say T~QUANG NAM - n~E"'NNS6~··/i~~rQ. - VNRAS

sa y T~QUANG NAMA n~E"'NNS6~··/i~~r.Q..~·~·-·,- A • - A·

BO Y t£ giiy·····'C6..... . XA HOI CHU NGBIA VIET NAM. ~,-~-.- .- ...ClJC QUAN LY DUQC DQc l~p - TlJ do - H~nh phuc

S6 :4-4-J, /QD-QLD Ha noi, ngayAO thong R ruim 2015

QUYETDlNHve viec rut so dang kj, dmh chi luu hanh va thu hoi thuoc chua hoat chat

Biphenyl dimethyl dicarboxylat va thuoc chua hoat chat Cefetametdang lUllhanh t~i Vi~t Nam

~"

Cl}C TRlfONG Cl}C QUAN LY DlfOC

Can cl! Luat Diroc ngay 1/4thang 6 nam 2005;CAn c:UNghi dinh s6 63/2012/ND-CP ngay 31/8/2012 cua Chinh phu quy

dinh chirc nang.nhiem vu, quyen han va co cau t6 chtrc cua B¢ Y te;can df~Quyet dinh s6 3861/QD-BYT ngay 30/9/2013 cua B¢ tnrong B¢ Y

te quy dinh clnrc nang, nhiem vu, quyen han va co cau t6 chtrc cua Cue Quan lyDiroc thuoc B¢ Y te;

Can cU Thong nr s6 44/2014m-BYT ngay 25/11/2014 cua B¢ Y te quydinh viec dang ky thu6c;

Can cU thong tin, khuyen cao cua Co quan quan ly Diroc mot s6 mroc trenthe gioi va ket luan cua Hoi D6ng Tu Vfu cap s6 dang ky thu6c - B¢ Y te ve vi~cthu6c chua hOC;ltchat Biphenyl dimethyl dicarboxylat ho~c Bifendat va thu6cchua hOC;ltchat Cefetamet chua dap Ung duqc hi~u qua thea quy dinh hi~n hanh;

Xet de nghi cua Truemg phong Dang ky thu6c, Trubng phong Quan lychat luqng thu6c - (\Ic Quan ly Duqc, .

QUYETDlNH:

Dieu 1. Rut s6 dang ky cac thu6c chua hOC;ltchat Biphenyl dimethyldicarboxylat, thu6c chua hOC;ltchat Cefetamet co ten trong Danh m\lc cac thu6crut s6 dang ky ban hanh kern thea Quyet diM nay.

Dieu 2. Dlnh chi lUll hanh tren toan qu6c va thu h6i toan b¢ cac thu6cchua hOC;ltchat Biphenyl dimethyl dicarboxylat, thu6c chua hOC;ltchat Cefetametco ten trong Danh m\lc cac thu6c dlnh chi lUll hanh va thu h6i ban hanh kernthea Quyet dinh nay.

Dieu 3. Giao cong ty dang ky ph6i hqp v6'i nha san xuat, nha nh~p khAu,nha phAn ph6i thu6c tht;rc hi¢n thu h6i va huy toan b¢ thu6c chua hOC;ltchatBiphenyl dimethyl dicarboxylat, thu6c chua hOC;ltchat Cefetamet va bao cao ketqua ve (\Ic Quan ly Duqc thea dung quy dinh tC;liThong tu s6 09/2010m-BYTngay 28/4/2010 cua B¢ Y te hUOngdfin vi¢c quan ly chat luqng thu6c.

Sa Y te cac tinh, thanh ph6 trt;rcthu¢c Trung uong co trach nhi¢m chi dC;lOgiam sat vi¢c tht;rchi¢n cong tac thu h6i va huy cac thu6c neu tren.

Nguyễn Thị Liên:K/c BGĐ, NVY,NVD, các đơn vị điềutrị, đưa ưeb

Dieu 4. Quyet dinh nay co hieu 11!ek~ tir ngay ky ban hanh va thay th€Quyet dinh so 423/QD-QLD ngay 29/7/2015 cua Cue Quan 1y DUQ'e.

Dieu 5. Giam doc Sa Y t€ cac tinh, thanh pho tnrc thuoc Trung uong,Giam doc cac dan vi kinh doanh thuoc, Giam doc eC1sa dang ky va/hoac nha sanxuAtcac thuoc neu tai Dieu 1 chiu trach nhiem thi hanh Quyet dinh nay.

CUCTRUO~. /!

BOYTECl)C QUANLY DlfOC

'" ,,_ A ? _ '"

CONG HOA XA HOI CHU NGHIA V~T NAMDQcl~p • Tl;ldo • H~nh phuc

DANHMl)C cAc THU6c RUT 86 DANG KY(Ban harmkern theo Quyet dinh s64-4-rt /QD-QLD ngayAO thang f nam 2015)

I. ThuBc chua hoat chit Biphenyl dimethyl dicarboxylat:

1. Cong ty dang kj: Cong ty CPTM va DlfQ'C phim NgQcThi~n (die: S6 10, Ngo 3, Duong LfBon, Phuong Ngo QuyJn, TP. Vtnh Yen, Tinh Vinh Phue).1.1. Nha san xuit: Boram Pharm. Co., Ltd. (ale: 471 Moknae-Dong, Danwon-gu, Ansan-Si,Kyungki-Do, Korea). -

STT Tenlhuac H~~dchit Dang bao ch~ sa dangkj

1 Decaxy Biphenyl Dimethyl Vien nen VN-IOO13-10Dicarboxylate 25mg

2. Cdng ty dang kj: Hanbul Pharm. Co., Ltd. (die: #40-8, Banje-Ri, Wongok, Anseung-Si,Gyeonggi-Do, Korea).2.1. Nha san xuit: Korea Arlico Pharm Co., Ltd. (ale: 160-17, Hoijuk-ri, Kwanghyewon-myun,Jinchun-gun, Chungeheongbuk-do, Korea).

STT Ten thuBc Ho~t chit Dang bao ch~ sa dangkj

2 Acterox Biphenyl Dimethyl Vien nen bao phim VN-1l822-11Dicarboxylate 25mg

3. Cong ty dang ky: Daewon Pharmaceutical Co., Ltd. (dlc: 467-24, Kunja-dong, Kwangjin-gu,Seoul, Korea).3.1. Nha san xuat: Daewon Pharmaceutical Co., Ltd. (dlc: 903-1, Sangshin-ri, Hyangnam-myun,Hw k K . d K )aseong- un, cyunggt- 0, orea.

STT Ten thuac Heat chit Deng bac ch~ sa dangkj

3 Liveko Biphenyl Dimethyl Vien nen bao phim VN-13107-11Dicarboxylate 25mg

4. Cong ty dang ky: DongKwang Pharmaceutical Co., Ltd. (die: Coryo DaeyoUngak Tower, 25-5, 1-Ka, Chungmuro, Chung-gu, Seoul, Korea).4.1. Nha san xuat: Dong Kwang Pharmaceutical Co., Ltd. (die: 439-1, Mogok-dong, PyongtaekCity, kyungki-do,Korea).

STT Ten thuac Hoat chit Dang bao ch~ sa dangkj

Biphenyl Dimethyl4 Talpax Tablet Dicarboxylate Vien nen VN-IIOI8-10

25mg

5. Cong ty dang ky: Hana Pharm. Co., Ltd. (die: 301 Bando BID, 946-18, Doguk-Dong,Kangnam-Ku, Seoul, Korea).5.1. Nha san xuat: Dae Han New Pharm Co., Ltd. (ale: #904-3, Sangshin-Ri, Hyangnam-Myun,Hwasung-Si, Kyunggi-Do,Korea).

1/7

STT Ten thuac Ho~t chit Dang bao ch~ sa dang kj

Biphenyl Dimethyl5 Bindicel Dicarboxylate Vien nen VN-II068-10

25mg5.2. Nha san xuat: Hankook Korus Pharm. Co., Ltd. (die: 253-12, Kangje-Dong, Jecheon-si,Chungbuk,Korea).


Biphenyl Dimethyl6 Kodicel Capsule Dicarboxylate Vien nang cirng VN-15918-12

7,5mgBiphenyl Dimethyl

7 Vien nen Novomin Dicarboxylate Vien nen VN-12488-1125mg

6. Cong ty dang ky: II Hwa Co., Ltd. (die: 437Sutaek-dong, Guri-shi, Kyonggi-do, Korea).6.1. Nha san-xuat:--Huons, Co., Ltd. (die: 907-6, Sangshin-ri, Hyangnam-myun, Hwaseong-kun,Kyunggi-do,Korea).

STT Ten thuac Ho~t chit Dang bao ch~ sa dangky----- ------------~ '._ - ----_ -Biphenyl Dimethyl- -_._. -----------_-----_ - ------ --- ---------

8 Huparan tab. Dicarboxylate Vien nen VN-14703-1225mg

6.2. Nha san xuat: Kyung Dong Pharm. Co., Ltd. (die: 535-3, Daeyang-li, Yanggam- myun,Hwasung-city, Kyunggi-do,Korea).


Biphenyl Dimethyl9 Mactagen Tab. Dicarboxylate Vien nen VN-I0304-10

25mg

6.3. Nha san xuat: Etex Pharm Inc. (die: #649-1, Choji-Dong, Danwon-Gu, Ansan ..-Si, GyeonggiDo,Korea).

STT Ten thuac Hoat chit Dang bao ch~ s6 dangkj

Biphenyl Dimethyl10 Hucona Tab. Dicarboxylate Vien nen VN-11905-11

25mgBiphenyl Dimethyl

11 Kommakid tab. Dicarboxylate Vien nen VN-11907-1125mg

7. Cong ty dang ky: Kolon I Networks Corporation (die: 533- 2 Gasan-dong, Geumcheon- gu,Seoul, Korea).7.1. Nha san xuat: Samjin Pharm Co., Ltd. (die: 904-2, Sangsin-ri, Hyangnam-myun, HwaSungSi, Kyungki-do,Korea).

STT Teo thuac Hoat chit sa dangky

2/7

Biphenyl Dimethyl12 Peaceliva Dicarboxylate Vien nen VN-12525-11

25mg

8. Cong ty dang ky: Kukje Pharma Ind. Co., Ltd. (d/c: 513- 2, Yatab-dong, Bundang-gu,Seongnam-City, Gyeonggi-Do, Korea).8.1.Nha san xuat: HutecsKorea PharmaceuticalCo.,Ltd. (d/c: 552-2 Young Cheun Ri, Dong tanMyen, Hwa Sung Shi, Kyeng Ki Do,Korea).

STT Ten thuac Do,t chit Dangbao ch~ sa dangkY

Biphenyl Dimethyl13 Kei-hepa Dicarboxylate Vien nang VN-11928-11- 7,5mg

9. Cong ty dang ky: Kyongbo Pharmaceutical Co., Ltd. (d/c: 345-6 Silok-Dong, Asan-si,Chungcheongnam-do 336- 020, Korea).9.1. Nha san xuat: Theragen Etex Co. Ltd. (d/c: #649-1, Choji-Dong, Danwon-Gu, Ansan-Si,Gyeonggi-Do,Korea).

STT Ten thuac Do,t chit Dangba« ch~ sa dangkY

Biphenyl Dimethyl14 Hepasilyn capsule Dicarboxylate Vien nang cimg VN-12540-11

7,5mg

10..Cong ty dang ky: Pharmix Corporation (d/c: 1304, Garak ID Tower, 99-7, Garak-dong,Songpa-gu, Seoul, Korea).10.1.Nha san xuat: Theragen Etex Co. Ltd. (d/c: #649-1, Choji-Dong, Danwon-Gu, Ansan-Si,Gyeonggi-Do,Korea).


Biphenyl Dimethyl15 Fomintab Tab. Dicarboxylate Vien nen VN-13305-11

25mg

10.2.Nha san xuat: Kyung Dong Pharm. Co., Ltd. (d/c: 535-3, Daeyang-li, Yanggam- myun,Hwasung-city, Kyunggi-do,Korea).

STT Ten thuac Hoat chit Dangba~ch~ sa dangkY

Biphenyl Dimethyl16 Hebidy Dicarboxylate Vien nen VN-11244-1O

25mg

10.3.Nha san xuat: Sky New Pharm. Co., Ltd. (d/c: 1234-3 Jeongwang-dong, Siheung-si,Gyeonggi-do,Korea).


Biphenyl Dimethyl17 Gadilat Dicarboxylate Vien nen VN-15571-12

25mg

3/7

10.4. Nha san xuat: Union Korea Pharm. Co., Ltd. (d/c: 5-9, Bangye-ri, Moonmak-eup, Wonju-si,Gangwondo, Korea).

STT Ten thu6c Ho~tchit Dang bao ch~ S6 dang kY

Biphenyl Dimethyl18 Bidalic Dicarboxylate Vien nen VN-13825-11

25mg

11. Cong ty dang ky: Phil International Co., Ltd. (dlc: 629-4 Yeoksam-Dong, Kangnam-Ku,Seoul, Korea).

11.1. Nha san xuat: Samchundang Pharmaceutical Co., Ltd. (d/c: 904-1 Sangshin-Ri, Hyangnam- Myun, Hwaseong-Gyeonggi-Do.Koreay.

~-

STT Ten thu6c Ho~tchit Dang bao ch~ S6 dangkY

Biphenyl Dimethyl19 Philkanema Tab Dicarboxylate Vien nen bao phim VN-13835-11

25mg

12. Cong ty dang ky: Schnell Korea Pharma Co., Ltd. (d/c: 4F, Haesung Bldg #747-2 Yeoksamdong, Kangnam-ku, Seoul, Korea).

12.1. Nha san xuat: Sky New Pharm. Co., Ltd. (d/c: 418-21 Daeya-dong, Siheung-si, Gyeonggi_~__!!o,Korea).- .. - - -

STT Ten thu6c Hoat chit Dgng bao ch~ S6 dangkY

Biphenyl Dimethyl20 Skadia Dicarboxylate Vien nen VN-I0567-10

25mg

13. Cong ty dang ky: Cdng ty c6 phAn dllQ'c Danapha (d/c: 253 Dung Si Thanh Khe, TP. DaNfmg).

13.1. Nha san xuat: Cdng ty c6 phAn dUQ'cDanapha (d/c: 253 DUng Si Thanh Khe, TP. Da Nang).

STT Ten thu6c Ho~t chit Dang bao ch~ S6 dangky

Biphenyl Dimethyl21 Hexyltab Dicarboxylate Vien nen VD-15331-11

25mg

14. Cong ty dang ky: Cdng ty C6 phAn DllQ'cphim Bos Ton Vi~t Nam (d/c: S643, Duong s6 8,KCN Vi?! Nam - Singapore, Thudn An, Binh Duong, Vi?t Nam).

14.1. Nha san xuat: Cong ty C6 phAn DllQ'cphim Bos Ton Vi~t Nam (ale: S643, Duimg s6 8,KCN Vi?t Nam - Singapore, Thugn An, Binh Ducrng, Vi?t Nam).

STT Ten thu6c Ho~t chit D~ng bao ch~ S6 dang ky

22 Timihepatic Biphenyl dimethyl Vien nen bao phim VD-14259-11dicarboxylat 25mg

15. Cong ty dang ky: Cong ty TNHH US Pharma USA (ale: L6 B1-10, auimg D2, KCN Tay BdcCli Chi, TP. H6 Chi Minh).

15.1. Nha san xuat: Cong ty TNHH US Pharma USA (ale: L6 B1-10, auimg D2, KCN Tay B6cCli Chi, TP. H6 Chi Minh). .

4/7

STT Ten thuac Ho~t chit Dang bao ch~ sa ding kY

23 Cadimetyl Biphenyl dimethyl Vien nen VD-14948-11dicarboxylat 25mg

16. Cong ty dang ky: Cdng ty c6 phin DllVc phim Phuong Dong (d/c: La s6 7, duong s6 2, KCNTan Tt;lo,P. Tan Tt;loA, Q. Binh Tan, TP.H6 Chi Minh).16.1. Nha san xuat: Cdng ty c6 phin DllVc phim Phuong Dong (d/c: La s6 7, duang s6 2, KCNTan Tt;lo,P. Tan Tt;loA, Q. Binh Tan, TP.H6 Chi Minh).

STT Ten thuac Ho~ltchit Dang bao ch~ sa ding kY

24 Fumethy 25mg Biphenyl dimethyl Vien nen dai bao VD-11671-10dicarboxylat 25mg phim

17. Cong ty dang ky: Cdng ty c6 ph in dllVC phim Vinh Phuc (d/c: 86 777 duimg Me LinhP.Khai Quang- TP. V'inhYen- Tinh V'inhPMc).17.1. Nha san xuat: Cdng ty c6 phin dllVc phim Vinh Phuc (d/c: 86 777 duong Me Linh-P.KhaiQuang- TP. V'inhYen- Tinh V'inhPMc).

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

25 Siganex Biphenyl dimethyl Vien nen bao phim VD-15665-11dicarboxylat 25mg

18. Cong ty dang ky: Cdng ty c6 phin san xuit - thirong mai DllVc phim Dong Nam (d/c: La2A, Duong s6 lA, KCN Tan Tt;lo,Q. Binh Tan, TP. H6 Chi Minh).18.1. Nha san xuat: Cdng ty c6 ph in san xuit - thirong mai DllVCphim Dong Nam (die: La 2A,Duimg s6 lA, KCN Tan Tt;lo,Q. Binh Tan, TP.H6 Chi Minh). .

STT Ten thuac HO\lt chit D\lng bao ch~ sa ding kYBiphenyl Dimethyl

26 Dothoprim 7,5 mg Dicarboxylat 7,5 Vien nang ctmg VD-19123-13mg

19. Cong ty dang ky: Cong ty DllVcTrung llong 3 (t1Ic:115-Nga Gia T1!- Da Nlmg).19.1. Nha san xuat: Cong ty DllVcTrung llong 3 (die: 115-Nga Gia T1!- Da Ndng).

STT Ten thuac HO\ltchit D~ng bao ch~ sa ding kYBiphenyl Dimethyl

27 Ceteco Foratec Dicarboxylat 7,5 Vien nang ctmg VD-12593-10mg

20. Cong ty dang ky: Cong ty TNHH dllVc phim D\lt Vi Phu (t1Ic:La M7A-CN, Duimg D17,KCN MyPhuac, tinh Binh Duang).20.1. Nha san xuat: Cong ty TNHH dU'Vcphim »,t Vi Pho. (t1Ic:La M7A-CN, Duimg D17. KeNMy Phuac, tinh Binh Duang).

STT Ten thuac J. D\lng bao ch~ Sa dingkYHotlt chat

28 Esseil Biphenyl dimethyl Vit~nnen dai bao VD-13650-10dicarboxylat 25mg phim

5(7

29 Maxkei Biphenyl dimethyl Vien nen dill bao VD-14586-11dicarboxylat 25mg phim

21. Cong ty dang ky: Cong ty TNHH Phil Inter Pharma (ale: s6 25, Duong s6 8, Khu CN Vi?tNam-Singapore, Thudn An, Binh Duong).21.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (ale: S625, Duong s68, Khu CN Vi?tNam-Singapore, Thudn An, Binh DU07lg).

STT Ten thuac HO\lt chit Dang bao ch~ SaaangIcy~/

30 Philcell Biphenyl dimethyl Vien nang mem VD-19216-13dicarboxylat 3mg

22. Cong ty dang ky: Cong ty TNHH san xuit thuong m\li dllQ'cphftm NIC (NIC Pharma) (ale:is lID dutrng C, Khu cong nghi?p Tan Tr;lO,qudn Binh Tan, tp. H6 Chi Minh).22.1. Nha san xuat: Cong ty TNHH san xuit thunng mai dllQ'cphftm NIC (NIC Pharma) (ale:is lID duimg C, Khu cong nghiep Tan Tgo, qudn Binh Tan, tp. H6 Chi Minh).

STT Ten thuac HO\lt chit Dang bao ch~ Sa_dangky

Biphenyl dimethyl31 Fortdex dicarboxylate Vien nen VD-12671-10

25mg

23. Ceng ty dang ky: Cdng ty c8 phAn cong ngh~ sinh hec dllQ'cphftm ICA (ale: Lo 10, Duongs65, KCN Vi?tNam - Singapore, Thudn An, tinh Binh Du07lg).23.1. Nha san xuat: Cong ty c8 phAn cong ngh~ sinh hec dllQ'cphftm ICA (ale: Lo 10, Duong s65, KCN Vi?tNam - Singapore, Thudn An, tinh Binh DU07lg).

STT Ten thuac J. Dang bao ch~ sa dang IcyHoat chat

32 Fortec Biphenyl dimethyl Vien nen VD-15314-11dicarboxylat 25mg

33 Forgentec Biphenyl dimethyl Viennen VD-16471-12dicarboxylat 25mg

24. C6ng ty dang ky: Cong ty TNHH Phil Inter Pharma (ale: s6 25, f)uang s6 8, Khu CN Vi?tNam-Singapore, Thu,JnAn, Binh Du07lg).24.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (ale: S625, f)uang s6 8, Khu CN Vi?tNam-Singapore, Thu,JnAn, Binh Du07lg).

STT Ten thuac HOftchit Dfngbao ch~ sa dang Icy

~, Biphenyl dimethyl Vien nang m~m34 Omitan >

dicarboxylat 3mg VD-16445-12

25. C6ng ty dang ky: CO~~ty cAphAn dllQ'cv~t tll Yt~ Hai Dllong (ale: 102 Chi Lang, thimh ph6Hili Du07lg). - - _

25.1. Nha san xuat: Cong ty c8 phAn dllQ'cv~t tll y t~ Hai Dllong (ale: 102 Chi Lang, thimh ph6Hai Du07lg).

STT Ten thuac Dfng bao ch~ sa dangky

6/7

35. Civacell Biphenyl dimethyl Vien nang mem VD-17079-12dicarboxylat 3mg

II. Thu8c chua hoat chit Cefetamet:

26. Cdng ty (Ung kj:Alembic Ltd. (d/c: Alembic Road Vadodara 390003, Gujarat State, India).26 I...1. Nha san xuat: Alembic Ltd. (d/c: Alembic Road Vadodara 390003, Gujarat State, India).

STT Ten thuac Ho~ltch§t Dang bao ch~ Sa clangkj

36 Altamet 250 Cefetamet Pivoxil Vien nen bao phim VN-15191-12Hydrochloride 250mg

27. Cdng ty clangkj:Cdng ty TNHH Nhan Sinh (dlc: DB 29 ss« Cat, P.14, Q. Tan Binh, TP. H6Chi Minh).27.1. Nha san xuit: Cdng ty TNHH US Pharma USA (tile: is BI-IO, duimg D2, KCN Tay B6cCu ', Chi, TP. us Chi Minh.

STT Ten thuac Ho~t chit Dang bao ch~ sa clang ky

37 Areplex Cefetamet Pivoxil Vien nen bao phim VD-15733-11Hydrochlorid 500mg

38 Areplex 250 Cefetamet Pivoxil Vien nen bao phim VD-16222-12Hydrochlorid 250mg

28. Cong ty dang ky: Cdng ty c8 ph§n xuit nh~p khAu y t~ Domesco (tile: 66-Qu6c 19 30-P. MyPhu-Thi xCiCao Lanh-Tinh D6ng Thdp).28.1. Nha sim xuat: Cdng ty c8 phin xuit nh~p khAu y t~ Domesco (d/c: 66-Qu6c 19 30-P. MyPh 'u-Thi xCiCao Ldnh-Tinh Dong Thdp).

STT Ten thuac Ho~t chit Dang bao ch~ sa clangkj

39 Cetamet Cefetamet pivoxil Vien nen delibao VD-11903-10250mg hydroclorid 250mg phim

40 Cetamet Cefetamet pivoxil Vien nen delibao VD-11904-10500mg hydroclorid 500mg phim

CUCTRlJ6~

Truong Qu6c CUOng

BQYTECl,IC QUAN LY DlfOC

CONGHoA xx. HOI CHUNGHIA V~T NAMI>Qc l~p - Tl_l do - H~nh plnic

DANH MUC cAc TRUOC DINH CHi LUU HANH vA TRU HOI(Ban harm kern thee Quyet dinh s6 -4t2/QD-QLD ngay _,{O thang f nam 2015)

I. Thuac di duClccip sa dang kY 11fUhanh:

I.A. Thuac chua hoat chit Biphenyl dimethyl dicarboxylat:I. Cong ty dang kj: Cong ty CPTM va DllQ'CphAmNgQcThifn (d/c: s6 10, Ngo 3, Duong LfBon, Phuong Ngo Quydn, TP. Vinh Yen, Tinh VinhPhuc).1.1. Nha san xuit: Boram Pharm. Co., Ltd. (d/c: 471 Moknae-Dong, Danwon-gu, Ansan-Si,Kyu ki D lG )n~J - 0, orea.

STT Ten thu6c HO\ltchit Dang bao ch~ S6 dangkj

1 Decaxy Biphenyl Dimethyl Vien nen VN-IOO13-10Dicarboxylate 25mg

2. Cong ty dang kj: Hanbul Pharm. Co., Ltd. (d/c: #40-8, Banje-Ri, Wongok, Anseung-Si,Gyeonggi-Do, Korea).2.1. Nha san xuit: Korea Arlico Pharm Co., Ltd. (die: 160-17, Hoijuk-ri, Kwanghyewon-myun,Jinchun-gun, Chungcheongbuk-do, Korea).

STT Ten thu6c HO\ltchit D\lngbao ch~ S6 dangkj

2 Acterox Biphenyl Dimethyl Vien nen bao phim VN-1l822-11Dicarboxylate 25mg

3. Cong ty dang ky: Daewon Pharmaceutical Co., Ltd. (die: 467-24, Kunja-dong, Kwangjin-gu,Seoul, Korea).3.1.Nha san xuat: Daewon Pharmaceutical Co., Ltd. (die: 903-1, Sangshin-ri, Hyangnam-myun,Hw k K . d K )aseong - un, .yunggt- 0, orea.

STT Ten thu6c Heat chit Dang bao ch~ S6 dangkj

3 Liveko Biphenyl Dimethyl Vien nen bao phim VN-13107-11Dicarboxylate 25mg

4. Cong ty dang ky: Dong Kwang Pharmaceutical Co., Ltd. (die: Coryo DaeyoUngak Tower,25-5, 1-Ka, Chungmuro, Chung-gu, Seoul, Korea).4.1. Nha san xuat: DongKwang Pharmaceutical Co., Ltd. (die: 439-1, Mogok-dong, PyongtaekCity, kyungki-do,Korea).

STT Ten thu6c J. Dang bao ch~ S6 dangkjHoat chat

Biphenyl Dimethyl4 Talpax Tablet Dicarboxylate Viennen VN-II018-10

25mg

5. Cong ty dang ky: Hana Pharm. Co., Ltd. (die: 301 Bando BID, 946-18, Doguk-Dong,Kangnam-Ku, Seoul, Korea).

1/19

5.1. Nha san xuat: Dae Han NewPharm Co., Ltd. (d/c: #904-3, Sangshin-Ri, Hyangnam-Myun,Hwasung-Si, Kyunggi-Do,Korea).

STT Ten thu6c Ho~ltchit Dang bao ch~ S6 dang kY

Biphenyl Dimethyl5 Bindicel Dicarboxylate Vien nen VN-II068-10

25mg5.2. Nha san xuat: Hankook Korus Pharm. Co., Ltd. (die: 253-12, Kangje-Dong, Jecheon-si,Chungbuk,Korea).

STT Ten thu6c Hogt chit Dang bao ch~ S6 dangkY

Biphenyl Dimethyl6 Kodicel Capsule Dicarboxylate Vien nang cimg VN-15918-12

7,5mgBiphenyl Dimethyl

7 Vien nen Novomin Dicarboxylate Vien nen VN-12488-1125mg

6. Cong ty dang ky: II Hwa Co., Ltd. (d/c: 437Sutaek-dong, Guri-shi, Kyonggi-do, Korea).6.1. Nha san xuat: Huons. Co., Ltd. (d/c: 907-6, Sangshin-ri, Hyangnam-myun, Hwaseong-kun,Kyunggi-do,Korea).

STT Ten thu6c J. Dang bao ch~ S6 dangkYHoat chat

Biphenyl Dimethyl8 Huparan tab. Dicarboxylate Vien nen VN-14703-12

25mg

6.2. Nha san xuat: Kyung Dong Pharm. Co., Ltd. (d/c: 535-3, Daeyang-li, Yanggam- myun,Hwasung-city, Kyunggi-do,Korea).

STT Ten thu6c HO\ltchit Dgng bao ch~ S6 dang kY

Biphenyl Dimethyl9 Mactagen Tab. Dicarboxylate Vien nen VN-I0304-10

25mg

6.3. Nha san xuat: Etex Pharm Inc. (die: #649-1, Choji-Dong, Danwon-Gu, Ansan-Si, GyeonggiDo,Korea).

STT Ten thu6c HO\ltchit Dang bao ch~ S6 dangkY

Biphenyl Dimethyl10 Hucona Tab. Dicarboxylate Vien nen VN-11905-11


11 Kommakid tab. Dicarboxylate Vien nen VN-11907-1125mg·

7. Cong ty dang ky: Kolon I Networks Corporation (die: 533- 2 Gasan-dong, Geumcheon- gu,Seoul, Korea).

7.1. Nha san xuat: Samjin Pharm Co.., Ltd. (die: 904-2, Sangsin-ri, Hyangnam-myun, HwaSungSi, Kyungki-do,Korea).

2/19

< " . "

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

12 Peaceliva Dicarboxylate Vien nen VN-12525-1125mg

8. Cong ty dang ky: Kukje Pharma Ind. Co., Ltd. (die: 513- 2, Yatab-dong, Bundang-gu,Seongnam-City, Gyeonggi-Do, Korea).8.1. Nha san xuat: Hutecs Korea Pharmaceutical Co., Ltd. (die: 552-2 Young Cheun Ri, Dongtan Myen, Hwa Sung Shi, Kyeng Ki Do,Korea).

STT Ten thu6c Ho~t chit Dgng bao ch~ S6 dangkj

Biphenyl Dimethyl13 Kei-hepa Dicarboxylate Vien nang VN-11928-11

7,5mg

9. Cong ty dang ky: Kyongbo Pharmaceutical Co., Ltd. (d/c: 345-6 Silok-Dong, Asan-si,Chungcheongnam-do 336- 020, Korea).9.1. Nha san xuat: Theragen Etex Co. Ltd. (die: #649-1, Choji-Dong, Danwon-Gu, Ansan-Si,Gyeonggi-Do,Korea).

STT Ten thu6c Heat chit Dang bao ch~ S6 dangkj

Biphenyl Dimethyl14 Hepasilyn capsule Dicarboxylate Vien nang cimg VN-12540-11

7,5mg

10. Cong ty dang ky: Pharmix Corporation (d/c: 1304, Garak ID Tower, 99-7, Garak-dong,Songpa-gu, Seoul, Korea).10.1. Nha san xuat: Theragen Etex Co. Ltd. (tile: #649-1, Choji-Dong, Danwon-Gu, Ansan-Si,Gyeonggi-Do,Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dangkj

Biphenyl Dimethyl15 Fomintab Tab. Dicarboxylate Vien nen VN-13305-11

25mg

10.2. Nha san xuat: Kyung Dong Pharm. Co., Ltd. (tile: 535-3, Daeyang-li, Yanggam- myun,Hwasung-city, Kyunggi-do,Korea).

STT Ten thu6c Ho~t chit Dang bao ch~ S6 dangkj

Biphenyl Dimethyl16 Hebidy Dicarboxylate Vien nen VN-11244-10

25mg

10.3. Nha san xuat: Sky New Pharm. Co., Ltd. (d/c: 1234-3 Jeongwang-dong, Siheung-si,Gyeonggi-do,Korea).

STT Ten thu6c Ho~t chdt Dang bao ch~ S6 dangkj

3/19

Biphenyl Dimethyl17 Gadilat Dicarboxylate Vien nen VN-15571-12

25mg

10.4. Nha san xuat: Union Korea Pharm. Co., Ltd. (d/c: 5-9, Bangye-ri, Moonmak-eup, Wonjusi, Gangwondo,Korea).

STT Ten thu6c Botttchit Dang bao ch~ S6 dangkj

Biphenyl Dimethyl18 Bidalic Dicarboxylate Vien nen VN-13825-11

25mg-

11. Cong ty dang ky: Phil International Co., Ltd. (d/c: 629-4 Yeoksam-Dong, Kangnam-Ku,Seoul, Korea).11.1. Nha san xuat: Samchundang Pharmaceutical Co., Ltd. (d/c: 904-1 Sangshin-Ri,Hyangnam - Myun, Hwaseong-Gyeonggi-Do.Koreay.

STT Ten thu6c Hoat chit nttng-bao ch~ sa dangky

Biphenyl Dimethyl19 Philkanema Tab Dicarboxylate Vien nen bao phim VN-13835-11

25mg-- _ ..

12. Cong ty dang ky: Schnell Korea Pharma Co., Ltd. (d/c: 4F, Haesung Bldg #747-2 Yeoksamdong, Kangnam-ku, Seoul, Korea).12.1. Nha san xuat: Sky New Pharm. Co., Ltd. (d/c: 418-21 Daeya-dong, Siheung-si, Gyeonggido, Korea).

STT Ten thu6c Bottt chit Dang bao ch~ sa dangkj

Biphenyl Dimethyl20 Skadia Dicarboxylate Vien nen VN-I0567-10

25mg

13. Cong ty dang ky: Cfing ty c6 phAn dUf}"cDanapha (d/c: 253 Dung Si Thanh Khe, TP. DaNdng).13.1. Nha san xuat: Cdng ty c6 phAn dUf}"cDanapha (die: 253 Dung Si Thanh Khe, TP. DaNdng).

STT Ten thu6c Bottt chit Dang bao ch~ S6 dangky

Biphenyl Dimethyl21 Hexyltab Dicarboxylate Vien nen VD-15331-11

25mg

14. C6ng ty dang ky: Cong ty C6 phAn DUf}"cphim Bos Ton Vi~t Nam (die: S643, Duong s6 8,KCN Vi~tNam - Singapore, Thudn An, Binh Duong, Vi~tNam).14.1. Nha san xuat: Cdng ty C6 phAn DUf}"cphim Bos Ton Vi~t Nam (die: S643, Duong s6 8,KCN VietNam - Singapore, Thuan An, Binh Duang, Viet Nam).

STT Ten thu6c Dttng bao ch~ S6 dang ky

4/19

22 Timihepatic Biphenyl dimethyl Vien nen bao phim VD-14259-11dicarboxylat 25mg

15. Cong ty dang ky: Cdng ty TNHH US Pharma USA (die: L6 B1-10, duong D2, KCNTay Biicca Chi, TP.H6 Chi Minh).15.1. Nha san xuat: Cdng ty TNHH US Pharma USA (d/c: L6 B1-10, duirng D2, KCN Tay BiicCu Chi, TP. H6 Chi Minh).

STT Ten thuac HOI...t chit Dang bao ch~ sa dangkY

23 Cadimetyl Biphenyl dimethyl Vien nen VD-14948-11dicarboxylat 25mg-

16. Cong ty dang ky: Cdng ty c6 phin DU'9'cphim Phuong Dong (d/c: L6 sa 7, duirng sa 2,KCN Tan Tr,zo,P. Tan Tr,zoA, Q. Binh Tan, TP. H6 Chi Minh).16.1. Nha san xuat: Cong ty c6 phin DU'9'cphim Phmrng Dong (d/c: L6 sa 7, duong sa 2, KCNTan te« P. Tan Tr,zoA, Q. Binh Tan, TP. H6 Chi Minh).

STT Ten thuac Hoat chit Dang bao ch~ sa dangkY

24 Fumethy 25mg Biphenyl dimethyl Vien nen dai bao VD-11671-10dicarboxylat 25mg phim

17. Ceng ty dang ky: Cdng ty c6 phin dU'9'cphim Vinh Phuc (d/c: sa 777 duong Me LinhP.Khai Quang- TP. Vinh Yen- Tinh Vinh PMc).17.1. Nha san xuat: Cong ty c6 phin dllf}'cphim Vinh Phue (d/c: sa 777 duang Me Linh-P.KhaiQuang- TP. Vinh Yen- Tinh Vinh Phuc).

STT Ten thuac Host chit Dgng bito ch~ sa dangkY

25 Siganex Biphenyl dimethyl Vien nen bao phim VD-15665-11dicarboxylat 25mg

18. Cong ty dang ky: Cdng ty c6 phin san xuit - thuoug mai Dll9'c phim Dong Nam (dlc: L62A, Duirng sa lA, KCN Tan Tr,zo,Q. Binh Tan, TP.H6 Chi Minh).18.1. Nha san xuat: Cong ty c6 plliu san xuit - thllong m\li DU'9'cphim Dong Nam (dlc: L62A, Duirng sa lA, KCN Tan Tr,zo,Q. Binh Tan, TP.H6 Chi Minh).

STT Ten thuac I. D\lng bito ch~ Sa dangkYHO\lt chat

Biphenyl Dimethyl26 Dothoprim 7,5 mg Dicarboxylat 7,5 Vien nang c(mg VD-19123-13

mg

19. Cong ty dang ky: Cong ty DU'9'cTrung U'ong3 (dlc: 115 - Ng6 Gia T1,l- Dil NJng).19.1. Nha san xuat: Cong ty DU'O'cTrung U'ong3 (dlc: 115 - Ng6 Gia T1,l- Dil NJng) ..

STT Ten thuac I. D\lng bito ch~ sa dingkYHO\lt chat

Biphenyl Dimethyl27 Ceteco Foratec Dicarboxylat 7,5 Vien nang c(mg VD-12593-10

mg

5/19

20. Cong ty dang ky: Cong ty TNHH dllVc phAm aft Vi Phu (d/c: L6 M7A-CN, Duong D17,KCN My Phuac, tinh Binh Du071g).20.1. Nha san xuat: Cong ty TNHH dllVc phAm »ft Vi Phu (d/c: L6 M7A-CN, Duong D17,KCN My Phutrc, tinh Binh Du071g).

STT Ten thu6c HOft chftt Dang bao ch~ S6 dangkY

28 Esseil Biphenyl dimethyl Vien nen dai bao VD-13650-10dicarboxylat 25mg phim

29 Maxkei Biphenyl dimethyl Vien nen dai bao VD-14586-11dicarboxylat 25mg phim

21. Cong ty dang ky: Cong ty TNHH Phil Inter Pharma (d/c: S625, Duong s6 8, Khu CN Vie:Nam-Singapore, Thudn An, Binh Ducrng).21.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (d/c: S625, Duong s6 8, Khu CN n«Nam-Singapore, Thudn An, Binh Ducrng).

STT Ten thu6c .{. Dang bao ch~ S6 dingkYHoat chat~-

30 Philcell Biphenyl dimethylVien nang m6m VD-19216-13dicarboxylat 3mg

22. Cong ty dang ky: Cong ty TNHI! san_!_1!~!_!hllO'Dgm,i <!1!'9'c_phAm_NIC!N:I~ P!tarma)_ (Jic: L6-1TI5Jil1!ng e,-Khu c6ngnghi~p Tan Tgo, qudn Binh Tan, tp. H6 Chi Minh).

22.1. Nha san xuat: Cong ty TNHH san xuftt thmmg mai dllVc phAm NIC (NIC Pharma) (die:L6 11D duimg C, Khu c6ng nghiep Tan Tao, qudn Binh Tan, tp. H6 Chi Minh).

STT Ten thu6c Hoat chftt Dang bao ch~ S6 dangkY

Biphenyl dimethyl31 Fortdex dicarboxylate Vien nen VD-12671-10

25mg

23. Cong ty dang ky: Cong ty c8 ph in cong ngh~ sinh hQcdllVc phAm ICA (die: L6 10, [)uimgs65, KCN Vi~tNam - Singapore, Thu~n An, tinh Binh DU071g).23.1. Nha san xuat: Cong ty c8 phin cong ngh~ sinh hQcdllVc phAm ICA (iJ/c:L6 -10,[)uimg s65, KCN Viet Nam - Singapore, Thuan An, tinh Binh Du071g).

STT Ten thu6c .{.D\lng bao ch~ S6 ding kYHO\lt chat

32 Fortec Biphenyl dimethyl Viennen VD-15314-11dicarboxylat 25mg

33 Forgentec Biphenyl dimethyl Viennen VD-16471-12dicarboxylat 25mg

24. Cong ty dang ky: Cong ty TNHH Phil Inter Pharma (iJ/c:s6 25,[)uimg s6 8,Khu CN Vi~tNam-Singapore, Thu~nAn, Binh Du071g).24.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (die: S625, [)uimg s6 8, Khu CN Vi~tNam-Singapore, Thuan An, Binh DU071g).

STT Ten thu6c HO\lt chftt D\lng bao ch~ S6 ding ky

34 Omitan Biphenyl dimethyl Vien nang m6m VD-16445-12dicarboxylat 3mg

6/19

< " , " . "

25.,C6ng ty dang ky: Cdng ty c&phdn dllQ'cv~t nr Y t~ Hal Duong (die: 102 Chi Lang, thanhpho Hili Duong).25.1. Nha san xuat: Cong ty c&phdn dllQ'cv,t nr Y t~ Hai Duong (die: 102 Chi Lang, thanh ph6Hili Duong).

STT Ten thu6c J. Dang bao ch~ S6 dangkYHoat chat

35 Civacell Biphenyl dimethyl Vien nang m€m VD-17079-12dicarboxylat 3mg

26. Cong ty dang ky: Boram Pharma Co., Ltd. (die: 471 Moknae-Dong.Danwon-gu, Ansan-Si,Kyungki-Do, Korea).26.1. Nha san xuat: Korea Prime Ph arm. Co., Ltd. (die: 616-3, Eungyo-ri, Iso-Myon, Wanjugun, Chonbuk, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dangkY

Biphenyl Dimethyl36 Hepahele Dicarboxylate Vien nen bao phim VN-5866-08

25mg

26.2. Nha san xuat: Korea Arlico Pharm. Co., Ltd. (die: 160-17, Whoijuk-ri, Gwanghyewonmyeon, Jineheon-gun, Chung eheongbuk-do, Korea).

STT Ten thu6c J. Dang bso ch~ S6 dangkyHost chat

Biphenyl Dimethyl37 Lefodine Tablet Dicarboxylate Vien nen bao phim VN-7994-09

25mg

27. Cong ty dang ky: Cdng ty TNHH dllQ'cph§m Dang Tam (die: 47 duimg s6 2, cu xil Lit Gia,Ph. 15, Q. 11, TP. H6 Chi Minh).27.1. Nha san xuat: Korea Arlico Pharm. Co., Ltd. (die: 160-17, Whoijuk-ri, Gwanghyewonmyeon, Jincheon-gun, Chung eheongbuk-do, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dangkY".

Biphenyl Dimethyl38 Activer Dicarboxylate Vien nen VN-6521-08

25mg

28. Cong ty dang ky: Cdng ty TNHH DllQ'cph§m Ti~n Minh (die: 136 Su Van Hanh (n6i dai),Qu~n 10, TP. H6 Chi Minh).28.1. Nha san xuat: Young Poong Pharma. Co., Ltd. (die: 621-9, Namehon-Dong, Namdong-Ku,Inchon City, Korea).

STT Ten thu6c HOft chit Dang bao ch~ S6 dangkY

Biphenyl Dimethyl39 Timihepatic Dicarboxylate Vien nen bao phim VN-7040-08

25mg

29. C6ng ty dang ky: Cong ty TNHH Thien Thanh (die: S61 - E4, Khu Btii than VQng,PhuimgfJ6ng Tam, QWJnHai Bil Trung, Hil N6i).

7/19

29.1. Nha san xuat: Hutecs Korea Pharmaceutical Co., Ltd. (d/c: 555-2 Youngcheun ri, Dongtan myen, HwasungShi, Kyeungki-do, Korea).

STT Ten thu6c Ho,tchit Dang bao ch~ S6 dingky

Biphenyl Dimethyl40 Bipheran capsule Dicarboxylate Vien nang VN-4871-07

75mg

30. Cong ty dang ky: Dae Hwa Pharm Co., Ltd. (d/c: 308-Masan-Ri, Hoengseong-Eup,Hoengseong-Gun, Gangwon-Do, Korea).

30.1. Nha san xmlt: Dae Hwa Pharm Co., Ltd. (d/c: 308-Masan-Ri, Hoengseong-Eup,- Hoengseong-Gun, Gangwon-Do, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 ding kYBiphenyl Dimethyl

41 Daehwabidica Dicarboxylate Vien nen VN-8144-0925mg

31.Ceng ty dang ky: DaewooPharm. Co.,Ltd. (ale: 579, Shinpyung-Dong, Pusan-City, Korea).31.1. Nha san xmlt: DaewooPharm. Co.,Ltd. (dlc: 579, Shinpyung-Dong, Pusan-City, Korea).

Biphenyl DimethylDicarboxylate Vien nen25mg

42 Dimeka

------- ,-----. _ ...,_.- _.__._-- -------

Dang bao ch~ S6 ding ky

VN-7637-09

32. Cong ty dang ky: Daewoong Pharmaceutical Co., Ltd. (ale: 223-23 Sangdaewon-Dong,Chungwon-Ku, Sungnam-City, Kyunggi-Do, Korea).32.1. Nha san xuat: Daewoong Pharmaceutical Co., Ltd. (d/c: 906-10, Sangsin-ri, Hyang nammyun, Hwasung city, Kyunggi-Do, Korea).

STT Ten thu6c Ho,tchit Dang bao ch~ S6 dingky

Biphenyl Dimethyl43 Didcartus Dicarboxylate Vien nang cirng VN-5497-08

7,5mg

33. Cong ty dang ky: Dasan Medichem Co., Ltd. (d/c: #10, Wasan-ri, Dogo-myeon, Asan-si,Chungcheongam-do, Korea).33.1. Nha san xuat: Hanbul Pharm. Co., Ltd. (ale: # 40-8, Banje-Ri, Wongok-Myeon, AnseungSi, Gyeonggi-Do, Korea).

STT Ten thu6c Ho,tchit Dang bao ch~ S6 dingky~Biphenyl Dimethyl

44 BDDE Tablet Dicarboxylate Vien nen VN-9176-0925mg

33.2. Nha san xmlt: Myungmoon Pharmaceutical Co.,' Ltd. (d/c: 901-1, Sangshin-Ri,Hyangnam-myun, Hwasung-city, Kyunggi-Do, Korea).

8/19

, " , " '. "

STT Ten thuac .I- Dang bao ch~ sa dangkYHost chat

Biphenyl Dimethyl45 BDCell Dicarboxylate Vien nen VN-5334-10

25mg33.3. Nha san xuat: Medica Korea Co., Ltd. (d/c: 904-6 Sangsin-Ri, Hyangnam-Myeon,Hwaseong-City, Gyeonggi-Do, Korea).

STT Ten thuac DO\lt chit. .I-

sa dangkYDang bao che

Biphenyl Dimethyl46 Riverurso Tab Dicarboxylate Vien nen VN-5333-10

25mg

34. Cong ty dang ky: Dana Ph arm. Co., Ltd. (ale: 301, Bando BID, 946-18, Doguk-Dong,Kangnam-Ku, Seoul, Korea).34.1. Nha san xuat: Chunggei Pharm. Co., Ltd. (ale: 1106-4. Daeyang-ri, Yanggam-myeon,Hwaseoung-si, Gyeonggi-do, Korea).

STT Ten thuac DO\lt chit Dang bao ch~ sa dangkY

Biphenyl Dimethyl47 USDIBI Dicarboxylate Vien nang ctmg VN-8399-09

7,5mg

35. Cong ty dang ky: Kolon I Networks Corporation (d/c: 161-17, Samsung-dong, Kangnam-gu,Seoul, Korea).35.1. Nha san xuat: Korea Pharma Co., Ltd. (d/c: 907-8 Sangsin-Ri, Hyangnam-Myun,Hwasung-Kun, Kyunggi-Do, Korea).

STT Ten thuac DO\lt chit Dang bso ch~ S6 dangkY

Biphenyl Dimethyl48 Kosoma Dicarboxylate Vien nen VN-6701-08

25mg

36. Cong ty dang ky: Kukje Pharma Ind. Co., Ltd. (d/c: 513, Yatab-dong, Bundang-gu,Seongnam-City, Gyeonggi-do, Korea).36.1. Nha san xuat: Hutecs Korea Pharmaceutical Co., Ltd. (d/c: 555-2 Young Cheon Ri, Dongtan Myen, Hwa Sung Shi, Kyungki-Do, Korea).

STT Ten thu6c Do,t chit Dang bilo ch~ S6 dangkY

Biphenyl Dimethyl49 Beebipheran Dicarboxylate Vien nang VN-8218-09

7,5mg

37. Cong ty dang ky: Ozia Pharmaceutical Pty. Ltd. (tllc: Marina Quay, 111-3 Manly road,Seaforth, NSW 2092, Australia).37.1. Nha san xuat: Boram Pharma Co., Ltd. (ale: 471 Moknae-Dong.Danwon-gu, Ansan-Si,Kyungki-Do, Korea).

9/19

STT Ten thu6c Bottt chit Dang bao ch~ S6 dangky

Biphenyl Dimethyl50 Biperide cap Dicarboxylate Vien nang VN-8246-09

25mg

37.2. Nha san xuat: Chunggei Pharm Co., Ltd. (d/c: 1106-4, Daeyang-ri, Yanggam-myeon,Hwaseoung-si, Gyeonggi-do, Korea).

STT Ten thu6c J. Dang bao che S6 dangkjBottt chat

Biphenyl Dimethyl -51 Ozia-BDD Cap Dicarboxylate Vien nang VN-9332-097,5mg

38. Cong ty dang ky: Pharmix Corporation (d/c: 1304, Garak ID Tower, 99:..7, Garak-dong,Songpa-gu, Seoul, Korea).38.1. Nha san xuat: Korea Prime Pharm. Co., Ltd. (d/c: 616-3, Eungyo-ri, Iseo-Myon, Wanjugun, Chonbuk, Korea).

STT Ten thu6c J. Dang bao che S6 dangkjHeat chat

-- -"-_ -- ~--~ --- - Biphenyl-Dimethyl - . --~-- .~----, -

52 Ganolat Tablets Dicarboxylate Vien nen VN-7793-0925mg

39. Cong ty dang ky: Phil International Co., Ltd. (d/c: R# 629-4 Yeoksam-dong, Kangnam-ku,Seoul, Korea).39.1. Nha san xuat: Medica Korea Co., Ltd. (d/c: 904-6 Sangshin-Ri, Hyangnam-Myun,Whasung-City, Kyunggi-Do, Korea).

STT Ten thu6c J. Dang bao che S6 dangkjHoat chat

Medicakanema vien Biphenyl Dimethyl53 nen Dicarboxylate Vien nen VN-5052-07

25mg

39.2. Nha san xuat: Asia Pharm. Co., Ltd. (die: 439 Mogok-dong, Pyungtaek-city, Kyungki-do,Korea).

STT Ten thu6c J. Dang bao che S6 dangkyBottt chat

Biphenyl Dimethyl54 Omitan vien nen Dicarboxylate Vien nen VN-5046-07

25mg

40. Cong ty dang ky: Schnell Korea Pharma Co., Ltd. (d/c: 4F, Haesung Bldg #747-2 Yeoksamdong, Kangnam-ku, Seoul, Korea).40.1. Nha san xuat: II Bwa Co., Ltd. (die: 437, Sutaek-Dong, Guri-city, Kyonggi-do, Korea).

STT Ten thu6c S6 dangky

10/19

, " , " , "

Biphenyl Dimethyl55 Hubopa Tab. Dicarboxylate Vien nen VN-7832-09

25mg

Biphenyl Dimethyl56 Ilselo Tab. Dicarboxylate Vien nen VN-7833-09

25mg

40.2. Nha san xuat: Kyung Dong Pharm Co., Ltd. (d/c: 535-3, Daeyang-li, Yanggammyun,Hwasung-city, Kyunggi-do, Korea).

STT Ten thuac Hoat chit Dgng bao ch~ sa dangkj

Biphenyl Dimethyl57 Seofotin Dicarboxylate Vien nen VN-7834-09


58 Livcility Tab. Dicarboxylate Vien nen VN-8905-0925mg

40.3. Nha san xuat: Cellart Pharm. Korea Co., Ltd. (die: 418-21 Daeya-dong, Siheung-Si,Gyeonggi-do, Korea).

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

Biphenyl Dimethyl59 Litofil Dicarboxylate Vien nen VN-6311-08

25mg

41. Cong ty dang ky: TDS Pharm. Corporation (d/c: 437-6, Pyunggok-Ri, Eumseong-Eup,Eumseong-Gun, Chungcheongbuk-do, Korea).41.1. Nha san xuat: KMS Pharm. Co., Ltd. (die: 492-1 Maetan-Dong, Yeongtong-Gtl, SuwonCity, Gyeonggi, Korea).

STT Ten thuac . HO\lt chit Dgng bao ch~ sa dangkj

60 Hepaphil Soft Caps. Biphenyl Dimethyl Vien nang mem VN-6849-08Dicarboxylate 3mg

42. Cong ty dang ky: Unico Alliance Co., Ltd. (die: Unit 1007 Tower B, Seaview Estate, 2-8Watson Road, North Point, Hongkong).42.1. Nha san xuat: Beijing Union Pharm Factory (die: 1Xian Nong Tan St., Beijing, China).

STT Ten thuac Ho~ltchit Dgng bao ch~ sa dangkj

Biphenyl Dimethyl61 Hepasel Dicarboxylate Vien nang VN-4656-07

7,5mg

42.2. Nha san xuat: Pharmaking Co., Ltd. (die: 826, Sinhung-Dong, Sung Nam-Si, Kyunggido,Korea).

STT Ten thuac Dang bao ch~ .ss dangky

11/19

Biphenyl Dimethyl62 Nissel tablet Dicarboxylate Vien nen VN-4657-07

25mg

43. Cong ty dang ky: Unimed Pharmaceuticals Inc. (ale: 251, Sil Ok-Dong, Asan-City, Choongcheong nam-Do, Korea).43.1. Nha san xuat: Unimed Pharmaceuticals Inc. (ale: 251, SilOk-Dong, Asan-City, Choongcheong nam-Do, Korea).

STT Ten thuac Ho,tchit Dang bao ch~ Sa dangky

Biphenyl Dimethyl63 Argi-B tablet Dicarboxylate Vien nen VN-5131-07

25mg

44. Cong ty dang ky: Young II Pharm Co., Ltd. (ale: 920-27, Bangbae-Dong, Seocho-Ku, Seoul,Korea).

44.1. Nha san xuat: Young II Pharm Co., Ltd. (d/c: 521-15, Sinjong-ri, Jinchon-kun,Chungchong-Bukdo, Korea).

STT Ten thuac Ho,tchit Dang ban ch~ Sa dangkj

- _ .. _.__ ._- -- ~- -.--- ---'--'_"_ ._._--- -_._- Biphenyl Dimethyl -~----- -----~----.- - ---_.._----_-----

64 Bedad Tablet Dicarboxylate Vien nen bao phim VN-5714-1025mg

45. Cong ty dang ky: Kolon I Networks Corporation (d/c: 161-17, Samsung-dong, Kangnam-gu,Seoul, Korea).45.1. Nha san xuat: Sinil Ph arm Co., Ltd. (d/c: San 5-1, Bonpyeong Ri, Angsung myun ChungjuSi Chungchongbuk-Do, Korea).

STT Ten thuac J. Dang bao ch~ sa dangkjHO\lt chat

Biphenyl Dimethyl65 RB-25 Dicarboxylate Vien nen VN-5623-08

25mg

46. Cong ty dang ky: Cong ty c6 phAn cong ngh~ sinh hec dU'Q'cphAm ICA (ale: Lo 10, Duongsa 5, KCN Vi~tNam - Singapore, Thudn An, tinh Binh Duongi.46.1. Nha san xuat: Cdng ty c6 phAn cong ngh~ sinh hQcdU'Q'cphAm ICA (d/c: Lo 10,Duong sa5, KCN Viet Nam - Singapore, Thudn An, tlnh Binh Duongy.

STT Ten thuac Heat chit Dang bao ch~ sa dangkj

66 Fortec Biphenyl dimethyl Vien nen VD-3713-07dicarboxylat 25mg

67 BIDIDI Biphenyl dimethyl Vien nen VD-7392-09dicarboxylat 25mg

, :? , :? , :?

47. Cong ty dang ky: Cong ty c6 phAn dU'Q'cDanapha (die: 253 Dung Sf Thanh Khe, TP. D«Nang).47.1. Nha san xuat: Cdng ty c6 phAn dU'Q'cDanapha (die: 253 Dung Sf Thanh Khe, TP. fJdNang).

. 12/19

STT Ten thu6c Ho~t chit Dang bao ch~ S6 dingkj

Biphenyl Dimethyl68 Livertis Dicarboxylate Vien nen VD-9977-10

25mg

48. Cong ty dang ky: Cong ty c6 phln Dll9'c phAm 3/2 (ille:s6 930 C2, Duong C,KCN Cat Ldi,P. Thr,mhMy L(Ji,Q2, TP. Ha Chi Minh).48.1. Nha san xuat: Cdng ty c6 phln Dll9'c phAm 3/2 (d/c: s6 930 C2, Duong C, KCN Cat Lai, P.Th(;mhMy L(Ji,Q2, TP. Ha Chi Minh).

STT Ten thu6c Ho~tchit Dang bae ch~ sa dingkj

Biphenyl Dimethyl69 VI - BDD - 25 mg Dicarboxylate Vien nen VD-6171-08

25mg

49. Cong ty dang ky: Cong ty c6 phln dll9'c phAm Cifu Long (d/c: 150 duimg 14/9, thi xii VinhLong, tinh Vinh Long).49.1. Nha san xuat: Cdng ty c6 phln dll9'c phAmCifu Long (d/c: 150 duong 14/9, thi xii VinhLong, tinh Vinh Long).

STT Ten thuac Ho~t chit Dang bao ch~ sa dingkj

Biphenyl Dimethyl70 Bifendate 25mg Dicarboxylate Vien nen dai VD-8571-09

25mg

50. Cong ty dang ky: Cdng ty c6 phln Dll9'c phAm OPV (d/c: s6 27, dutmg 3A, Khu cong nghi~pBien Hoil 2, Dang Nai).50.1. Nha san xuat: Cdng ty c6 phln Dll9'c phAm OPV (d/c: S627, duimg 3A, Khu cong nghi~pBien Hoil 2, Dang Nai).

STT Ten thuac Ho~t chit D~ngbao ch~ sa dangkj

Biphenyl Dimethyl71 Livocal Dicarboxylate Vien nen bao phim VD-7245-09


72 Opelycid Dicarboxylate Vien nen bao phim VD-9475-0925mg

51. Cong ty dang ky: GlaxoSmithKline Pte., Ltd. (ille: 150 Beach Road # 21-00 Gateway West,Singapore 189720, Singapore).51.1. Nha san xuat: Cong ty c8 phln dll9'c phim SAVI (SAVIPHARM) (ille: Lo Z01-02-03aKCN/KCXT{m Thuan, P. Tan Thuan Dong, Q7, Tp. Ha Chi Minh).

STT Ten thuBc Ho~t chit D~ng bao ch~ sa dangkj

Biphenyl Dimethyl73 BDDGSK25mg Dicarboxylat Vien nen trim VD-I0384-10

25mg

13/19

52. Cong ty dang ky: Cong ty C6 phln D1fC}'cphim trung uong I - Pharbaco (ale: 160 Ton DucThdng, Ha Npi (SX Thanh Xudn, Soc San, HaNpi).52.1. Nha san xuat: Cong ty C6 phln D1fC}'cphim trung uong I-Pharbaco (ale: 160 Ton DucThang, Ha Noi (SX Thanh Xudn, Soc San, Ha Noi).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dangkj

Biphenyl Dimethyl74 Citava Dicarboxylate Vien nen VD-I0432-10

25mg

53. Cong ty dang ky: Cong ty c6 phin d1fC}'cphim TV.Pharm (d/c: 27 Di~n Bien Phil, thi xii TraVinh~tinh Tril Vinh).53.1. Nha san xuat: Cong ty c6 phln d1fC}'cphim TV.Pharm {d/c: 27 Di~n Bien Phil, thi xti TraVinh, tinh t-s Vinh).

STT Ten thu6c Ho~ltchit Dang bao ch~ S6 dang kj

Biphenyl dimethyl Biphenyl Dimethyl75 dicarboxylat 25mg Dicarboxylate Vien nen VD-7601-09

25mg

54. Cong ty dang ky:Cong ty c6 phin d1fl}'ctrung uong Mediplantex (tJ/c:Thon Trung Hdu, xiitiliz7)hon£huy~n M~Linh, VilihPhuc). --- -- - --- --~ --~. ~- --~~ ~--~-.----~---~---~- -- ~~~~

54.1. Nha san xuat: Cdng ty c6 ph in d1fl}'ctrung 1fong Mediplantex {d/c: Than Trung Hdu, xiiTiJn Phong, huyen Me Linh, V'inhPhuc).

STT Ten thu6c Hoat chit Dfng bao ch~ S6 dangkj

Biphenyl Dimethyl76 Medfotec Dicarboxylate Viennen VD-8866-09

25mg

55. Cong ty dang ky: Cong ty c6 phin d1fqc va thi~t bi y t~ Ha Tmh (tJ/c:167Ha Huy Tgp, thixii Hiz Tinh, tinh Hiz Tinh). .55.1. Nha san xuat: Cong ty c6 phin d1fqcva thi@tbi Yt~ Ha Tinh (tJ/c:167Ha Huy Tgp, thi xiiHa Tinh, tinh Ha Tinh).

STT Ten thu6c HOftchit Dfng bao ch~ S6 dangkj

Biphenyl Dimethyl Vien nen dellbao77 Laditonic - 25 mg Dicarboxylat phim VD-7653-0925mg

56. Cong ty dang ky: Cong ty c6 phln d1fqc-vi.t t1f Y t~ Thanh Hoa (tJ/c: VP: 232 Tran Phu -TP. Thanh Hoa SX s64 DuOng Quang Trung - TP. Thanh Hoa).56.1. Nha san xuat: Cong ty c6 phin d1fC}'c-vi.tt1f Yt~ Thanh Hoa (tJ/c: VP: 232 Tran Phil - TP.Thanh Hoa SX s6 4 DuOng Quang Trung - TP. Thanh Hoa.

STT Ten thu6c HOft chit Dfng bao ch~ S6 dang kj

Biphenyl Dimethyl78 HP-Argyl Dicarboxylate Vien nen did VD-8184-09

25mg

14/19. ". . ".

57. Cong ty dang ky: Cdng ty c8 phin Pymepharco (d/c: VP: 166 - 170 Nguyin Hue, Tuy Hail,PM Yen).57.1. Nha san xuat: Cdng ty c8 ph in Pymepharco (tile: VP: 166 - 170 Nguyin Hue, Tuy Hail,PM Yen).


PymeReobil - 25 Biphenyl Dimethyl79 Dicarboxylat Vien nen VD-6462-08mg 25mg

58. Cong ty dang ky: Cong ty c6 ph in san xuit - tlnrong m~i Dllq'Cph§m Bong Nam (tile: Lo2A, Duong s6 lA, KCN. Tan T(1o,Q. Binh Tan, TP. H6 Chi Minh).58.1. Nha san xuat: Cdng ty c8 phin san xuit - thurrng mai Dllq'Cph§m Bong Nam (tile: Lo2A, Duong s6 lA, KCN. Tan Tao, Q. Binh Tan, TP. H6 Chi Minh).

STT Ten thuac Hoat chit J. sa dangkjDang bao che

80 Doproca 25 mg Biphenyl dimethyl Vien bao phim VD-4038-07dicarboxylat 25mgBiphenyl dimethyl

Vien nang mem81 Dotricla dicarboxylat, VD-4042-07VitaminE, C

82 Dothoprim Biphenyl dimethyl Vien nang VD-4437-07dicarboxylat

83 BDD25mg Biphenyl dimethyl Vien nang mem VD-8222-09dicarboxylat 25mg

84 BDD Orient 25 mg Biphenyl dimethyl Vien bao phim VD-8223-09dicarboxylat 25mg

59. Cong ty dang ky: Cdng ty c8 phin SPM (d/c: Lo 51- Dutmg s6 2- KCN Tan T(1o-Q. BinhTan- TP. HCM).59.1. Nha san xuat: Cong ty c8 phin SPM (tile: Lo 51- Duirng s6 2- KCN Tan T(1o-Q. Binh TanTP. HCM).

STT Ten thuac Ho~t chit Dang bao ch~ . sa dangkj

85 BDD Biphenyl dimethyl Vien nen VD-7039-09dicarboxylat 25mg

60. Cong ty dang ky: Cong ty c8 ph in xuit nh,p kh§u y t~ Domesco (d/c: 66-Qu6e 1930-P. MyPM-Thj xii Cao Ldnh-Tinh D6ng Thdp),60.1. Nha san xuat: Cdng ty c6 phin xuit nh,p khftu y t~ Domesco (tile: 66-Qu6e 19 30-P. MyPh 'u-Thj xii Cao Liinh-Tinh Dom Thap).

STT Ten thuac Ho~t chit D~ng bao ch~ sa dangky

86 Doliv 25 mg Biphenyl dimethyl Vien bao phim VD-4460-07dicarboxylat 25mg

61. Cong ty dang ky: Cong ty DlfQ'CTrung llO'Dg3 (tile: 115 - Ng6 Gia T1!- Dil Nfmg).611 Nh'? .' C" D T 3 (tlJ; 115 N ~G· 11 D' N? ).. a san xuat: ongty lfO"C rung lfO'D2 e: - Igo za 1!- a ang,.

STT Ten thuac Ho,t chit n~ng bao ch~ sa dangkj

15/19

Biphenyl dimethyl87 Ceteco Foratec dicarboxylat Vien nen bao phim VD-11294-10

7,5mg

62. Cong ty dang ky: Cong ty lien doanh Meyer - BPC (ale: 6A3-qu6e 19 60, phuong PhuKhuong - TX Bin Tre, tlnh Bin Tre)..62.1. Nha san xuat: Cdng ty lien doanh Meyer - BPC (ale: 6A3-qu6e 1960, phuong Phu Khuong- T. 'x Ben Tre, tinh Bin Tre).

STT Ten tbu6c Eo DtlDgbao ch~ S6 ding kyHo,lt chat

88 Meyerbinyl Biphenyl dimethyl Vien nen VD-8292-09dicarboxylat 25mg

63. Cong ty dang ky: Cong ty Roussel Vi~t Nam (die: SXtr;zi:01, Duong 03 VSIP-Thugn An-BinhDuong- Vi~tNam).63.1. Nha san xuat: Cong ty Roussel Vi~t Nam (die: SXtr;zi: 01, Duong 03 VSIP-Thugn An-BinhDuonJ(-Vi~tNam).

STT Ten thu6c Eo Dang bao ch~ S6 dingkjHoat chat

89 Tridisel Biphenyl dimethyl Vien nen VD-11325-10dicarboxylat 25mg

64. €ong ty dang ky: €ong-ty TNIllI-dU'Q'c-pbAm-B\lt -Vi Pbu-(aic: Lo MlA'-CN, Dutmg D17,KCN My Phuoc, tinh Binh Duong).64.1. Nha san xuat: Cong ty TNHH dllQ'CphAm B\lt Vi Phu (We: ia M7A-CN, Duong D17,KC'NMy Phuoc, tinh Binh Duong).

STT Ten thu6c Eo Dang bao ch~ S6 dingkjHO\ltchat

90 Maxkei - 25mg Biphenyl dimethyl Vien bao phim VD-6090-08dicarboxylat 25mg

91 Esseil - 25mg Biphenyl dimethyl Vien bao phim VD-6559-08dicarboxylat 25mg

92 Davi Activer Biphenyl dimethyl Vien bao phim VD-7784-09dicarboxylat 25mg

93 Rebecca Biphenyl dimethyl Vien nen bao phim VD-11330-10dicarboxylat 25mg

65. Cong ty dang ky: Cong ty TNHH mi}t thanh vien dllQ'CphAm va sinh hC}cy t~ (ale: Lo 111-18 duong s6 13, Khu eong nghi~p Tan Binh, Qugn Tan Phu, TP. H6 Chi Minh).65.1. Nha san xuat: Cong ty TNHH mqt thanh vien dllQ'CphAm va sinh hC}cy t~ (ale: Lo III -18~ , .irngso 13, Khu eonf( nf(hi~1JTan Binh, Qugn Tan Phu, TP. H6 Chi Minh).

STT Ten thu6c Eo D,lDgbao ch~ S6 ding kjHO\ltchat

94 B.D.D-25mg Biphenyl dimethyl Viennen dfti VD-5656-08dicarboxylat 25mg

66. Cong ty dang ky: Cong ty TNHH Phil Inter Pharma (ale: S625, Duirng s6 8, Khu CN Vi¢tNam-Singapore, Thugn An, Binh Duong).66.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (ale: s6 25, Duirng s6 8, Khu CN Vi¢tNam-Singapore, Thugn An, Binh Duong).

< ? < ? < ?

16/19

STT Ten thuAc Ho~t chit Dang bao ch~ sA dangkj

Philcell 3 mg Biphenyl dimethyl Vien nang mem95 (SXNQ ella Deawon VD-5035-08pharm. Co.Ltd) dicarboxylat 3mg

96 ICA-BDD3 mg Biphenyl dimethyl Vien nang mem VD-5291-08dicarboxylat 3mg

67. Cong ty dang ky: Cdng ty TNHH thmrng m~i dUQ'cphdm, bao bi y t~ Quang Minh (die:194 D Trdn Quang Khai, Qu4n 1, TP. H6 Chi Minh (SX- S6 4 Ich Thr;mh,Qu4n 9, TP. H6 ChiMinh).67.1. Nha san xuat: Cong ty TNHH thuong m~i duQ'cphdm, bao bi y t@Quang Minh (die: 194D Trdn Quang Khai, Quan 1, TP. H6 Chi Minh (SX- S64 Ich Tht;mh,Qu4n 9, TP. H6 Chi Minh).

STT Ten thuAc Hoat chit D~ng bao ch@ sA dangkj

97 Timi Hepatic - Biphenyl dimethyl Vien nen bao phim VD-5334-0825mg dicarboxylat 25mg

I.B. Thu6c chua hoat chit Cefetamet:

68. Cong ty dang kj: Alembic Ltd. (die: Alembic Road Vadodara 390003, Gujarat State, India).68 ~.1. Nha san xuat: Alembic Ltd. (d/c: Alembic Road Vadodara 390003, Guiarat State, India).

STT Ten thuAc Ho~t chit Dang ban ch~ sA dangkj


69. Cong ty dang kj: Cong ty TNHH Nhan Sinh (d/c: DB 29 Bilu Cat, P.14, Q. Tan Binh, TP.H6 Chi Minh).69.1. Nha san xuit: Cdng ty TNHH us Pharma USA (d/c: to B1-10, duang D2, KCN Tdy BJcCu ', Chi, TP. Ho Chi Minh .

STT Ten thuac Ho~tchit Dang bao ch~ sa ding ky

99 Areplex Cefetamet Pivoxil Vien nen bao phim VD-15733-11Hydrochlorid 500mg

100 Areplex 250 Cefetamet Pivoxil Vien nen bao phim VD-16222-12Hydrochlorid 250mg

70. Cong ty dang ky: Cdng ty ca phdn xuit nh~p khdu y t~ Domesco (d/c: 66-Qu6c l(j 30-P. MyPhu-Thi xa Cao Liinh-Tinh D6ng Thap).70.1. Nha san xuat: Cong ty ca phdn xuit nh~p khdu y t~ Domesco (die: 66-Qu6c l(j 30-P. MyPh 'u-Thj xii Cao Liinh-Tinh Dong Thap).

STT Ten thuac HOloltchit Dl.lngbao ch~ sA dangky

101 Cetamet Cefetamet pivoxil Vien nen dai bao VD':11903-10250mg hydroclorid 250mg phim

102 Cetamet Cefetamet pivoxil Vien nen dai bao VD-11904-10500mg hydroclorid 500mg phim

17/19

71. Cong ty ding Icy: AlembicLtd. (die: Alembic Road Vadodara 390003, Gujarat State, India).71.1. Nha san xuit: AlembicLtd. (die: GIDC Naroda Ahmedabad, India).

STT Ten thuac HOl.ltchAt Dang bao chS sa ding kY


72. Cong ty ding Icy: AlembicChemicalWorks Co., Ltd. (d/c: Alembic Road Vadodara 390 003,India).72.1.Nha san xuit: Alembic Chemical Works Co., Ltd. (d/c: Alembic Road Vadodara 390 003,India).

STT Ten thuac J. Dang bao ch@ sa dingkYHeat chat

104 Dazzidime Cefetamet Pivoxil Vien nen bao pbim VN-4957-l0Hydrochloride 500mg

73. Cong ty ding Icy: Cong ty TNHH DuQ'cph§m RAngYang (d/c: Phong 4A, tdng 4, Toil nhasong t» 1, Ngo I65 cciu Gidy, Hil N9i).73.1. Nha san xuAt:Alembic Chemical Works Co., Ltd. (d/c: Alembic Road Vadodara 390003,India). "

··STT .- -Ten thuac ---- --Hoft chAt-~- - --.···-·-Dfng-bao··ch@-~ . ---Salling ky ...

105 Nitagol Cefetamet Pivoxil Vien nen bao phim VN-9553-10Hydrochloride 500mg

II. Thuoc dft dUC1Ccap gblYphep nhap khAu thuac thanh phim chua co sa dang Icy:

II.A. Thuac chua hoat chAt Biphenyl dimethyl dicarboxylat:

sa cong Dang H:.m Nhl'l sannn Ham van NgaycAp xuAt- Cong ty nh~pSTT thuac Ho,t chAt hrQ'Dg duy~t GPNK bao dung NlI"ac kh§u

nMp ch@ (thang) san xu!tCarnitine orotate,liver ext. antitoxic 150mg/lfraction, Biphenyl 2,5mg/25 C6ngtyDimethyl mg/2,5m 11951 Vien Celltrion TNHHMTV1 Vohetin Dicarboxylate, g/25mg/0 QLD-KD 24/112013 36 Pharm.In DUQ"cphamAdenin, nang c-KoreaPyridoxine, ,5mg/0,1 Trung uong2

Riboflavin, 25mg

CyanocobalaminBiphenyl Pharma Cong ty C6

2 Nissel Dimethyl 25mg 52661 09/4/2013 vien 36 King phan DuccDicarboxylate QLD-KD nen Co., Ltd. phdm-TBYT25mg - Korea HN - HapharcoBiphenyl Pharma Cong ty Co

3 Nissel Dimethyl 25mg 187021 8/1112013 vien 36 King phdnDuqcDicarboxylate QLD-KD nen Co., Ltd. pham - TBYT25mg - Korea HN - Hapharco

18/19

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rII.B. Thu6c chua host chAtCefetamet:

s6 cong Dang H~nNha san.

STT Ten Ho~t chAtHam van Ngay cAp bao dung xuAt- . Cong~ nh~p

thu6c hrQ'I1g duy~t GPNK chS (thang) NllcYc khaunMp san xuAt

Vien Bharat Cong ty Co

4 Alfigold Cefetamet Pivoxil 250mg 92561 13/6/2013 nen 18 Parenter phan YDuQ'c250 HCI QLD-KD bao als Ltd. - pham

phim India VimedimexBharat Cong ty

5 Alfigold Cefetamet Pivoxil500mg 57951 16/4/2013 Vien

24 Parenter TNHHMTV500 HCI QLD-KD nen als Ltd. - Duoc pham

India TWI

ruong Qu6c Cuong

19/19

say T~QUANG NAM - n~E"'NNS6~··/i~~rQ. - VNRAS

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