giiy···'C6... . XA HOI CHU ... NGBIA VIET NAM ClJC QUAN LY DUQC DQc l~p - TlJ do - H~nh phuc

(1)

sa y T~QUANG NAM

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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 QUYETDlNH

v e viec rut so dang kj, dmh chi luu hanh va thu hoi thuoc chua hoat chat Biphenyl dimethyl dicarboxylat va thuoc chua hoat chat Cefetamet

dang lUllhanh t~i Vi~t Nam

~"

Cl}C TRlfONG Cl}C QUAN L Y DlfOC

Can cl! Luat Diroc ngay 1/4 thang 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 ly Diroc thuoc B¢ Y te;

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

Can cU thong tin, khuyen cao cua Co quan quan ly Diroc mot s6 mroc tren the gioi va ket luan cua Hoi D6ng Tu Vfu cap s6 dang ky thu6c - B¢ Y te ve vi~c thu6c chua hOC;ltchat Biphenyl dimethyl dicarboxylat ho~c Bifendat va thu6c chua hOC;lt chat 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 ly

chat luqng thu6c - (\Ic Quan ly Duqc, .

QUYETDlNH:

Dieu 1. Rut s6 dang ky cac thu6c chua hOC;ltchat Biphenyl dimethyl dicarboxylat, thu6c chua hOC;lt chat Cefetamet co ten trong Danh m\lc cac thu6c rut 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 thu6c chua hOC;lt chat Biphenyl dimethyl dicarboxylat, thu6c chua hOC;lt chat Cefetamet co ten trong Danh m\lc cac thu6c dlnh chi lUll hanh va thu h6i ban hanh kern thea 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;ltchat Biphenyl dimethyl dicarboxylat, thu6c chua hOC;lt chat Cefetamet va bao cao ket qua ve (\Ic Quan ly Duqc thea dung quy dinh tC;liThong tu s6 09/2010m-BYT ngay 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;lO giam 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 điều trị, đưa ưeb

(2)

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 eC1 sa dang ky va/hoac nha san

xu Atcac thuoc neu tai Dieu 1 chiu trach nhiem thi hanh Quyet dinh nay.

CUCTRUO~ . /

!

(3)

BOYTE

Cl)C QUANL

Y

DlfOC

'" ,,_ A ? _ '"

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

DANH Ml)C cAc THU6c RUT 86

DANG

KY

(Ban

harm kern

theo Quyetdinh

s64-4-rt /QD-QLD ngay AO

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 Lf Bon,Phuong Ngo QuyJn, TP. VtnhYen, Tinh VinhPhue).

1.1. Nha san xuit: Boram Pharm. Co., Ltd.

(ale: 471 Moknae-Dong, Danwon-gu, Ansan-Si,

Kyungki-Do, Korea). -

STT Tenlhuac

H~~d

chit Dang bao ch~ sa dangkj

1 Decaxy Biphenyl Dimethyl

Vien nen VN-IOO13-10

Dicarboxylate 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-1l822-11 Dicarboxylate 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, Hwaseong- un,k Kcyunggt-. d0,Korea.)

STT Ten thuac Heat chit Deng bac ch~ sa dangkj

3 Liveko Biphenyl Dimethyl

Vien nen bao phim VN-13107-11 Dicarboxylate 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: Dong Kwang Pharmaceutical Co., Ltd.

(die: 439-1, Mogok-dong, Pyongtaek City, kyungki-do,Korea).

STT Ten thuac Hoat chit Dang bao ch~ sa dangkj

Biphenyl Dimethyl

4 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

(4)

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

5 Bindicel Dicarboxylate Vien nen VN-II068-10

25mg

5.2.

Nha san xuat: Hankook Korus Pharm. Co., Ltd.

(die: 253-12, Kangje-Dong, Jecheon-si, Chungbuk,Korea).

Biphenyl Dimethyl

6 Kodicel Capsule Dicarboxylate Vien nang cirng VN-15918-12 7,5mg

Biphenyl Dimethyl

7 Vien nen Novomin Dicarboxylate Vien nen VN-12488-11 25mg

6. Cong ty dangky: 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-14703-12

25mg

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

Biphenyl Dimethyl

9 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, Gyeonggi- Do,Korea).

STT Ten thuac Hoat chit Dang bao ch~ s6 dangkj

Biphenyl Dimethyl

10 Hucona Tab. Dicarboxylate Vien nen VN-11905-11

25mg

Biphenyl Dimethyl

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

25mg

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, HwaSung- Si,Kyungki-do,Korea).

STT Teo thuac Hoat chit sa dangky

(5)

Biphenyl Dimethyl

12 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 Pharmaceutical Co., Ltd.

(d/c:552-2 Young CheunRi, Dong tan Myen, Hwa Sung Shi, Kyeng Ki Do,Korea).

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

Biphenyl Dimethyl

13 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 Dimethyl

14 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 Dimethyl

15 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 Dimethyl

16 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 Dimethyl

17 Gadilat Dicarboxylate Vien nen VN-15571-12

25mg

3/7

(6)

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 Dimethyl

18 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 Dimethyl

19 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 Yeoksam- dong, Kangnam-ku, Seoul, Korea).

12.1. Nha san xuat: Sky New Ph arm. Co., Ltd. (d/c: 418-21 Daeya-dong, Siheung-si, Gyeonggi-

_~__ !!o,

Korea)._- _.. _-

- -

STT Ten thu6c Hoat chit Dgng bao ch~ S6 dangkY

Biphenyl Dimethyl

20 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. Da Nfmg).

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

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

Biphenyl Dimethyl

21 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-14259-11 dicarboxylat 25mg

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

15.1. Nha san xuat: Cong ty TNHH US Pharma USA (ale: L6 B1-10, auimg D2, KCN Tay B6c

(7)

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

kY

23 Cadimetyl Biphenyl dimethyl

Vien nen VD-14948-11

dicarboxylat 25mg

16. Cong ty dang ky: Cdng ty c6 phin DllVc phim Phuong Dong (d/c: La

s6

7,duong

s6

2,KCN Tan 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,KCN Tan 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-11671-10 dicarboxylat 25mg phim

17. Cong ty dang ky: Cdng ty c6 ph in dllVC phim Vinh Phuc (d/c:

86

777duimg Me Linh- P.Khai Quang- TP. V'inhYen- Tinh V'inhPMc).

17.1. Nha san xuat: Cdng ty c6 phin dllVc phim Vinh Phuc (d/c:

86

777duong Me Linh-P.Khai Quang- TP. V'inhYen- Tinh V'inhPMc).

STT Ten thuac Hoat chit Dang bao ch~ sa ding

kY

25 Siganex Biphenyl dimethyl

18. Cong ty dang ky: Cdng ty c6 phin san xuit - thirong mai DllVc phim Dong Nam (d/c: La 2A, 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

kY

Biphenyl Dimethyl

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

19. Cong ty dang ky: Cong ty DllVc Trung llong 3(t1Ic:115-Nga Gia T1!- Da Nlmg).

19.1. Nha san xuat: Cong ty DllVc Trung llong 3 (die:115-Nga Gia T1!- Da Ndng).

STT Ten thuac HO\lt chit D~ng bao ch~ sa ding

kY

Biphenyl Dimethyl

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

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 tyTNHH dU'Vcphim »,t Vi Pho.(t1Ic:La M7A-CN, Duimg D17. KeN My Phuac, tinh Binh Duang).

STT Ten thuac Hotlt chat^J. D\lng bao ch~ Sa ding

kY

28 Esseil Biphenyl dimethyl Vit~nnen dai bao

VD-13650-10 dicarboxylat25mg phim

5(7

(8)

29 Maxkei Biphenyl dimethyl Vien nen dill bao

21. Cong ty dang ky: Cong tyTNHH Phil Inter Pharma (ale:

s6

25, Duong s6 8,Khu CN Vi?t Nam-Singapore, Thudn An, Binh Duong).

21.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (ale: S625, Duong s68, Khu CN Vi?t Nam-Singapore, Thudn An, Binh DU07lg).

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

~/

30 Philcell Biphenyl dimethyl

Vien nang mem VD-19216-13 dicarboxylat 3mg

22. Cong ty dang ky: Cong tyTNHH san xuit thuong m\li dllQ'cphftm NIC (NIC Pharma) (ale:

islID dutrngC, Khu cong nghi?p Tan Tr;lO,qudn Binh Tan, tp. H6 Chi Minh).

22.1. Nha san xuat: Cong tyTNHH san xuit thunng mai dllQ'c phftm 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 dimethyl

31 Fortdex dicarboxylate Vien nen VD-12671-10

25mg

23. Ceng ty dang ky: Cdng tyc8 phAn cong ngh~ sinh hec dllQ'cphftm ICA (ale: Lo 10,Duong s65, KCN Vi?tNam - Singapore, Thudn An, tinh Binh Du07lg).

23.1. Nha san xuat: Cong tyc8 phAn cong ngh~ sinh hec dllQ'cphftm ICA (ale: Lo 10,Duong s6 5, KCN Vi?t Nam-Singapore, Thudn An, tinh Binh DU07lg).

STT Ten thuac Hoat chat^J. Dang bao ch~ sa dang Icy 32 Fortec Biphenyl dimethyl

dicarboxylat 25mg 33 Forgentec Biphenyl dimethyl

Viennen VD-16471-12

dicarboxylat 25mg

24. C6ng ty dang ky: Cong tyTNHH Phil Inter Pharma (ale:

s6

25, f)uang s6 8, Khu CN Vi?t Nam-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?t Nam-Singapore, Thu,JnAn, Binh Du07lg).

STT Ten thuac HOftchit Dfngbao ch~ sa dang Icy

~, Biphenyl dimethyl

Vien nang m~m 34 Omitan ^>

dicarboxylat 3mg VD-16445-12

25. C6ng ty dang ky: CO~~tycAphAn dllQ'cv~t tll Yt~ Hai Dllong (ale: 102 Chi Lang, thimh ph6

Hili Du07lg). - - _

25.1. Nha san xuat: Cong tyc8 phAn dllQ'cv~t tll yt~ Hai Dllong (ale: 102 Chi Lang, thimh ph6 Hai Du07lg).

STT Ten thuac Dfng bao ch~ sa dangky

(9)

35. Civacell Biphenyl dimethyl

II. Thu8c chua hoat chit Cefetamet:

26. Cdng ty (Ung

kj:Alembic Ltd. (d/c: Alembic Road Vadodara 390003, Gujarat State, India).

26

.1. Nha san xuat: Alembic Ltd.

I.. (d/c: Alembic Road Vadodara 390003, Gujarat State, India).

STT Ten thuac Ho~lt ch§t Dang bao ch~ Sa clang

kj

36 Altamet 250 Cefetamet Pivoxil

Vien nen bao phim VN-15191-12 Hydrochloride 250mg

27. Cdng ty clang

kj:Cdng ty TNHH Nhan Sinh (dlc:

DB 29 ss« Cat, P.14, Q. Tan Binh, TP. H6

Chi Minh).

27.1. Nha san xuit: Cdng ty TNHH US Pharma USA

(tile:

is

BI-IO, duimg D2, KCN

Tay

B6c Cu,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-15733-11 Hydrochlorid 500mg

38 Areplex 250 Cefetamet Pivoxil

28. Cong

ty

dang

ky:

Cdng ty c8 ph§n xu it nh~p khAu

y

t~ Domesco

(tile: 66-Qu6c 1930-P.

My

Phu-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 1930-P.

My

Phu-Thi xCiCao Ldnh-Tinh Dong Thdp).'

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

kj

39 Cetamet Cefetamet pivoxil Vien nen delibao

VD-11903-10 250mg hydroclorid 250mg phim

40 Cetamet Cefetamet pivoxil Vien nen delibao

CUCTRlJ6~

Truong Qu6c CUOng

(10)

BQYTE

Cl,IC QUAN L Y DlfOC

CONG HoA xx. HOI CHU NGHIA V~T NAM I>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 Lf Bon, Phuong Ngo Quydn, TP. Vinh Yen, Tinh Vinh Phuc).

1.1. Nha san xuit: Boram Pharm. Co., Ltd.

(d/c: 471 Moknae-Dong, Danwon-gu, Ansan-Si, Kyun~J -ki D^0,lGorea.)

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

1 Decaxy Biphenyl Dimethyl

Vien nen VN-IOO13-10

Dicarboxylate 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\lng bao ch~ S6 dangkj

2 Acterox Biphenyl Dimethyl

Vien nen bao phim VN-1l822-11 Dicarboxylate 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_aseong - un,k K.yunggt-. d0,Korea.)

STT Ten thu6c Heat chit Dang bao ch~ S6 dangkj

3 Liveko Biphenyl Dimethyl

Vien nen bao phim VN-13107-11 Dicarboxylate 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: Dong Kwang Pharmaceutical Co., Ltd.

(die:439-1, Mogok-dong, Pyongtaek City,kyungki-do,Korea).

STT Ten thu6c Hoat chat

^J.

Dang bao ch~ S6 dangkj

Biphenyl Dimethyl

4 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).

(11)

5.1. Nha san xuat: Dae Han New Pharm 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 Dimethyl

5 Bindicel Dicarboxylate Vien nen VN-II068-10

25mg

5.2.

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 Dimethyl

6 Kodicel Capsule Dicarboxylate Vien nang cimg VN-15918-12 7,5mg

Biphenyl Dimethyl

7 Vien nen Novomin Dicarboxylate Vien nen VN-12488-11 25mg

6. Cong ty dang ky: II Hwa Co., Ltd.

(d/c:

437

Sutaek-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).

^J.

Dang bao ch~ S6 dangkY

Biphenyl Dimethyl

8 Huparantab. 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 Dimethyl

9 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, Gyeonggi- Do,Korea).

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

Biphenyl Dimethyl

10 Hucona Tab. Dicarboxylate Vien nen VN-11905-11

25mg

Biphenyl Dimethyl

11 Kommakid tab. Dicarboxylate Vien nen VN-11907-11 25mg·

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, HwaSung- Si,Kyungki-do,Korea).

2/19

< "

.

"

(12)

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

kY

Biphenyl Dimethyl

12 Peaceliva Dicarboxylate Vien nen VN-12525-11

25mg

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 CheunRi,Dong tan Myen,Hwa Sung Shi, Kyeng Ki Do,Korea).

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

Biphenyl Dimethyl

13 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 Dimethyl

14 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 Dimethyl

15 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 Dimethyl

16 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

(13)

Biphenyl Dimethyl

17 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, Wonju- si, Gangwondo,Korea).

STT Ten thu6c Botttchit Dang bao ch~ S6 dangkj

Biphenyl Dimethyl

18 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 Dimethyl

19 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 Yeoksam- dong, Kangnam-ku, Seoul, Korea).

12.1. Nha san xuat: Sky New Ph arm. Co., Ltd. (d/c: 418-21Daeya-dong, Siheung-si, Gyeonggi- do, Korea).

STT Ten thu6c Bottt chit Dang bao ch~

sa

dangkj

Biphenyl Dimethyl

20 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. Da Ndng).

13.1. Nha san xuat: Cdng ty c6 phAn dUf}"cDanapha (die: 253 Dung Si Thanh Khe, TP. Da Ndng).

STT Ten thu6c Bottt chit Dang bao ch~ S6 dangky

Biphenyl Dimethyl

21 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 s68, 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 Viet Nam - Singapore, Thuan An, Binh Duang, Viet Nam).

STT Ten thu6c Dttng bao ch~ S6 dang ky

4/19

(14)

22 Timihepatic Biphenyl dimethyl

15. Cong ty dang

ky:

Cdng ty TNHH US Pharma USA (die: L6 B1-10, duong D2, KCNTay Biic

ca

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 Biic Cu Chi, TP.

H6

Chi Minh).

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

23 Cadimetyl Biphenyl dimethyl

dicarboxylat 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,^KCN

Tan

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

17. Ceng ty dang ky: Cdng ty c6 phin dU'9'cphim Vinh Phuc (d/c:

sa

⁷⁷⁷ ^duong ^{Me Linh-}

P.Khai Quang- TP. Vinh Yen- Tinh Vinh PMc).

17.1. Nha san xuat: Cong ty c6 phin dllf}'cphim Vinh Phue (d/c:

sa

777duang Me Linh-P.Khai Quang- TP. Vinh Yen- Tinh Vinh Phuc).

STT Ten thuac Host chit Dgng bito ch~ sa dangkY

25 Siganex Biphenyl dimethyl

18. Cong ty dang ky:Cdng ty c6 phin san xuit - thuoug mai Dll9'c phim Dong Nam (dlc: L6 2A,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: L6 2A, Duirng

sa

lA, KCN Tan Tr,zo,Q.Binh Tan, TP.

H6

Chi Minh).

STT Ten thuac HO\lt chat^I. D\lng bito ch~ Sa dangkY Biphenyl Dimethyl

26 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'ong 3

.

(dlc:115 -Ng6 Gia T1,l- Dil NJng) . STT Ten thuac HO\lt chat^I. D\lng bito ch~ sa dingkY

Biphenyl Dimethyl

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

(15)

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 MyPhutrc, tinh Binh Du071g).

STT Ten thu6c HOft chftt Dang bao ch~ S6 dangkY

28 Esseil Biphenyl dimethyl Vien nen dai bao

29 Maxkei Biphenyl dimethyl Vien nen dai bao

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 Hoat chat^.{. Dang bao ch~ S6 dingkY

~-

30 Philcell Biphenyl dimethyl

Vien nang m6m VD-19216-13 dicarboxylat 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 dimethyl

31 Fortdex dicarboxylate Vien nen VD-12671-10

25mg

23.Congty dang ky: Cong ty c8 ph in cong ngh~ sinh hQc dllVc phAm ICA (die:L6 10, [)uimg s65, KCN Vi~tNam - Singapore, Thu~n An, tinh Binh DU071g).

23.1. Nha san xuat: Cong ty c8 phin cong ngh~ sinh hQc dllVc phAm ICA (iJ/c:L6-10,[)uimg s6 5,KCN Viet Nam - Singapore, Thuan An, tinh Binh Du071g).

STT Ten thu6c HO\lt chat^.{. D\lng bao ch~ S6 ding kY 32 Fortec Biphenyl dimethyl

Viennen VD-15314-11

dicarboxylat 25mg 33 Forgentec Biphenyl dimethyl

Viennen VD-16471-12

dicarboxylat 25mg

24. Cong ty dang ky: Cong ty TNHH Phil Inter Pharma (iJ/c:

s6

25,[)uimg s6 8,Khu CN Vi~t Nam-Singapore, Thu~n An, Binh Du071g).

24.1. Nha san xuat: Cong ty TNHH Phil Inter Pharma (die: S625, [)uimg s6 8, Khu CN Vi~t Nam-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-16445-12 dicarboxylat 3mg

6/19

< " ,"

.

"

(16)

25.,C6ng ty dang ky: Cdng ty c&phdn dllQ'c v~t nr Y t~ Hal Duong (die: 102 Chi Lang, thanh phoHili Duong).

25.1. Nha san xuat: Cong ty c&phdn dllQ'cv,t nr Yt~ Hai Duong (die: 102 Chi Lang, thanh ph6 Hili Duong).

STT Ten thu6c Hoat chat^J. Dang bao ch~ S6 dangkY

35 Civacell Biphenyl dimethyl

Vien nang m€m VD-17079-12 dicarboxylat 3mg

26. Cong ty dang ky: Boram Pharma Co., Ltd. (die: 471Moknae-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, Wanju- gun, Chonbuk, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dangkY

Biphenyl Dimethyl

36 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, Gwanghyewon- myeon, Jineheon-gun, Chung eheongbuk-do, Korea).

STT Ten thu6c Host chat^J. Dang bsoch~ S6 dangky

Biphenyl Dimethyl

37 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:47duimgs6 2,cuxil 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, Gwanghyewon- myeon, Jincheon-gun, Chung eheongbuk-do, Korea).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dangkY

".

Biphenyl Dimethyl

38 Activer Dicarboxylate Vien nen VN-6521-08

25mg

28. Cong ty dang ky: Cdng ty TNHH DllQ'cph§m Ti~n Minh (die:136Su 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 Dimethyl

39 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,Phuimg

(17)

29.1.

Nha san xuat: Hutecs Korea Pharmaceutical Co., Ltd.

(d/c: 555-2 Youngcheun ri, Dong tan myen, HwasungShi, Kyeungki-do, Korea).

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

Biphenyl Dimethyl

40 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 kY

Biphenyl Dimethyl

41 Daehwabidica Dicarboxylate

Vien nen

_VN-8144-09

25mg

31.

Ceng

ty dang

ky:

Daewoo Pharm. Co., Ltd.

(ale: 579,Shinpyung-Dong, Pusan-City, Korea).

31.1. Nha

san xmlt: Daewoo Pharm. Co., Ltd.

(dlc:579,Shinpyung-Dong, Pusan-City, Korea).

Biphenyl Dimethyl

Dicarboxylate Vien nen 25mg

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 nam- myun,Hwasung city,Kyunggi-Do, Korea).

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

Biphenyl Dimethyl

43 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, Anseung- Si, Gyeonggi-Do, Korea).

STT Ten thu6c Ho,tchit Dang bao ch~

_~

S6 dingky

Biphenyl Dimethyl

44 BDDE Tablet Dicarboxylate Vien nen VN-9176-09

25mg

33.2.

Nha san xmlt: Myungmoon Pharmaceutical Co.,' Ltd.

(d/c: 901-1, Sangshin-Ri, Hyangnam-myun, Hwasung-city, Kyunggi-Do, Korea).

8/19

," ," '. "

(18)

STT Ten thuac Host chat^.I- Dang bao ch~ sa dangkY Biphenyl Dimethyl

45 BDCell Dicarboxylate Vien nen VN-5334-10

25mg

33.3. 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 Dang bao che^. ^.I- sa dangkY Biphenyl Dimethyl

46 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 Dimethyl

47 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 Dimethyl

48 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, Dong tanMyen,Hwa Sung Shi, Kyungki-Do, Korea).

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

Biphenyl Dimethyl

49 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).

(19)

STT Ten thu6c Bottt chit Dang bao ch~ S6 dangky Biphenyl Dimethyl

50 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 Bottt chat

^J.

Dang bao che S6 dangkj

Biphenyl Dimethyl -

51 Ozia-BDD Cap Dicarboxylate Vien nang VN-9332-09 7,5mg

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, Wanju- gun, Chonbuk, Korea).

STT Ten thu6c Heat chat

^J.

Dang bao che S6 dangkj

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

52 Ganolat Tablets Dicarboxylate Vien nen VN-7793-09 25mg

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).

^J.

Dang bao che S6 dangkj

Medicakanema vien Biphenyl Dimethyl

53 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 Bottt chat

^J.

Dang bao che S6 dangky

Biphenyl Dimethyl

54 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 Yeoksam- dong, 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

, " _," ,"

(20)

Biphenyl Dimethyl

55 Hubopa Tab. Dicarboxylate Vien nen VN-7832-09

25mg

Biphenyl Dimethyl

56 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, Yanggam- myun,Hwasung-city, Kyunggi-do, Korea).

STT Ten thuac Hoat chit Dgng bao ch~ sa dangkj

Biphenyl Dimethyl

57 Seofotin Dicarboxylate Vien nen VN-7834-09

25mg

Biphenyl Dimethyl

58 Livcility Tab. Dicarboxylate Vien nen VN-8905-09 25mg

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 Dimethyl

59 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, Suwon City, Gyeonggi, Korea).

STT Ten thuac .HO\lt chit Dgng bao ch~ sa dangkj 60 Hepaphil Soft Caps. Biphenyl Dimethyl

Viennang mem VN-6849-08 Dicarboxylate 3mg

42. Cong ty dang ky: Unico Alliance Co., Ltd. (die: Unit 1007 Tower B, Seaview Estate, 2-8 Watson Road, North Point, Hongkong).

42.1.Nhasan xuat: Beijing Union Pharm Factory (die:1Xian Nong Tan St.,Beijing, China).

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

Biphenyl Dimethyl

61 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

(21)

Biphenyl Dimethyl

62 Nissel tablet Dicarboxylate Vien nen VN-4657-07

25mg

43. Cong ty dang ky: Unimed Pharmaceuticals Inc. (ale: 251,Sil Ok-Dong, Asan-City, Choong cheong nam-Do, Korea).

43.1. Nha san xuat: Unimed Pharmaceuticals Inc. (ale: 251, SilOk-Dong, Asan-City, Choong cheong nam-Do, Korea).

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

Biphenyl Dimethyl

63 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-5714-10 25mg

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 Chungju Si Chungchongbuk-Do, Korea).

STT Ten thuac HO\lt chat^J. Dang bao ch~ sa dangkj Biphenyl Dimethyl

65 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,Duong sa5,KCN Vi~tNam - Singapore, Thudn An, tinh Binh Duongi.

46.1. Nha san xuat: Cdng ty c6 phAn cong ngh~ sinh hQc dU'Q'cphAm ICA (d/c:Lo 10,Duongsa 5, KCN Viet Nam - Singapore, Thudn An, tlnh BinhDuongy.

STT Ten thuac Heat chit Dang bao ch~ sa dangkj

66 _Fortec Biphenyl dimethyl

Vien nen VD-3713-07

dicarboxylat 25mg 67 BIDIDI Biphenyl dimethyl

Vien nen VD-7392-09

dicarboxylat 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. fJd Nang).

.12/19

(22)

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

68 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 CatLai,P.

Th(;mhMy L(Ji, Q2, TP.Ha Chi Minh).

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

Biphenyl Dimethyl

69 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:150duimg14/9, thi xii Vinh Long, tinh Vinh Long).

49.1. Nha san

xuat:

Cdng ty c6 phln dll9'c ph Am Cifu Long (d/c: 150 duong 14/9, thi xii Vinh Long, tinh Vinh Long).

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

Biphenyl Dimethyl

70 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~p Bien Hoil2, Dang Nai).

50.1. Nha san xuat: Cdng ty c6 phln Dll9'c phAm OPV (d/c:S627, duimg 3A, Khu cong nghi~p Bien Hoil2,Dang Nai).

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

Biphenyl Dimethyl

71 Livocal Dicarboxylate Vien nen bao phim VD-7245-09 25mg

Biphenyl Dimethyl

72 Opelycid Dicarboxylate Vien nen bao phim VD-9475-09 25mg

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 Z01-02-03a KCN/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 Dimethyl

73 BDDGSK25mg Dicarboxylat Vien nen trim VD-I0384-10 25mg

(23)

52.

Cong

ty dang ky:Cong ty C6 phln D1fC}'cphim trung

uong I -

Pharbaco (ale: 160 Ton Duc Thdng,HaNpi (SX ThanhXudn, Soc San,HaNpi).

52.1. Nha san xuat: Cong ty C6 phln D1fC}'cphim trung uong I -Pharbaco (ale: 160 Ton Duc Thang,Ha Noi (SX Thanh Xudn, Soc San, Ha Noi).

STT Ten thu6c Hoat chit Dang bao ch~ S6 dangkj

Biphenyl Dimethyl

74 Citava Dicarboxylate Vien nen VD-I0432-10

25mg

53. Cong ty dang ky: Cong ty c6 phin d1fC}'cphim TV.Pharm (d/c:27Di~n Bien Phil, thi xii Tra Vinh~tinh Tril Vinh).

53.1. Nha san xuat: Cong ty c6 phln d1fC}'cphim TV.Pharm {d/c: 27 Di~n Bien Phil, thixti Tra Vinh, tinh

t-s

^Vinh).

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

Biphenyl dimethyl Biphenyl Dimethyl

75 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,xii tiliz7)hon£huy~n

M~ Linh, Vilih

Phuc). --- -- - --- --~ --~.~- --~~ ~-- ~-.----~---~---~- -- ~~~~

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

STT Ten thu6c Hoat chit Dfng bao ch~ S6 dangkj

Biphenyl Dimethyl

76 Medfotec Dicarboxylate Viennen VD-8866-09

25mg

55. Cong ty dang ky: Cong ty c6 phin d1fqc va thi~t bi yt~ Ha Tmh (tJ/c:167Ha Huy Tgp, thi

xii Hiz Tinh, tinh Hiz Tinh). .

55.1. Nha san xuat: Cong ty c6 phin d1fqc va thi@tbi Yt~ Ha Tinh (tJ/c:167Ha Huy Tgp, thi xii Ha Tinh, tinh Ha Tinh).

STT Ten thu6c HOftchit Dfng bao ch~ S6 dangkj

Biphenyl Dimethyl

Vien nen dellbao 77 Laditonic - 25 mg Dicarboxylat

phim VD-7653-09

25mg

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.tt1fYt~ Thanh Hoa (tJ/c: VP:232 Tran Phil - TP.

Thanh Hoa SX

s6

4DuOng Quang Trung - TP. Thanh Hoa.

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

Biphenyl Dimethyl

78 HP-Argyl Dicarboxylate Vien nen did VD-8184-09 25mg

14/19

.

^".

.

^".

(24)

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 Dimethyl

79 Dicarboxylat Vien nen VD-6462-08

mg 25mg

58. Cong ty dang ky: Cong ty c6 ph in san xuit - tlnrong m~i Dllq'Cph§m Bong Nam (tile: Lo 2A,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:Lo 2A, Duong

s6

lA, KCN. Tan Tao,Q.Binh Tan,TP. H6 Chi Minh).

STT Ten thuac Hoat chit Dang bao che^J. sa dangkj

80 Doproca 25 mg Biphenyl dimethyl

Vien bao phim VD-4038-07 dicarboxylat 25mg

Biphenyl dimethyl

Vien nang mem

81 Dotricla dicarboxylat, VD-4042-07

VitaminE, C 82 Dothoprim Biphenyl dimethyl

Vien nang VD-4437-07

dicarboxylat 83 BDD25mg Biphenyl dimethyl

84 BDD Orient 25 mg Biphenyl dimethyl

59. Cong ty dang ky: Cdng ty c8 phin SPM

(d/c:

Lo 51- Dutmg

s6

2- KCN Tan T(1o-Q. Binh Tan- TP. HCM).

59.1. Nha san xuat: Cong ty c8 phin SPM (tile:Lo 51-Duirng

s6

2-KCN Tan T(1o-

Q.

Binh Tan- TP. HCM).

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

85 BDD Biphenyl dimethyl

Vien nen VD-7039-09

dicarboxylat 25mg

60.Cong ty dang ky: Cong ty c8 ph in xu it nh,p kh§u y t~ Domesco (d/c: 66-Qu6e 1930-P.

My

PM-Thj xii Cao Ldnh-Tinh D6ng Thdp),

60.1. Nha san xuat: Cdng ty c6 phin xuit nh,p khftu yt~ Domesco (tile:66-Qu6e

19

30-P.

My

Phu-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

61. Cong ty dang ky: Cong ty DlfQ'CTrung llO'Dg3(tile:115 -Ng6 Gia T1!- Dil Nfmg).

611 Nh'?

..

a san xuat:.' C"ongty DlfO"C rung lfO'D2T 3(tlJ;e: 115

-

N ~Igo zaG· 111!-D' N? )a ang,.

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

(25)

Biphenyl dimethyl

87 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 Phu Khuong - 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 Ho,lt chat^Eo DtlDg bao ch~ S6 ding ky 88 Meyerbinyl Biphenyl dimethyl

Vien nen VD-8292-09

dicarboxylat 25mg

63. Cong ty dang ky:Cong ty Roussel Vi~t Nam (die: SXtr;zi:01,Duong 03 VSIP-Thugn An-Binh Duong- Vi~tNam).

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

STT Ten thu6c Hoat chat^Eo Dang bao ch~ S6 dingkj 89 Tridisel Biphenyl dimethyl

dicarboxylat 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'N My Phuoc, tinh BinhDuong).

STT Ten thu6c HO\ltchat^Eo Dang bao ch~ S6 dingkj 90 Maxkei - 25mg Biphenyl dimethyl

91 Esseil - 25mg Biphenyl dimethyl

92 Davi Activer Biphenyl dimethyl

93 Rebecca Biphenyl dimethyl

65. Cong ty dang ky:Cong ty TNHH mi}t thanh vien dllQ'CphAm va sinh hC}cyt~ (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}cyt~(ale: Lo III -18

~ _{irng so},_13,Khu eonf( nf(hi~1JTan Binh, Qugn Tan Phu, TP. H6 Chi Minh).

.

STT Ten thu6c HO\ltchat^Eo D,lDg bao ch~ S6 ding kj 94 B.D.D-25mg Biphenyl dimethyl

Viennen dfti VD-5656-08 dicarboxylat 25mg

66. Cong ty dang ky:Cong ty TNHH Phil Inter Pharma (ale: S625, Duirng s6 8,Khu CN Vi¢t Nam-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¢t Nam-Singapore, Thugn An, Binh Duong).

< ? < ? < ?

16/19

(26)

STT Ten thuAc Ho~t chit Dang bao ch~ sA dangkj Philcell 3 mg

Biphenyl dimethyl

Vien nang mem

95 (SXNQ ella Deawon VD-5035-08

pharm. Co.Ltd) dicarboxylat 3mg 96 ICA-BDD3 mg Biphenyl dimethyl

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 Chi Minh).

67.1.Nhasan xuat: Cong ty TNHH thuong m~i duQ'c phdm, bao bi y t@Quang Minh (die: 194 D Trdn Quang Khai, Quan 1,TP. H6 Chi Minh (SX- S64 Ich Tht;mh,Qu4n9, TP. H6 Chi Minh).

STT Ten thuAc Hoatchit D~ng bao ch@ sA dangkj

97 Timi Hepatic - Biphenyl dimethyl

Vien nen bao phim VD-5334-08

25mg 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 29Bilu Cat, P.14, Q. Tan Binh, TP.

H6 Chi Minh).

69.1. Nha san xuit: Cdng ty TNHH us Pharma USA (d/c:toB1-10, duang D2, KCN Tdy BJc Cu,Chi, TP.Ho'Chi Minh .

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

99 Areplex Cefetamet Pivoxil

100 Areplex 250 Cefetamet Pivoxil

70. Cong ty dang ky: Cdng ty ca phdn xuit nh~p khdu y t~ Domesco (d/c: 66-Qu6c l(j 30-P.My Phu-Thi xaCao Liinh-Tinh D6ng Thap).

70.1. Nha san xuat: Cong ty ca phdn xu it nh~p khdu y t~ Domesco (die: 66-Qu6c l(j 30-P. My Phu-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':11903-10 250mg hydroclorid 250mg phim

102 Cetamet Cefetamet pivoxil Vien nen dai bao

(27)

71.

Cong

ty

ding

Icy:

Alembic Ltd.

(die:Alembic Road Vadodara 390003, Gujarat State,India).

71.1.

Nha san xuit: Alembic Ltd.

(die: GIDC Naroda Ahmedabad, India).

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

72. Cong

ty

ding

Icy:

Alembic Chemical Works 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 Heat chat

^J.

Dang bao ch@ sa dingkY

104 Dazzidime Cefetamet Pivoxil

Vien nen bao pbim VN-4957-l0 Hydrochloride 500mg

73.

Cong

ty

ding

Icy:

Cong

ty

TNHH DuQ'cph§m RAngYang

(d/c: Phong 4A, tdng4, Toil nha song

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

II. Thuoc dft dUC1C cap 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 san

nn Ham van NgaycAp xuAt- Cong ty nh~p

STT thuac Ho,t chAt

hrQ'Dg duy~t GPNK bao dung

NlI"ac kh§u

nMp ch@ (thang)

san xu!t Carnitine orotate,

liver ext. antitoxic

150mg/l fraction, Biphenyl

2,5mg/25 C6ngty

Dimethyl

mg/2,5m 11951 Vien Celltrion

TNHHMTV 1 Vohetin Dicarboxylate,

g/25mg/0 QLD-KD 24/112013 36 Pharm.In

DUQ"cpham

Adenin, nang

c-Korea

Pyridoxine, ,5mg/0,1 Trung uong2

Riboflavin, 25mg

Cyanocobalamin

Biphenyl Pharma Cong ty C6

2 Nissel Dimethyl

25mg 52661

09/4/2013 vien

36 King phan Ducc

Dicarboxylate QLD-KD nen Co., Ltd. phdm-TBYT

25mg - Korea HN - Hapharco

Biphenyl Pharma CongtyCo

3 Nissel Dimethyl

25mg 187021

8/1112013 vien

36 King phdnDuqc

Dicarboxylate QLD-KD nen Co., Ltd. pham - TBYT

25mg - Korea HN - Hapharco

18/19

< "

(28)

r

II.B. Thu6c chua host chAt Cefetamet:

s6cong

Dang H~n Nha san.

STT Ten

Ho~t chAt Ham van Ngay cAp

bao dung xuAt- . Cong~ nh~p

thu6c hrQ'I1g duy~t GPNK

chS (thang) NllcYc khau

nMp san xu At

Vien Bharat Cong ty Co

4 Alfigold Cefetamet Pivoxil

250mg 92561

13/6/2013 ^nen 18 ^Parenter phan YDuQ'c

250 HCI QLD-KD bao als Ltd. - pham

phim India Vimedimex

Bharat Cong ty 5 Alfigold Cefetamet Pivoxil

500mg 57951

16/4/2013 ^Vien 24 Parenter TNHHMTV

500 HCI QLD-KD nen als Ltd. - Duoc pham

India TWI

giiy···'C6... . XA HOI CHU ... NGBIA VIET NAM ClJC QUAN LY DUQC DQc l~p - TlJ do - H~nh phuc

sa y T~QUANG NAM

dang lUllhanh t~i Vi~t Nam

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

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

Nguyễn Thị Liên:

Dieu 4. Quyet dinh nay co hieu 11!ek~ tir ngay ky ban hanh va thay th€

BOYTE

phim NgQcThi~n

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

4. Cong ty dang

5.1. Nha san xuat: Dae Han New Pharm Co., Ltd.

8. Cong ty dang

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

10.2.Nha san xuat: Kyung Dong Pharm. Co., Ltd.

II. Thu8c chua hoat chit Cefetamet:

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

t~ Domesco

Truong Qu6c CUOng

Cong ty dang kj: Cong ty CPTM va DllQ'CphAmNgQcThifn

STT Ten thu6c HO\ltchit D\lng bao ch~ S6 dangkj

4. Cong ty dang

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

6. Cong ty dang ky: II Hwa Co., Ltd.

Nha san xuat: Etex Pharm Inc.

Nha san xuat:

Nha san xuat: Hutecs Korea Pharmaceutical Co., Ltd.

Vien nen

33. Cong ty dang

Nha san xuat: Chunggei Pharm Co., Ltd.

Dang bao che S6 dangkj

Nha san xuat: Asia Pharm. Co., Ltd.

Vien nen

uong I -

M~ Linh, Vilih

Alembic Ltd.

STT Ten thuac Heat chat

II. Thuoc dft dUC1C cap gblYphep nhap khAu thuac thanh phim chua co sa dang

II.B. Thu6c chua host chAt Cefetamet:

ruong Qu6c Cuong