchdard:Tointhin:phum§t Lduf : Thing bio cho btic sy nhdng tie dt/ng khdng mong muSn g$p phal khi stidgng thuoc.QUA LlgllVA XLfTRi:Lim glim huyil ip vi cic trliu chUng khicnhu:suy hdhip, tan miu.ddng miurairic ndimgch vi suy thin.XO trl: chuyin ngay d£n co sd y ti gin mil di diiu tr| chu yiu li diiu lr| theotripuchUng. !DACtInH DLfOC Ulc HOC: 1Nhdm dupe ty: thude tiiu chit nhiy. Mi ATC: R05CB01Acetylcystein li din chit N-acetyl cua L-cystein. mpt acid amin Ip nhlin.Thude cd tic dung lim tiiu chit nhiy do sulhydryl tu do lim glim dp quinhcua ddm d phdl cd mu hoic khdng bing cich tich ddi ciu ndi dlsultua trongmucoprotein vi tao thuin Ipi di tdng ddm ra ngoii bing ho. din tUu tu th£hoic bing phUdng phip co hpc.DAC TfNH DUOC BONG HOC:Sau khi udng. acetylcystein dupe hip thu nhanh d dudng tiiu hda vi dpt ndng dd dlnh trong huyit tuong khoing 0.5-1 gid sau khi udng liiu 200-600mg, p| gan khir acetyl thinh cystein vi sau dd dupe chuyin hda. Slnh khi dung khi udng thip chi khoing 4 • 10% tiiu diing. cd thi do chuyin hda trong thinh rudt vi chuyin hda bude diu trong gan. 83% thude gin vdl protein huyit tuong. Thdi gian bdn th&i t„ = 2\ Op thanh thii thdn cd thi chiim 30% dp thanh thii toin thin.QUY CACH BONG Gbit HPp 10 vlx 10 viin nang cUng, hpp SO vfx 10 vldn nang cOng. chai 100 viin nang cOng. chai 190 vldn nang ciing, chai 300 viinnangcClng.BAOQUAN - HAN BUNG:Bio quin: DUdi 30’C. Ndi khd rio, trinh inh sing.Hin diing: 36 thing ki til ngiy sin xuit. r/iuebuin: DBVNIV.

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