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C0NG HOA XA HQ.I CHU NGHIA VIET NAM Boc lap - Ty do - Hanh phuc

— oa 0 so ™m

Pharma

S6:-7^/2020/C V-KI) TP. Ho Chi Minh, ngay J8 {hang 05 nam 2020(l'/v thay doi ten ca so

mrmdl’leh llmoc trimg than) • T-\U3>:r‘;: :

yjQgjJ j Kinh sui: SO Y TE TINH NINH THUAN

^^^Irirae-hej, Ban Giam Doc Cong ty TNHH Dir<?c pham Khurong Duy

.., six hgfp.tac cua Qiiy Sa vai Cong ty chung toi trong suot thai gian qua.

^Y-ifa^qua, Cong ty TNHH Dirge pham Khixcmg Duy co trung thau theo Quyih dinh s6 3000/QD-SYT ngay 06/08/2019 va 3OO8/Q0-SYT ngay 07/08/2019 cua Giam doc S6 Y t6 tinh Ninh Thuan, ve vice phe duyet kel qua lira chon nha thSu Goi thki s6 1 - Thuoc Generic nam 2019.

Hien tai, Trong danh muc thuoc trung thau co mot hu6c da dirge nha san xuit thay ddi thong tin nhu sau:

- Doi ten Co' so' san xuat moi: theo thong bao thay doi ten co1 so' dang ky, co" sa san xuat cua Cue Quan ly Dirge (dinh kem cong van so 20246/QLD-DK ngay 04/12/2019 cua Cue Quan Ly Dugc)

- Poi ten thuoc: theo cong van V/v thay doi ten thuoc thanh pham, mau nhan (dinh kem cong van cua Cue Quan Ly Dirge) cu the:

xin chan thanh cam cm•’ i. ^ € j.......

L-.n! h‘l •

Thong tin thuoc theo Quyet dinh trung thau Thong tin thuoc xin thay doiSTT Ten thuong

mai So dang ky Hang san xuat Hang san xuatTT Ten thuong maiHSMTChi nhanh Cong ty TNHH Lien doanh Stada- Viet Nam

Cong ty TNHH Lien doanh Stcllapharm - Chi nhanh 1

Clarithromycin Stada 500mg

VD-26559- Clarithromycin Stella 500 mg

1 G10274 17

Chi nhanh Cong ty TNHH Lien doanh Stada - Viet Nam

Cong ty TNHH Lien doanh Stcllapharm - Chi nhanh 1

VD-26574-2 G10306 Indopril 5 17

Nhtrng thong tin con lai cua mat hang neu tren van giu nguyen khong thay ddi nhu: ten hogt chat, so dang ky, ham lugng. quy each dong goi, dang bao che, nuac san xu§t. tieu chu^n va chat lugng san pham....

Bang van ban nay, kinh mong Quy So chap thuan cho Cong ty chung toi dugc ti£p tuc cung cap thuoc trung thau theo thong tin thay doi cho cac co so y te tren dja ban tinh Ninh Thuan. Dong thdi tao dieu kien de Bao hiem thanh toan vai ca hai thong tin thude trung thau neu tren.

Chan thanh cam on.

Tran trong,

jj^CONG TY^uff<yf CONGTY V-^'

*1 DUQC PHAM jliPAieiKiNGniiv 9*.

AVr/ nhan: •_Nhu Iren ■ Liru HC

L i6ngg)AmbScDS. Nguyin Thi Viet Hoakb$iNy^ ^

7#/ :CONG TY TNHH Dl/gC PHAM KHUONG OUY NNI-NN1A B?ch MS, Phirdng 15, Qu^n 10, TP. Ho Chi Minh Website: www.khuongduy.com.vnDT: 028. 3863 2083 Fax: 028.3977 0850

f

BO yt£CQC QTJAN LY DlTOC

S6: /QLD-BKV/v thong bio thay doi ten .ccr scr

ding ky, co sit sin xuit

GONG h6A XA HOI CHt NGHIA VIETNAM £)§c lap - Tv do - Hanh phtic

HaNgi, ngay 0*f thdng siZ- ndm 2019

Klnh gin: C6ng ty TNHH Lien doanh Stellapharm.£)fa chi: K63/1 Nguyin Thi Sdc, ap My Hda 2, xa Xudn Thai Dong huy$n H6c Mon, Tp. HCM.

Ngay 24/10/2019, Cue Quan ly Du^rc .nhan h6 scr dang ky thay doi. cua cong ty (so tiep nhan 4461/TDTN) ve vice thay doi ten co so d&ng ky, co sdr sin

t ? ? t t*

xuat doi vai thuoc san xuat trong mroc da dugc cap so dang ky liru hanh,Can cu Thong tu so 32/2018/TT-BYT ngay 12/11/2018 cua Bp tnrong Bo

Y te quy dinh viec dang ky liru hanh thuoc, nguyen lieu lam thuoc;Can cu ket luan tai Bien ban tham dinh ho scr thay doi/bo sung cua cong

ty, Cpc Quan ly Dugc co y kien nhu sau: •% ♦ ^ ♦ * * t r

Dong y de cong ty dugc thay dot tSn co sd dang ky, co so san xuat doi vdi 222 thuoc theo danh muc dinh kem cong van nay, cu the nhu sau:

1. Thay doi ten co sd dang ky:- Ten co sd dang ky da phe duyet: Cong ty TNHH Lien doanh Stada -

Viet Nam.- Ten co sd dang ky thay doi: Cong ty TNHH Lien doanh Stellaphami.2. Thay doi ten cO sd san xuat:- Ten co sd san xuit da phe duy§t; Chi nhanh Cong ty TNHH Lien doanh

Stada - Vi^t Nam.- Ten co sd san xuat thay doi: Cong ty TNHH Lien doanh Stellapharm- ,

?t%

Chi nhanh 1.♦ * *Ngoai ngi dung dugc thay doi tren, tat ca cac ngi dung khac giu nguyen

nhu ho so dang ky thuoc luu tai Cue Quan ly Dugc.Co sd dang ky, co sd san xuat phai chju trach nhiem ve chat lugng ddi vdi

thuoc luu hanh tren thi trudng va co trach nhiem thong bao su thay doi nay den cac co quan lien quan va khach hing.

Sau 06 thang ke tir ngay ky cong van nay, thuoc khdng dugc sia\ xuat vdi cac ngi dung cu da de nghi thay doi.

Cue Quan ly Dugc thdng bao de cong ty biet va thuc hign dung cac " quy dinh cua Viet Nam ve san xuat va luu hanh thuoc./.

kt. eye TRITONG nt^£yc TRirdNGp Y bAn chiNoi nhan:

• Nhu trenL/- CT.Vu^i- Luu:

^32948^

*( ouqcpHmflM|i^:iB-05- 2020 /7r

n i

t6ng giAm docOS. Nguy4n Thi Vift Hoa

en Thanh Lam

BO Y'Tficvc quAn ly Di/gfc

CONG h6a XA HOI CHU NGHlA VIET NAM 9$c lap - Ty do - Hanh phiic

DANHMVCCac thuoc de nghi thay doi ten cor s& ding ky, ccr sa san xuat

(Kem iheo cong van sojftztffa/QLD-DK ngayCfy thang/iL ndm 2019)

S£ dSng kyTen thn6cTT

1. VD-26553-17Acyclovir STADA 200 mg

2. Acyclovir STADA 400 mg VD-21528-14

3. VD-23346-T5Acyclovir STADA 800 mg

4. Acyclovir STADA 800 mg VD-29496-18

5. Adefovir STADA 10 mg VD-2502746

VD-26554-176. Albendazol STADA 200 mg

7. Algelstad VD-23335-15

8. YD-23985-15Allopurinol STADA 300 mg

9, VD-23962-15Almasane 4

10. Arastad 20 : VD-17765-12

n. Argistad 1G VD-23336-15

12, Aspirin STADA 81 mg VD-27517-17

13. VD-26555-17Asthmatin.10

14. Asthmatin 4 VD-26556-17

15. VD-26557-17Asthmatin 5

16. Atenolol STADA 100 mg VD-29497-18 •

17. Atenstad 50 VD-25980-16

18, VD-20541-14Azicine

19. Azicine 500,. VD-33095-19

20. VD-3239'849Bamstad

21, Betahistine STADA 16 mg VD-25487-16V •>., \\

22, VD-26558-17Bicimax

1

1f

23. Bisoplus HGT 5/12.5 VD-18530-13^ . .. .

BisOpIus. HCX10 mg/25 mg; >

24. VD-19188-13

25, Bisoprolol 2.5 mg Tablets VD-3239,9-19

26. Bisoprolol STADA 10 mg VD-21529-14

27. Bisoprolol STADA. 5 mg VD-21530-14

28. Bisostad 2.5 VD-24559-16

29. Bisostad 5 VD-23337-15

30. VD-27518-17Calcium STADA 500 mg

31. Calciiun .STADA Vitamin C, PP VD-2598M6

32. VD-22668-15Captopril STADA 25 mg

33:. Captopril STADA 25 mg ^0-27519-17< •

34. Carvestad 12.5 VD-22669-15

35. Carvestad 6.25 VD-29498-18

36, Cetirizine STADA 10 mg VD-30834-18

37. Citalopram STADA 10 mg VD-27520-17

38. -RACICitalopram STADA 20 mg VD-27521-17Of-

■: / 39. Clarithromycin STADA 250 mg VD-31395-18

40. ■ foClarithromycin STADA 500 mg VD-26559-17

41. Clindastad 150 VD-24560-16 .

42. Clopistad VD-23964-15

43. Cotrimstada VD-23965-15

44. Cotrimstada forte VD-23966-15 -

45. Diltiazem STADA 60 mg VD-27522-17

46. Diosmin 500 VD-22349-15

47. Domperidon STADA 10 mg VD-28558-17

48. Dudencer VD-23338-15

49. QLDB-787-19Efatrio

50. Efevirenz STADA 600 mg VD-26560-17

2

51. VD-32400-19Elnitine

52. Enalapril STADA 10 mg VD-21768-14

53. VD-26561-17Enalapril STADA 5 mg

54. QLDB-560-16Entecavir STADA 0.5 mg

.55. VD-23339-15Esomeprazol STADA 20 mg

56. VD-23967-15Esomeprazol STADA 40 mg

57. Pebustad40 QLBB-687-18

58. Febustad 80 QLDB-563-16

59. Felodipin STADA 5 mg retard VD-26562-17

60. VD-26563-17Fenostad 160

61. Fenostad 200 yD-25983-16

62. Fexostad 120 VD-25478-16

63. Fexostad 180 VD-23968-15

64. Flucoldstad VD-18109-12

65.t-’. Fluconazol STADA 150 mg. VD-32401-19X ’

66. Fluotin 20 VD-18851-13

67. Fluzinstad 5 VD-25479-16

68. Gastrylstad VD-25986-16

69 Gemfibstad 300 VD-24561-16

70. Glimepiride STADA 2 mg VD-24575-16

71. Glimepiride STADA 4 mg VD-23969-15

72. Grippostad C VD-23340-15 -

73. Hemarexin VD-16718-12

74. Ibuprofen STADA 600 mg YD-26564-17

75. Indopril 5 VD-26574-17

76. Irbesartan STADA 150 mg VD-19189-13

77. VD-18533-13Irbesartan STADA 300 mg

78. VD-22671-15Itranstad

3

79. VD-27523-17Keamine

80. Kidviton VD-22006-14

81. VD-27524-17Lactulose STADA

82. Lamivudin STADA 150 mg VD-32402-19

83, Lamone 100 VD-21099-14

84. VD-29499-18Lamivudine Tablets T50 mg

85. Lampstad 100 VD-24562-16

86. VD-24563-16Lamostad 200

87. Lamostad 25 VD-25480-16

88, VD-24564-16Lamostad 50

89. Lamzidivir VD-29500-18

90, Lansoprazpl STADA 30 mg VD-21532-14

91. Lercastad 10 VD-21101-14

92. VD-21104-14Levetstad 250\329«.93. Levetstad 500 VD-21105-14'6ng94. «HI'M ILevofloxacin STADA 250 mg VD-31396-187cpf

95. Linestad 600 VD-25984-16

96. Lipistad 10 VD-23970-15 ph6

97. Lipistad 20 VD-23341-15

98. Lirystad 150 VD-30107-18

99. Lirystad 75 VD-31397-18

100; Lisinopril STADA 10 mg VD-21.533-14

101. Lisinopril STADA 2,5 mg VD-23342-15

102, Lisinopril STADA 20 mg VD-23343-15

103. Lisinopril STADA 5 mg VD-22672-15 •

104. Lisiplus HCT 10/12.5 VD-17766-12

105. Lisiplus HCT 20/12,5 VD-18111-12

106. Liverstad 140 VD-22673-15

4

107. Loperamid STADA VD-23971-15

108. Loperamid STADA VD-25985-16

109. Lorastad 10 Tab. VD-23354-1S

110. Lorastad D VD-23353-15

111. VD-23972-15Lorastad Sp.

112. Loratadin STADA 10 mg VD-24566-16

113. VD-23973-15Losartan STADA 100 mg

114. Losartan STADA 12,5 mg VD-23974-15

115. LostadHCT 100/12,5 mg VD-27525-17

116. LostadHCT 100/25 mg VD-23975-15

117. LostadHCT 50/12.5 ,VD-24567-16

118. Lostad T25 VD-21534-14

119. Lostad T50 VD-20373-13

120. L-Stafloxin 500 VD-24565-16

121. Mangistad VD-23355-15

Metformin STADA 1000 mg122. VD-27526-17MR123. Metformin STADA 500 mg VD-23976-15

124. Metformin STADA 850 mg VD-26565-17

125. Mirastad30 VD-27527-17

126. Myopain 150 VD-20084-13

127. Myopain 50 VD-20085-13-

128. NAC 200 eff VD-22674-15

129. Nebivolol STADA 5 mg VD-23344-15

130. Neuronstad VD-26566-17

131. VD-24568-16Nifedipin T20 retard

132. Odistad 120 VD-21535-14

133. VD-26567-17Odistad 120

134. VD-12624-10Odistad 605

‘ :v-i V-

135. Olanstad 10 VD-27528-17

136. Olanstad 5 VD-2548M6

137. Osarstad 80 VD-26571‘17

138. Pahtostad.40 CAP VD-1721M2

139. VD-3309d-19Pantoprazole STADA 40 mg

140. Pantostad 20 VD-18534-13

141. Pantostad 40 VD-18535-13

142. Partamol 150 VD-24569-16

143. Partamol 250 VD-18852-13

144. Partamol 325 VD-21536-14

145. Partamol 500 •VD-21111-14

146. Partamol 80 VD-23977-15

147. Partamol C VD-21112-14

148. Partamol Codein eff. VD-14577-11

149. Partamol Codein Tab. VD-29504-18rY

150. '/UMPartamol eff. VD-24570-16

151. Partamol Tab. VD-23978-15 ma152. Partamol-Cafein VD-21113-14

153. Pracetam 1200 VD-18536-13

154. Pracetam 400 VD-22675-15 ‘

155. Pracetam 400 CAP VD-25554-16

156. Pracetam 800 VD-18538-13 '

157. Pranstad 1 VD-21114-14

158. Pravitce VD-22346-15

159. Praxinstad 400 VD-21115-14

160. Quetiapin STADA 200 mg VD-27530-17

161. Quetiapin STADA.100 ing VD-27529-17

162. Quetiapin STADA 25 mg VD-27531-17 •

6

163. Rabestad 20 VD-20543-14

164. Ribastad 200 VD-32403-19

165. VD-18853-13Risperstad 1

166. Risperstad 2 VD-18854-13

167. VD-19690-13Rosuvastatih STADA 10 mg

168. Rosuvastatin STADA 20 mg VD-19691-13

169. VD-22676-15Scanax 500

170. VD-2267745Scanneuron

171. Scanneuron-Forte VD-22013-14

172. VD-30835-18Sestad

173. Sezstad 10 #.VD-211.16-14• ■

174. VD-27532-17Sifstad 0.18

175. Sifstad 0.7 VD-27533-17

176. Simvastatin STADA 10 mg VD-22347-15

177. Simvastatin STADA 10 mg VD-26568-17

178. Simvastatin STADA 20 mg VD-30836-18«;

179. Staclazide 30 MR VD-28559-17

180. Staclazide 60 MR VD-29501-18

181. Stacytine 200 VDr20374-13

182. Stacytine 200 CAP VD-22667-15

183. Stacytine 600 VD-23979rl5

184. Stadeliine VD-27542-17 . '•

185. VD-27543-17Stadleucin

186. VD-25555-16Stadloric 100

187. Stadloric 200 VD-22678-15

188. Stadnex 20 VD-23980-15

189. VD-22345-15Stadnex 20 CAP

190. Stadnex 40 VD-23981-15

7

191. Stadnex 40 CAP VD-22670-15

192. . VD-23963-15Stadnolol 50

193. VD-30105-18Stadovas 10 Tab.

194. VD-19692-13Stadovas 5 CAP

195. VD-30106-18Stadovas 5 Tab.

196. VD-25028-16Stadpizide 50

197. Stadsidon 20 VD^25482-16

198. VD-21109-14Stadxicam 7.5

199. VD-21117-14Statripsine

200. Tadalafil ST ADA 10 mg VD-21118-14

201. •VD-29502-18Tadalafil STADA 2,5 mg

202. Tadalafil STADA 20 mg VD-25483-16

203. Tadalafil STADA 5 mg VD-24571-16

204. VD-22348-15Tamsustad

205. Tefostad T300 VD-23982-15

206. VD-28560-17Tefostad 300

207. VD-22679-15Telmisartan STADA 40 mg

208. VD-26569-17Telmisartan STADA 40 mg

209. VD-23345-15Telmisartan STADA 80 mg

210. Telmisartan STADA 80 mg VD-25484-16

211. Trimetazidin STADA 20 mg VD-27534-17

Trimetazidine STADA 35 mg212. VD-25029-16MR213. VD-23983-15Tusstadt

214. VD-22007-14Ultradol

215. VD-25030-16Valsartan STADA 160 mg

. 216. Valsartan STADA 40 mg VD-26570-17

217. Venlafaxine STADA 37,5 mg VD-25485-16

218. VD-23984-15Venlafaxine STADA 75 mg8

219. VD-25486-16Yitamin C STADA1 g

220. Yorifend 500 VD-32594-19

- 221. VD-27535-17Yorifend Forte

222. Zopistad 7.5 VD-18856-13

Danh muc g6m 09 traiig 222thu6c./.

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9

#;

CONG H6a XA HOI CHU NGHlA VI$T NAM figc lap - Ty do - Hanh phiic

Ha Noi, ngay $> thdng 3 ndm 2020

BQ YTEeye QUAN LY DU0C

S6: /QLD-DKV/v thay doi ten ihudc th^nh pham,

mau nhan

Kinh gi>i: Cong ty TNHH Lien doanh Stellapharm£)ia chi: K63/1 Nguyen Thi S6c, dp My Hoa 2, xa Xudn Thai £>dng, huyinHoc Mon, Tp. HCM.

Cue Quan ly Duac nhan du(?c ho scr so tiep nhan 4650/TDTN ng&y 05/11/2019 doi v6i thuoc san xuat trong nude da dugc cap giay dang ky luu hanh.

Can cu Thong tur s6 32/2018/TT-BYT ngay 12/11/2018 cua B$ trudng Bg Y* rtf

le quy dinh viec dang ky luu hanh thuoc, nguyen lieu lam thuoc; Thong tu so 01/2018/TT-BYT ngay 18/01/2018 cua Bp trudng Bp Y te quy dinh ghi nhan thuoc, nguyen lieu lam thuoc va Id hudng dan su dung thuoc;

t 4 % * *

Can cu ket luan tai Bien b&n tham dinh ho sa thay ddi/bo sung cua cong ty, Cue Quan ly Dupe co y kien nliu sau:

Dong y de cong ty dupe thay doi ten thuoc thanh pham, mau nhan doi vdi thuoc Clarithromycin Stada 500 mg, so dang ky: VD-26559-17, cu the nhu sau:

1. Thay doi ten thuoc:- Ten.thuoc da phe duyet: Clarithromycin Stada 500 mg.- Ten thuoc thay doi: Clarithromycin Stella 500 mg.2. Thay doi mau nhan; Mau nhan thay doi dupe dong dau xac nhan cua Cue

Quan ly Dupe kem theo Cong van nay.Ngoai noi dung dupe thay ddi tren, tat ca cac npi dung khac giu nguyen nhu

ho so dang ky thuoc luu tai Cue Quan ly Dupe.Ca sd dang ky, ca sd san xuat phai chiu trach nhiem ve chat lupng doi vdi

thuoc luu hanh tren thj trudng va co trach nhiem thdng bao su thay ddi nay den cac ca quan lien quan va khach hang.

* tt

Sau 06 thang ke tu ngay ky cong van nay, thuoc khdng dupe san xuat vdi cac npi dung cu da de nghj thay doi.

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Cue Quan ly Dupe thong bao de cong ty biet va thuc hien dung cac quy dinh cua Viet Nam ve san xuat va luu hanh thuoc./.No'inhan: ^-Nhirtrcn; k '- Cue mrcmg (de b/c);- Liru: VT, DK (Chi).

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