BO GlAO THONG V!N TAl CQNG HOA xA HQI NGHiAVI~TNAM eve …cucytegiaothong.mt.gov.vn/Uploads/File/CV 1122 NVYD.pdf · BO GlAO THONG V!N TAl CQNG HOA xAHQI cmrNGHiAVI~TNAM eveYTE DQcl~p-Tl]'do

BO GlAO THONG V!N TAl CQNG HOA xA HQI cmr NGHiA VI~TNAMeve Y TE DQc l~p - Tl]' do - H~nh phuc

S6:AAWCYT-NVYD&TTBYT Ha Noi, ngaYAA thong 12 nam 2014VIv rut 86 dang ky luu hanh thuocra khoi danh muc cac thuoc duoce~p s6 dang ky tai Vi~tNam.

Kinh giri:- Cac Benh vien, Phong kham da khoa GTVT;- Cac Trung tam Y t~ chuyen nganh GTVT.

Ngay 0311112014 B9 Y t~ c6 Cong van s6 626/QB- QLD, s6 627/QBQLD v~ viec nit s6 dang ky luu hanh thuoc ra khoi danh muc cac thuoc dirocdp s6 dang kY tai Viet Nam.

N9i dung cu th€ cua cac Cong van n6i tren duoc dang tai tren Website cuaCue http://cucytegiaothong.mt.gov.vn; chuyen muc Chi dao va hirong d~nnghiep vu y t~).

C\lC thong bao d€ cac don vi biet d€ c~p nhat va thirc hi~n./.~

Nai nhljn:- Nhu tren;- LUll: VT, NVYD & TTBYT.

CVCTRU'ONG

Vii Van Tri~n

BOYTEcue QUliN LV DUQC

S6: ~j_-f /QD-QLD

" ,,_ A ? _ A

CONG HOA XA HOI CHU NGHIA V~T NAMDQclap - TI! do - H~nh plnic

sa N9i, nga» OJ thdng Af ndm 2014

QuYETDlNHtit so dang ky hru hanh thuoc ra khoi danh muc cac thuoc

duoc cap so dang ky t~i Vi~t Nam

CVCTRDONGCvcQuANLYDDQCII SO': ... 2.12-,k ........" Can err Luat Diroc ngay 14 thang 6 nam 2005;- NVa Can eu Nghi dinh so 63/2012/ND-CP ngay 31/8/2012 ciia Chfnh phu quy::,~'ft . dinh chirc nang, nhiem Y\1, quyen han va co cau t6 chirc cua B¢ Y te;

_,,/ Can err Quyet dinh so 3861/QD-BYT ngay 30/9/2013 cua B¢ tnrong B¢ Yte quy dinh clnrc nang, nhiem Y\1, quyen han va co can t6 chirc ciia Cue QU,lmly

, diroc thuoc B¢ Y te;Can eu Thong nr so 22/2009m-BYT ngay 24/11/2009 cua B¢ Y te quy

dinh viec dang ky thuoc;Xet don de nghi nit so dang ky thuoc cua Cong ty C6 phan Diroc pham

Imexpharm va Cong ty C6 phan Korea United Pharm. Int'l;Xet de nghi cua Tnrong phong Dang ky thuoe - C1;leQuan ly duqe,

QUi'ET D~NH:

Dieu 1. Rut so dang ky eua cae thuoe (co danh m1;lekern theo) ra kh6iDanh m1;lecae thuoe duqe cap so dang ky lUllhanh tcp.Vi~t Nam.

Dieu 2. Quyet dinh nay co hi~u h;rek~ tit ngay ky ban hanh.Dieu 3. Giam doc Sa Y te cae tinh, thanh pho tn;re thu¢e Trung uoog, cae

doo vi kinh doanh thuoe va Giam doc co sa co thuoe n~u tC;liDieu 1 ehiu traehnhi~m thi hanh Quyet diM nay.Noi nh~n:- NhuDi~u 3;- BT. Nguyen Thi Kim Tien (de b/e);- Ct.IeQulln Y - BQ Qu6e phong, Ct.IeY te - B¢ COng an; y

- Ct.IeY te Giao thOng v~ tai - B9 Giao thOng v~n tai;...-- 0~_ -: _.,r- T6ng et.IeHiti.quan - BQ Hi ehinh, Bao hiem Xii h¢i Vi¢t N ; / &'~,~- ~V Phap ehe, eVe Quan 19 :' D.uqe e6 truy~n, Cl,le Q~an ' ~, ; ,:l,'~:'/~>chua b¢nh, Thanh tra BQ Y te, Vl¢n KN th!l6e TW, Vl¢n tKili5c ':I.JTP. HCM; :c '~'-+ /-:,- T6ng COng ty Duqe Vi¢t Nam, cae C6ng ty XNK Duqe ph ';' A~:::/';" .,.~.- Cae B¢nh vi¢n & Vi¢n co giuang b¢nh tIVe thu¢e BQ Y te; .....~'.j:#---- Website CVe QLD, T,!-pchi Duqe &My phfun-Cl,le QLD;- Luu: VP, QLKDD, QLCLT, TTrD-MP, DKT(12).

..Truong Quoc Cubng

i: x..

DANHMl)C cAc THU6c RUTso DANGKY(Ban hanh kern theo Quyet dinh s6 6J6 /QD-QLD ngay 03 thangA1 nam 2014)

1. Cong ty dang ky: Cong ty c6 phan DUQ'c pham Imexpharm (dlc:So'4, duang3014,Thanh pho' Cao Ldnh, Tinh Do'rlg Thap).1.1. Nha san xuat: Robinson Pharma INC. (dlc: 2632-2638 S.Croddy Way, SantaAna CA 92704, USA).

STT Ten thu6c ;. Dang bao ch@ S6 dang kYHo,t chat

Calcium 350mg,

1 Calcium from milk phosphorous Vien nen bao phim VN-5057-10150mg, VitaminD 100IU

2 Coenzyme Q10 Coenzym QI0 Vien nang mem VN-5058-1030mg 30mgGinseng extract,

3 Geriton h6n hop vitamin Vien nang mem VN-5059-10va khoang chAtCoenzym Q10, L-

4 Heart care Carnitine Vien nang rnem VN-5060-10Fumarate,Vitamin C, E

5 Robinson pharma Vitamin B1, B6 , Vien nen bao phim VN-5061-10Vitamin 3B Caplet B12

6 Super Vitamin BC H6n hop vitamin Vien nang cirng VN-5062-10Complex

7 Vitamin B1 250mg Vitamin Bl Vien nen bao phim VN-5064-10250mg

8 Vitamin B 1-B6- Vitamin B1, B6, Vien nang mem VN-5065-10B12 Softgel Bl2

9 Vitamin C 500mg Acid ascorbic Vien nen bao phim VN-5066-10500mg

10 Coenzyme Q10 Coenzym QI0 Vien nang mem VN-9480-1050mg 50mgVitamin A, D, C,

11 One daily Multiple Bl, B2, B6, B12, Vien nen bao phim VN-9481-10vitamins Niacin,Pantothenic acid

12 Calcium +D 500mg Calci, Vien nen bao phim VN-I0807-10Vitamin D 200IU

1

I I De':~~lJB1~~C'}\!atural ! I ,

I IEPA,DHA.,

Ii13 Alaska Fish oil Vien nang mem VN-l 0808-1 0 I

Vitamin E I, Omega-S iI

14 Garlic Oil Softgel Garlic oil 10rng Vien nang mern VN-10809-10 I

2. Cong ty dang ky: Cong ty ca phin Korea United Pharm. Int'l (d/c:S62A Dai 16T1!Do, Khu cong nghiep n« Nam-Singapore, ThUtj,nAn, Binh Duong).2.1. Nha san xuat: Cdng ty ca phin Korea United Pharm. Int'I (d/c:S62A Dai 16T1!Do, Khu cong nghiep Vi¢t Nam-Singapore, ThUtj,nAn, Binh Duong).

STT Ten thuac I. Dang bao ch~ sa dang kyHo~t chat

15 Clovagine Clotrirnazol 1% Thuoc kern VD-13967-11

16 Kupfusigel Natri fusidat Thuoc mo VD-13968-1120rnglgkemHeparin natri500ru (4mg),

Gel Kupscarcare dich chiet hanh17 1000rng (tuong Gel VD-14811-11109 duong spiraosid

20rncg); allatoin100mg

18 Kuptrisone Terbinafin Thuoc kem VD-14812-11hydroclorid 1%Zoylin

19 (NhUQ'Ilgquyen: Acyclovir 250rng Thu6c kern VD-18055-12Korea UnitedPharm. Inc, Korea)

Betamethason

Kupderma valerat 0,61 rnglg

(NhUQ'Ilgquyen: kern; Gentamicin20 (duoi dang Thu6c kern VD-19778-13Korea United

Pharm. Inc, Korea) Gentamicinsulfat) 1 rnglgkern

ICl)C TRl/QNG. _

Truong Qu6c CUOng

2

II\I S6. j} 1k ...... Cl)C TRUONG cvc QuANLY DUQC

. -- Can ClILu~t Diroc ngay 14 thang 6 nam 2005;.-t}:;J.l?~! Can cir Nghi dinh s6 63/f012INB-CP 1}ga"y3118/2012 cua Chinh phu quy0/ "'1 -: dinh chirc nang, nhiem vu, quyen han va co cau to chirc cua BQY te; .

)/ Can cir Quyet dinh s5 3861/Qf)-~YT ngay 30/9/_20q cua Bi.\ tnrong Bi.\Y te

quy dinh chirc nang, nhiern vu, quyen han va co cau to chirc cua C\lC Quan lyDiroc thuoc BQY te;

Can cu Thong tu s6 22/2009/TT-BYT ngay 24/11/2009 cua BQY tS quy dinh

viec dang ky thuoc;Can cir Thong tu s9 23/20 13/TT-BYT ngay 23/8/2013 cua BQY tS huong dful

hoat dQng gia cong thuoc;Xet d@nghi cua TruOng phong Dang kY thu6c - C\lCQuan ly Duqc,

QUYET BINH:Di~u L,Bat} hanh kern theo QuySt dilL}}nay danh rn\lc 02 thu6c san xuit gia

cong duqc cap so dang kY luu hanh t~i Vi~t Nam.Di~u 2. Cong ty san xuit va cong ty dang kY co thu6c luu hanh phai in s6

dang kY duqc BQ Y !S cip len nhan th~6c va ph~i chip hanh dung cac quy chS colien quan t61 sat: xuat va luu hanp. thuoc. Cae so dang kY co kY hi~u GC ...-14 cogia tri 05 narn ke tir ngay kY Quyet dinh.

Dieu 3. Cham dUt hi~u h;rc s6 dang ky cua cac thu~c Ibaton}c-Calci, SDK:VD-l7617-12 va Ibatonic-F, SDK: VD-17618-12 t~i Quyet dinh so 224/QD-QLDngay 24/9/2012 cua C\lCtruOng C\lCQuan ly Duqc.

Dieu 4. Quy€t diM nay co hi~u h;rck~ tit ngay ky ban hanh.Dieu 5. Giam d6c sa Y t€ cac tinh, thanh ph6 tn;tc thu9C trung uang va giam

d6c dan vi co thu6c t'.lidieu 1 chiu trach nhi~m thi hanh Quy€t dinh nay.

n« N9i, ngay )7- thang)if ndm 2014

cue Y_TEGI!\O THIJNG \/I-\N TAil QUYET DlNHCONe '/i\N~'~C ap so dang ky san xuat gia cong trong mroc cho 02 thucc

n dllqc phep hru hanh tai Vi~t Namu ~L

BOYTECVC QUAN LY DUQC

S6 ·650 IQD-QLD

CONG HoA xA HOI CHU NGHiA VI¥.T NAMDQcl,p - TV do - H~nb pbuc

I

Noi nh{in: ,-NhuDieu 4;_BT. Nguy~n Thi Kim Ti€n (d8 b/c);_C\lCQuan y - BQQu6c phong, C\lCY t€ - BQCA;_C\lCY t6 giao thong v~n tii- BQGTVT;_T6ng C\lCHili Quan- BQHjChinh;_Bao hi8m xa hQiVi~tNam; " ~. .~~~----------_ V\l Phap ch€, C\lCQu~ 1yY DuQ'cc6 ~y~n, C\lCQuh;;!X~- .Kham, chua b~nh - BQY te; Thanh tra BQY te;~Vi~nKN thu6c TV va VKN thu6c TP.HCM;_T6ng Cong ty DuQ'cVN;_Cac b~nh vi~n, Vi~n co giuang b~nh tnrc thuQcBYT;_Website ctia C\lCQLD, T~p chi DuQ'cMy phAm- C\lCQLD;_Luu: VP, KDD, DKT (2b).

Truong QuAc CUOng

BOYTECVC QuAN LY DUQC

CONG HOA xA HOI cmr NGIllA VI$T NAMDQc l~p - TV do - Hanh phiic

DANH Ml,JC2 THUOC sAN XUAT GIA CONG DVOC cAP SO DANG KY HI$U r.trc 5 NAMBan hanh kern thea quyet dinh s6:b3.D...lQD-QLD, ngay){:..I..d/./2014

1. Cong ty dang ky: (CO'sO'di-t gia cfmg):Cfmg ty c8 phin dlfQ'Cva thi~t hi y t~ Ha Tay (Die:s6 10, Ngo 4, Ph6 x6m, Phil Ldm, Ha Dong, Thanh ph6 Ha N9i -)

1.1Nha san xuit: (co SO'nh~n gia cong): Cdng ty c8 phin dlfQ'c phim Ha Tay (Die: La Khe, HaDong, Thanhph6 Ha N9i-)

STT Ten thu6c Hoat chAtchinh -Ham hrong

Tu6i Tieu Quy eachthQ chuin dong goi S6 dang Icy

Ibatonic-Calci Calci (dum dangCalci glucoheptonat500 mg) 40,8 mg;Vitamin D2 200 IV;Vitamin e 30 mg;Vitamin PP 20 mg

Vien nangm~m

Lysin hydroclorid15 mg; Vitamin B 110 mg; Vitamin B25 mg; Vitamin B610 mg; Vitamin PP15 mg; Vitamin E 5IV; Calciglycerophosphat 10mg; Acidglycerophosphoric 5mg

Vien nangm~m

{-~,.:

"'<""'<.:

Trang I

36 TCCS H9P 2 vi, 10 vithang x 10 vien

24 TCeS H9P 12 vi x 5thang vien.H9P 2 vi x

15 vien

GC-234-14

GC-235-142 Ibatonic-F

CONG HoA ]L~«H(H CHi) NGHIA VI~T NAIV[DQc h~p - Tt,r do - H~nh phucCCC QU_4.NLY DUde

I~ 0 "'"So: t,~~ /QD-QLD Ha noi, ngaY()3 thang A1ndm 2014

leue Y TECIAOTHoVl/,[iTA1 QuvETD~NHI C{)NG V'\ N A~~C flit so dang ky luu hanh thuoc ra khoi danh muc cac thuocI f! 1. ! I duoc dip so dang ky t~i Vi¢t Namlso "'if-iS _ ,I Cl,JCT~lfONG,Cl,JC ~UAN LY Dl10C

. Can co Luat DUQ'cngay 14 thang 6 nam 2005;,1, .: /vt,w. C~n c~uNghi.?jnh s6 63~~012!N?-CP ~ga~ 31(8/2?12 cua <:_hinhphu quy

/J4j.fr, . dinh clnrc nang, nhiem Y1;1, quyen han va co cau to.chtrc cua BQY t~;.L- 'f'P//.l / Can cu Quyet dinh s6 3861/QD-BYT ngay 30/9/2013 cua BQtnrong BQY

•./i' te quy dinh chtrc nang, nhiem Y1;1, quyen han va co can t6 chrrc cua Cue Quan 1ydiroc thuoc BQY te;

Can ctr Thong ur s6 22/2009m-BYT ngay 24/11/2009 cua BQY te quydinh viec dang ky thu6c;

Can err ket luan cua HQi Dong tu van cap s6 dang ky thu6c BQY te ngay24/07/2014 dfi diroc BQY te phe duyet ve viec rut s6 dang ky d6i voi cac thu6cchua hoat chat Lysozym;

X6t de nghi cua Truemg phong Dang ky thu6c - Ct;tcQulm1y DuQ'c,

QuvETDlNHDieu 1. Rut s6 dang ky cua cac thu6c chua hOC;ltchat Lysozym ra khoi

Danh mvc cac thu6c dUQ'Ccap s6 dang ky lUll hanh tC;liVi¢t Nam (co Danh mvckern theo).

* Ly do: Theo c~p nh~t mm nhat cua Co quan Quan 1y dUQ'cphAm Phap,dUQ'Cchat Lysozym co 1¢ feh trong dieu tq kh6ng cao hon so vm nguy co dothu6e gay ra.

Dieu 2. Quyet djnh nay co hi¢u ll;tc ke tit ngay k:Y ban hanh.Dieu 3. Giam d6c SOY te cac tinh, thanh ph6 tfl!c thuQc Trung uong,

Giam d6c cae don vi kinh doanh thu6c, Giam d6c co sa dang ky va/ho~c nha sanxuat cac thu6c n~u tC;liDieu 1 chiu trach nhi¢m thi hanh Quyet djnh nay.Nui nh~n:- NhuDieu 3;- BT.Nguy~nTh!Kim Tien (de b/c);- Cl;lcQufulY - B¢ Qu6c phong, G,lcY te - B¢ COngan;- Cl,lcY te Giao tMng v~ till - B¢ Giao th6ng v~ tid; ,..,.-- T6ng CI,lCHai quan - B¢ Tai chinh, Bao hiem Xii h¢i Vi¢t N- vl,l Phap cM, CI,lCQuiin ly Y, Duqc c6 truyen, Cl;lcQuiin lychua b¢nh, Thanh tra B¢ Y te, Vi~n KN thu6c TW, Vi~nTP.HCM;- T6ng COngty Duqc Vi¢t Nam, Oic C6ng ty XNK Duqc phfun;- Cac B?nhvi¢n & Vi~n co giuang b¢nh trl!c thu¢c B¢ Y te;- Website Cl;lcQLD, T~p chi Duqc & My phfun-Cl;lcQLD;- Luu: VP, QLKDD, QLCLT, TTrD-MP, DKT(12). Truong Quoc Cubng

BOYTECl}C QUAN LV DU'QC

A ,,_ A ., - A

eONG HOA XAHOI eHU NGHIA V~T NAMDQcl~p - Tl,Ido - H~nh pluic

DANH MUC cAc THU6c NU'OC NGoAI CHUA HOAT CHAT LYSOZYM. B] RUT s6 DANG KY .

(Ban hanh kern theo Quyet dinh s6trJ.f /QD-QLD ngay ~3 thangA'1 nam 2014)

1. Cong ty dang ky: Boehringer Ingelheim International GmbH (dlc: Binger St.173,55216 Ingelheim am Rhein, Germany).1.1. Nha san xuat: Delpharm Reims (die: 10 rue Colonel Charbonneaux 51100Reims, Germany).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dang kYCetylpyridinium

1 Lysopainechloride 1,Smg; Vien ngam VN-13S1S-11Lysozyme HCI20mg

2. Cong ty dang ky: BRN science Co., Ltd. (die: 924 Wangam-dong, lecheon-si,Chungcheongbuk-do, Korea).2.1. Nha san xuat: BRN science Co., Ltd. (die: 924 Wangam-dong, lecheon-si,Chungcheongbuk-do, Korea).

STT Ten thu6c Hoat chit Dangbao ch~ S6 dang kY

2 Lysomole Lysozyme Vien nen VN-1289S-11chloride 90mg

"

3. Cong ty dang ky: Cong ty CPDP Sam rna ki (dlc: 319-A9 Ly Thuang Kiet,Phuong 15, Qudn 11, TP. H6 Chi Minh).3.1. Nha san xuat: Ahn Gook Pharmaceutical Co., Ltd. (die: 903-2, Shanghin-ri,Hyangnam-myeon, Hwaseong-si Kyunggi-do, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dang kY

3 Phatkaday tablet Lysozyme Vien nen VN-15798-12chloride 90mg

4. Cong ty dang ky: Daewon Pharmaceutical Co., Ltd. (die: 467-24, Kunja-dong,Kwangjin-gu, Seoul, Korea).4.1. Nha san xuat: Asia Pharmaceuticals Co., Ltd. (die: 439, Mogok-Dong,Pyungtack-City, Kyungki-Do, Seoul, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dang ky

1

4 Philkazyme Tab. LysozymeVien nen VN-l 0992-1 0chloride 90mg

5. Cong ty dang ky: Daewoo Pharrn. Co., Ltd. (die: 579,Shin Pyung-Dong, Saha-gu,Pusan city, Korea).5.1. Nha san xuat: Daewoo Pharrn. Co., Ltd. (dlc: 579, Shin Pyung-Dong, Saha-gu,Pusan city, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 (Ung ky

5 Peptudase Tab. Lysozyme Vien nen VN-13111-11chloride 90mg

6 L-Zymtab Lysozyme Vien nen VN-13112-11chloride 90mg

7 Wonsozym Lysozyme Vien nen VN-10212-1Ochloride 90mg

6. Cong ty dang ky: Phil International Co., Ltd. (dlc: 629-4 Yeoksam-Dong,Kangnam-Ku, Seoul, Korea).6.1. Nha san xuat: Asia Pharrn. IND. Co., Ltd. (dlc: 439, Mogok-Dong PyungtaekCity, Kyungki-Do, Korea).

STT Ten thu6c Host chit Dang bao ch~ S6 dang Icy

Dextromethorphan hydrobromide

8 Maxcom Capsule 30mg; Vien nang cirng VN-16017-12Diprophylline100mg; Lysozymchloride 20mg

7. Cong ty dang ky: Schnell Korea Pharrna Co., Ltd. (dlc: 4F, Haesung Bldg, #747-2 Yeoksam-Dong, Kangnam-Ku, Seoul, Korea).7.1. Nha san xuat: Schnell Biopharrnaceuticals, Inc (dlc: 448-2, Mongnae-dong,Danwon-gu, Ansan-si, Gyeonggi-do, Korea).

STT Ten thu6c HOft chit Dang bao ch~ S6 dang ky

9 Lozym Lysozyme Vien nen VN-16904-13chloride 90mg

8. Cong ty dang ky: Standard Chern. & Pharrn. Co., Ltd. (dlc: No. 6- 20, Tu- Kuu,Hsin- Ying, Tainan, Taiwan).8.1. Nha san xuat: Standard Chern. & Pharrn. Co., Ltd. (dlc: No. 6- 20, Tu- Ku u,Hsin- Ying, Tainan, Taiwan).

STT Ten thu6c I.. Dang bao ch~ S6 dang kyHo,t chat

2

Dextromethor-phan HBr 20mg;

Mbrtuss-DMKali VN-I0578-10

10 Cresolsulfonat Vien nang cirngCapsules 90mg;

Lysozym Clorid20mg

9. Cong ty dang ky: Suheung Capsule Co., Ltd. (dlc: 6th Floor lung-An Bldg, 435-5Jangan 3Dong, Dongdaemun-Gu, Korea).9.1. Nha san xuat: Suheung Capsule. Co., Ltd. (die: 317 - Songnae-l-Dong, SosaGu, Bucheon City, Kyunggi-do, Korea).

STT Ten thuAc :. Dang bao ch~ sAdang kyHov.tchat

Acid ascorbic,

11 Dentihylysozym chlorid, Vien nang ctrng

VN-9862-10carbazochrom,acetattocopherol

10. Cong ty dang ky: TDS Pharm. Corporation (dlc: Pyeonggok-ri, 437-6Eumseong-eup, Eumseong-gun, Chungcheongbuk-do, Korea).10.1. Nha san xuat: Chunggei Pharm Co., Ltd. (dlc: 1106-4, Daeyang-ri, Yanggammyeon, Hwaseoung-si, Gyeonggi-do, Korea).

STT Ten thu8c :. Dang bao ch~ sAdangkjHov.tchat

Lysozyme Vi~n nen12 Antisolam Tablet chloride 90mg VN-l 060 1-10

Lysozyme Vi~n nen13 Sylamzym Tablet chloride 90mg VN-5679-10

Lysozyme Vien nen14 Synlopzyme Tablet chloride 90mg VN-9874-10

10.2. Nha san xuat: KMS Pharm. Co., Ltd. (die: 492-1 Maetan-Dong, YoungtongGU, Suwon City, Gyeonggi, Korea).

STT Ten thu8c Hoat chit Dang bao ch~ sAdangky

Lysozyme Vien nen15 Lyzyso Tab. chloride 90mg VN-I1367-10

10.3. Nha san xuat: Jell Pharmaceutical Co., Ltd. (dlc: 739, Daecheon-Dong,Dalseo-Gu, Daegu, Korea).

STT Ten thu8c :. Dang bao ch~ se dang kyHoat chat

3

Lysozyme Vien nen16 Numazym tablet chloride 90mg VN-9876-10

11. Cong ty dang ky: Young II Pharm Co., Ltd. (dlc: 920-27, Bangbae-Dong,Seocho-Ku, Seoul, Korea).11.1. Nhil san xuat: Crown pharm. Co., Ltd. (dlc: 218-7, Anyang 7-Dong, MananGu, Anyang-City, Kyunggi-Do, Korea).

STT Ten thuac ~ Dang bao ch~ Sa dang kyHoat chat

Lysozyme Vien nangChloride,

17 Dent. F Capsule Carbazochrome, VN-12128-11TocopherolAcetate 50%,Acid ascorbic

11.2. Nha san xuat: Korea Prime Pharm. Co., Ltd. (die: 865-1, Dunsan-ri,Bongdong-eup, Wanju-gun, Chonbuk, Korea).

STT Ten thuac Dang bao ch~ sa dang ky

18 ZoridLysozymechloride 90mg

Vien nen VN-16427-13

Truong Quec CUOng

4

BOYTECl}C QUA.N LY DUqC

A ,,_ A ? _ A

CONG HOA XA HOI CHU NGHIA VI~T NAl\IDQc I~p - T1;fdo - H~nh phuc

DANH Ml}C cAc THUOC TRONG NUOC CHUA HO~T CHAT LYSOZYMB~ RUT SO DANG KY

/(Ban hanh kern thea Quyet dinh s6 6)f /QD-QLD ngay D3 thangAI nam 2014)

1. Cong ty dang ky: Cfing ty ce ph§n BV Pharma (ale: Xii Tan Thanh Tdy-HuyenCUChi - TP. H6 Chi Minh).1.1. Nha san xuat: Cong ty ca ph§n BV Pharma (d/c: Xa Tan Thanh Tdy-Huyen CUChi - TP. H6 Chi Minh).

STT Ten thuac Hoat chAt Dang bao chS sa dang kyLysozymhydroclorid

1 Ho superheal 20rng, Vien nen ngam VD-15959-11Cetylpyridinclorid 1,5rng

2. Cong ty dang ky: Cong ty ca ph§n Durrc Becamex (ale: Duong NA6, KCN MyPhuoc 2, B~n Cat, Binh Duong).2.1. Nha san xuat: Cong ty ca ph§n DU'Q'cBecamex (d/c: Duong NA6, KCN MyPhuac 2, B~n Cat, Binh Duong).

STT Ten thuac Hoat chAt Dang bao chS sa dang kYLysozyrn

2 Zyrnzym tab hydroclorid Vien nen bao phirn VD-12107-1O90rng

3. Cong ty dang ky: Cdng ty ca ph§n Duec phim 3/2 (ale: s6 930 C2, Duong C,KCN Cat Ldi, P. Thanh My L9'i, Q.2, TP. H6 Chi Minh).3.1. Nha san xuat: Ceng ty ca ph§n DU'Q'cphim 3/2 (d/c: s6 930 C2, Duong C,KCN Cat is; P. Thgnh My L9'i, Q.2, TP. H6 Chi Minh).

STT Ten thuAc Hoat chAt Dang bao chS sa dang ky

3 Amlyzen Lysozyme Vien nen VD-13293-10chloride 90mg

4. Cong ty dang ky: Cdng ty ca ph§n DU'Q'cphim Agimexpharm (alc: Kh6mThgnh An, P. My Th6'i, TP. Long Xuyen, An Giang).4.1. Nha san xmlt: Cong ty ca ph§n DU'Q'cphim Agimexpharm (alc: Kh6m ThgnhAn, P. My Thai, TP. Long Xuyen, An Giang).

1

STT Ten thu8c Hoat chAt Dang bao ch~ S8 dang ky

4 Agilyzym LysozymeVien nen bao phim VD-9306-09chloride 90mg

5 Aupazym Lysozyme Vien nen VD-10068-l0chloride 90mg

S. Cong ~y dang ky: Cong ty C6 phin DIfQ'cphim Bos Ton Vi~t Nam (die: S643,Duong so 8, KCN Vi?tNam - Singapore, ThudnAn, Binh Duong, VietNam).S.l. Nha ,san xuat: Cong ty C8 phin DIfQ'cphim Bos Ton Vi~t Nam (d/c: S643,Duong so 8, KCN VietNam - Singapore, Thudn An, Binh Duong, VietNam).


Lysozyme6 Lysozym Boston hydrochloride Vien nen bao phim VD-17394-l2

90mg

6. Cong ty dang ky: Cong ty C6 phin DIfQ'cphim cin Giir (die: 186-188 Le ThanhTon, P. Bin Thanh, Q.ll, TP. H6 ChiMinh).6.1. Nha san xuat: Cong ty C8 ph in DIfQ'cphim cin Giir (die: Lo B1-10, duongD2, KCN Tdy Bilc Cu Chi, TP. H6 Chi Minh). -_.---

STT Ten thu8c Ho,t chAt Dang bao ch~ S8 dang ky

Lysozym_] Tazemy .hydroclorid _. Vien nen VD-IIOOO-lO

90mg

6.2. Nha san xuat: Cong ty TNHH US Pharma USA (die: is Bl-lO, Duong D2,KCN Tdy Bilc Cu Chi, TP. H6 Chi Minh).


Cetyl pyridiniumclorid 1,5mg,

8 Sonozym lysozym Vien nen VD-l 7401-12hydroc1orid20mg

Lysozym 90- Lysozym9 hydroc1orid Vien nen VD-17286-l2

COP 90mg

7. Cong ty dang ky: Cdng ty c8 phin DIfQ'cphim cin Giir (die: Lau 2, Khu 2F-C1,Toa nha Mirae Bussiness Center, 268 ToHiin Thanh, P.15, Q.lO, TP. H6 ChiMinh).7.1. Nha SaD xuat: Cong ty TNHH US Pharma USA (die: Lo B1-10, DuOng D2,KCN Tdy Bilc Cu Chi, TP. H6 Chi Minh).

2

STT Ten thu6c Hoat chit Dang bao ch~ S6 dang ky.Lysozym

10 Tenlyso hydroclorid Vien nen VD-17898-I290mg

8. Cong ty dang ky: Cong ty C6 ph§n Duoc phim Ciru Long (die: 150 duong 1419,TP. Vlnh Long, tinh Vlnh Long).8.1. Nha san xuat: Cong ty c6 ph§n Duec phim Ciru Long (die: 150 duong 1419,TP. Vinh Long, tinh Vinh Long).

STT Ten thu6c Hoat chit Dang bao ch~ sa dang ky

11 Luxnorlux Lysozyme clorid Vien nenVD-I1004-1090mg

Prasozyme

12 (SXNQ: Korea Lysozyme clorid Vien nen VD-10I50-10Prime Pharm. Co., 90mgLtd)

9. Cong ty dang ky: Cong ty C6 ph§n Duoc phim Euvipharm (d/c: tip Binh TiJn 2,xii Due HOGhC;Z,Due HOG,Long An).9.1. Nha san xuan-Cong ty ca phin Duoc phim Euvipharm (die: tip Binh tu« 2,xii Due HOGhC;Z,Due HOG,Long An).

STT Ten thu6c Ho~t chit Dang bao ch~ sa dang kyCetylpyridinium

Cetylpyridin- chlorid 1,5 mg,13 Lysozym Vien nen ngam VD-14280-11Lysozym

hydroclorid20mgLysozym

14 Lysozym 90 mg hydroclorid Vien nen VD-12830-1090mg

10. Cong ty dang ky: Cong ty C6 ph§n Dutrc phim Glomed (d/c: 35 Dai 19 Tu do,KCN Viet Nam - Singapore, tinh Binh Du011g).10.1. Nha san xuat: Cong ty C6 ph§n Duoc phim Glomed (die: 35 Dai 19 Tu' do,KCN Vi¢t Nam - Singapore, tinh Binh DU'011g).

STT Ten thuac .f.. Dang bao ch~ Sa dang kyHo~t chat

Lysozym15 Globeta hydroclorid Vien nen VD-19348-13

90mg

3

11. Cong ty dang ky: Cdng ty ca phftn DllQ'C phim OPV (d/c: S6 27, duong 3A,Khu cong nghiep Bien HoG:2, D6ng Nai).

11.1. Nha san xuat: Cdng ty ca phftn DllQ'C phim OPV (d/c: S6 27, duong 3A, Khucong nghiep Bien HoG:2, D6ng Nai).

STT Ten thu8c J. Dang bao ch~ sA dang kyHoat chat

Lysozymhydroclorid20mg,

16 Ametuss lyso Cetylpiridin Vien ngam VD-I0291-10doridmonohydrat1,5mg

17 Bacizim Lysozym clorid Vien nen VD-l 0295-1 090mg

Lysozym clorid15mg,Carbazochrom

18 Bacizim Plus lrng, alpha Vien nang VD-l 0296-1 0tocopherol acetat17mg, acidascorbic 78mg

-....-Lysozymhydroclorid15mg,

19 Opevizyme Plus Carbazochrom Vien nang VB-l 1659-10-.----~-

lmg, alphatocopherol acetat17mg, acidascorbic 78mgLysozym

20 Opezyme hydroclorid Vien nen VD-I0321-1090mgLysozymhydroclorid20mg,cetylpyridin

21 Star lyso clorid 1,5mg Vien nen ngam VD-ll107-10(diroi dangCetylpyridincloridmonohydrat1,58mg)

12. Cong ty dang ky: Cong ty ca phftn DllQ'C phim Trung uong Vidipha (d/c: 18-Nguyln Van Tr6i-QwJ,nm« Nhu4n-Tp. H6 Chi Minh).

4

12.1. Nha san xuat: Cong ty C& ph in Duoc pham Trung irong Vidipha (die: apTan Binh, xii Tan Hi¢p, huyen Tan Uyen, tinh Binh Duong).


Lysozym22 Lysozym hydroclorid Vien nen VD-12961-10

90mg

13. Cong ty dang ky: Cdng ty C&phin Duec ph§m Trung uong Vidipha (die:18412u Van Sy, P.10, Qudn Phil Nhudn, TP. H6 Chi Minh).13.1.Nha san xuat: Chi nhanh Cdng ty C&pbin Duec pb§m Trung UO'DgVidipba(die: dp Tan Binh, xii Tan Hiep, huyen Tan Uyen, tinh Binh Duong).

STT Ten thu6c Ho~t chit Dang bao ch~ S6 dang kYLysozym

23 Lysotab tab. hydroclorid Vien nen VD-16046-1190mgLysozym

24 Dotida hydroclorid Vien nen bao phim VD-19486-1390mg

;.-~

14. Cong ty dang ky: Cong ty C&ph in DuQ'c pb§m Truong TbQ (die: 93 LinhLang, Ba Dinh, Hil N9i).14.1. Nha san xuat: Cong ty C&phin Duec pb§m Truong TbQ (die: L6 Ml duongN3, KCN Hoil Xli, Nam Dinh).

STT Ten tbu6c Hoat chit Dang bao ch~ S6 dang ky

Dextromethorphan hydrobromid30mg;

25 Codcerin-exp DiprophyllinVien nang mem

VD-11164-10100mg;Lysozymhydroclorid20mg

15. Cong ty dang ky: Cdng ty c&phin Pymepharco (d/c: 166 - 170 Nguyin Hue,Tuy tt». Phil Yen).15.1. Nha san xuat: Cong ty c&phin Pymepharco (d/c: 166- 170 Nguyin Hue, Tuyno« Phil Yen).

STT Ten thu6c D~ng bao ch~ S6 dang ky

5

26 LZ 90 - LysozymeLysozyme clorid Vien nen90mg VD-13583-10

27 SuzymeLysozyme clorid Vien nen90mg VD-16659-12

16. Cong ty dang ky: Cong ty c8 ph in SPM (die: La 51- Duong s6 2- KCN TanTqo- Q. Binh Tan- TP. H6 Chi Minh).16.1. Nha san xuat: Cong ty c8 phin SPM (die: La 51- Duong s6 2- KeN Tim TqoQ. Binh Tan- TP. H6 Chi Minh).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dang kyLysozym

28 Galezin hydroclorid Vien nen bao phim VD-17701-1290mgDextromethorphanHBr 15mg; Vien nang mem

29 Recotus light Diprophyllin VD-19614-13100mg;Lysozymhydroclorid20mg

17. Cong ty dang ky: Cong ty C8 ph in Thuong mai Duec phim Quang Minh(die: s64A La Lu, P. Truong Thqnh, Qudn 9, TP. H6 Chi Minh).17.1. Nha san xuat: Cong ty C8 phin Thuong mai Diroc phim Quang Minh (die:S6 4A£iJ-fiU;P; Tru8'ng Thqnh, Qudn 9,- T-P;-HJ-ChiMinh).

STT Ten thu6c Ho~t chit Dang bao ch~ S6 dang kyCetylpyridinClorid 1,5mg;

30 Lysobapen-F Lysozym Vien nen ngam VD-I8486-13hydroclorid 20mg

18. Cong ty dang ky: Cdng ty CP duq'c phim Khanh Hoa (die: Duong 2 thang 4,p.Vlnh ns« Nha Trang, Khanh Hoa).18.1. Nha san xuat: Ceng ty CP duq'c phim Khanh Hoa (die: Duong 2 thdng 4, p.Vinh Hoa, Nha Trang, Khanh Hoa).


31 LysozymeLysozym clorid Vien nen bao phim

VD-17178-1290mg

6

19. Cong ty dang ky: Cong ty TNHH mQt thanh vien dllQ'c phAm va sinh hoc y t@(die: 31 Nga Thai Nhiem, P. 6, Q. 3, TP. H6 Chi Minh).19.1. Nha san xuat: Cong ty TNHH mQt thanh vien dllQ'c phAm va sinh hoc y t@(die: La III - 18, diarng s6 13, Khu cong nghiep Tan Binh, Qudn Tan Phil, TP. H6 ChiMinh).

STT Ten thu6c Hoat chit Dang bao ch@ S6 dang kYLysozyme Vien nen

32 Kivizyme hydroclorid VD-18862-1390mgLysozyme Vien nen

33 Lysoflux hydroclorid VD-18552-1390mg

20. Cong ty dang ky: Cong ty TNHH Phil Inter Pharma (d/c: s6 25, Duong s6 8,Khu CN Vi~tNam-Singapore, ThudnAn, Binh Duong).20.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (die: S625, Duong s6 8,Khu CN VietNam-Singapore, ThudnAn, Binh Duong).

STT Ten thu6c HO\lt chit /.. S6 dang kYDang bao che

d-Chlorpheniraminmaleat, dl-

34 Brancopain Methylephedrin VD-9844-09hydroclorid, Cao Vien nang memBelladon,Lysozym elorid

21. Cong ty dang ky: Cong ty TNHH dllQ'c phAm USA - NIC (d/c: La lID duongC, Khu cong nghiep Tan Tao, qudn Binh Tan, TP. H6 Chi Minh).21.1. Nha san xuat: Cong ty TNHH dllQ'c phAm USA - NIC (die: La lID dutmg C,Khu cong nghiep Tan Tc;zo,qudn Binh Tan, TP. H6 Chi Minh).

STT Ten thu6c Hoat chit Dang bao ch@ S6 dang kY

35 Lysozym 90 mgLysozym Vien nenhydroelorid 90mg VD-19721-13

22. Cong ty dang ky: Cdng ty TNHH san xu it thllong m\li dU'Q'cphAm NIC (NICPharma) (dlc: La lID duang C, Khu cang nghi~p Tan Tc;zo,qugn Binh Tan, TP. H6Chi Minh).

22.1. Nhfl san xuat: Cong ty TNHH san xuit thtrong m\li dtrQ'c phAm NIC (NICPharma) (die: La lID duang C, Khu cang nghi~p Tan Tc;zo,qugn Binh Tan, TP. H6Chi Minh).

7

STT Ten thuac HO\lt chit Dang bao ch~ sa dang ky

36 Lysonic Cap Lysozym Vien nang cimg VD-l 0832-1 0hydroclorid 90mg

37 Lysonic Soft Lysozym Vien nang mem VD-10833-10hydroclorid 90mg

23. Cong ty dang ky: Cong ty TNHH SX-TM duvc phAm Thanh Nam (d/c: 60 Dai19D9C ldp, KCN Vi~tNam - Singapore, Binh Duong).23.1. Nha san xuat: Cong ty TNHH SX-TM duvc phAm Thanh Nam (die: 60 Dai19D9c ldp, KCN Vi~tNam - Singapore, Binh Duong).

STT Ten thuac Hoat chit Dang bao ch~ sa dang kY

38 LysozymLysozym Vien nen

VD-120S4-10hydroclorid 90mg

Truong Qu6c CUOng

8

Documents

BO GlAO THONG V!N TAl CQNG HOA xA HQI NGHiAVI~TNAM eve …cucytegiaothong.mt.gov.vn/Uploads/File/CV 1122 NVYD.pdf · BO GlAO THONG V!N TAl CQNG HOA xAHQI cmrNGHiAVI~TNAM eveYTE DQcl~p-Tl]'do