• Không có kết quả nào được tìm thấy

Can cu Thong t u s6 44/2014/TT-BYT ngay 25/11/2014 cua Bo Y t8 qui dinh viec dang Icy thuoc,

N/A
N/A
Protected

Academic year: 2022

Chia sẻ "Can cu Thong t u s6 44/2014/TT-BYT ngay 25/11/2014 cua Bo Y t8 qui dinh viec dang Icy thuoc, "

Copied!
68
0
0

Loading.... (view fulltext now)

Văn bản

(1)

B O Y T E

c u e Q UAN L Y D U ' O C

S6: S'^ / Q D - Q L D

C O N G H O A X A H O I C H U N G H I A V I E T N A M f)oc lap - T y do - H a n h phuc

,.; Ha Npi, ngayjb^thdng Jj nam 2016

Q U Y E T D I N H

V e viec ban h a n h d a n h m u c 469 thuoc san x ua t trong nu-6-c du-o-c c a p so dang ky lu-u h a n h tai V i e t N a m - Bo-t 156

- -J t, '

e y e T R U ' C T N G C U C Q U A N L Y D L T O C

C a n c u L u a t D u g c n g a y 1 4 t h a n g 6 n a m 2 0 0 5 ; .

Can cu Nghi diiih s6 63/2012/ND-CP ngay 31/8/2012 cua Chinh phu quy dinh chuc nang, nhiem vu, quyen han va ca cau to chuc cua Bo Y te;

Can cu Quyet dinh s6 3861/QD-BYT ngay 30/9/2013 cua Bo truong Bo Y te quy dinli chuc nang, nhiem vu, quyen han va ca c l u to chuc cua Cue Quan ly Dugc thuoc B o Y t a ;

Can cu Thong t u s6 44/2014/TT-BYT ngay 25/11/2014 cua Bo Y t8 qui dinh viec dang Icy thuoc,

r \ r r r f

Can cu y kien cua H o i dong t u van cap so dang k y Imi hanh thuoc Bo Y te;

Xet de nghi cua Phong Dang l<y thuoc - Cue Quan ly Dugc,

Q U Y E T D I N H :

Dieu 1. Ban hanh kem theo Quyet dinh nay danh muc 469 thuoc san xuat trong

nuac dugc cap so dang Icy luu hanh tai Viet Nam - Dgt 156.

"y r ^ r

Dieu 2. Cong ty san xuat va cong ty dang k y co thuoc luu hanh phai in so dang

ley dugc Bg Y te cap len nhan thuoc va phai chap hanh dung cac quy che co lien quan tai san xuat va l u u hanh thuoc. Cac so dang ky co ky hieu VD-...-16 co gia tri 05 nam ke t u ngay ky Quyet dinh.

Dieu 3. Quyet dinh nay co hieu lire ke t u ngay k y ban hanh.

Dieu 4: Giam doc Sa Y te cac tinh, thanh pho true thuoc trung uang va giam

doc cong ty san xuat va cong ty dang ky co thuoc tai Dieu 1 chiu trach nhiem thi hanh Quyet dinh nay.

Nai nhan:

- Nhu Dilu 4;

- BT. Nguyen Thi Kim Tien (de b/c);

- TT. Le Quang Cuong (de b/c);

- Cue Quan y - Bo Quoc phong, Cue Y t l - Bo CA;

- Cyc Y te giao thong van tai- Bo GTVT;

- Tong Cue Hai Quan-Bo Tai Chinh;

- Bao hilm xa hoi Viet Nam;

- Vu Phap che, Cue Quan ly Y Duoc c6 truyen, Cue Quan ly Kham, chua benh - Bo Y tS; Thanh tra Bo Y t6;

- Vien KN thuoc TU" va VKN thu6c TP.HCM;

- T6ng Cong ty Dugc VN;

- Cac benh vien, Vien co giuong benh true thuoc BYT;

Tru-o-ng Q u o c Cu-o-ng

(2)

BO Y TE

c u e QUAN LY DU'OC

CONG HOA XA HOl CHU NGHIA VIET N A M Doc lap - Tu- do - Hanh phuc

D A N H M U C 4 6 9 T H U O C S A N X U A T T R O N G NlSdC

D U ' O C C A P S O D A N G K Y H I E U L I / C 0 5 N A M - D O T 1 5 6

Ban hanh kem theo quySt dinh s6:

J . . / Q D - Q L D ,

ngay A£j...M.J..20£

1. Cong ty dang ky: C h i nhanh cong ty T N H H san xuat - kinh doanh ducrc pham Dam San (D/c: Gian E22-E23 - Trung tdm thucmg mai duac phdm va trang thief biy te -134/1 To Hien Thdnh - Phuang 15 - Quan 10-TP. Hd Chi Minh - Viet Nam)

L I Nha san xuSt: Cong ty T N H H duffc phSm U S A - N I C (USA - N I C Pharma) (D/c: Ld IID duang C - KCN Tdn Tgo - Phuang Tan Tgo A - Quan Binh Tan - TP. Hd Chi Minh - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lu-gng

Dang bao 'che

Tu6i tho

Tieu chuan

Quy each

dong goi S6 dang ky Ceratex

Dasamex - DS

Cetirizin

dihydroclorid lOmg Paracetamol 500mg

Vien nang cung Vien nang cirng

36 thang

"36 thang

TCCS

DDVN IV

HQP l O v i x 10 vien; Chai 200 vien

H Q j" r 0 v i 7 l 0 ' vien; Chai 100 vien; Chai 500 vien

VD-25566-16

VD-25567-16

Devaligen - ND Paracetamoi 500rag;

Phenylephrin hydroclorid lOmg

Vien nen 36 thang

TCCS Hop 25 vi x 4 vien; Hpp 10 vi X 10 vien; Hop 5 vi X 20 vien

VD-25568-16

Ibucine 400 Ibuprofen 400mg Vien nen bao phim

36 thang

DDVN Hop 02 v i x 10 IV vien; Hop 10 vi

X 10 vien; Chai 100 vien

VD-25569-16

Pancres Pancreatin 170mg

(tuangu-ng vdi 238 l U Protease, 3400IU Lipase, 4080 l U Amylase)

Vien nen bao tan trong ruot

36 thang

TCCS Hpp 10 v i x 10 vien; Chai 100 vien

VD-25570-16

Tagimex Cimetidin 300mg Vien nen bao phim

36 thang

TCCS Hop 10 v i x 10 vien; Chai 100 vien

VD-25571-16

2. Cong ty dang ky: Co" s& san xuat dong duffc C m i Long (D/c: 28 Huynh Phan Ho, Trd An, Binh Thuy, Can Tha - Viet Nam)

(3)

2.1 Nha san xudt: Cff so* san xuat dong dugc C u u L o n g (D/c: 28 Huynh Phan Ho, Tra An, Binh Thuy, Cdn Tha - Viet Nam)

S i r Ten thuoc Hoat chat chinh - Ham lugng

Dang bao Tnhi th9

Tieu chuan

Quy each

dong goi So dang ky 7 GastraQK9 Bpt v6 mu u 250mg;

Bot mai muc 50mg;

Bgt nghe lOmg

Vien nen 24 thang

TCCS Hop 1 chai 100 vien

VD-25572-16

3. Cong ty dang ky: Cong ty C 6 phan B V Pharma (D/c: Ap 2, Xa Tdn Thanh Tdy-Huyen Cu Chi-Thdnh phS Hd Chi Minh - Viet Nam)

3.1 mk san xuat: C6ng ty Co ph^n B V Pharma (D/c: Ap 2, Xd Tdn Thanh Tdy-Huyen Cu Chi-Thdnh phd Hd Chi Minh - Viet Nam)

STT Ten thuoc Hoat ch^t chinh - Ham luong

Dang hko c h i

Tuoi th9

Tieu chuan

Quy each

d6ng goi So dang ky 8

9

Bivicarbo Bivinadol 325

Acarbose 50mg Paracetamol 325mg

Vien nen Vien nen bao phim

36 thang

48 thang

TCCS TCCS

H d p l O v i x l O vien

Chai 500 vien, h6p 10 v i x 10 vien, hpp 1 chai 200 vien

VD-25573-16 VD-25574-16

~ i o ~ Tenofovir - BVP Tenofovir disoproxil fumarat 300mg

Vien n6n bao phim

~36~

thang f e e s " H 6 p 3 v r x l o "

vien

" VD-25575-r6'

11 Vixcar Clopidogrel (dual dang Clopidogrel bisulfat) 300mg

Vien n6n bao phim

24 thing

TCCS H 9 p 3 v i x l 0 vien

VD-25576-16

4. Cong ty dang ky: Cong ty co phan cong nghf cao Traphaco (D/c: Xd Tdn Quang, huyen Van Ldm, tinh Himg Yen -)

4.1 N h i s i n xuat: C6ng ty c6 ph^n cong nghf cao Traphaco (D/c: Xd Tdn Quang, huyen Van Ldm, tinh Hung Yen - Viet Nam)

s i r Ten thuoc Hoat chat chinh - Ham lugng

Dang bao che

Tuoi th9

Tieu chuan

Quy each

dong goi So dang ky 12 Hoan Dieu kinh bo

huyet

M6i 5 g chura: Thyc dja l,2g; Duomg qui

l,2g; Bachthugc 0,3g; Xuyen khung 0,3g; Cao d^c ich

Vien hoan curng

36 thdng

TCCS HOp 1 0 t u i x 5 gam; hop 20 tiii x 5 gam

VD-25577-16

(4)

13 Nhan sam tarn that

mau (tuang duang 2,4 g ich mau) 0,3g;

Cao dac ngai cuu (tuang duang 1,2 g ngai cuu) 0,15g;

Huang phu che 1,2g

VD-25578-16 13 Nhan sam tarn that Nhan sam 140mg;

Tarn that 60mg

Vien nen 36 thang

TCCS Hop 5 VI X 12 vien; hop 10 vi X 15 vien

VD-25578-16

5. Cong ty dang ky: Cong ty co phan Dw&c A T M (D/c: 89F, Nguyen Van Troi, P. Phuomg Liet, Q. Thanh Xudn, Tp Hd Ndi - Viet Nam)

5.1 Nha san xuat: Cong ty co phan diro'c v^t tu-y te Hai Du-ong (D/c: 102 Chi Lang, thdnh phd Hdi Duomg - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lirgng

Dang bao ehl

Tuoi tho

Tieu chuan

Quy each

dong goi So dangky 14 Atmethysla 500mg Inj Moi 4ml chu-a:

Etamsylat 500mg

Dung djch thuoc tiem

36 thang

TCCS Hop 10 ong X 4ml

VD-25579-16

6. Cong ty dang ky: Cong ty c6 phSn dwgc Danapha (D/c: 253 - Dung ST Thanh Khe - Quan Thanh Khe - Tp. Dd Nang - Viet Nam)

6.1 Nha san xuat: Cong ty co phSn du-o-c Danapha (D/c: 253 - Dung ST Thanh Khe - Quan Thanh Khe - Tp Dd Ndng - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lu-pug

D^ng bao che

Tuoi th9

Tieu chuan

Quy each

dong goi So dang ky 15 Daquetin 25 Quetiapin (du6i Vien nen bao 36 TCCS Hop 3 vi X 10 VD-25580-16

dang Quetiapin phim thang vien fumarat) 25 mg

Myolaxyl Mephenesin 250 mg Vien nen bao ' 3 6 " TCCS~ Hop 2 vi X 25 "vD-25 581-16""

duorng thang vien

17 Sorbitol 5g Moi goi 5g chu-a: Thuoc bpt 24 TCCS Hop 20 goi 5g VD-25582-16 Sorbitol 5g pha dung thang

dich uong

7. Cong ty dang ky: Cong ty co phan duffc Dong Nai. (D/c: 22IB Pham Van Thudn, p. Tdn Tien, Tp. Bien Hod, Dong Nai - Viet Nam)

7.1 Nha san xuat: Cong ty co phan duo-c Dong Nai. (D/c: 22IB Pham Van Thudn, p. Tdn Tien, Tp. Bien Hod, DdngNai - Viet Nam)

(5)

STT Ten thuoc Hoat chat chinh - Ham lugng

D^ng bao che

Tuoi tho

Tieu chuan

Quy each

dong goi So dang ky

18 Lazzy Lamivudin lOOmg Vien nang

cung _ 36 thang

TCCS Hop3 v i x 10 vien

VD-25583-16 19 Losartan 25 Losartan kali 25mg Vien nen ~36"

thang

f e e s H9p3 v T x l o " ' vien

VD-25584^16 20 Mepragold 10 mg Atorvastatin (dirdri

dang Atorvastatin calci) lOmg

Vien nen bao phim

36 thang

TCCS Hop 5 v i x 10 viSn

VD-25585-16

21 Mepragold 20 mg Atorvastatin (du6i dang Atorvastatin calci) 20mg

Vien n6n bao phim

" 36"

thing

f e e s Hop's v r x 10 ' vien

VD-25586-16 '

22 Mylenfa II Nhom hydroxyd 200mg; Magnesi hydroxyd 200mg;

Simethicon 20mg

Vien n6n 24 thing

TCCS H O p l O v i x l O vien, chai 50 vi6n, chai 100 viSn

VD-25587-16

23 Toptropin 800 mg Piracetam 800mg Vien n6n bao phim

36 thing

TCCS Hop 10 v i x 10 vien

VD-25588^r6

8. Cong ty dang k y : Cong ty co plian Dwqc H a Tinh (D/c: So 167 duang Hd Huy Tap, phuang Nam Hd, thdnh phd Hd TTnh, tinh Hd Tinh - Vi$t Nam)

8.1 Nha san xu^t: Cong t y co phan dir^c Hk TTnh. (D/c: Cum congnghiep - Tiiu thu congnghiep \ Bac Cam Xuyen, xd Cdm Vinh, huyen Cdm Xuyen, Hd Tinh - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lu-Qtig

Dang hko c h l

Tu6i thQ

Tieu chuan

Quy each

d6ng goi So dang ky 24 Sang mat Moi 125ml chua

djch chiet tij* cic dugrc lieu tucmg tag v6i: Thuc d}a 23g;

San thu 11,5g; Mau dan bi 8,6g; Hoai son 1 l,5g; Phuc linh 8,6g; Trach ti'8,6g;

Cau ky tur 8,6g; Cue hoa 8,6g; Duomg quy 8,6g; Bach thugc 8,6g; Bach t i t le 8,6g; Thacli quyet minh 11,5g

Siro 36

thing

TCCS HQP 1 IQ X

60ml, 100ml, 125ml; hOp 10 ong, 15 ong, 20 ong X 10ml

VD.25589-16

25 Tumegas M6i 15ml chua: Bpt nghe vang 4,5g

Gel uong 36 thing

TCCS Hop 10 goi, 20 goi, 30 goi X

15ml; hpp 1 lo X 60ml, 90ml,

VD-25590-16

(6)

26 Vien tang sue Dau nanh 60mg;

Hoai son lOmg; Y dT lOmg; Mat ong 5mg

Vien bao duong

36 thang

TCCS

100ml, 125ml, 200ml

Goi 60 vien, 80 vien, 100 vien, 200 vien; hop 1 lo X 60 vien, 80 vien, 100 vien, 200 vien

VD-25591-16

9. Cong ty dang ky: Cong ty c6 ph3n dvt&c Hau Giang (D/c: 288 Bis Nguyin Van Cie, p. An Hod, Q. Ninh Kiiu, Cdn Tha- Viet Nam)

9.1 Nha san xu3t: Cong ty co phan du-o-c Hgu Giang (D/c: 288 Bis Nguyin Van Cir, p. An Hod, Q. Ninh Kiiu, Cdn Tha - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham hrqng

Dang bao chl

Tuoi th9

Tieu chuan

Quy each

dong goi So dang ky 27 E'Rossan Shampoo Moi 5ml chira:

Ketoconazol lOOmg;

D-panthenol 70mg

Dau goi 24 thang

TCCS Hop 24 goi X

5ml, hop 1 chai x60ml

VD-25592-16

10. Cong ty ding ky: Cong ty co phan du-ac p h i m 2/9 T P H C M (D/c: 299/22 Ly Thuang Kiit, Phuang 15, Quan 11, TP. Hd Chi Minh - Viet Nam)

10.1 Nha san xuat: Cong ty co phan du-ffc pham 2/9 T P H C M (D/c: 930 C4, Duong C, Khu cdng nghiep Cat Lai, Cum 2, phuang Thanh My Lai, Q.2, TP HCM - Viet Nam)

STT Ten thuoc Hoat chat chinh - Hkm lu-ong

Dang bao chi

Tuoi tho

Tieu chuan

Quy each

dong goi So dang 28 Hemafolic M6i 10 ml dung

djch chua: Phuc hgp hydroxyd sSt (III) va Polymaltose tinh theo ion sat (III) 100 mg; Acid folic 1 mg

Dung djch u6ng

36 thang

TCCS Hop lOongx 10 ml

VD-25593-16

11. Cong ty ding ky: Cong ty c6 phan du-o-c phSm 3/2 (D/c: 601 Cdch Mang Thdng Tdm, Phuang 15, Qudn 10, TP. Hd Chi Minh - Viet Nam)

11.1 Nha san xuat: Cong ty c6 phan Du-o-c phSm 3/2 (D/c: So 930 C2, Dudmg C, KCN Cat Lai, P.

Thanh My Lai, Q2, TP. Hd Chi Minh - ViitNam)

(7)

STT Ten thuoc Hoat chat chinh - Ham lirg-ng

Dang bao che

Tuoi th9

Tieu chuan

Quy each

dong goi So dang ky 29 ACM Control 4 Acenocoumarol

4mg

Vien nen 24 thang

TCCS Hop2 v i x 10 vien; hop 10 vi x 10 vien

VD-25594-16

"30" Bisoprolol 2,5 Bisoprolol fumarat 2,5mg

Vien nen bao phim

"24"

thang

f e e s Hop 3~vi x l o ^ vien; hpp 10 vi X 10 vien

VD-25595-16

31 Eftimol 8 Paracetamol 500mg; Codein phosphat

hemihydrat 8mg

Vien nang cung

36 thang

TCCS HQP 10 v i x 10 vien

VD-25596-16

32 Nebivolol 2,5 Nebivolol (dual dang Nebivolol hydroclorid) 2,5mg

Vien nen 24 thang

TCCS Hop 3 v i x 10 vien; hpp 10 vi X 10 vien

VD-25597-16

33 Nebivolol 5 Nebivolol (dudi dang Nebivolol hydroclorid) 5mg

Vi6n nen 24 thang

TCCS Hop3 v i x 10 vien; hop 10 vi X 10 viSn

VD-25598-16

34 Spibiotic 1,5 MIU Spiramycin 1,5MIU Vien nen bao phim

36 thang

TCCS HQP 3 v i x 10 vien; hop 10 vi X 10 vien

VD-25599-16

"35" Tragutan Cineol 0,5mg; Tinh

dku hung chanh Img; Tinh dku gCmg 0,5mg

Vien n6n ngam

"24"

thang

f e e s ' HOp i O v i x 10 vien; hop 24 vien

VD-25600-r6'

12. Cong ty dang ky: Cong ty co ph^n du-g-c pham Agimexpharm (D/c: Sd 27 Nguyin Thdi Hoc, Phuang My Binh, Tp. Long Xuyen, An Giang - ViitNam)

12.1 Nha san xuat: C h i nhanh cdng ty co phan dug-c pham Agimexpharm- N h i may san xuat duQ-c pham Agimexpharm (D/c: Duong VU Trong Phung, Khom Thgnh An, P. My Thdi, TP. Long Xuyen, Tinh An Giang - Viet Nam)

STT Ten thuoc Hoat chat chinh - Him lu-9-ng

Dang bio che

Tu6i th9

Tigu chuan

Quy each

d6ng g6i S6 dang ky 36 Agibetadex Betamethason 0,25

mg;

Dexclorpheniramin maleat 2 mg

Vien n6n 36 thang

TCCS H0p3 v i x 10 vien; Chai 500 vien

VD-25601-16

37 Agicipro Ciprofloxacin (du6i dang Ciprofloxacin HCl) 500 mg

Vien n6n bao phim

36 thang

TCCS HQP 10 v i x 10 vien

VD-25602-16

38 Agiclovir 200 Aciclovir 200 mg Vien nen 36 thang

TCCS HQP 2 vi X 10 vien

VD-25603-16 39 Agidecotyl 500 Mephenesin 500 Vien nen 24 TCCS HQP 2 vi X 12 VD-25604-16

(8)

mg _ bao phim thang vien

40 Agimfast 60 Fexofenadin Vien nen bao ~ 36 TCCS Hop 1 vi x 10 VD-25605-16 hydroclorid 60 mg phim thang vien

41 Agirofen Ibuprofen 600 mg Vien nen bao 24 TCCS Hop 10 v i x 10 VD-25606-16

phim thang vien

42 Agisimva 10 Simvastatin 10 mg Vien nen bao ~36" TCCS Hop3 v i x 10 VD-25607-16

phim thang vien

43 Agivastar 40 Pravastatin natri 40 Vien nen " 36 • TCCS Hop 3 v i x 10 VD-25608-16

mg thang vien

44 Agivitamin B I Vitamin B I Vien nen bao 24 f e e s Hop 10 vi X 10 VD-25609-16

(Thiamin phim thang vien

mononitrat) 250 mg _ _ _ _ _

45 Arbosnew 100 Acarbose 100 mg Vien nen bao f e e s Hop3 v i x l o " VD-25610-16

phim thang vien

"46 Ihybes-H 150 Irbesartan 150 mg; Vien nen bao " 3 6 " f e e s HQpf^vixlo VD-256ir-16~

Hydroclorothiazid phim thang vien 12,5 mg

47 Levagim Levofloxacin (duai Vien nen bao 36" TCCS Hop 1 v i x 10 'VD-2"5612-16"

dang Levofloxacin phim thang vien hemihydrat) 500 mg

"48 Magisix Magnesi lactat Vien nen bao

_ _ _ _ _

TCCS Hop 1 0 v i x lo' 'VD-"25613-r6"

dihydrat 470 mg; phim thdng vien Pyridoxin

hydroclorid 5 mg

49 Mebendazol Mebendazol 500 mg Vien n6n bao ~36" f e e s ' Hop r v T x l " " VD-25614-16

phim thang vien

50 Olangim Olanzapin 10 mg Vien nen bao 36 TCCS Hop 5 v i x 10 VD-25615-16

phim thang vien

s i " Smecgim M6i goi 3,67g chura: Thuoc bot ~ 2 4 " f e e s Hop 30 goi X VD-25616-16~

Dioctahedral pha hon dich thang 3,67g smectite 3000 mg uong

52 Sulpragi Sulpirid 50 mg Vien nang 24 TCCS Hop 3 v i X 10 VD-25617-16

cung thang vien

13. Cong ty dang ky: Cong ty co phan du-g-c phim A m V i (D/c: Lo B14-3,16 14-4, duang Nl3, KCN Dong Nam, Cu Chi, TP. H6 Chi Minh - ViitNam)

13.1 Nha san xuit: Cong ty cb phan du-o-c pham A m V i (D/c: Lo B14-3, 16 14-4, duang Nl3, KCN Dong Nam. Cu Chi, TP. H6 Chi Minh - ViitNam)

STT Ten thuoc Hoat chat chinh - Ham lirQTng

Dang bao che

Tuoi tho

Tieu chuan

Quy each

dong goi So dang ky 53 Asasea 500mg/100ml M6i 100 ml chua:

Levofloxacin (dual dang Levofloxacin

Dung dich tiem truydn tmh mach

24 thang

TCCS Hop 1 tui 100 mi

VD-25618-16

(9)

hemihydrat) SOOmg

14. Cong ty dang ky: Cong ty co p h i n dirg-c pham Ampharco U.S.A (D/c: KCN Nhan Trgch 3, xa Hiep Phuac, huyen Nhan Trgch, tinh Dong Nai - Viet Nam)

14.1 Nhk san xuat: Cong ty co phan dveqfc pham Ampharco U.S.A (D/c: KCN Nhan Trgch 3;xa Hiep Phuac, huyen Nhan Trgch, tinh DdngNai - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lu-gng

Dang bao

"che

Tuoi th9

Tieu chuan

Quy each

dong goi So dang ky 54 Maxxacne-A Mdituyp 15ggel

chura: Adapalene 15 mg

Gel boi da 24 thang

TCCS H6p 1 tuyp nhom 15g;Hop

1 tuyp nhira 15g

VD-25619-16

55 Maxxflame - C Celecoxib 200 mg Vien nang curng

(trSng-trSng) 36 thang

TCCS Hop 1 vi, 3 vi, 10 v i x 10 vien;

Hop 1 tui nhom chira 1 vi, 3 vi, 10 vi x 10 vien

VD-25620-16

14.2 Nha san xuat: C6ng ty T N H H U S Pharma U S A (D/c: Ld Bl-10, Duong D2, KCN Tdy Bdc Cu Chi, TP. Hd Chi Minh - Viet Nam)

STT Ten thuoc Ho^t chat chinh - Ham lu-gng

Dang bao Chi

Tuoi th9

Tieu chuan

Quy each

dong goi So dang ky 56 Maxxvenprex 500 Cephalexin (du6i

deing Cephalexin monohydrat) 500mg

Vien nang cung

36 thang

TCCS HQP 10 v i x 10 vien

VD-25621-16

15. Cong ty dang ky: Cong ty Co phan Du-ffc pham A n Thien (D/c: 314 Bong Sao, Phuomg 5, Quan 8, TP. Hd Chi Minh - Vi?tNam)

15.1 Nha san xuit: Cong ty C6 phan Duyc pham An Thien (D/c: CI6. duong sd 9, KCNHiep Phuac, huyen Nha Be, TP. Ho Chi Minh - Vi?t Nam)

STT Ten thuoc Hoat chat chinh - H i m liTQUg

Dang bio che

Tuoi th9

Tigu chuan

Quy each

dong goi So dang ky 57 A.T Arginin Arginin hydroclorid

400mg

Vien nang curng

24 thang

TCCS HQP 2 vi, hQp 3 vi, hop 5 V I ,

h Q p l O v i x l O vien. H6p 1 chai 30 vien, hop 1 chai 60 ,

VD-25622-16

(10)

vien, hop 1 chai 100 vien

58 A.T Arginin 200 Arginin hydroclorid 200mg

Vien nang cung

24 thang

TCCS Hop 2 vi, hop 3 vi, hop 5 VI,

hop 10 vi X 10 vien. Hop 1 chai 30 vien, hop 1 chai 60 vien, hop 1 chai

100 vien

VD-25623-16

59 A.T Ascorbic syrup Acid ascorbic 100mg/5ml

Dung djch uong

"24'

thang f e e s " Hop 20 ong, hop 30 ong, hop 50 6ng nhua x 5ml (dong ong til mang PVC/PE). Hop 1 chai 30ml, hop 1 chai 66ml, hop 1 chai 100ml (Chai nhua PET)

VD-25624-16

60 A.T Bisoprolol 2.5 Bisoprolol fumarat 2,5mg

Vien nen 24 thang

TCCS Hop 2 vi, hop 3 vi, hgp 5 vi, hOp 10 v i x 10 vien. Hop 1 chai 30 vien, hop 1 chai 60 vien, hop 1 chai

100 vien

VD-25625-16

61 A.T Cetam 400 Moi 10ml chura:

Piracetam 400mg

Dung djch uong

24 thang

TCCS Hop 20 ong, hop 30 ong, hop 50 ong nhua x 10ml

VD-25626-16

62" A.T Diosmectit M6i goi 3,5g chura Diosmectit 3000mg

Thu6c com 24 thang

TCCS Hop 10 goi, hop 20 goi, hop 30 goi, hop 50 goi x3.5g

VD-25627-16

63 A.T Flu Moi 5ml chura:

Guaifenesin lOOmg;

Phenylephrin hydroclorid 2,5mg;

Dextromethorphan hydrobromid 5mg

Dung dich uong

24 thdng

TCCS Hop 20 6ng, hop 30 6ng, hop 50 ong X 5ml.

Hop 1 chai 60ml

VD-25628-16

64 A.T Furosemid inj Furosemid Dung djch 24 TCCS Hop 5 6ng, hop VD-25629-16

(11)

20mg/2ml tiem thang 10 ong, hop 20 ong X 2ml 65 A.T Glutathione 900 inj. Glutathion 900mg Bot dong

kho pha tiem 24 thang

TCCS Hop 1 lo thuoc + 1 ong dung moi, hop 3 lo thuoc + 3 ong dung moi, hop 5 lo thuoc + 5 ong dung moi.

Ong dung moi 10ml: Nuoc cat pha tiem

VD-25630-16

66 A.T Ibuprofen Syrup Ibuprofen 100mg/5ml

Hon dich uong

24 thang

TCCS Hop 20 ong, hop 30 ong, hop 50 ong X 5ml.

Hop 1 chai 30ml, hOp 1 chai 60ml, hop

1 chai 100ml

VD-25631-16

67 A.T Lamivudin Lamivudin lOOmg Vien nen bao phim

24 thang

TCCS Hop 2 vi, hop 3 vi, hop 5 vi, hop 10 v i x 10 vien. Hop 1 chai 30 viSn, hop 1 chai 60 vien, hop 1 chai

100 vien

VD-25632-16

68 A.T Luc vi Moi 8ml cao long chua djch chiet cua:

Thuc dja l,6g;Hoai som 0,8g; Son thu 0,8g; Mau dan bi 0,6g; Bach linh 0,6g; Trach ta 0,6g

Cao long 24 thang

TCCS Hop 20 ong, hOp 30 ong, hgp 50 6ng nhua x 8ml. HQP 1 chai 120ml

VD-25633-16

69 A.T Rosuvastatin 20 Rosuvastatin (dxidi dang Rosuvastatin caici) 20mg

Vien n6n bao phim

24 thang

TCCS Hop 2 vi, hop 3 vi, hop 5 vi, hOp i O v i x 10 viSn. HOp 1 chai 30 vien, hpp 1 chai 60 vien, hpp 1 chai 100 vien

VD-25634-16

70 A.T Rosuvastatin 5 Rosuvastatin (du6i dang Rosuvastatin calci) 5mg

V i l n n6n bao phim

24 thang

TCCS HOp 2 vi, hop 3 vi, hpp 5 vi, hOp 10 v i x 10 vien. Hpp 1 chai 30 vien.

VD-25635-16

(12)

hop 1 chai 60 vien, hop 1 chai 100 vien

71 A.T Sucralfate M6i goi 5g bot chua: Sucralfat

lOOOmg

Bot pha hon dich uong

24 thang

TCCS Hop 20 goi, hop 50 goi X 5g

VD-25636-16

72 A.T Tobramycine inj Tobramycin 80mg/2ml

Dung djch tiem

24"

thang

TCCS Hop 5 ong, hop 10 ong, hop 20 ong X 2ml

VD-25637-16

73" A.T Tranexamic inj Tranexamic acid 250mg/5ml

Dung djch

tiem thang

TCCS Hop 5 6ng, hop 10 ong, hop 20 ong X 5ml

VD-25638-16

74 Antimuc 100 sac Moi goi 3g thu6c c6m chua: N-Acetyl cystein lOOmg

Thuoc com ""24"

thang

TCCS Hop 10 goi, hop 20 goi, hop 30 goi, hop 50 goi x 3 g

VD-25639-16

"75" Antirova plus Spiramycin 750000 l U ; Metronidazol

125mg

Vien nen bao phim

"24"

thang TCCS Hop 2 vi, hop 3 vi, hop 5 vi, hop 10 v i x 10 vien. Hop 1 chai 30 vien, hop 1 chai 60 vien, hop 1 chai

100 vien

VD-25640-16

76 Atifolin 100 inj Moi 10ml chua Acid folinic (dudri dang Calci folinat) lOOmg

Dung djch tiem

-24"

thang

TCCS Hop i IQ, hop 3 IQ, hop 5 IQ X

ibml

VD-25641-16

77 Atiglucinol inj M6i ong 4ml chura:

Phloroglucinol (dual dang Phloroglucinol dihydrat) 40mg;

Trimethyl phloroglucinol 0,04mg

Dung djch tiem

24 thang

TCCS Hop 5 ong, hop 10 ong, hop 20 ong X 4ml

VD-25642-16

78 Atigluco 1500 sac Moi 3g chua:

Glucosamin (dual dang Glucosamin HCl) 1500mg

Thuoc com 24 thang

TCCS Hop 10 goi, hop 20 goi, hop 30 g6i, hop 50 goi x 3 g

VD-25643-16

" 7 9 " Atihepam 150 L-Ornithin

L-aspartat 150mg

Vien nen 24 thang

TCCS Hop 2 vi, hop 3 vi, hop 5 vi, hop 10 v i x 10 vien. HQP 1 chai 30 vien, hop 1 chai 60

VD-25644-16

(13)

vien, hop 1 chai 100 vien

80 Atileucine inj N-Acetyl-dl-leucin 500mg/5ml

Dung dich tiem

24 thang

TCCS Hop 5 6ng, hop 10 6ng, hop 20 ong X 5ml

VD-25645-16

81 Atipantozo! Pantoprazol (dual dang Pantoprazol natri sesquihydrat) 40mg

Vien nen bao phim tan trong ruot

24 thang

TCCS Hop 2 vi, hop 3 vi, hop 5 vi, hop 10 v i x 10 vien. Hop 1 chai 30 viSn, hop 1 chai 60 vien, hop 1 chai

100 vien

VD-25646-16

" 8 2 " Atisalbu M6i 5ml chua Salbutamol (duori dang Salbutamol sulfat) 2mg

Dung djch uong

"24"

thang TCCS Hop 20 ong, hop 30 ong, hop 50 6ng x 5ml.

Chai 30ml, chai 60ml, chai

100ml

VD-25647-16

83 Atisolu 125 inj Methyl prednisolon (duori d^ng Methyl prednisolon natri succinat) 125mg

Bot dong kho pha tiem

24 thang

TCCS Hop 1 lo thuoc + 1 ong dung moi, hop 3 lo thuoc + 3 ong dung moi, hop 5 lo thu6c + 5 ong dung moi.

Ong dung moi 2ml: Nuorc cat pha tiem

VD-25648-16

84 Atizinc siro Kem (dudri dang Kem gluconat)

10mg/5ml

Dung dich uong

24 thang

TCCS Hgp 20 ong, hgp 30 ong, hgp 50 6ng nhua x 5ml. Hop 1 chai 30ml, hgp 1 chai 60ml, hop

1 chai 100ml

VD-25649-16

"85~ Bambuterol 10 A.T Bambuterol hydroclorid lOmg

ViSn n6n bao phim

"24~

thing fees" H g p 2 v i r h g p T vi, hgp 5 vi, hgp 10 v i x 10 vien. Hop 1 chai 30 vien, hgp 1 chai 60 vien, hOp 1 chai

100 vien

VD"-2"5650^i6

86 Betahistin 8 A.T Betahistin

dihydroclorid 8mg

Vien nen 24 thang

TCCS Hgp 2 vi, hgp 3 vi, hop 5 vi.

VD-25651-16

(14)

hop 10 vi X 10 vien. Chai 30 vien, chai 60 vien, chai 100 vien

87 Bromhexine A.T Bromhexin hydroclorid 4mg/5ml

Dung dich uong

24 thang

TCCS Hop 20 ong, hop 30 ong, hop 50 6ng X 5ml.

Chai 30ml, chai 60ml, chai

100ml

VD-25652-16

8~8~ Citicolin A.T Citicolin (dual dang Citicolin natri) SOOmg

Vien nen bao phim

"24""

thang TCCS Hop 2 vi, hop 3 vi, hop 5 vi, hop i O v i x 10 vien. Hop 1 chai 30 vien, hop 1 chai 60 vien, hop 1 chai

100 vien

VD-25653"-16~

89 Deferiprone A.T Deferipron SOOmg Vien nen bao phim

24"

thang TCCS Hop"2vi,hop3 vi, hop 5 vi, hop i o v i x 10 vien. Chai 30 vien, chai 60 vien, chai 100 vien

"vbV25654~-16"

90 Fosfomycin 2000 A.T Fosfomycin (dual dang Fosfomycin natri) 2000mg

Bot dong kho pha tiem

24 thang

TCCS Hop 1 I9 thuoc + 2 ong dung moi. Hop 3 lo thuoc + 6 ong dung moi. Hop 5 lo thuoc + i o 6ng dung moi.

Ong dung moi:

Nucfc cat pha tiem X 10ml

VD-25655-16

91 Ivermectin 3 A.T Ivermectin 3mg Vien nen bao phim

24 thang

TCCS Hop 1 vi, hpp 10 vi X 4 vien.

Hop 1 chai x 30 vien

VD-25656-16

92

93

Ketorolac A.T

Metpredni 16 A.T

Ketorolac tromethamin 30mg/2ml

Methylprednisolon 16mg

Dung dich tiem Vien nang cu-ng

24 thang

24 thang

TCCS

TCCS

Hop 5 ong, hop 10 ong, hop 20 ong X 2mi Hop 2 vi, hop 3 vi, hop 5 vi, hop i O v i x 10 vien. Hop 1

VD-25657-16

VD-25658-16

(15)

chai 30 vien, hop 1 chai 60 vien, hop 1 chai

100 vien 94 Nitroglycerin inj Nitroglycerin (du6i

dang Nitroglycerin 5% trong Propylen glycol) 5mg/5ml

Dung dich tiem

24 thang

TCCS HOp 5 ong, hOp 10 ong, hop 20 ong X 5ml

VD-25659-16

Paracetamol A.T 250 sac Moi g6i 3g chira Paracetamol 250mg

Com pha hon djch uong

"24~

thang

f e e s Hop 10 goi, hop 20 goi, hop 30 goi, hOp 50 goi x 3 g

VD-25660-r6

~96~ Telmisartan 20 A.T Telmisartan 20mg Vien nen "24"

thang TCCS H0p2vi7h0p3 vi, hgp 5 vi, hOp 10 v i X 10 vien. HOp 1 chai 30 vien, hop 1 chai 60 vien, hOp 1 chai

100 vien

VD-2566r-16'

97 Thap toan dai bo A.T M6i 8ml cao long chua dich chiet:

Duong quy 200mg;

Xuyen khung 66,66mg; Thuc dia 200mg; Bach thugrc

133,33mg; Dang sam 133,33mg;

Bach linh 133,33mg; Bach truat 133,33mg;

Cam thdo 66,66mg;

Hoang ky 133,33mg; Qui nhuc 33,33mg

Cao long 24 thang

TCCS HOp 20 ong, hOp 30 ong, hOp 50 ong nhua x 8ml. HOp i chai 120ml

VD-25662-16

98 Vancomycin 1000 A.T Vancomycin (duai dang Vancomycin hydroclorid)

lOOOmg

Bpt dong kho pha tiem

24 thang

TCCS HOp 1 I9 thuoc + 2 Ong dung moi. HOp 3 lo thuoc + 6 ong dung moi. HOp 5 1<? thuoc + io ong dung moi.

6ng dung moi 10ml: Nuorc cat pha tiem

VD-25663-16

99 Vancomycin 500 A.T Vancomycin (du6i dang Vancomycin

Bpt dong kho pha

24 thang

TCCS HOp 1 lo thuoc + 1 ong dung

VD-25664-16

(16)

hydroclorid) SOOmg tiem moi, hop 3 lo thuoc + 3 ong dung moi, hop 5 lo thu6c + 5 ong dung moi.

Ong dung moi 10ml: Nuoc cat pha tiem

16. Cong ty dang ky: Cong ty co phSn du'o'c phSm BSc Ninh (D/c: 21 Nguyen Van Cu, phuong Ninh Xd, TP Bdc Ninh, tinh Bdc Ninh - Viet Nam)

16.1 Nha san xuat: Cong ty c6 phSn du-ffc ph§m BSc Ninh (D/c: Lo Cl-1- KCN Qui Vo, Huy?n Qui Vo, tinh Bdc Ninh - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lu-g-ng

Dang bao che

Tu6i tho

Tieu chuan

Quy each

d6ng goi So dang ky 100 Siro ho bo phe Moi 100ml siro

chura: Bach linh 0,72g; Cat canh

l,366g; Tang bach bi l,5g; Ma hoang 0,52Sg; Thien mon 0,966g; Bac ha l,333g; Ban ha chl l,5g; Bach bp 7g;

Mamu6i l,125g;

Cam thdo 0,473g;

Phen chua 0,166g;

Tinh dSu bac ha 0,125g

Siro 24

thang

TCCS Hop 1 chai 100ml, 110ml.

VD-25665-16

101 Vien ngam bac ha Tinh dau bac ha 2mg

Vien nen 24 thang

TCCS Lp nhua 150 vien

VD-2S666-16

17, Cong ty dang ky: Cong ty C 6 phSn Du-grc p h i m Boston Vift Nam (D/c: So 43, Dudmg sd 8, KCN Vi?t Nam - Singapore, Thudn An, Binh Duong - Viet Nam)

17.1 Nha san xuat: Cong ty Co phSn Dugc p h i m Boston Vift Nam (D/c: Sd 43, Duong sd 8, KCN Viet Nam - Singapore, Thudn An, Binh Duong - Vi?t Nam)

STT Ten thuoc Hoat chat chinh - Ham lugrng

Dang bao che

Tuoi tho

Tieu chuan

Quy each

dong goi So dang ky 102

103

Effer-paralmax 150

Paralmax

Moi goi l,5g chura:

Paracetamol ISOmg Paracetamol SOOmg

Thuoc bpt sui bot Vien nen

36 thang

36

TCCS

TCCS

Hop 30 goi X

l,5g; hop 50 goix l,5g Hop 10 v i x 12

VD-25667-16

VD-25668-16

(17)

bao phim thang vien; hop 15 vi X 12 vien

18. Cong ty dang ky: Cong ty co phan Du-ffc pham C P C l H a Noi (B/c: Cum cong nghiep Ha Binh Phuong, Thuang Tin, Ha Noi - Viet Nam)

18.1 Nha san xuat: Cong ty co phan Dug^c pham C P C l H i Ngi (B/c: Cum congnghiep Hd Binh Phuang, Thuang Tin, Hd Ngi - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lu-g-ng

Dang bao che

Tuoi thg

Tieu chuin

Quy each

dong goi S6 dang ky 104 BFS-Furosemide

40mg/4ml

Furosemid 40mg/4ml

Dung dich tiem

24 thang

TCCS Hop 5 v i X 2 tui nhom X 1 ong nhua X 4ml

VD-25669-16

19. Cong ty dang ky: Cong ty co phan du-g-c pham C u u Long (B/c: Sd 150 dudmg 14 thdng 9, phudng 5, TP. VTnh Long, tinh VTnh Long - Viet Nam)

19.1 Nha san xuat: Cong ty c6 phan dvrffc pham Cu-u Long (B/c: So 150 duong 14 thdng 9, phudng 5, TP. VTnh Long, tinh VTnh Long - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lirg-ng

Dang bao che

Tu6i thg

TiSu chuan

Quy each

dong goi So dang ky 105 DrocefVPC 500 Cefadroxil (dudri

dang Cefadroxil monohydrat) 500 mg

Moi goi Ig chu^a:

Paracetamol 250 mg

Vien nang cung

(xanh-xanh) 36 thing

TCCS Hop 10 v i x 10 vien; Chai 100 vien

VD-25670-16

106 Panalganeffer 250

Cefadroxil (dudri dang Cefadroxil monohydrat) 500 mg

Moi goi Ig chu^a:

Paracetamol 250 mg

Thuoc com sui bot

24 thang

TCCS Hop 12 goi X Ig VD-25671-16

20. Cong ty dang ky: Cong ty co p h i n dug-c pham dug-c lif u Pharmedic (B/c: 367 Nguyin Trdi -Q.l-TP. Hd Chi Minh - Viet Nam)

20.1 Nha san xuat: Cong ty c6 p h i n duffc phim dug-c lifu Pharmedic (B/c: 1/67 Nguyin Van Qud, Qucin 12, TP. Hd Chi Minh - ViitNam)

STT Ten thuoc Hoat chat chinh - Ham lugrng

Dang bao che

Tuoi thg

Tieu chuan

Quy cich

dong goi So dang ky 107 Nacofar M6i 60 ml chura:

Natri clorid 0,54g

Dung dich diing ngoii

30 thing

TCCS Hop 1 chai 60 mi

VD-25672-16

21. Cong ty dang ky: Cong ty co phan Dug-c p h i m Euvipharm - Thanh vien tap doan Valeant (B/c: dp Binh Tiin 2, xdBuc Hod ha, Buc Hod, Long An - ViitNam)

(18)

2 L 1 Nha san x u l t : Cong ty co p h i n Diro'c phSm E u v i p h a r m - T h a n h vien tap doan Valeant (D/c: dp Binh Tiin 2, xa Due Hod hq, Due Hod, Long An - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lirong

Dang bao che

Tu6i tho

Tieu chuan

Quy each

dong goi So dang ky 108

109

Acefalgan 250 Arginin Euvipharm

Moi 1,5 g chura:

Paracetamol 250mg Moi 5 ml chua: L - Arginin hydroclorid

lOOOmg

C6m sui hot Dung djch uong

36 thang

36 thang

TCCS f e e s

Hop 20 goi X

gam Hop 2 v i x 10 6ng 5 ml

VD-2S673-16 VD-2S674-16

110 Eulexcin 250 Moi 1,5 g chua:

Cephalexin (dudri dang Cephalexin monohydrat) 250mg

Bgt pha uong

24 thang

TCCS Hop 20 goi X

1,5 gam

VD-2S675-16

111

\\2

113

^114

Eumoxin 250

Euprocin 500

Euxamus 200

Kevizole

Moi 1,5 g chura:

Amoxicillin (dudri

dang Amoxicillin trihydrat) 250mg Ciprofloxacin (duai dang Ciprofloxacin hydrochlorid) 500mg Acetylcystein 200mg

Moi 5 g chua:

Ketoconazol lOOmg

Bot pha u6ng

Vien nen bao phim

Vien nang cung Kem boi da

24 thang

36"

thang

24 thang

"24"

thang TCCS

f e e s "

TCCS

f c c s ^

Hop 12 goi X

1,5 gam

Hop 10 vi X 7 vien

Hop 10 v i x 10 vien; hop 1 chai

100 vien Hop 1 tuyp 5 gam

VD-25676-16

VD-2S677-16

VD-25678-16

VD-2S679'-16"

115"

117

Motiridon

Nicobion 500 Sitrizol

Domperidon (dudri dang Domperidon maleat) lOmg Nicotinamid SOOmg Moi 10 g chura:

Clotrimazol lOOmg;

Betamethason dipropionat 6,4mg;

Gentamicin sulfat lOmg

Vien nang cu-ng Vien nen Kem boi da

"36~

thang 36 thang

24 thang

TCCS

TCCS TCCS

Hop fo v i x 10"

vien; hop 1 chai 100 vien

Hop 1 chai 30 vien

Hop 1 tuyp 10 gam

VD-25680"-16"

VD-2S681-16 VD-25682-16

118 Vidagyl Spiramycin

750.000IU;

Metronidazol 12Smg

Vien nen bao phim

36 thang

TCCS Hop 2 vi X 10 vien

VD-25683-16

(19)

22. Cong ty dang ky: Cong ty co phan diro'c pham d o m e d (D/c: 35 Dai 16 Tudo, KCN Viet Nam - Singapore, thi xd Thudn An, tinh Binh Duang - Viet Nam)

22.1 Nha s i n xuit: Cong ty co phan du-oc phim Glomed (D/c: 35 Dai 16 Tu do, KCN Viet Nam - Singapore, thi xd Thudn An, tinh Binh Duang - Viet Nam)

STT Ten thuoc Hoait chat chinh - Ham liryng

Dang b i o che

Tu6i thp

Tieu chuan

Quy each

dong goi So dang ky 119 Cefoxitin 500 Cefoxitin (dudi dang Thuoc bot 24 USP Hop 10 lo VD-25684-16

Cefoxitin natri pha ti6m thang 36 0,526g) 0,5g

120 Glomazin Moi Ig thuoc ma Thuoc m& 36 TCCS Hop 1 tuyp 5g, VD-25685-16 chte: Betamethason boi da thang lOg, 15g

dipropionat 0,64 mg; Acid salicylic 30 mg

121 Medxium 40 Esomeprazol (dang Vien nang 24 TCCS Hop 2 v i x 10 VD-25686-16 vi hat Ijao tan trong Cling chiia thing vien; H6p 2 vi x

ruQt chua hat bao tan 7 viSn; H6p 4 vi

Esomeprazol trong ruot x 7 vien

magnesium dihydrat) 40 mg

122 Mysomed 500 Methocarbamol 500 Vien nen 36 USP Hop 3 vi, 5 v i . VD-25687-16

mg thing 36 10 v i x 10 vien;

Hop 1 chai 50 vi§n, 100 vien.

123 Zadirex H Losartan kaki 50 ViSn nen bao 36 TCCS H9p3 vi, lOvi, VD-25688-16

mg; phim thing 30 v i x 10 vien

Hydroclorothiazid 12,5 mg

23. C6ng ty dang k}^: C6ng ty c6 phan du-gc pham H i Tay (D/c: lOA - Quang Trung -Hd Dong -Hd Ndi-Viet Nam)

23.1 Nha s i n xuit: C6ng ty co phan dugc phim H i T a y (D/c: Td dan phd sd 4 - La Khe - Hd Dong - Tp. Hd Npi - Viet Nam)

STT Ten thuoc Hofit chat chinh - H i m lirgtig

D^ng bao che

Tuoi th9

T i i u chuin

Quy cich

dong g6i So dang ky 124 Atorvastatin TP Atorvastatin (duai Vien nang 24 TCCS Hop 10 v i x 10 VD-25689-16

dang Atorvastatin mem thing vien (vi

calci) 10 mg nhom-PVC)

125 Cefaclor 250 mg Moi goi 3g chura: Thuoc bot 24 TCCS Hop 20 goi X 3g VD-25690.16 Cefaclor 250 mg pha h6n thing

(20)

126 Cefdina 300 Cefdinir 300 mg

dich uong

Vien nang 36 TCCS Hop 3 v i x 10 VD-25691-16 cung (xanh - thang vien

trSng)

127 Fasthio! Moi 5 ml siro chura: Siro 24 TCCS Hop 1 chai 125 VD-25692-16 Carbocistein 100 mg thang m i

n i Hepsonic Hepsonic Moi 6ng 10 ml cao Cao long TCCs" Hop 30 ong VD-25693-16 long chu'a: cao dac thang (ong nhua

actiso (1:25) 0,2g PVC) X 10 ml

129 Mezabastin Ebastin 10 mg Vien nen bao ^36 TCCS H6p2"viV30"" ' VD-25694-r6

phim thang vien

Meza-Calci Moi goi 2g chua: Thuoc bot "36~ TCCS Hop 30 goi X 2g VD-25695"-16"

Calci (duoi dang pha hon djch thang tricalcium phosphat uong

l,65g)0,6g

" l i f Mezaterol 20 Bambuterol Vien n6n "36 TCCS H O p T v T x l o " " VD-25696'-i6~

hydroclorid 20 mg thang vien

132" Pacemin Paracetamol 325 Vien nang 36 TCCS" Hop 10 v i x 10 VD-256"97-r6'' mg; Clorpheniramin cung(do thang vien; Ig 100

maleat 2 mg trong - trang vien, 200 vien trong)

24. Cong ty dang ky: Cong ty co phan du-ffc pham Hoa Viet (D/c: So 124, dudmg Trudmg Chinh, p. Minh Khai, Tp. Phu Ly, Ha Nam - Viet Nam)

24.1 Nha san xuit: C h i nhanh san xuat thuoc, my pham, thuc pham chuc nang Hoa Viet (D/c:

Ld C9, KCN Chdu San, Tp. Phu Ly, Hd Nam - Viet Nam)

STT Ten thuoc Hoat chat chinh - H i m lu-gvg

Dang bao che

Tuoi thg

Tieu chuan

Quy each

dong goi So dang ky 133 Vien nang curng Ngoc

Ty

Cao dac hon hgp dugc lieu (tuang duang vai l,050g dugc lieu g6m:

Thuang nhT tu 150mg;Tan di hoa 300mg; Bach chi 600mg) 105mg; Bac ha 300mg

Vien nang cung

24 thang

TCCS Hgp 1 Ig x 60 vien

VD-25698-16

134" Vien nang quang tri Cao kho hon hgp dugc li?u (tuang duang vori: Cam thao 0,17g; Cat canh 0,26g; Chi xac 0,35g; Dao nhan 0,7g; Duang quy

Vien nang cung

24 thang

TCCS Hop 1 tui X 3 vi X 10 vien

VD-25699-16

(21)

0,52g; Hong hoa 0,52g; Ngiru tat 0,52g; Sai h6 0,17g;

Sinh dia 0,52g;

Xuyen khung 0,26g) 320mg

25. Cong ty dang ky: C6ng ty co phan dirge pham Imexpharm (£>/c: S6 04, dudmg 30/4, Phudng 1, Tp. Cao Ldnh, Tinh Dong Thdp - Viet Nam)

25.1 Nha san xuat: C h i nhanh 3 - Cong ty co phan du-gc pham Imexpharm tai Binh Dirong.

(D/c: Sd 22, dudmg sd 2, KCN Viet Nam-Singapore II, Phuang Hda Phu, TP Thu Dau Mot, tinh Binh Duomg - Viet Nam)

STT Ten thuoc Hoat chit chinh - Ham lugng

D^ng bao chl

Tu6i thg

Tieu chuin

Quy each

d6ng goi So dang ky 135 Zobacta 3,375g Piperacillin (dudi

dang piperacillin natri) 3g;

Tazobactam (duai dang Tazobactam natri) 0,375g

Thuoc bgt pha tiem

24 thing

TCCS Hgpllg,hgp 10 Ig

VD-2S700-16

25.2 N h i s i n xuat: C h i nhanh cong ty co phan dirge pham Agimexpharm- N h i may s i n xuat dugc p h i m Agimexpharm (D/c: Dudmg Vu Trgng Phung, Khom Thanh An, P. My Thai, TP. Long Xuyen, Tinh An Giang - Vi?t Nam)

STT Ten thuoc Hoat chit chinh - Him lugng

Dang bao

"che

Tuoi thg

Tieu chuin

Quy each

dong goi S6 dang ky 136 Dexamethasone 0,5mg Dexamethason (dudi

dang Dexamethason acetat) 0,5 mg

Vien nen 36 thing

TCCS Hop 60 vi X 40 vien

VD-25701-16

25.3 N h i s i n xuit: C6ng ty co p h i n dugc pham Imexpharm (D/c: Sd 04, dudmg 30/4, Phuomg 1, Tp. Cao Ldnh, Tinh Ddng Thdp - Viet Nam)

STT Ten thuoc Hoatt chit chinh - Ham lugng

D^ng bio che

Tuoi thg

Tieu chuin

Quy each

d6ng goi So dang ky 137 Pharmox SA SOOmg Amoxicilin (dudi

dang Amoxicilin trihydrat) SOOmg

Vien nang

C l i n g (do -

cam)

36 thing

TCCS Chai 100 vien, chai 200 vien

VD-25702-16

138 Vitamin B6 125mg Pyridoxin Vien nen 36 TCCS Hgp 10 vix 10 VD-25703-16

(22)

10 mg;

Betamethason 6,4 mg; Clotrimazol 100 mg

Medi-Domperidone Domperidon (du6i dang Domperidone maleate) 10 mg

Vien nen 36 thang

TCCS Hop r O v i x' l o "

vien

VD-257l2-16

Medospira Metronidazol 125 mg; Spiramycin 750000 l U

Vien nen bao phim

" 3 6 "

thang

TCCS Hop2 vi, 10 vi x 10 vien

VD-257T3-r6"

149 Sizecin Fexofenadin

hydroclorid 120 mg

Vien nen bao phim

36 thang

TCCS Hop3 v i x 10 vien

VD-25714-16

28. Cong ty dang k^: C6ng ty co phan dvtqtc pham Minh Dan (D/c: L6 E2, duang N4, KCN Hod Xd, xd Loc Hda, TP Nam Dinh, tinh Nam Dinh - Viet Nam)

28.1 Nha san xuat: Cong ty co phan du-ffc pham Minh Dan (D/c: Ld N8, duang N5, KCN Hod Xd, xa MyXd, TP Nam Dinh, tinh Nam Dinh - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham luQfng

Dang hko chi

Tu6i tho

Tieu chuan

Quy each

dong goi So dang I<y 150 Bicalutamide 50 mg Bicalutamide 50 mg ViSn nen bao 36 TCCS Hop 03 v i x 10 VD-25715-16

phim thdng vien

151 Dexamethason Dexamethason Dung djch 24 TCCS Hop 10 ong X 1 VD-25716-16 phosphat (du6i dang tiem thdng ml

Dexamethason natri phosphat) 4 mg/lml

152" Dexamethason 0,1% Dexamethason Thuoc nh6 24 TCCS Hop 1 IQ 5 ml; VD-25717-16 phosphat (dudri dang mit thdng H o p l IQ 10 ml

Dexamethason natri phosphat) 5mg/5ml

153 Diclofenac 50 mg Diclofenac natri 50 Vien nen bao 36 DDVN HQP 10 v i x 10 VD-25718-16

mg phim tan thdng IV vien

trong ruQt

154 Doripenem 0,25g Doripenem (dudi Thuoc bot 36 TCCS HQP 10 IQ loai VD-25719-16 dang Doripenem pha tiSm thdng dung tfch 20 ml

monohydrat) 0,25 g

155 Doripenem 0,5g Doripenem (du6i Thu6c bOt 36 TCCS H6p 1 IQ loai VD-25720-16 dang Doripenem pha tiem thdng dung tich 20 ml

monohydrat) 0,5 g

156 Loperamid 2mg Loperamid Vien nang 36 DDVN Hop 10 v i x 10 VD-25721-16 hydroclorid 2 mg curng thdng IV vi6n

157 Midaman l,5g/0,lg Ticarcilin (dudi Thuoc bpt 36 TCCS Hop 1 IQ VD-25722-16 dang Ticarcilin pha tiem thdng

(23)

hydroclorid 125mg bao phim thang vien

26, Cong ty dang k y : Cong ty c6 phan d w c pham K h a n h Hoa (D/c: 74 Thdng Nhdt. TP. Nha Trang, Khdnh Hod - Viet Nam)

26.1 Nha san xuSt: Cong ty c6 phSn diroc pham K h a n h Hoa (D/c: Dudmg 2 thdng 4, P. Vinh Hod, TP. Nha Trang, Khdnh Hod - Viet Nam)

STT Ten thudc Hoat chat chinh - Ham lu-gng

Dang bao che

Tu6i tho

Tieu chuan

Quy each

dong goi So dang ky 139 Allopurinol Allopurinol 300mg Vien nen 36

thang USP 37

Hop 10 v i x 10 vien; hop 1 chai

100 vien; hop 1 chai 300 vien

VD-25704-16

140 Dogtapine Sulpirid 50mg Vien nen "36~

thang f e e s " Hop3 v i x 10 vien; hop 10 v i X 10 vien; hop 1 chai 100 vien;

hop 1 chai 200 vien

VD-25705-16

141 142

Drotaverin Hydrocolacyl

Drotaverin

hydroclorid 40mg Prednisolon 5mg

Vien n^n Vien nang cu-ng

" 3 6 "

thang 36 thang

f e e s Tees

Hop l o ' v i x i o "

vien

H 6 p 3 v i x 10 vien; hop 10 vi X 10 vien

' VD-25706'-r6"

VD-25707-16

143 Kamydazol Spiramycin 750.000IU;

Metronidazol 125mg

Vien nen bao phim

36 thang

Tees H 9 p 2 v i x 10 vien; hop 10 vi X 10 vien

VD-25708-16

27. Cong ty dang ky: Cong ty co phan dugc pham Me Di Sun (D/c: 521 khu phd An Loi, phuomg Hod Lai, thi xd Bin Cdt, tinh Binh Duang - Viet Nam)

27.1 Nha san xuat: Cong ty c6 phan dugc p h i m Me Di Sun (D/c: 521 khu phd An Lai, phudng Hod Lai, thi xd Bin Cdt, tinh Binh Duang - Viet Nam)

s n Ten thu6c Hoat chit chinh - H i m lugng

Dang bao che

Tuoi tho

Tieu chuan

Quy each

d6ng goi So dang ky 144 Anduxtane eandesartan Vien nen 36 Tees Hop 3 v i x 10 VD-25709-16

cilexetil 16 mg thang vien

145 Bepromatol 2.5 Bisoprolol fumarat Vien nen bao 36 Tees Hop 3 v i x 10 VD-25710-16

2,5 mg phim thang vien

'146' FURMET cream Moi tuyp 10 g kem Kem boi "36" f e e s ' Hop 1 tuyp lOg VD-25711-16 boi da chura ngoai da thang

Gentamycin sulfat

(24)

natri) 1,5 g; Acid clavulanic (duai dang Kali clavulanat) 0,1 g

158 Midanefo 300/25 Irbesartan 300 mg; Vien nen bao 24 TCCS Hop 1 tui x 3 vi VD-25723-16 Hydroclorothiazid phim thang X 10 vien

25 mg

159 Midantin Amoxicilin (duai Thuoc bot 36 TCCS Hop 1 lo loai VD-25724-l'6 dang Amoxicilin pha tiem thang dung tfch 20

natri) 1 g; Acid ml; Hop 10 lo

clavulanic (dudi loai dung tfch

dang Kali clavulanat 20 ml

) 0 , 2 g

160 Midapezon Cefoperazon (du6i Thuoc bot " 36 " TCCS Hop 1 lo loai VD-25725-16"

dang Cefoperazon pha tiem thang dung tfch 20

natri) 0,5 g; ml; Hop 10 lo

Sulbactam (duai loai dung tfch

dang sulbactam 15 ml

natri) 0,5 g

161 Netilmicin 100mg/2ml Netilmicin (duai Dung djch 36 TCCS Hop 10 6 n g x 2 VD-25726-16 dang Netilmicin tiem thang ml

sulfat) 100 mg/2ml

"162 Netilmicin 300mg/3ml Netilmicin (duai Dung dich 36 TCCs" Hop 10 6ng X 3 VD-25727-i6~

dang Netilmicin tiem thang m i

sulfat) 300 mg/3ml

Ondansetron 8 mg Ondansetron (duoi Vien nen " 2 4 " T C C ^ Hop 1 tui X 1 vi VD-257Y8"-16~

dang Ondansetron phan tan thang X 10 vien; Hop hydrochlorid) 8 mg trong mifng 1 t u i x 3 v i x 10

vien; Hpp 1 tui x 10 v i x 10 vien

29. Cong ty dang ky: Cong ty c6 phan Diro'c p h i m O P C . (D/c: 10J7 Hdng Bang - quan 6 - TP.

Hd Chi Minh - Viet Nam)

29.1 Nha san xuat: C h i nhanh Cong ty C6 phan Duffc pham O P C tai Binh Duong - Nha may Duffc pham O P C (D/c: Sd 09/DX 04-TH, td 7, Ap Tan Hda, Xa Tdn VTnh Hiep - Tdn Uyen - Binh Duomg - Viet Nam)

STT Ten thuoc Ho^t chat chinh - Ham luong

Dang bao che

Tu6i tho

Tieu chuan

Quy each

d6ng goi So dang ky 164 Chi xac (phien) Chi xac Nguyen lieu

Ian thuoc

18 thang

TCCS Tui lOg, 15g, 20g, 25g, 30g, 50g, lOOg, 200g, 250g, 500g,lkg, 2kg, 3kg, 5kg, 10kg

VD-25729-16

(25)

165 Cue hoa VN (Cue hoa vang)

Cue hoa VN (Cue hoa vang)

Nguyen lieu lam thuoc

18 thang

TCCS Tiii lOg, 15g, 20g, 25g, 30g, 50g, lOOg, 200g, 250g, 500g, lkg,2kg, 3kg, 5kg, 10kg

VD-25730-16

166 Dan sam (phien) Dan sam Nguyen lieu lam thudc

18 thang

TCCS Tiii lOg, 15g, 20g,25g,30g, 50g, lOOg, 200g, 250g, 500g, lkg,2kg, 3kg, 5kg, 10kg

VD-25731-16

167 Ha thu 6 do (phien) Hathiiodo Nguyen lieu lam thuoc

18 thang

TCCS Tui lOg, 15g, 20g, 25g, 30g, 50g, lOOg, 200g, 250g, 500g. 1kg, 2kg, 3kg, 5kg, 10kg

VD-25732-16

168 Hoai sofn (philn) Hoai son Nguyen lieu lam thuoc

18 thang

TCCS Tiii lOg, 15g, 20g,25g,30g, 50g, lOOg, 200g, 250g, 500g, 1kg, 2kg, 3kg, 5kg, 10kg

VD-25733-16

169 Huong phu (phien) Huang phu Nguyen lieu lam thuoc

18 thdng

TCCS Tui lOg, 15g, 20g, 25g, 30g, 50g, lOOg, 200g, 250g, 500g, 1kg, 2kg, 3kg, 5kg, 10kg

VD-25734-16

170 Ngu gia bi chan chim Ngu gia bi chdn chim

Nguyen lifu lam thu6c

18 thdng

TCCS Tui lOg, 15g, 20g,25g, 30g, 50g, lOOg, 200g, 250g, 500g, 1kg, 2kg, 3kg, 5kg, 10kg

VD-25735-16

~m San tra (phien) San tra Nguyen lieu lam thu6c

18 thdng

TCCS Tui lOg, 15g, 20g,25g,30g, 30g,50g,100g, 200g, 250g.

500g, 1kg, 2kg, 3kg, 5kg, 10kg

VD-25736-16

172 Tarn that (philn) Tam that Nguyen lieu lam thuoc

18 thang

TCCS Tui lOg, 15g, 20g, 25g, 30g, 50g, lOOg, 200g, 250g, 500g, 1kg, 2kg, 3kg, 5kg, 10kg

VD-25737-16

(26)

173 Trinh nu hoang cung Trinh nu' hoang cung Nguyen lieu 18 TCCS Tui lOg, 15g, VD-25738-16 lam thuoc thang 20g, 25g, 30g,

50g, lOOg, 200g, 250g, 500g, 1kg, 2kg, 3kg, 5kg, 10kg

30. Cong ty dang ky: Cong ty Co phan Dutfc pham O P V (B/c: Ld 27, Buang 3A, KCN Bien Hda II, thdnh phd Bien Hda, tinh Bdng Nai. - Viet Nam)

30.1 Nha san xuSt: Cong ty C6 phan Duo-c p h i m O P V (B/c: Ld 27, Buang 3A. KCN Bien Hda II, thdnh phd Bien Hda, tinh Bdng Nai. - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham lu-gng

Dang bao che

Tuoi tho

Tieu chuan

Quy each

dong goi So dang ky 174 Ambrolex 0,3% Ambroxol Siro 36 TCCS Hop 1 chai VD-25739-16

hydroclorid thang 60ml, hpp 1

15mg/5ml chai 90ml siro

T75 Ambrolex 30 Ambroxol Vien nen " 3 6 " TCCS Hop 2 v i x 10 VD-25740"-f6"

hydroclorid 30mg thang vien

"vie Ameproxen 550 Naproxen (duai Vien nen ~48 ' IJSP36 Hop 10 v i x 10" 'vD-2574r-16"

dang Naproxen bao phim thang vien natri) SOOmg

177 Babygaz Babygaz Moi chai 30ml chura: H6n djch ' 2 4 ~ USP36 Hop 1 chai VD-25742-16 Simethicon (duai u6ng thdng 30ml

dang Simethicon emulsion 30%) 2000mg

178 Cefalox 100 Celecoxib lOOmg Vien nang T 6 ~ TCCs" Hop rv"i"x4""" VD-25743~-r6"

curng thang vien; hop 3 vi x 10 vien; hpp 1 chai X 100 vien

179 Cifitin Ebastin lOmg Vien nen bao 36 TCCS Hop 10 v i x 10 VD-25744-16

phim thang vien

180 Deslotid 5 Desloratadin Smg Vien nen '36~ TCCS

Hpp i vixlo

VD-25745-16 bao phim thang vien; hpp 10 vi

X 10 vien

l i f Dobutil 8 Perindopril Vien nen " 3 6 " TCCS H 6 p 3"vrxlo"" VD-25746-16

tert-butylamin Smg thang vien

182 Fenidofex 120 Fexofenadin Vien nen bao 36 TCCS

Hop fvixlo"

VD-25747-16 hydroclorid 120mg phim thang vien; hop 10 vi

X 10 vien

TsY' Fenofib 100 Fenofibrat lOOmg Vien nang "36'" TCCS Hop 5 vi X 4 VD-25748-16

cung thang vien; hop 7 vi x 4 vien; hop 5

(27)

vi x 6 vien

184 Ibrafen Ibuprofen

100mg/5ml

Hon dich uong

24 thang

TCCS Hop 1 chai 30ml; hop 1 chai 60ml

VD-25749-16

185 KorofestlSO Fexofenadin

hydroclorid 180mg

Vi8n nen bao phim

36 thang

TCCS Hop 1 vi X 10 vien; hop 10 vi

VD-25750-16 X 10 vien

Melic 7.5 Meloxicam 7,5mg Vien nen bao phim

36 thang

TCCS Hop 2 vi X 10 vien; hop 4 vi x 7 vien

VD-25751-16

187 Nutuss Dextromethorphan hydrobromid 15mg

Vien nen bao phim

36 thdng

TCCS H O p l O v i x l O vien; chai 200 vien

VD-25752-16

188 Ocefib 200 Fenofibrat (duai dang vi hat chira 66% (kl/kl) fenofibrat) 200mg

Vien nang cung

36 thang

TCCS Hop 7 vi X 4 vien; hop 4 vi x 7 vien

VD-25753-16

189 Opeambrox 0,3% Moi 5ml chua:

Ambroxol HCl

Siro 36

thdng

TCCS Hop 1 chai 60ml; hpp 1

VD-25754-16

15mg chai 90 ml

190 Osteotis 10 Acid alendronic (duai dang Alendronat natri)

lOmg

Vien nen bao phim

"36"

thdng f e e s " H o^ f v r x l o " "

vien; hop 10 vi x 10 vien

VD-2"5755-r6 "

191 Sartanpo plus Losartan kali 50mg;

Hydrochlorothiazid

Vien nen bao phim

36 thdng

USP36 H6p3 v i x 10 vien

VD-25756-16 12,5mg

Uristic 200 Acid

ursodeoxycholic 200mg

Vien nen bao phim

36"

thdng

f e e s " i f o p 4 v r x l o ~ "

vien

VD-25757-16

31. Cong ty dang k^: Cong ty co phan du-yc pham Phong Phu (D/c: Ld sS 12 Duong sS 8, khu congnghiep Tdn Tgo, phudng Tdn Tgo A, qudn Binh Tdn, TP. Hd Chi Minh. - ViitNam)

31.1 N h i san xu4t: C h i nhanh Cong ty co phin duyrc pham Phong P h u - N h i may s i n xuat duffc pham Usarichpharm (D/c: Ld sd 12 Dudmg so 8, khu cdng nghiep Tdn Tgo, phudng Tdn Tgo A, qugn Binh Tdn, TP. Hd Chi Minh. - ViitNam)

STT Ten thuoc Hoat chat chinh - H i m lu-gng

Dang bao

"chi

Tuoi thp

TiSu chuan

Quy cich

dong g6i So dang ky 193 Richcogen Paracetamol 500 mg Vien n^n 36

thdng

TCCS HQP 25 vl X 20 vien; Hop 25 vi X 4 vien

VD-25758-16

194 Vitamin AD Vitamin A 5000 lU;

Vitamin D3 500 l U

Vien nang mem

36 thdng

TCCS HQP 10 v i x 10 vien; HQP 1 chai 100 vien

VD-25759-16

(28)

32. Cong ty i S o g k y : Cong ty co phae Diro'c pham Phuro'ng Dong (D/c: Lo 7, duong so 2, Khu cong nghiep Tdn Tao, Qudn Binh Tdn, Tp. Hd Chi Minh - Viet Nam)

32,1 Nha san xuSt: Cong ty co phan Diro'c pham Phirong Dong (D/c: Ld 7, duong sd 2, Khu cdng nghiep Tdn Tao, Qudn Binh Tdn, Tp. Hd Chi Minh - Viet Nam)

STT Ten thuoc Hoat chat chinh - Ham luwng

Dang bao c h i

Tuoi tho

Tieu chuan

Quy each

dong goi So dang ky 195 Dasoltac 400 M6i 6ng 8 ml chua:

Piracetam 400 mg

Dung dich uong

36 thang

TCCS Hop 12 6ng, 24 ong, 36 ong, 48 ong X 8 ml

VD-25760-16

Orientfe 200 mg Cefpodoxim (duai dang Cefpodoxim proxetil) 200 mg

Vien nen bao phim thang

USP "

38

Hop 1 vi, 2 vi, 3 v i , 6 v i , 10 vi X 10 vien; Chai 30 vien, 60 vien, 100 vien

VD-25761-16

197 Oriphospha Moi goi 20g chura:

Nhom phosphat gel 20 % (tuang duang vdi 2,476 g nhom phosphat) 12,38 g

Hon djch u6ng

36 thang

TCCS H9P 10 goi, 20 goi, 30 goi X

20g

VD-25762-16

33, Cong ty dang ity: Cong ty co phan dirffc pham Quang Binh (D/c: 46 Duong Hitu Nghi - TP.

Ddng Hdi - Quang Binh - Viet Nam)

33,1 N h i san xuit: Cong ty co phan du'o'c pham Quang Binh (D/c: 46 Duong Hihi Nghi - TP.

Ddng Hoi - Qudng Binh - Viet Nam)

s r i Ten thuoc Hoat chat chinh -

Ham lugng

Dang bao che

Tuoi thg

Tieu chuan

Quy each

dong goi So dang k^^

198 Gentamicin 0,3% Moi 5g chua:

Gentamicin (duai dang Gentamicin sulfat) 0,015g

Ma tra mSt 36 thang

TCCS Hop 1 tuyp 5 gam

VD-25763-16

199 Glutoz Acid ascorbic 50mg Vien nen

ngam thang

f e e s " Hop 30 goix 10 vien; hop 30 goi x 20 vien;

hop 1 lo 20 vien; hgp 1 lo 50 vien

VD-25764"-16"

200 Vitamin B I 100 mg Thiamin hydoclorid lOOmg

Vien nen 36 '

thang DDVN IV

Hop 10 vix" 10 vien; hop 100 vi X 10 vien

VD-25765-16

201 Vitamin B6 100 mg Pyridoxin

hydroclorid lOOmg

Vien nen 36 thang

DDVN IV

Hop 10 vi X 10 vien; hop 100 vi X 10 vien

VD-2"5766"-r6"

(29)

202 Vitamin C 100 mg Acid ascorbic Vien nen 24 DDVN Hop l l o 100 VD-25767-16

lOOmg thang IV vien; lo 1000

vien

203 Vitamin C 500 mg Acid ascorbic Vien nen bao "24~ f e e s " H o p f o V i x fo" VD-25768-16

SOOmg phim thang vien; hop 100

vi X 10 vien

34. C6ng ty dang ky: Cong ty Co phan Diro'c p h i m Sanofi-Synthelabo Viet Nam (Bfc: 10 Ham Nghi, P. Ben Nghe, Qudn 1, TP. Ho Chi Minh - Viet Nam)

34.1 Nha s i n xuat: Cong ty Ch phan Dugc pham Sanofi-Synthelabo Viet Nam (D/c: 15/6C Ddng Van Bi-Thu Duc-Tp Ho Chi Minh - Viet Nam)

STT Ten thu6c Hoat chat chinh - Ham lugng

D^ng bao che

Tu6i thg

Tieu chuan

Quy each

dong goi So dang ky 204 Fumafer B9 eorbiere

daily use

sat (II) fumarat (tuang duang 60mg sit nguyen to)

182,04mg; Acid Folic 0,4mg

Vien nen bao phim

24 thang

Tees Hop 8 v i x IS vien

VD-2S769-16

35. Cong ty dang ky: Cong ty co phan dug'c p h i m SaVi (D/c: Ld Z.01-02-03a KCN trong KCX Tdn Thudn, phuomg Tdn Thudn Ddng, qudn 7, Tp. HCM- Viet Nam)

35.1 Nha san xult: Cong ty co phan dugc p h i m SaVi (D/c: Ld Z.01-02-03a KCN trong KCX Tdn Thudn, phudng Tdn Thudn Ddng, qudn 7, Tp. HCM- ViitNam)

STT Ten thuoc Hoat chat chinh - Ham lugng

D^ng bao che

Tuoi thg

Tieu chuan

Quy each

dong g6i S6 dang ky 205 eetampir plus Piracetam 400mg; Vien nen bao 36 Tees Hgp 3 v i x 10 VD-2S770-16

einnarizin 25mg phim thang vien, hop lOvl X 10 vien

"206~ Ramasav Drotaverin Vien nen bao 36 Tees Hgp3 v i x 10 VD-25771-16 hydroclorid 40mg phim thing vien, hgp 10 vi

X 10 vien

"207~ Rimezig Pyridostigmin Vien nen bao 36 Tees Hop 3 v i X 10 VD-2S772-16

bromid 60mg phim thang vien

208 SaVi eolchicine 1 eolchicin Img Vien nen 36 USP Hgp2 v i x 10 VD-25773-16 thang 38 vien

209 SaVi Deferipron 250 Deferipron 250mg Vien nen bao 36 Tees Hop 3 v i x 10 VD-25774-16 phim thang vien, hop 1 chai

100 vien

210 SaViFexo 60 Fexofenadin Hei Vien nen bao 36 USP Hop 1 v i x 10 VD-25775-16

60mg phim thang 38 vien, hop 1 chai

X 100 vien

211 Senwar 1 Warfarin natri Img Vien nen 36 Tees Hop 3 v i x 10 VD-25776-16

(30)

bao phim thang vien, hop 1 chai X 100 vien 212 Senwar 2 Warfarin natri 2mg Vien nen bao

phim

" 36"

thang

TCCS Hop 3 v i x 10 vien, hop 1 chai X 100 vien

VD-25777-16

213 Senwar 5 Warfarin natri Smg Vien nen bao phim

36 thang

TCCS Hop 3 vi X 10 vien, hop 1 chai X 100 vien

VD-25778-16

36. Cong ty dang ky: Cong ty co phSn diro'c pham Tipharco (B/c: 15 Bdc Binh Kieu, phudng 2, thdnh phd My Tho, tinh Tien Giang - Vi^t Nam)

36.1 Nha san xuit: Cong ty c6 p h i n dug'c phim Tipharco (B/c: 15 Bdc Binh Kiiu, phuang 2, thdnh pho My Tho, tinh Tiin Giang - Viet Nam)

STT Ten thuoc Hoat chit chinh - Ham lugng

Dang bao che

Tuoi thg

Tieu chuin

Quy each

dong goi So dang ky 214

215

Auclanityl 2S0/31,2Smg

Cefadroxil 2S0mg

Moi goi 3,8g chua:

Amoxicillin (dudi dang Amoxicillin trihydrat) 250mg;

Acid clavulanic (duai dang Clavulanat kali) 31,25mg

M6i goi 2g chura:

Cefadroxil (duori dang Cefadroxil monohydrat) 2S0mg

Thu6c bot pha h6n djch uong

36 thang

TCCS Hop 12 goi X 3,8g

HQP 30 goi X

2g

VD-25779-16

VD-25780-16 214

215

Auclanityl 2S0/31,2Smg

Cefadroxil 2S0mg

Moi goi 3,8g chua:

Amoxicillin (dudi dang Amoxicillin trihydrat) 250mg;

Acid clavulanic (duai dang Clavulanat kali) 31,25mg

M6i goi 2g chura:

Cefadroxil (duori dang Cefadroxil monohydrat) 2S0mg

Thu6c bot 36 thang

TCCS

Hop 12 goi X

3,8g

HQP 30 goi X

2g

VD-25779-16

VD-25780-16

216 Mefenamic acid SOOmg Acid mefenamic Mefenamic acid SOOmg Vien nen bao 36 TCCS Hop 10 v i x 10 VD-25781-16

SOOmg phim thang vien

217 Tiamoxicilin 2S0 Moi g6i Sg chua: Thuoc bot 1 36 TCCS Hop 100 goix ^ VD-2S782-16 Amoxicillin (duai pha hon djch thang Sg; hop 20 goi

dang Amoxicillin uong xSg

trihydrat) 2S0mg

218 Tiptusxin Tiptusxin Paracetamol SOOmg; Vien nen 36 TCCS Hop 10 v i x 10 VD-25783-16 Phenylephrin HCl bao phim thang vien; hop 1 chai

lOmg; X 100 vien

Clorpheniramin maleat 2mg

37. Cong ty dang ky: Cong ty co phan dug'c p h i m T r u n g uong Vidipha (B/c: 184/2 Le Van Sy, Phuang 10, Q. Phu Nhudn, TP. Ho Chi Minh - Viet Nam)

Tài liệu tham khảo

Tài liệu liên quan

Sau khi co chit truang dOng Y dm Ban Thuang vv Bang ity va Ban Giant dOc So Y te, chant nhat trong tho'i gian 15 ngay lam viec, ca quart don vi tien hanh quy trinh giai thieu

xuất và một số điều kiện cần thiết để sản xuất, giải thích vì sao đồng bằng duyên hải miền Trung lại có các hoạt động sản xuất trên..

được đầu tư xây dựng nhiều nhà máy nên đồng bằng Nam Bộ đã trở thành vùng có ngành công nghiệp phát triển mạnh nhất nước ta với một số ngành nghề chính như:

Nhờ có thiên nhiên ưu đãi, người dân cần cù lao động, đồng bằng Nam Bộ đã trở thành vùng sản xuất lúa gạo, trái cây, thuỷ sản lớn nhất cả nước. Các sản phẩm

Thgc ィゥセョ@ nghTa Vl,l dong gop tai chinh cho nha truOng vai muc 10% (muai phAn tram) tinh tren kinh phi phia nuac ngoai chi tni cho

Cac thuoc thir hoac san pham duoc cung c~p boi cac chu sa hfru khac nhau co th@nhom vao cling mot b9 xet nghiem IVD nSu dan vi dang ky co th@cung c~p du cac thong tin theo yeu c~u

dQc va nguyen lieu dQc lam thuoc; cong ty dang ky, co sa san xufit phai c~p nhat quy dinh vS thuoc dQc tren nhan va huang dfuI sir dung theo quy dinh tai Thong tu 01/2018/TT-BYT

Sau khi duqc cfip gifiy dang ky lUll hanh, cO'sa dang ky ph6i hQ'Pvai cO' sa san xu5.t tiSp t\lC danh gia tinh an toan, tinh sinh miSn dich tren qufin th~ dich t(;1iVi~t Nam trong