tri - Cục Y tế Giao thông Vận tảicucytegiaothong.mt.gov.vn/Uploads/File/QD 115 BYT.pdfCan cu Quy~t djnh s6 2962/QI>-BYT ngay 22/08/2012 cua B() Y t~ ve vi~c ban hanh Quy djnh

BQYTE

S6: .AJS /QD-BYT

CQNG HOA xA HQI CHiJ NGHiA VI~T NAM DQc l~p - Tl}' do - H~nh phuc

Ha N(Ji, ngay ,AA thang .A niim 2013

QUYETDJNII Cong b6 Danh IDt}C thu6c bi~t dtrQ'C g6c (Dqtl) va Danh ffit}C thu6c co tai li~u

chung minh tuong dtrong sinh hqc (D(}'t 2)

B(> TRUONG B(> Y TE

Can cu Lu~t Dugc s6 34/2005/QH11 ngay 14/06/2005; Can cu Nghi djnh s6 63/2012/ND-CP ngay 31/08/2012 cua Chinh phu quy djnh

chuc nang, nhi~m V\1, quyen hc:tn va ca c~u t6 chile cua B9 Y t~; Can cu Thong tu lien tich s6 01/2012/TTLT- BYT- BTC ngay 19/01/2012 cua

Lien B9 Y t~- B9 Tai chinh hu6ng dful d~u thAu mua thu6c trong cac ca say t~; Can cu Quy~t djnh s6 2962/QI>-BYT ngay 22/08/2012 cua B() Y t~ ve vi~c ban

hanh Quy djnh tc:tm thai ve cac tai li~u cAn cung c~p dS cong b6 cac danh ID\lC thu6c bi~t dugc g6c, thu6c tuang duang dieu tri v6i thu6c bi~t dugc g6c, thu6c c6 tai li~u chilng minh tuang duang sinh hQc;

Can cu y ki~n cua H()i d6ng xet duy~t danh ID\lC thu6c bi~t dugc g6c, thu6c tuang duang dieu tri v6i thu6c bi~t dugc g6c, thu6c c6 tai li~u chilng minh tuang duang sinh hQC cua B9 y t~;

Xet de nghi cua Ong C\lC tru6ng C\lC Quan ly dugc - B9 y t~,

QUYETDJNH:

Di~u 1. Cong b6 kern theo Quy~t dinh nay cac danh ID\lC: - Danh ID\lC thu6c bi~t dugc g6c (I>gt 1) g6m 96 thu6c. - Danh ID\lC thu6c c6 tai li~u chilng minh tuang duang sinh hQc (Dgt 2) g6m 44

thu6c. Di~u 2. Quy~t djnh nay c6 hi~u h,rc kS tir ngay kY ban hanh. Di~u 3. Cac ong, ba: Chanh Van phong B(), C\lc tru6ng cac C\lc: Quan ly dugc,

Quan ly kham chua b~nh, Quan ly Y dugc c6 truyen, Khoa hQc Cong ngh~ va Dao tc:to; V\1 tru6ng cac V\1: Phap ch~, Bao hiSm y t~, K~ hoc:tch- Tai chinh; Giam d6c So Y t~ cac tinh, thanh ph6 tf\Ic thu()c Trung uang; Giam d6c cac b~nh vi~n, vi~n c6 giuang b~nh tn,rc thu()c B9 Y t~; Giam dfJc cac ca sa san xu~t thu6c c6 thu6c dugc cong b6 tc:ti Dieu 1 va Thu tru6ng cac dan vi c6 lien quan chiu trach nhi~m thi hanh Quy~t dinh nay./. .

Nui nhlin: - Nhu Di~u 3; - BTr. Nguy8n Thi Kim TiBn (d~ b/c); - Cac Thu tru6ng; - Bao hi~m xa h<)i VN; - T6ng Cong ty dugc Vi~t Nam; - Hi~p hQi Doanh nghi~p dugc Vi~t Nam; - C\lc Quan y-B9 Qu6c phong; C\lc Y t~-B9 Cong an; - C\lc Y t~ giao thong v~n tai-B9 GTVT; - C6ng thong tin di~n tU B9 Y t~ ;

· -Website cua C\lc QLD; - Luu: VT, QLD (02b).

B(>YTE

SIT Ten thufic

I Aldan Tablets 10 mg

2 Aldan Tablets 5 mg

3 Arnlaxopin 5mg

4 Arnlocor-5

5 Amlodipin 10mg

6 Amlodipin 5mg

7 Am tim

8 Augbactam 625

9 Aumakin625

10 AzukonMR

11 Bifumax 125

12 Bifumax 500

11 Carbatol-200

14 . Clarithromycin tablets

15 Diuresin SR

16 Dorodipin 10mg

17 Egilok

18 Euzimnat 500

19 Felodil ER

C(>NG HOA xA H(>I CHU NGHIA VI E:T NAM

D(}c l~p - TlJ do- H~nh phuc

Ha N(Ji, ngay AA thimgD~ nam 2013 . DANH Ml)C 44 THUOC CO TAl Lllj:U CHUNG MINH TUONG DUONG SINH HQC (DQ'T 2)

(Ban hanh kern theo Quyit tlinh s6 AA 5 /QD-BYTngayAA I v~ 12013 cua B(J truang B(J Yd)

Ho~t chit Ham hrvng D~ng bao ch~ Quy each d6ng g6i sa dang icy Or slY san xuit Dja chi CO' slY san xuit

Arnlodipine IOmg Vien nen HOp 3 vi x 10 vien VN-15792-12 Polfarmex S.A 9 Jozefow Stress!, 99-300 Kutno

Arnlodipine 5mg Viennen HOp 3 vi x 10 vien VN-15793-12 Polfarmex S.A 9 Jozefow Stress!, 99-300 Kutno

Arnlodipine besilate tucrng ducrng 5mg Vien nen HOp 3 vi x 10 vien VN-16025-12 Actavis HF

Reykjavi kurgegur 76-78, PO 5mg Amlodipine Box420 220 Hafnarfjordur Arnlodipine besylat tucrng ducrng

5mg Vien nen HOp 3 vi x 10 vil!n VN-16076-12 Torrent Pharmaceuticals Ltd. Vili .Bhud &Makhnu Majra, Baddi-

5mg Arnlodipine 173205 Arnlodipin besylat tucrng ducrng I Omg

10mg Vil!nnen HOp I vi x 10 vien, chai 90

VD-11902-10 COng ty CO phAn XNK Y t~ Domesco 66 Qu6c 10 30, Phuimg My PhU,

Arnlodioine vien nen TP.Cao Unh Tinh DOni!. Thao Arnlodipin besylat tucrng ducrng 5mg 66 Qu6c 10 30, Phuimg My Phu, Amlodipine

5mg Viennang HOp 3 vi x 10 vien VD-15242-11 Cling ty C6 phAn XNK Y t~ Domesco TP.Cao Unh Tinh DOni!. Thao

Amlodipin 5mg Vien nang cling HOp 1 vi, 3 vi, I 0 vi x 10 vil!n VD-13757-11 COng ty CO phAn Duqc phfun KCN Nhcrn Tr(lch 3, Huyen Nhcrn Ampharco U.S.A Tr(lch Tinh DOng Nai

Amoxicillin, Acid clavulanic 500mg + 125mg Vien nen bao HOp 2 vi x 5 vien; Hop 2 vi x

VD-6443-08 Cling ty C6 phan H6a-Duqc ph!\m 297/5 Ly Thuang Kiet, Phuang 15,

ohim 7vil!n Mekoohar louan 11 To. HO Chf Minh

Vien nen bao HOp 2 vi x 5 vien; HOp 2 vi x

Cling ty C6 phAn H6a-Duqc ph!\m 297/5 Ly Thuimg Kiet, Phuimg 15, Arnoxicillin, Acid clavunalic 500mg + 125mg

phim 7 vil!n; HOp 5 vi x 4 vien nen VD-12496-10

Mekophar Quiin II , Tp. HO Chi Minh bao ohim

Gliclazide 30mg Vil!n nen ph6ng

HOp 10 vi x 10 vien VN-12682-11 Torrent Pharmaceuticals Ltd. Indrad~382721 , Dist. Mehsana thfch chdm

Cefuroxim axetil 125mg G6i HOp 10 g6i X 4g VD-16851-12 COng ty Co phan Duqc phdm 499 Nguyen Thai Hoc, Tp Quy Nhan, Bidiohar 1 Blnh Dinh

Cefuroxim axetil 500mg Vien nen bao

HOp 2 vi x 5 vien VD-10086-10 COng ty CO phan Duqc ph!\m 498 Nguyen Thai Hoc, Tp Quy Nhan,

lohim Bidiohar I Binh Dinh

Carbamazepine 200mg Vien nen HOp I 0 vi x 1 0 vi en VN-16077-12 Torrent Pharmaceuticals Ltd. Indrad-382721 , Dist. Mehsana

Clarithromycin 250mg

Vien nen bao Hop d\lllg 1 0 hOp VN-15738-12 Brawn Laboratories Ltd. 13, New Industrial Township, lohim nh6 x I vi x 10 vi en Faridabad 121001 Harvana

Indapamide Vien nen bao

1,5mg ·phim giai ph6ng HOp 3 vi x 10 vien VN-15794-12 Polfarmex S.A 9 Jozefow Stresst, 99-300 Kutno keo dai

Amlodipin besylat tucrng ducrng lOmg 10mg Vien nen

HOp 1 vi x 10 vi en, chai 90 VD-11911-10 COng ty C6 phAn XNK Y te Domesco

66 Qu6c lo 30, Phuimg My PhU, Amlodipin vien nen TP.Cao Unh Tinh DOng Thap

Metoprolol tartrate 25mg Vien nen HOp 1 lo 60 vien VN-15892-12 Egis Pharmaceuticals Public Ltd., 1106, Budapest, Kereszruri ut, Co. 30-38

Cefuroxim axetil tucrng ducrng 500mg 500mg

Vien nen dai bao HOp 2 vi x 5 vien VD-11346-10

COng ty TNHH MTV Duqc ph!\m va LO Ill-18 Duimg 13, KCN Tan Binh, Cefuroxim phim sinh hoc v te O.Tan Phu Tp. HO Chf Minh

Vicn nen bao 404-10, Nojang-Ri, Jeondong-Myeon,

Felodipin 5mg phim ph6ng thfch HOp 10 vi x 10 vien VN-15946-12 Korea United Pharm. Inc., keo dai

Yeongi-kun, Chungnam -

Trang 1/3

Ntr6'c san xuit

BaLan

BaLan

Iceland

AnD¢

VietNam,

I

VietNam 1

VietNam I

VietNam

vietNam

An Do

vietNam

VietNam

AnD¢

AnD¢

BaLan

VietNam I

Hungary

Vi¢tNam

Han Qu6c

SIT Ten thuBc Ho~t ch§t Ham IU'Q'Dg D~ng bao ch~ Quy each dong g6i s6 dang ky CO' sO' san xuM Dja chi cO' sO' san xu§t NU'6'C san

xu§t H¢p 3 vi x 10 vien, H¢p 10 vi E>u<mg sli2-Khu CN Elling An-Thu~ ' 20 Gabahasan 300 Gabapentin 300mg Vien nang c(mg x 10 vien

VD-7365-09 Cling ty TNHH Hasan-Dermapharm An-Binh Duong VietNam

21 Glumefonn 500 Metfonnin hydroclorid 500mg Vien nen dai bao

H¢p 10 vi x 10 vien VD-9261-09 Cling ty CO phAn Duqc H~u Giang 288 Bis, Nguyen van Cir, P. An Hoa,

VietNam lohim Ninh Kieu cAn Tho

22 Haginat 125 Cefuroxim 125mg G6i thu6c b¢t pha H¢p 24 g6i x 3,5g thu6c b¢t

VD-9263-09 Cling ty CO phAn Duqc H~u Giang 288 Bis, Nguyen van Cii, P. An Hoa,

VietNam h6n djch u6ng pha h6n djch u6ng Ninh Kitu, CAn Tho

23 Haginat 250 Cefuroxim 250mg Vien nen bao H¢p 2 vi x 5 vien nen bao

VD-7872-09 Cling ty Cd phAn Duqc H~u Giang 288 Bis, Nguyen van Cir, P. An Hoa,

VietNam lphim lphim Ninh Kieu cAn Tho

24 lndatab SR lndapamide 1,5mg Vien nen giai

H¢p 3 vi x 10 vien VN-16078-12 Torrent Pharmaceuticals Ltd. lndrad-382721, Dist. Mehsana An E>¢ I oh6ng keo dai

25 Kalecin 500 Clarithromycin 500mg Vien nen bao Hop 2 vi x 5 vien nen bao

VD-8941-09 Cling ty Cll phan H6a-Duqc phfull 297/5 Ly Thu<mg Kiet, Phu<mg 15,

vietNam ohim lohim Mekophar 10uan II To. HO Chi Minh

26 Medaxetine 250mg Cefuroxime Axetil, tuong duong

250mg Vien m\n bao

Hop 1 vi X 10 vien VN-15975-12 Medochemie Ltd. 1-10 Constantinoupoleos Street, 3011

Cyprus 250mg Cefuroxime phim Limas sol

27 Medaxetine 500mg Cefuroxime Axetil tuong duong

500mg Vien nen bao

Hop I vi X 10 vien VN-15976-12 Medochemie Ltd. 1-10 Constantinoupoleos Street, 30 II

Cyprus 500mg Cefuroxime phim Limassol

28(') Midancef250 Cefuroxim axetil 250mg Yen nen dai bao

hQp I rui X 1 vi X 10 vien VD-3883-07 Cong ty Cll phAn Duqc phfull Minh Lll E2, du<mg N4, Khu CN HoaX A,

VietNam ohim Dan TPNamE>inh

29 Pamlonor Amlodipine besylate tuong duong

5mg Vien nen Hop 3 vi x 10 vien VN-16024-12 Pharmaceutical Works Polfa in 5 Marszalka-J.Pilsudskiego St. 95-200

BaLan 5mg Amlodrnine Pabianice Joint Stock Co. Pabianice

30 Plendil Felodipine 5mg Vien nen ph6ng

Hop 3 vi X 10 vien VN-9938-10 AstraZeneca Pharma India Ltd. 12th Mile Bellary Road, Bangalore-

An E>o thlch keo dai 560 063

31 pms-Ciaminat

Amoxicilin, acid clavulanic 250/31.25mg G6i thullc bot pha

Hop 12 g6i VD-5141-08 Cling ty C6 phAn Duqc phfun S6 4, E>u<mg 30/4, Tp Cao L!inh, Tlnh

vietNam 250mg/31 25mg h3n djch lmexoharm E>Ong Thao

Amoxicilin, acid clavulanic 500/125mg Vien nen dai baa

H¢p 2 vi x 7 vien VD-4748-08 Cling ty Cll phtlnDuqc phAm S6 4, E>u<mg 30/4, Tp Cao L!inh, Tinh

vietNam 32 pms-Ciaminat 625mg ohim lmexoharm E>Ong Thao

Cefuroxim (duai di!llg Cefuroxim Vien nen dai bao Cling ty CO phAnouqc phfun s6 02, E>u<mg s6 02, Khu cling nghiep

vietNam I 33 pms-Zanimex 500mg 500mg Hop 2 vi x 5 vien VD-4761-08 VietNam-Singapore II, Thanh ph6 axetil) phim lmexpharm

Thli Dau M¢t, Tinh Binh Duong

34 PymeAMIO Amlodipin (duai di!llg Amlodipin

IOmg Vien nen Hop 2 vi x 15 vien, H()p 3 vi x

VD-6996-09 Cling ty CO phAn Pymepharco 166-170 Nguyen Hue, Tp. Tuy Hoa,

vietNam besylat) 10 vien, Hop 10 vi x 14 vien Tinh PM Yen

35(' ) Quincef 125 Cefuroxim 125mg 125mg G6i thu6c bot, Hop 12 g6i x 3,8g thu6c bot,

VD-2922-07 Cling ty CO phfut H6a-Duqc phAm 297/5 Ly Thu<mg Kiet, Phu<mg 15,

VietNam HOo 10 g6i x 3 8g thu6c bOt Mekoohar Quan 11 To. H6 Chi Minh

Vien nen bao 404-10, Nojang-Ri, Jeondong-Myeon,

36 Speenac CR Aceclofenac 200mg phim ph6ng thlch Hop 3 vi x 10 vien VN-15948-12 Korea United Pharm. Inc. Han Qu6c c6 kiem soat

Yeongi-kun, Chungnam

Metoprolol succinat tuong duong Vien nen bao

Otto-von-Guericke-AJiee 1, D-39179 37 Succi pres 25mg 25mg phim ph6ng thlch Hop 3 vi x 10 vien VN-15927-12 Salutas Pharma GmbH E>irc

25mg metoprolol tartrate keo dai Barleben

Metoprolol succinat tuong duong Vien nen bao Otto-von-Guericke-AJiee 1, D-39179

38 Succipres 50mg 50mg phim ph6ng thlch H¢p 3 vi x 10 vien VN-15928-12 Salutas Pharma GmbH E>irc 50mg metoprolol tartrate keo dai

Barleben

500mg Vien nen dai bao Hop 10 vi X 10 vien nen dai

VD-8219-09 Cling ty Cd phAn Pymepharco 166-170 Nguyen Hue, Tp. Tuy Hoa,

vietNam 39 Tatanol Acetaminophen ohim bao ohim TinhPhli Yen

40 Turbezid Rifampicin, Isoniazid, Pyrazinamid 150mg, 75mg,

Vien m\n H()p 3 vi x 12 vien, h(lp 10 vi

VD-12726-10 Cling ty CO phAn Duqc phAm Nam

415 Han Thuyen, TP Nam E>inh vietNam 400mg x 12 vien H8

41 Valparin chrono 500 Sodium Valproate 333mg, Valproic

500mg Vien nen ph6ng

H()p 10 vi x 10 vien VN-5681-10 . Torrent Pharmaceuticals Ltd. Indrad-382721, Dist. Mehsana AnE>¢ acid 145mg thlch c6 ki~m soat

Trang 2/3

~

SIT Ten thuBc Ho{lt chit Ham hrQ'Dg D{lng bao ch~ Quy each dong goi sa dangkj CO' sir san xu§t Dja chi CO' sir san xu§t Ntr&c san

xu§t I I

Diluted isosorbide mononitrate tuang Vitn nen ph6ng . . HOp Ian chua 2 hOp nh6 x 2 vi 42 Vasotrate-60 OD

duang 30mg isosorbide mononitrate 30mg

thlch keo dai x 7 vitn VN-9422-09 Torrent Pharmaceuticals Ltd. Indrad-382721 , Dist. Mehsana An Do

Vitn bao phim Hop 2 vi X 30 vien, Hop I vi X 166-170 Nguyln Hu~, Tp. Tuy Holi,

43 Vaspycar MR-35mg Trimetazidin HCL 35mg ph6ng thich c6 VD-6047-08 Cllng ty C6 phfut Pymepharco VietNam kitmsoat

30 vitn Tinh Phu Yen

44 Zinmax Cefuroxim axetil tuong duang 500mg

500mg Vien nen dai bao HOp 2 vi x 5 vitn; Hop I, 2, 3

VD-11919-10 Cllng ty C6 phftn XNK Y te Domesco 66 Qu6c Io 30, Phulmg My Phu,

vietNam Cefilroxjm ohim vi x 10 vien TP.Cao Unh Tinh Dilng IMQ __

GhichU:

<·>: Thu6c da h~t h~ s6 dang Icy nhung dm;rc phep luu hlmh d~n h~t h~n dung ctia thu6c.

Trang 3/3

B<)YTE

STT Ten thu6c

1 Arimidex

2 Bam bee

3 Betaloc Zok 25 mg

4 Betaloc Zok 50 mg

5 Ciprobay

6 Ciprobay IV .

7 Concor

8 ConcorCor

9 Coversy110mg

10 Coversyl 5mg

Crestor (D6ng g6i: 11 AstraZeneca UK Ltd.,

UK)

C(>NG HOA xA H(>I CHU NGHiA VI~T NAM D{>c l~p- Tl! do - H~nh phuc

Ha N9i, ngay A A thimg 01 niim 2013 DANH MVC 96 THUOC B.i¥T DUQC GOC (DQT 1)

(Ban hanh kern theo Quyit ainh s6 A As- IQD-BYT ngay ;1 ,\ I 0}. 12013 cua B9 truirng B9 Y ti)

Ho~t chit Ham hrQ1lg D~ng bao cb@, Quy each

S6 dAng ky CO' sO' san xuit Dja chi cO' sO' san xuit d6ne e6i

AstraZeneca Phannaceuticals

Anastrozole 1mg Villn nen bao phim, hQp 2 vi X 14

VN-10735-10 LP. USA (Co sa san xudt)- Newark, Delaware 19702 (Co sa san

villn AstraZeneca UK Ltd. (Co sa xudt) d6ng g6i)

AstraZeneca All· (Co sa san SE-151 85 Sodertalje. (Co sa san xudt)

Bambuterol HCI 10mg Villn nen, hQp 3 vi X 10 villn VN-9935-10 xudt) - Interphil Labotories Inc. Canlubang Industrial Estate, Bo. Pittland, Cabuyao, Laguna, Philippines

(Co sa d6ng g6i) (Co sa d6ng g6i)

23,75 mg metoprolol

Metoprolol succinate succinate tuang duang Villn nen ph6ng thfch keo diU,

VN-6895-08 . AstraZeneca AB SE-151 85 Sodertalje v&i 25 mg metoprolol h~p 1 vi x 14 villn tartrate

47,5 mg metoprolol succinate tuang duang Villn nen ph6ng thfch keo diU,

Metoprolol succinate vm so mg metoprolol chai 30 vien, hQp 2 vi x 14 vien

VN-6896-08 AstraZeneca AB SE-151 85 Sodertalje

tartrate

Ciprofloxacin 500mg H~p 1 vi x 10 vien bao phim VN-14009-11 Bayer Schering Phanna AG D-51368 Leverkusen

Ciprofloxacin 200mg H{lp 1 IQ 1 OOml djch truy~n VN-14008-11 Bayer Schering Phanna AG D-51368 Leverkusen

Bisoprolol fumarate Villn nen bao phim, H~p 3 vi X 10 250 Frankfurter Strasse, 64293

(Phenoxy-amino- 5mg VN-7748-09 MerckKGaA propanols)

vi en Dannstadt

Bisoprolol fumarate Vien nen bao phim, H()p 2 vi X 14 250 Frankfurter Strasse, 64293

(Phenoxy-amino- 2,5mg VN-7267-08 MerckKGaA propanols)

v1en Dannstadt

Perindopril Arginine 1 Omg 10mg H()p 1 IQ chua 30 vien nen bao

VN-5642-08 Les Laboratoires Servier

905 Route de Saran, 45520 Gidy phim Industrie

Perindopril Arginine 5mg 5mg H(lp 1 IQ chua 30 vien nen bao


905 Route de Saran, 45520 Gidy phim Industrie

Rosuvastatin calcium 10,4 Vien nen bao phim, hQp 2 vi X 14

Rosuvastatin mg, tuang duang vi en

VN-8439-09 iPR Phannaceuticals Inc. Canovanas, Puerto Rico, PR 00729

- ·------ ---rosuvastatin 1 ()_ mg

Trang 1 /7

NtrcYC san xu it

HoaKy

Th\lY Dian

Thvy Dien

i

Thvy Dien

Due

Due

Due

Due

Phap

Phap

HoaKy

STT Ten thu6c Ho\lt chAt Ham hrQllg D\lng bao ch~, Quy each so dang kY Ca sO' san xuAt Dja chi cO' sO' san xuAt

Nu6'c san ·dong goi xuAt

Crestor (D6ng g6i: Rosuvastatin calcium 20,8 Vien m!n bao phim, hQp 2 vi x 14

12 AstraZeneca UK Ltd., Rosuvastatin mg, tuang duang VN-8440-09 iPR Pharmaceuticals Inc. Canovanas, Puerto Rico, PR 00729 HoaKy

UK) rosuvastatin 20 mg vi en

Crestor (D6ng g6i: Rosuvastatin calcium 5,2 Vien nen bao phim, hQp 2 vi X 14

13 AstraZeneca UK Ltd., Rosuvastatin mg, tuang duang vi en

VN-12164-11 iPR Pharmaceuticals Inc. Canovanas, Puerto Rico, PR 00729 HoaKy

UK) rosuvastatin 5 mg

14 Cymevene Ganciclovir sodium 500mg HOp l lQ bQt d5ng kM VN-5354-10 F .Hoffinann-La Roche Ltd. Grenzacherstrasse 124, CH-4070 Basel Thvy Si

166 Moo 16 Bangpa-In Industrial 15 Daktarin oral gel Miconazole 20mg/g HOp l tuyp lOg gel r<J mi~ng VN-14214-11 Olic (Thailand) Ltd. Estate, Udomsorayuth Road, Bangpa-In Thai Lan

District, Ayutthaya Province

16 Dermovate cream Clobetasol propionate 0.05%, 5g HOp l tuyp 5g kern b5i ngoai da VN-7185-08 Glaxo Operations UK Ltd Hamire road, Barnard castle, Durham,

Anh DL128DT

17 Diarnicron MR Gliclazide 30mg 30mg HOp 2 vi X 30 vien nen giai ph6ng

VN-12558-ll Les Laboratoires Servier

905 Route de Saran, 45520 Gidy Phap c6 kiem soat lndustrie

18 Diamicron MR 60 Gliclazide 60mg 60mg HOp 2 vi x 15 vien nen giai ph6ng


905 Route de Saran, 45520 Gidy Phap keo dai lndustrie

19 Elthon 50mg Itopride hydrochloride 50mg HOp 2 vi X l 0 vien nen bao phim VN-8408-09 Abbott Japan Co.Ltd 2-1, Inokuchi, 37 Katsuyama, Fukui

Nh~Ban 911-8555

20 Eumovate cream Ciobetasol butyrate 0.05%, 5g HOp l tuyp 5g kern b5i ngoai da· VN-7687-09 Glaxo Operations UK Ltd Hamire road, Barnard castle, Durham,

Anh DL128DT

166 Moo 16 Bangpa-In Industrial

21 Fugacar Mebendazole 500mg HOp l vi X l vien nen VN-11118-10 Olic (Thailand) Ltd. Estate, Udomsorayuth Road, Bangpa-In Thai Lan District, Ayutthaya Province

22 Gadovist Gadobutrol lmrnoVml HOpi xylanh x 5ml, hQp 5 xylanh

VN-12876-11 Bayer Schering Pharma AG D-13342 Berlin Dire x l Oml dung djch tiem

23 Glucobay 50 Acarbose 50mg HOp 10 vi X 10 vien nen VN-10758-10 Bayer Schering Pharma AG D-51368 Leverkusen Dire

24 Glucobay 100 Acarbose lOOmg HOp 10 vi X l 0 vien nen VN-10757-10 Bayer Schering Pharma AG D-51368 Leverkusen Dire

Gyno-Pevaryl Depot Econazole nitrate l50mg HOp l vi x 2 vien trirng d(U fun ·

VN-11127-10 Xian-Janssen Pharmaceutical 34 North Wanshou Road, Xian,

Trung Qu5c 25 d~to Ltd. Shaanxi

Iloprost trometamol HOp 5 6ng lml dung djch d~ d~c Poligono Industrial Santa Rosa S/n, E- ' I

26 Ilomedin 20 27mcg/lml tuang duang 20 mcg/lml de pha tiem truyen

VN-9947-10 Berlimed S.A 28806 Alcala de Henares, Madrid

TayBanNha

20mcg/lml Iloprost

166 Moo 16 Bangpa-In Industrial

27 1m odium Loperamide hydrocloride 2mg HOp 25 vi x 4 vien nang VN-13196-ll Olic (Thailand) Ltd. Estate, Udomsorayuth Road, Bangpa-In Thai Lan District, Ayutthaya Province

Trang 217

STT Ten thu6c Ho~t chit Ham hrQllg D~ng bao ch~, Quy each

S6 dAng kj CO' sO' san xuit Dja chi cO' sO' san xuit Ntr6"c san

d6ng g6i xuAt

AstraZeneca UK Limited. (Co Silk Road Business Park, Macclesfield,

28 Ires sa Gefitinib 250 mg Vien nen bao phim. Hop 3 vi X 10

VN- 15209-12 sa san xudt)- AstraZeneca Cheshire, SKIO 2NA (Co sa san xudt)-

Anh v1en Pharmaceutical Co.,Ltd (Co sa sb 2 duang HuangShan, Wuxi, Jiangsu,

d6ng g6i) Trung Qubc (Co sa d6ng g6i)

29(') Klacid Clarithromycine 125mg/5ml Cbm pha hfin djch ubng. Hop 1 lo

VN-4142-07 PT.Abbott Indonesia Jl, Ray a 1 akarta Bogo Krn3 7, Bogo

Indonesia 60ml & Hop 1 Io 30m! 16415

30 Lacipil2mg Lacidipin 2mg Hop 4 vi X 7 vien nen bao phim VN-9227-09 Glaxo Wellcome SA Avda De Extremadura no 3, 09400

TayBanNha Aranda de duero, Burgos

31 Lacipil 4mg Lacidipin 4mg Hop 4 vi X 7 vien nen bao phim VN-9228-09 Glaxo Wellcome SA Avda. De Extremadura no 3, 09400

TayBanNha Aranda de duero, Burgos

32 Levitra Vardenafil 10 mg Hop 1 vi X 4 vien nen bao phim VN-6928-08 Bayer Schering Pharma AG D-51368 Leverkusen Due

33 Levitra Vardenafil 20 mg Hop 1 yi X 4 vien nen bao phim VN-6929-08 Bayer Schering Pharma AG D-51368 Leverkusen Due

34 Levitra Vardenafil 5mg Hop 1 vi X 4 vien nen bao phim VN-6930-08 Bayer Schering Pharma AG D-51368 Leverkusen Due

Omeprazole sodium 42,6 Bot va dung moi

35 Losee Omeprazole

mg tuang duang pha dung djch tiem tinh m~ch,

VN-9444-10 AstraZeneca AB SE-151 85 Sodertalje Th1,1yDi~n sodium hQp I lo chUa bQt dong kho va 1

Omeprazole 40 mg bngdungmoi

Omeprazole magnesium Vien nen khang djch d~ day , hQp

36 Losecmups Omeprazole magnesium 20,6 mg tuang duang VN-10733-10 AstraZeneca AB SE-151 85 Sodertalje Th1,1yDi~n Omeprazole 20 mg

2 vi x 7 vien

37 Magnevist Gadopentetate

469.01 mg/ml, lOrn! Hop I lo I o ml dung djch tiem VN-14921-12 Bayer Schering Pharma AG D-13342 Berlin Due dimeglumine

38 Mabie Meloxicam 15 mg/1,5 ml Hop 5 bng x 1,5ml VN-6453-08 Boehringer Ingelheim Espana Prat de Ia Riba, 50, 08174, sant Cugat

TayBanNha S.A del Valles (Barcelona)

39 Mabie Meloxicam 7,5mg Vien nen, hQp 2, 3 vi X 10 vien VN-5222-08 Boehringer Ingelheim Pharma Binger Str.l73 55216 Ingelheim am

Due GmbH&Co.KG, Rhein

40 Mabie Meloxicam 15 mg Vien nen, hQp 2, 3 vi X 10 vien VN-5221-08 Boehringer Ingelheim Pharma Binger Str.l73 55216 lngelheim am

Due GmbH&Co.KG, Rhein

Hop I chai 30m!, hQp 1 chai 60ml 166 Moo 16 Bangpa-In Industrial

41 Motilium Domperidone lmg/ml Hein djch ubng

VN-13739-ll Olic (Thailand) Ltd. Estate, Udomsorayuth Road, Bangpa-In ThaiLan District, Ayutthaya Province

166 Moo 16 Bangpa-In Industrial 42 Motilium-M Domperidone lOmg Hop 10 vi X 10 vien nen VN-14215-ll Olic (Thailand) Ltd. Estate, Udomsorayuth Road, Bangpa-In Thai Lan


43 Mucosta Rebamipide lOOmg Hop 10 vi X 10 vien nen VN-12336-11 Korea Otsuka Pharmaceutical 903 Sangsin-ri Hyangnam-eup

Han Qubc Co., Ltd. Hwaseong-si Gyeonggi-do

44 Nexavar Sorafenib tosylate 200 mg Hop 6 vi X 1 0 vi en nen bao phim VN-9946-10 Bayer Schering Pharma AG D-51368 Leverkusen Due --

Trang 3/7

J. Nu6'c san STT Ten thu6c Ho~t chAt Ham luQ'Dg

D~ng bao che, Quy each s6 di'ing ky CO' sO' san xuit Dja chi cO' sO' san xuit

d6ne; e;6i xu it

45 Nirnotop Nirnodipine 300mg Hc;>p 3 vi 10 vien nen VN-10759-10 Bayer Schering Pharma AG D-51368 Leverkusen Due

Tamoxifen citrate 30,4 mg Silk Road Business Park, Macclesfield,

46 Nolvadex- D 20 mg Tamoxifen tuang duang voi Vien nen bao, hQp 3 vi x 10 vien VN-7977-09 AstraZenneca UK limited Cheshire, SK 10 2NA

Anh Tamoxifen 120mg Tamoxifen citrate 15,2 mg

Silk Road Business Park, Macclesfield, 47 Nolvadex 10 mg Tamoxifen tuang duang v6i Vien nen bao. Hc;>p 3 vi x 10 vien VN-13483-11 AstraZeneca UK Limited

Cheshire, SK 10 2NA Anh

Tamoxifen lOmg

Bristol-Myers Squibb. (Co sa 4601 Highway 62 East, Mount Vernon,

48 Onglyza 2,5 mg Saxagliptin 2,5mg Vien nen bao phim. Hc;>p 2 vi X 14

VN2-l-12 san xudt) - Bristol-Myers Indiana 47620 (Co sa san xudt)-

HoaKy v1en

Squibb S.r.l. (Ca sa d6ng g6i) Contrada Fontana del Ceraso, 03012 Anagni, Y (Co sa d6ng g6i)

Bristol-Myers Squibb. (Co sa 4601 Highway 62 East, Mount Vernon,

49 Onglyza5 mg Saxagliptin 5mg Vien nen bao phirn, hQp 2 vi X 14

VN2-2-12 san xudt) - Bristol-Myers Indiana 47620 (Co sa san xudt)-

HoaKy vi en Contrada Fontana del Ceraso, 03012

Squibb S.r.l. (Ca sa d6ng g6i) Anagni, Y (Co sa d6ng g6i)

50 Pletaal Cilostazol 50mg Hc;>p 10 vi x 10 vien nen VN-12337-11 Korea Otsuka Pharmaceutical 903 Sangsin-ri Hyangnam-eup

HanQu6c Co., Ltd. Hwaseong-si Gyeonggi-do

51 Pletaal Cilostazol 100mg Hc;>p 10 vi x 10 vien nen VN-12338-11 Korea Otsuka Pharmaceutical 903 Sangsin-ri Hyangnam-eup

HanQu6c Co., Ltd. Hwaseong-si Gyeonggi-do

52(•) Pneumorel Fenspiride HCl 80mg 80mg Hc;>p 2 vi x 15 vien bao VN-3074-07 Les Laboratoires Servier

905 Route de Saran, 45520 Gidy Phap Industrie

53(•) Procoralan 5mg lvabradine 5mg 5mg Hc;>p 4 vi X 14 vien nen bao phirn VN-4520-07 Les Laboratoires Servier


54(•) Procoralan 7.5mg 1vabradine 7.5mg 7.5mg Hc;>p 4 vi X 14 vien nen bao phirn VN-4521-07 Les Laboratoires Servier


55(•) Protelos Strontinium Ranelate 2g 2g Hc;>p 28 g6i bQt pha hfin djch u6ng VN-5007-07 Les Laboratoires Servier

905 Route de Saran, 45520 Gidy PMp Industrie

56 Provironum Mesterolone 25mg Vien nen. H()p 5 vi X 10 vien nen VN-9007-09 Schering do Brasil quirnica E Rua Cancionerio de Evora, 255-Cep

Brasil Farmaceutica Ltds. 04708-010 Sao Paulo

57 Risperdallmg Risperidone 1mg H()p 6 vi X 10 vien nen VN-10312-10 Janssen-Cilag SpA.-Via C.

04010 Borgo S. Michele, Latina y Janssen

58 Risperdal 2mg Risperidone 2mg H()p 6 vi X 10 vien nen VN-5438-10 Janssen-Cilag SpA.-Via C.

04010 Borgo S. Michele, Latina y Janssen

H()p 1 IQ bQt pha tiem tinh m\).ch 59 Rocephin Ceftriaxone lg lg + 1 6ng dung djch ph a ticm 10 VN-6149-08 F. Hoffmann-La Roche Ltd CH-4303 Kaiseraugst Thvy Si

ml

60 Rocephin Ceftriaxone 250mg H()p 1 IQ bQt pha tiem tinh m\).ch +

VN-6148-08 F. Hoffmann-La Roche Ltd CH-4303 Kaiseraugst Thvy Si 1 6ng dung djch pha tiem 5ml ---- - ----L_ ---

Trang 4/7

STT Ten thu6c Ho~t chAt Ham hrQllg D~ng bao ch~, Quy each

S6 dAng kY CCY sir san xuAt Dja chi cCY si'r san xuAt Nli'O'C san

done: e:oi xu it Quetiapine fumarate

Vien nen ph6ng thich keo dru, h(lp Silk Road Business Park, Macclesfield, 61 Seroque1 xr 200 mg Quetiapine 230,26 mg tuang duang VN-4976-10 AstraZeneca UK Limited Anh

Quetiapine 200 mg 3 vi x 10 vien Cheshire, SK 10 2NA

Quetiapine fumarate Vien nen ph6ng thich keo dru, hQp Silk Road Business Park, Macclesfield,

62 Seroquel xr 300 mg Quetiapine 345,38 mg tuang duang VN-4977-10 AstraZeneca UK Limited Anh Quetiapine 300 mg

3 vi x 10 vien Cheshire, SK 10 2NA

Quetiapine fumarate Vien nen ph6ng thich keo dAi, hQp Silk Road Business Park, Macclesfield,



Quetiapine fumarate Vien nen ph6ng thich keo dru, hQp Silk Road Business Park, Macclesfield,



65 Sifrol Pramipexole HCI 1.5mg H(lp 3 vi x 1 0 vien nang giru

VN1-408-11 Boehringer Ingelheim Pharma Binger Str. 173 55216 Ingelheim am

Due ph6ngch~ GmbH&Co.KG Rhein

66 Sifrol IR Pramipexole HCI 0.25mg H(lp 3 vi x 10 vien nang giru

VN-10785-10 Boehringer Ingelheim Pharma Binger Str. 173 55216 Ingelheim am I

ph6ngch~ GmbH&Co.KG Rhein Due

67 Sifrol IR Pramipexole HCI 1mg H(lp 3 vi x 10 vien nang giru

VN-14928-12 Boehringer Ingelheim Pharma Binger Str. 173 55216 Ingelheim am

Due ph6ngch~ GmbH&Co.KG Rhein

Vi en nang khi dung; h(lp 3 vi x 10 Boehringer lngelheim Pharma Binger Str.l73 55216 Ingelheim am

68 Spiriva Tiotropium bromide 18 meg vi en ho~c 1 vi x 1 0 vien kern d\IIlg VN-6939-08 · Due Cl,l d~ hit

GmbH&Co.KG Rhein

69 Spiriva Respimat Tiotropium bromide 2,5 mcg/xjt Dung djch phun mu, H(lp 60 nhat

VN-6456-08 Boehringer Ingelheim Pharma Binger Str.173 55216 Ingelheim am

Due xjt. GmbH&Co.KG Rhein

166 Moo 16 Bangpa-In Industrial 70 Sporal Itraconazole IOOmg H(lp 1 vi x 4 vien nang VN-13740-11 Olic (Thailand) Ltd. Estate, Udomsorayuth Road, Bangpa-ln Thai Lan


B(l san phfun bao gbm 1 hQp thu6c Sporanox IV chua 1 6ng thu6c

71 SporanoxiV Itraconazole 250mg/25ml 25ml, I tili dung moi NaCI 0.9% VN-15479-12 Janssen Pharmaceutica N.Y. Turnhoutseweg 30, B-2340, Beerse Bi va 1 bQ day c6 n6i kh6a van hai chiSu

166 Moo 16 Bangpa-In Industrial 72 Stugeron Cinnarizine 25mg H(lp 25 vi x 1 0 vi en VN-14218-11 Olic (Thailand) Ltd. Estate, Udomsorayuth Road, Bangpa-Jn Thai Lan


73 Survanta Phospholipid (Bovine lung

25mg/ml H&n djch dimg dubng n9i khi

VN-12133-11 Abbott Laboratories North Chicago, IL 60064 HoaKy lipids) quan, H9p 1 IQ 4ml

Trang 5 I 7

STT Ten thuAc Ho~t chit Ham hrQllg D~ng bao chS, Quy each

sA dang kY Ca sO' san xu!t Dja chi ca sO' san xu!t Ntr6'c san

c16ne; e;6i xu it

74 Tanatril 5mg Imidapril 5mg Vien nen, MP 10 vi X 10 vien VN-13231-11 P.T. Tanabe Indonesia n Rumah Sakit No.104 Ujungberung

Indonesia Bandung 40612

75 Tanatril10mg Imidapril 10mg Vien nen, h(>p 10 vi X 10 vien VN-13230-11 P.T. Tanabe Indonesia n Rumah Sakit No.1 04 Ujungberung

Indonesia I Bandung 40612

76 Tavanic Levofloxacin 500mg Dung djch tiem truyen, Mp 1 IQ

VN-11312-10 Sanofi -Aventis Deutschland Bruningstrasse 50 D-65926 Frankfurt

Due lOOm! GmbH am Main

77 Tavanic Levofloxacin 500mg Vien nen bao phim, Mp 1 vi X 5

VN-10551-10 Sanofi Winthrop lndustrie 56, Route de Choisy-au-Bac 60205

Phap vien Compiegne

78 Tavanic Levofloxacin 250mg Dung djch tiem truySn, h(>p 1 IQ

VN-11311-10 Sanofi -Aventis Deutschland Bruningstrasse 50 D-65926 Frankfurt

Due 50ml GmbH am Main

79 Topamax Topiramate 50mg H(>p 6 vi x 10 vien VN-12512-11 CilagAG Hochstrasse 201, 8200 Schaffhausen Th\IY si

so<'> Trivastal Retard Piribedil 50mg 50mg H(>p 2 vi x 15 vien bao ph6ng


905 Route de Saran, 45520 Gidy Phap thlchch~ lndustrie H(>p 10 chai 50 ml, H(>p 10 chai

81 Ultravist 300 Iopromide 623.40mg/ml lOOm! dung djch tiem ho~c tiem VN-14922-12 Bayer Schering PharmaAG D-13342 Berlin Due truyen H(>p 10 chai 50 ml, H(lp 10 chai

82 Ultravist 370 Iopromide 768.86mglml 100ml dung djch tiem hoi;ic tiem VN-14923-12 Bayer Schering Pharma AG D-13342 Berlin Due truySn

83 Viramune Nevirapine hemihydrate 50mg/5ml HOp djch u6ng, chai 20ml va

VN-5864-08 Boehringer lngelheim Roxane

Columbus, OH 43228 HoaKy 240ml Inc.

84 Xarelto Rivaroxaban 10mg H(>p 1 vi x10 nen bao phim VN-13506-11 Bayer Schering Pharma AG D-51368 Leverkusen Due

85 Xeloda Capecitabine 500mg HOp 12 vi X 10 vien nen bao phim VN-10242-10 Hoffmann-La Roche Inc. 340 Kingsland Street, Nurley NJ 07110 HoaKy

Via Isidro Fabela Nte.1536-B. Productos Roche S.A de C.V CP50030 Col. Parque Industrial Toluca

86 Xeloda Capecitabine 500mg H(lp 12 vi X 10 vien nen bao phim VNl-604-12 (Ca sa sim xudt)- F. Hoffmann (Ca sa sim xudt) - CH-4303 Mexico La Roche Ltd. (Co sa d6ng g6i) Kaiseraugst., Switzeland (Ca sa d6ng

g6i)

87 Zeffix tablets Lamivudin lOOmg H(lp 2 vi X 14 vien nen bao phim VN-10262-10 Glaxo Operations UK Ltd Priory street, Ware, Hertforshire, SG12

Anh ODJ Lll 27, E>uang s6 3A, Khu cllng nghiep I

88 Zentel 200mg A1bedazole 200mg H(>p 1 vi X 2 vien nen bao phim GC-0182-12 Cong ty C6 phdn duqc phfun.

Bien Hoa II, Thanh ph6 Bien Hoa, tinh VietNam OPV

E>AngNai

Lisinopril Lisinopril dihydrate 10,89

Silk Road Business Park, Macclesfield, 89 Zestril 10 mg

dihydrate mg, tuang duang v(ri _ 1 ~ Vien nen, Mp 2 vi X 14 vien VN-15212-12 AstraZeneca UK Limited

Cheshire, SKIO 2NA Anh

mg lisinopril khan Lisinopril dihydritte 21,78

Silk Road Business Park, Macclesfield, 90 Zestril 20 mg Lisinopril dihydrate mg, tuang duang v(ri 20 Vien nen, h(>p 2 vi X 14 vien VN-15211-12 AstraZeneca UK Limited Anh

mg lisinopril khan · Cheshire, SK10 2NA

----

Trang 6/7

STT Ten thu6c Ho~t ch~t Ham hrQllg . D~ng bao ch~, Quy each

s6 dang kY ' I. D!a chi cO' so· san xu~t

NtrO'c san d6n2 26i

CO' sO' san xuat xu~t

Lisinopril dihydrate 5,45 Silk Road Business Park, Macclesfieid,

91 Zestril5 mg Lisinopril dihydrate mg, tuang duang v6'i 5 Vien nen, hop 2 vi x14 vien VN-15213-12 AstraZeneca UK Limited Anh mg lisinopril khan

Cheshire, SK10 2NA

92 Zinacef Ceftrroxime(du6'id~g

750mg Hop 1 1Q bot pha tiem ho~c truyen VN-10706-10 GlaxoSmithKline

Via A. Fleming 2, Verona, 3 713 5 y Cefuroxime natri) Manufacturing S.p.A

93 Zinnat suspension Ceftrroxime ( du6i d~g

125mg/5ml Hop 1 chai ho~c 10 g6i c6m pha

VN-9663-10 Glaxo Operations UK Ltd Harmire road, Barnard castle, Durham,

Anh Ceftrroxime axetil) hfin djch u6ng DL128DT

94 Zinnat tablets Ceftrroxime(du6'id~g

500mg Hop 1 vi X 10 vi en nen bao phim VN-10261-10 Glaxo Operations UK Ltd Harmire road, Barnard castle, Durham,

Anh Cefuroxime axetil) DL128DT

95 Zinnat tablets 250mg Ceftrroxime(du6'id~g

250mg Hop 1 vi X 1 0 vi en nen bao phim VN-5372-10 Glaxo Operations UK Ltd Harmire Road, Barnard Castle, Durham,

Anh Ceftrroxime axetil) DL128DT

96 Zinnat tabletsl25mg Cefuroxime ( du6i d~g

125mg Hop 1 vi X 10 vi en nen bao phim VN-10260-10 Glaxo Operations UK Ltd Harmire Road, Barnard Castle, Durham,

Anh Cefuroxime axetil) DL128DT

Ghi chU:

<·>: Thu6c da h~t h1,ID s6 dang kY nhtmg dugc phep luu hfmh d~n h~t h\ln dung cua thu6c.

Trang 717

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tri - Cục Y tế Giao thông Vận tảicucytegiaothong.mt.gov.vn/Uploads/File/QD 115 BYT.pdfCan cu Quy~t djnh s6 2962/QI>-BYT ngay 22/08/2012 cua B() Y t~ ve vi~c ban hanh Quy djnh