Quyết định cấp số đăng ký thuốc trong nước từ đợt 127 đến đợt 145 - Vietnam Regulatory Affairs Society

BOYTE

eve QUAN LY ^Dl1Qe

CQNG HOA xA HQJ CHU NGHIA VIST NAM D{)c

l~p

- Tl}' do -

H~nh

phiic

DANH MUC 10 THUOC TU DVdC LIEU SAN XUAT TRONG NVOC DVdC cAP SO DANG KY

STT 1

STT 2

.

HIBULl}CDENHETNGAY31/12/2013 -DOT 142.

Ban harm

kern

theo quy6t

d!nh

s6: .~~ ... ./QD-QLD, ngay fft . .l./d./ .. ~5

1. eong ty dang

ky:

CO' s<r san xuit thuAc Y hQc cA

truy~n

Bao PhuO'Dg (Die: Than Thiing Ddu - Hoa Thc;zeh - Qu6e Oai- TP. Ha N9i)

1.1 Nha san xuit: CO' s<r san xuit thuBc Y hQc cB

_truy~n

Bao PhuO'Dg (Die: Die: Than Thfing Ddu - Hoa Thc;zeh - Qu6e Oai- TP. Ha N9i)

Ten thuac Ho~t chAt chinh - D~ng bao TuAi Tieu Quy each

sa dang

kY .

Ham luQ'Dg ch~ thQ chuln

.

dong goi

Cam cum Bao Phuong B~c ha, Thanh hao, Caolong 24 TCCS HQp 11Q x 60 V332-H12-13

Dia lien, Thich gia thang ml

d~ng, Kim ngan, Tia to, Kinh gi&i

2. eong ty dang

ky:

Cong

ty

CB phin BV Pharma (Die: ip 2, Xii Tan Thc;znh

Tay-Huy~n

Cit Chi-Thanh ph6 H6 Chi Minh-

Vi~t

Nam)

2.1 Nha san xuit: Cong

ty

CB phin BV Pharma (Die: ip 2, Xii Tan Thc;znh

Tay-Huy~n

Cit Chi-Thanhph6 H6 Chi Minh-

_Vi~t

Nam)

Ten thuac Ho~t chAt chinh - D~ngbao TuAi Tieu Quycach_

sa dang

kY

Ham ltrQ'Dg _ch~ thQ chuln dong goi

Lipidan Mfli vien chua 380 Vien nen bao 36 TCCS H9p 3, 6 vi x 1 0 V333-H12-13 mg cao kho chi~t

tir

phim thang vien (vi nhom-

4090 mg cac duqc nhom), H9p 3,

li~u sau: ban h~ nam 6vix 10vien

440 mg; B~ch linh (vi nhom-

890 mg; Xa tien tir PVC), H9p 1

440 mg; Ngii gia bi chai 45 vien

chan chim 440 mg; (chai nhl,l'a

Sinh khuang 11 0 HDPE ho~c

mg; TrAn bi 440 mg; chai thuy tinh

R\lt 560 mg; San tra mau nau)

440 mg; H~u phac

- nam 330 mg

j

STT 3

STT 4

STT 5

3. Cong ty dang ky: Cong ty co phan dugc H~u Giang (Die: 288 Bis Nguyen Van Cit, p. An Hoa,

Q.

Ninh KiJu, Cdn Tha- Vi?t Nam)

3.1 Nha san xu§t: Cong ty cB ph~n dugc H~u Giang (Die: 288 Bis Nguyin Van Cit, p. An Hoa,

Q.

Ninh Ki~u, Cdn Tha- Vi?t Nam)

Ten thuBc Ho:_1t ch~t chinh - D:_1ng biw TuBi Tieu Quy each

s6

dang

ky

Ham luQ'ng ch~ thQ chuAn dong goi

Kim ti~n thito Cao kho kim ti~n Vien nen bao 36 TCCS H()p 1 chai x V334-H12-13 thao 200 mg phim thang 100 vien

4. Cong ty dang ky: Cong ty

CB

ph~n Dugc Lam DAng - Ladophar. (Die: 6A Ng6 Quy~n, Phuimg 6, TP. Da Lq;t, tinh Ldm D6ng- Vi?t Nam)

4.1 Nha san xu§t: Cong ty

CB

ph~n Dugc Lam DAng- Ladophar. (Die: 6A Ng6 Quy~n, Phudng 6, TP. Da Lq;t, tinh Ldm D6ng - Vi?t Nam)

Ten thuBc Ho:_1t ch~t chinh - D:_1ng bao TuBi Tieu Quy each

s6

dang

ky

Ham luQ'Dg ch~ thQ chuAn dong goi Cynaphytoi cao actiso (mang Vien nang ">r rr",...,,...,....,

Hyp 1 chai 100 ^" 1"") '1 ~ T T 1 1"'\ 1 .,

.)0 1 \ ... .-\. . .-.::! V JJ..J-Cll..::.-IJ

duang v6i 375 mg c(rng thang vien, H()p 2 vi, cao d~c actiso) 300 5 vi x 10 vien mg

5. Cong ty dang ky: Cong ty cB ph~n Dugc phiim C~n Gi<r (Die: 186-188 Le Thanh Ton, P. B~n Thanh, Q1, Tp HCM- Vi?t Nam)

5.1 Nha san xu§t: Cong ty TNHH US pharma USA (Die: L6 B1-10, Duimg D2. KCN Tdy Bcic Cit Chi";Tp. HCM- Vi?t Nam)

Ten thuBc Ho:_1t ch~t chinh - D:_1ng bao TuAi Tieu Quy each

s6

dang

ky

Ham luQ'ng ch~ thQ chuAn dong goi

Flatokan Cao b~ch qua 80 mg Vien nen bao 36 TCCS H()p 6 vi x 10 V336-H12-13

phim thang vi en

6. Cong ty dang ky: Cong ty cB ph~n dugc phiim Tipharco (Die: 15 D6c Binh Ki~u, phuang 2, thanh ph6 .~1y T0,o, tinh Tiin Giang- Vift Nom)

6.1 Nha san xufit: Cong ty cB ph~n dugc phiim Tipharco (Die: 15 D6c Binh KiJu, phuimg 2, thanh ph6

My

Tho, tinh Ti~n Giang - Vi?t Nam)

STTI Ten thuBc Ho:_1t ch~t chinh - D:_1ng bao TuBi Tieu Quy each

s6

dang

ky

Ham luQ'Dg ch~ thQ chuAn dong goi

6 Cbiregutin Tablet Cao kho Cardus Vien nen 36 TCCS H()p 10 vi x 10 V337-H12-13

Trang 2

STT 7

·-··

STT 8

STT 9

-

marianus (tuang bao ducmg thang vi en duang v6i Silymarin

70mg) lOOmg

7. Cong ty dang

ky:

Coiig ty cA phftn

dtrqc-v~t

ttr y

t~

Thanh Hoa

(Die: 232 Trim Phu, Thanh Hoa"" ~i¢t Nam)

7.1 Nha san xuit: Cong ty cA phftn

dtrqc-v~t

ttr y

t~

Thanh Hoa.

(Die: Lo 4-5-6 khu eong nghi¢p Tdy Biie Ga, phuang Dong Th9, thimh'ph6 Thanh Hoa - Vi¢t Nam)

Ten thuac Ho~t ch§t chinh - D~ng biw Tu6i Tieu Quy each

sa dang

kY

Ham hrc;mg ch~ thq chuin . dong goi

Cao d~c fch m~u Cao d~c ich mau Cao d~c 60 TCCS Thung 1 Okg cao V338-Hl2-13 (tuang duang 85kg thang d~c dong trong

fch m~u) I 0 kg 2 IAn rui PE -

··-- .. -··· ·-·· ·-·· ··-- -···

8. Cong ty dang kj: Cong ty cA phftn Y Dtrqc phim Vimedimex

(Die: 246 C6ng Quynh, Q.l, TP. H6 Chi Minh)

8.1 Nha san xuit: Cong ty cA phftn BV Pharma

(FJ/e: lp 2,

xa

Tan Thgnh Tdy-Huy¢n Cu Chi-Thimh ph6 H6 Chi Minh- Vi¢t Nam) ·

Ten thuac Ho~t chit chinh - D~ng bao Tu6i Tieu Quy each

sa dang

ky

Ham luc;mg ch~ thQ chuin dong goi

. f

Cam xuyen huang - VM Xu yen Khung 3, 78 caol6ng 24 TCCS H{>p 1 chai 90 V339-H12-13 g; B~ch chi 5,22 g; thang ml ( chai thuy

Hu<;mg ph1,1 3,78 g; tinh mau nau) Que

o,

18 g; Girng

0,48 g; Cam thao 0,15 g

... -- ... ... - . --·· ·- . -···

'

~· Cong ty dang kj: Cong ty TNHH dU'(fc phim Nhit Nhit (Die: Alll37 du&ng Mai Ba HuO'ng, xa Le Minh Xudn, huy¢n Binh Chanh, Tp. HCM- Vi¢t Nam)

9.1 Nha san xuit: Cong ty TNHH dU'Q'c phim Nhit Nhit

(Die: Alll37 du&ng Mai Ba HuO'ng, xa · Le Minh Xudn, huy¢n Binh Chanh, Tp. HCM- Vi¢t Nam)

Ten thuac Ho~t chit chinh - D~ng bao Tu6i Tieu Quycach

sa <lang

kY

Ham luc;mg ch~ thQ chuin dong goi

Thu6c ho Nh~t Nh~i Tinh diu b~c ha 2,4 V_ien ng~m 36 TCCS HQp 3 vi x 10 V340-H12-13 mg; 66,95mg cao thang vien, hQp 12 vi

d~c _tuang duang ' x 10 vien, h{>p 1

v6i: B~ch linh 36 IQ 30 vien,

~115, '-'"""' ""'uu.' vu, ... ^{HY.P ~ IY vv v 1\..tl l}

mg; Ma hoang 26,5 mg;

'!_'y ba

di~p

130

.. mg; 0 mai 60 mg;

Cam th£10 25 mg;

Ban h\1 60mg;

Bach h9 75 mg;

Tang b~ch bi 75 mg;

Thien man dong 48,5 mg; B~c ha 65 mg

·····-

10. Cong ty <tang Icy: Cong

ty

TNHH san xuit thrrong m,i

dtrQ'C

phim NIC (NIC Pharma)

(Die: L6 liD duemg

C,

Khu c6ng nghi?p Tan Tc;zo, qugn Binh Tan, tp.

H6

Chi Minh- Vi?t Nam)

-

10.1 Nha san xuit

: Co

ng ty TNHH san xuit thrrong m'

i

dtrQ'c p

him NIC (NIC Pharma)

(Die: L6 liD duemg C, Khu c6ng nghi?p Tan Tc;zo, qugn Binh Tan, tp.

H6

Chi Minh- Vi?t Nam)

STT Ten thu6c 10 Taniki

Ho~t cb§t chinh - D~ng bao Tu6i Tieu Ham hrQ'Ilg · ch~ thQ chuin Cao h\lch

qua

80 mg Vien nen bao 36 TCCS

phim thang

Quy each dong goi H()p 10 vi x 10 vi en

I I

"---··

Truong

QuAe

Ctrimg

Trang 4

s6

dang

kY

V341-H12-13