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
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)
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
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)
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
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)
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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 viX 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 viX 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
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
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"
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
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)