B Y t

cng ho x hi ch ngha vit nam

c lp - T do - Hnh phc S: 08/2009/TT-BYT H Ni, ngy 01 thng 7 nm 2009

Thng t Ban hnh Danh mc thuc khng k n Cn c Ngh nh s 188/2007/N-CP ngy 27 thng 12 nm 2007 ca Chnh ph quy nh chc nng, nhim v, quyn hn v t chc b my B Y t; Cn c Lut Dc s 34/2005/QH11 ngy 14 thng 6 nm 2005; m bo an ton cho ngi s dng thuc ng thi to iu kin thun li cho ngi bnh c th mua thuc t iu tr cc bnh nh v triu chng thng thng, B Y t ban hnh v hng dn thc hin "Danh mc thuc khng k n" nh sau: iu 1. Ban hnh km theo Thng t ny "Danh mc thuc khng k n", bao gm: 1. Danh mc thuc ho dc; 2. Danh mc thuc c ngun gc t dc liu. iu 2. Gii thch t ng 1. Thuc khng k n l thuc khi cp pht, bn v s dng khng cn n thuc. 2. Thuc k n l thuc nu s dng khng theo ng ch nh ca ngi k n th c th nguy him ti tnh mng, sc kho; khi cp pht, bn l, s dng cho bnh nhn ngoi tr phi theo n thuc. iu 3. Nguyn tc xy dng "Danh mc thuc khng k n" 1. Danh mc thuc khng k n c xy dng trn c s cc tiu ch c th v tnh cht dc l v tnh an ton ca thuc. 2. Danh mc thuc khng k n c xy dng ph hp vi thc t s dng, cung ng thuc ca Vit Nam v c tham kho cch phn loi thuc khng k n (Over The Counter - OTC) ca mt s nc nh Australia, M, mt s nc Chu u, Philippines, Singapore, Trung Quc. 3. Danh mc thuc khng k n c sa i, b sung hng nm. Trong trng hp cn thit, m bo an ton cho ngi s dng, mt s loi thuc c th b loi b khi danh mc thuc khng k n nu c nhng tc dng c hi nghim trng c pht hin. iu 4. Tiu ch la chn thuc khng k n
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Thuc p ng ng thi cc tiu ch sau c la chn vo Danh mc thuc khng k n: 1. Thuc c c tnh thp, khng to ra cc sn phm phn hu c c tnh, khng c nhng tc dng c hi nghim trng (l nhng tc dng c hi gy hu qu t vong, nguy him n tnh mng, cn phi nhp vin iu tr hay ko di thi gian iu tr, gy tn tt vnh vin hay nng n, sinh con d dng, d tt bm sinh v cc hu qu tng ng,...) c bit v/hoc khuyn co c tc dng ny. 2. Thuc c phm vi liu dng rng, an ton cho cc nhm tui, t c nh hng n vic chn on v iu tr cc bnh cn theo di lm sng. 3. Thuc c ch nh trong iu tr cc bnh thng thng v bnh nhn c th t iu tr, khng nht thit phi c s thm khm, t vn v theo di ca thy thuc. 4. ng dng, dng dng n gin (ch yu l ng ung, dng ngoi da) vi hm lng, nng thch hp cho vic t iu tr. 5. Thuc t tng tc vi cc thuc khc v thc n, ung thng dng. 6. Thuc khng gy tnh trng l thuc. iu 5. p dng "Danh mc thuc khng k n" 1. Danh mc thuc khng k n l cn c phn loi thuc khng k n v thuc k n. Thuc khng k n c php cp pht, bn v s dng khng cn n thuc. 2. Danh mc thuc khng k n l c s php l xy dng v ban hnh cc quy nh, hng dn i vi thuc khng k n trong ng k thuc, sn xut, xut khu, nhp khu, lu thng phn phi thuc, thng tin qung co thuc v phm vi hot ng ca cc c s bn l thuc. 3. i vi cc thuc c ch nh trnh thai c phn loi l thuc khng k n trong Danh mc ny, cn b y t phi c trch nhim hng dn s dng thuc trc khi cp, pht hoc bn cho ngi tiu dng. 4. Cc phm vi p dng khc ca Danh mc thuc khng k n s c hng dn c th trong cc vn bn lin quan. iu 6. T chc thc hin 1. i vi c s bn l thuc: K t ngy Thng t ny c hiu lc, cc c s bn l c php bn l khng cn n thuc i vi cc thuc trong danh mc thuc khng k n. 2. i vi c s sn xut, kinh doanh thuc:
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a) i vi h s ng k lu hnh thuc ti Vit Nam v h s nhp khu thuc cha c s ng k np ti Cc Qun l dc trc ngy Thng t ny c hiu lc, cc c s phi tin hnh thc hin vic phn loi, sa i, b sung cc ti liu c lin quan n vic phn loi thuc theo quy nh ti Thng t ny trc khi xem xt cp s ng k hoc giy php nhp khu. b) i vi cc thuc c s ng k lu hnh hoc c php nhp khu trc ngy Thng t ny c hiu lc: - Cc thuc c sn xut, nhp khu trong thi hn 12 thng k t ngy Thng t ny c hiu lc m a ra lu thng trn th trng th c php lu thng n ht hn dng ca thuc. - Sau 12 thng k t ngy Thng t ny c hiu lc, cc c s phi phn loi, cp nht, b sung cc thng tin trn nhn, t hng dn s dng thuc lin quan n vic phn loi thuc theo quy nh ti Thng t ny mi c php a thuc ra lu thng trn th trng. iu 7. iu khon thi hnh 1. Thng t ny c hiu lc thi hnh sau 45 ngy k t ngy k ban hnh. 2. Cc Qun l dc, cc n v trc thuc B Y t, S Y t cc tnh, thnh ph trc thuc trung ng, Tng cng ty dc Vit Nam, cc doanh nghip sn xut, kinh doanh dc phm, cc cng ty nc ngoi c giy php hot ng trong lnh vc dc c trch nhim thc hin Thng t ny. 3. Trong qu trnh thc hin nu c vn vng mc, ngh cc t chc, c nhn kp thi phn nh v B Y t (Cc Qun l dc) xem xt, gii quyt./.
Ni nhn:
- Vn phng Chnh ph (Phng cng bo VPCP, Website Chnh ph); - B T php (Cc Kim tra vn bn); - Y t ngnh (Quc phng, Cng an, Bu chnh-Vin thng, Giao Thng Vn ti); - Cc V, Cc, T.tra B Y t; Tng cng ty Dc VN; - S Y t cc tnh, thnh ph trc thuc T; - Hip hi SXKDDVN; - Website B Y t; - Lu: VT, PC, QLD (2 bn).

KT. B Trng Th trng

( k)

Cao Minh Quang

B Y t

Cng ho x hi ch ngha Vit nam

c lp T do Hnh phc DANH MC Thuc khng k n (Ban hnh km theo Thng t s:08/2009/TT-BYT ngy 01 thng 7 nm 2009) 1. DANH MC Thuc ho dc:
ng dng, dng bo ch, gii hn hm lng, nng Ung: cc dng Ung: cc dng Ung: cc dng Dng ngoi: cc dng

TT 1 2 3

Thnh phn hot cht Acetylcystein Acetylleucin Acid Acetylsalicylic (Aspirin) dng n cht hoc phi hp vi Vitamin C v/hoc Acid citric v/hoc Natri bicarbonat v/hoc Natri salicylat

Ghi ch

Acid Alginic (Natri Alginat) Ung: cc dng n cht hay phi hp vi cc hp cht ca nhm, magnesi Acid amin n cht hoc phi hp (bao gm c dng phi hp vi cc Vitamin) Ung: cc dng Vi ch nh b sung acid amin, vitamin cho c th

6 7 8 9

Acid Aminobenzoic (Acid para aminobenzoic) Acid Benzoic n cht hoc phi hp Acid Boric n cht hoc phi hp Acid Citric phi hp vi cc mui Natri, Kali

Ung: cc dng Dng ngoi Ung: vin ngm Dng ngoi Thuc tra mt Ung: cc dng
4

10 Acid Cromoglicic v cc dng mui Cromoglicat

Thuc tra mt, tra mi vi gii hn nng tnh theo acid Cromoglicic 2% Ung: cc dng Vi ch nh chng thiu mu, b sung dinh dng. Ghi ch

11 Acid Dimecrotic

12 Acid Folic n cht hoc Ung: cc dng phi hp vi st v/hoc cc Vitamin nhm B, khong cht, Sorbitol

TT

Thnh phn hot cht

ng dng, dng bo ch, gii hn hm lng, nng

13 Acid Glycyrrhizinic Ung: cc dng, bao gm (Glycyrrhizinat) phi hp c dng vin ngm vi mt s hot cht khc Dng ngoi nh Chlorpheniramin maleat, Dlmethylephedrin, Cafein... 14 Acid Mefenamic 15 Acid Salicylic n cht hoc phi hp trong cc thnh phm dng ngoi (phi hp Lactic acid; Lu hunh kt ta...) 16 Acyclovir Ung: cc dng Dng ngoi

Dng ngoi: thuc bi ngoi da vi nng Acyclovir 5% Ung: cc dng Vi ch nh tr giun

17 Albendazol

18 Alcol Diclorobenzyl dng phi hp trong cc thnh phm vin ngm 19 Alcol Polyvinyl 20 Alimemazin tartrat (Trimeprazin tartrat)

Ung: vin ngm

Dng ngoi Ung: cc dng

21 Allantoin phi hp trong cc thnh phm dng ngoi, thuc t hu mn (Cao Cepae fluid; Heparin...) 22 Allatoin phi hp vi cc Vitamin v/hoc Chondroitin 23 Almagat 24 Ambroxol n cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au

Dng ngoi Thuc t hu mn

Thuc tra mt

Ung: cc dng Ung: cc dng vi gii hn hot cht nh sau: - chia liu Ambroxol clorhydrat 30mg/n v - Cha chia liu: Ambroxol clorhydrat 0,8% Ung: cc dng

25 Amyllase dng n cht hoc phi hp vi Protease v/hoc Lipase v/hoc Cellulase TT Thnh phn hot cht

ng dng, dng bo ch, gii hn hm lng, nng

Ghi ch

26 Amylmetacresol dng Ung: vin ngm phi hp trong cc thnh phm vin ngm (nh vi cc tinh du, Bacitracin...) 27 Argyron 28 Aspartam 29 Aspartat 30 Attapulgit 31 Azelastin 32 Bc Sulphadiazin 33 Bacillus claussi 35 Bacitracin phi hp vi mt s hot cht khc trong cc thnh phm Thuc tra mt Dng ngoi Ung: cc dng Ung: cc dng Ung: cc dng Thuc tra mt, tra mi Dng ngoi Ung: cc dng Ung: vin ngm
6

34 Bacillus subtilis ng kh Ung: cc dng .

vin ngm (phi hp vi Neomycin sulfat; Amylocain; Tixocortol...) 36 Beclomethason dipropionat Thuc tra mi: dng kh dung vi gii hn liu dng ti a 1 ngy 400mcg, ng gi 200 liu (tnh theo hot cht khng c mui)

37 Benzalkonium phi hp Dng ngoi trong cc thnh phm Ung: vin ngm dng ngoi (vi Cholin; acid salicylic; Nystatin; Diiodohydroxyquin ...), trong cc thnh phm vin ngm (vi Tyrothricin, Bacitracin, tinh du...) 38 Benzocain dng phi hp Dng ngoi: cc dng vi gii hn Benzocain 10%; Vin t hu mn Ung: vin ngm Dng ngoi: cc dng vi gii hn nng 10% ng dng, dng bo ch, gii hn hm lng, nng Dng ngoi: kem bi nim mc ming, nc xc ming, thuc xt hng Ung: vin ngm Dng ngoi Dng ngoi: cc dng Ming dn

39 Benzoyl peroxid n cht hoc phi hp vi Iod v/hoc lu hunh TT Thnh phn hot cht

Ghi ch

40 Benzydamin HCl n cht hoc phi hp

41 Benzydamin salicylat n cht hoc phi hp 42 Benzyl benzoat phi hp trong cc thnh phm dng ngoi (vi cc tinh du, Cn Isopropyl...) 43 Berberin 44 Biclotymol n cht hoc phi hp vi Enoxolon v/hoc Phenylephrin HCl

Ung: cc dng Dng ngoi Thuc tra mi Ung: vin ngm

7

v/hoc Clorpheniramin maleat v/hoc tinh du 45 Bifonazol n cht hoc Dng ngoi phi hp vi Urea 46 Bisacodyl Ung: cc dng chia liu vi hm lng 10mg/n v Ung: cc dng Ung: cc dng Ung: cc dng vi gii hn Bromhexin HCl nh sau: - chia liu 8mg/n v; - Cha chia liu 0,8% Thuc t hu mn Ung: cc dng

47 Boldin 48 Bromelain n cht hoc phi hp vi Trypsin 49 Bromhexin HCl n cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au (nh vi Dextromethorphan HBr; Diphenhydramin; Guaiphenesin...) 50 Brompheniramin maleat n cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au 51 Budesonid

Thuc tra mi: dng kh dung, ng ht, thuc bt ht vi gii hn liu dng ti a 1 ngy 400mcg, ng gi 200 liu ng dng, dng bo ch, gii hn hm lng, nng Dng ngoi Thuc t hu mn

TT Thnh phn hot cht 52 Bufexamac n cht hoc phi hp trong cc thnh phm dng ngoi, thuc t hu mn (nh vi Titan Dioxid, Bismuth, Subgallat, Lidocain...) 53 Butoconazol 54 Cc hp cht Calci (tr Calcitriol) n cht

Ghi ch

Dng ngoi Ung: cc dng

8

Vi ch nh b sung calci

hoc phi hp vi Vitamin D v/hoc cc Vitamin v/hoc Ipriflavon 55 Cc hp cht ca Nhm, Magnesi, Calci dng n cht v phi hp Ung: cc dng

cho c th

Vi ch nh trung ha acid dch v, cha lot d dy, hnh t trng. Vi ch nh b sung st cho c th.

56 Cc hp cht st

Ung: cc dng

57 Cc men tiu ha n cht hoc phi hp vi cc vitamin 58 Cc mui bismuth 59 Cc mui magnesi

Ung: cc dng

Ung: cc dng Ung: cc dng Vi cc ch nh b sung magi cho c th, trung ha acid dch v nhun trng. Vi ch nh b sung khong cht cho c th. Bao gm c cc dng phi hp vi cc Vitamin.

60 Cc nguyn t vi lng: Crm, ng, kali, magnesi, mangan, Natri,

Ung: cc dng

61 Cc tinh du (Menthol, Pinen, Camphor; Cineol, Fenchone, Borneol, Anethol, Eucaliptol...) 62 Calamin n cht hoc phi hp trong cc thnh phm dng ngoi Thnh phn hot cht

Ung: cc dng Dng ngoi: thuc bi ngoi da, nc xc ming, thuc bi nim mc ming Dng ngoi

TT

ng dng, dng bo ch, gii hn hm lng, nng Ung: cc dng vi gii

9

Ghi ch Thnh phm

63 Carbinoxamin n

cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au (vi Pseudoephedrin HClv/hoc Bromhexin v/hoc Paracetamol) 64 Carbocystein 65 Carbomer 66 Catalase n cht hoc phi hp trong cac sthnh phm dng ngoi (vi Neomycin) 67 Cetirizin dihydroclorid 68 Cetrimid phi hp vi mt s hot cht khc trong cc thnh phm dng ngoi (Lidocain, Km, Calamin, Aminacrine, tinh du...)

hn Pseudoephedrin (tnh theo dng base) nh sau: - chia liu: 120mg/ n v; - Dng cha chia liu: 0,5% Ung: cc dng Dng ngoi Thuc tra mt Dng ngoi

cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng.

Ung: cc dng Dng ngoi

69 Cetrimonium phi hp Dng ngoi trong cc thnh phm Ung: vin ngm dng ngoi, vin ngm (phi hp vi Lidocain; Tyrothricin, tinh du...) 70 Chitosan (Polyglusam) 71 Cholin n cht hoc phi hp cc acid amin, Vitamin trong cc thnh phm dng ung; phi hp vi acid Salicylic, Benzalkonium... trong cc thnh phm dng ngoi 72 Chondroitin n cht hoc phi hp vi Glucosamin v/hoc du c v/hoc cc Dng ngoi Ung: cc dng Dng ngoi

Ung: cc dng

10

Vitamin v/hoc cc acid amin 73 Chondroitin phi hp cc Vitamin 74 Chondroitin phi hp trong cc thnh phm dng ngoi TT Thnh phn hot cht Thuc tra mt Dng ngoi

ng dng, dng bo ch, gii hn hm lng, nng Dng ngoi Ung: dng chia liu vi gii hn hm lng Cimetidin 200mg/n v Ung: cc dng Dng ngoi Thuc t hu mn

Ghi ch

75 Ciclopirox olamin 76 Cimetidin

77 Cinarizin 78 Cinchocain phi hp trong cc thnh phm dng ngoi, thuc t hu mn (nh vi Hydrocortison, Neomycin, Esculin...) 79 Citrullin 80 Clobetason butyrat 81 Clorhexidin 82 Clorophyl 83 Clorpheniramin maleat n cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au (phi hp vi Phenylephrin HCl, Paracetamol, Dextromethorphan HBr...) 84 Clorpheniramin maleat phi hp Chondroitin v/hoc cc Vitamin 85 Clotrimazol

Ung: cc dng Dng ngoi Dng ngoi Ung: cc dng Ung: cc dng. Dng n cht chia liu: Clorpheniramin maleat 4mg/n v.

Thuc tra mt

Dng ngoi: cc dng vi

11

gii hn nng 3% Vin t m o 86 Coenzym Q10 n cht hoc phi hp vi cc Vitamin 87 Crotamiton 88 ng sulfat Ung: cc dng

Dng ngoi Dng ngoi

89 Dequalinium n cht Dng ngoi hoc phi hp trong Vin t m o cc thnh phm dng Ung: vin ngm ngoi, vin ngm (Tyrothricin; Hydrocortison; acid Glycyrrhetinic; Lidocain...) ng dng, dng bo ch, gii hn hm lng, nng

TT Thnh phn hot cht

Ghi ch

90 Dexbrompheniramin Ung: cc dng maleat n cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au. 91 Dexclorpheniramin Ung: cc dng maleat n cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au 92 Dexibuprofen 93 Dexpanthenol 94 Dextromethorphan HBr n cht hoc phi hp trong thnh phm thuc ho, h nhit, gim au Ung: cc dng Thuc tra mt Dng ngoi Ung: cc dng vi gii hn nh sau (tnh theo dng base): - Dng chia liu: Dextromethophan 15mg; - Dng cha chia liu: Dextromethophan 0,6%;
12

Thnh phm cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng.

95 Diclofenac n cht Dng ngoi hoc phi hp vi Methyl Thuc tra mt (dng n salicylat; Tinh du... cht) 96 Dicyclomin 97 Diethylphtalat (DEP) 98 Dimenhydrinat 99 Dimethicon (Dimethylpolysiloxan) n cht hoc phi hp vi Guaiazulen 10 Dimethicon phi hp 0 trong cc thnh phm dng ngoi (vi Km; Calamin; Cetrimid...) 10 Dimethinden 1 10 Dinatri Inosin 2 monophosphat 10 Diosmectit 3 (Dioctahedral smectit) Ung: cc dng Dng ngoi Ung: cc dng Ung: cc dng

Dng ngoi

Ung: cc dng Dng ngoi Thuc tra mt Ung: cc dng

10 Diosmin phi hp Ung: cc dng 4 Hesperidin v/hoc mt s cao dc liu cha Flavonoid TT Thnh phn hot cht 10 Diphenhydramin 5 hydroclorid hoc monocitrat ng dng, dng bo ch, gii hn hm lng, nng Ung: cc dng vi gii hn hm lng (tnh theo dng base) nh sau: - chia liu 50mg/n v; - Cha chia liu: 2,5% Ung: cc dng vi gii hn nh sau: - chia liu 10mg/n v; - Cha chia liu: 0,1% Thnh phm Ghi ch

10 Domperidon 6

10 Doxylamin phi hp Ung: cc dng vi gii hn 7 trong thnh phm thuc Pseudoephedrin nh sau
13

ho, h nhit, gim au (nh vi Paracetamol; Pseudoephedrin HCl; Dextromethorphan HBr; cc Vitamin...) 10 Econazol n cht 8 hoc phi hp vi Hydrocortison 10 Enoxolon n cht 9 hoc phi hp trong cc thnh phm dng ngoi, vin ngm 11 Ephedrin HCl 0 11 Eprazinon 1 11 Esdepallethrin phi hp 2 trong cc thnh phm dng ngoi (vi Piperonyl, Spregal, tinh du...) 11 Estradiol n cht v 3 phi hp Dydrogesteron

(tnh theo dng base): - Dng chia liu 120mg/ n v; - Dng cha chia liu 0,5% Dng ngoi, gii hn nng Hydrocortison tnh theo dng base 0,05% Dng ngoi: thuc bi ngoi da, kem bi nim mc ming, nc xc ming Ung: vin ngm Thuc tra mt, mi: dung dch 1% Ung: cc dng Dng ngoi

cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng.

Ung: thuc chia liu

Ch nh trnh thai

11 Ethanol n cht hoc Dng ngoi (cn st trng) 4 phi hp Ung: dng phi hp 11 Ethinylestradiol n 5 cht v phi hp Cyproteron Ung: thuc chia liu Ch nh trnh thai Ch nh trnh thai Ghi ch Ch nh trnh thai Ch nh trnh thai

11 Ethylestradiol n cht Ung: thuc chia liu 6 v phi hp Desogestrel TT Thnh phn hot cht ng dng, dng bo ch, gii hn hm lng, nng

11 Ethylestradiol n cht Ung: thuc chia liu 7 v phi hp Gestodene 11 Ethylestradiol n cht Ung: thuc chia liu 8 v phi hp Levonorgestrel
14

11 Etofenamat 9 12 Famotidin 0

Dng ngoi Ung: cc dng Bn khng cn n ti a cho 15 ngy s dng.

12 Fenticonazol 1 12 Fexofenadin 2 12 Flurbiprofen 3 12 Glucosamin n cht 4 hoc phi hp vi Chondroitin v/hoc cc Vitamin 12 Glucose hoc Dextrose 5 n cht hoc phi hp vi cc mui natri, kali 12 Glycerin n cht 6 hoc phi hp trong cc thnh phm dng ngoi, thuc tra mt (vi Polysorbat 80) 12 Glycerol phi hp vi 7 dch chit dc liu 12 Guaiphenesin n cht 8 hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au (vi Paracetamol; Pseudoephedrin HCl; Dextromethorphan HBr...) 12 Hexamidin n cht 9 hoc phi hp (vi Cetrimid, Lidocain, Clotrimazol, Catalase) 13 Hexetidin n cht

Dng ngoi Ung: cc dng Vin ngm Dng ngoi Thuc tra mt Ung: cc dng

Ung: cc dng

Vi ch nh b sung ng, cht in gii.

Dng ngoi Thuc tra mt

Thuc tht trc trng Ung: cc dng vi gii hn Pseudoephedrin nh sau (tnh theo dng base): - Dng chia liu 120mg/ n v; - Dng cha chia liu 0,5% Dng ngoi Thnh phm cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng.

Dng ngoi: thuc bi

15

hoc phi hp (vi Benzydamin, Cetylpyridinum, Cholin Salicylat, Methyl salicylat, tinh du...) TT Thnh phn hot cht

ngoi da, dung dch xc ming

ng dng, dng bo ch, gii hn hm lng, nng

Ghi ch

13 Hydrocortison n cht Dng ngoi: cc dng vi 1 hoc phi hp (vi nng Hydrocortison Miconazol, Econazol, 0,5% Tioconazol, Neomycin) 13 Hydrogen Peroxid (Oxy 2 gi) n cht hoc phi hp Natri Lauryl sulfat v/hoc tinh du... 13 Hydrotalcit 3 13 Hydroxypropyl 4 methylcellulose (HPMC) 13 Hypromellose n 5 cht hoc phi hp Dextran 70 13 Ibuprofen 6 13 Ichthammol 7 13 Indomethacin 8 13 Iod phi hp Kali Iodid 9 v/hoc Acid Benzoic v/hoc Acid Salicylic 14 Isoconazol 0 14 Isopropyl Methylphenol 1 14 Ketoconazol n cht 2 hoc phi hp vi Km Pirythion v/hoc Hydrocortison v/hoc Dng ngoi

Ung: cc dng Thuc tra mt Thuc tra mt: cc dng

Ung: cc dng Dng ngoi Dng ngoi Dng ngoi Dng ngoi vi nng Iod 5% Dng ngoi Dng ngoi Dng ngoi: cc dng vi nng Ketoconazol 2%
16

Trolamin 14 Ketoprofen 3 14 Km oxid, Km pyrithion, 4 Km Gluconat, Km undecylenat n cht hoc phi hp trong cc thnh phm dng ngoi 14 Km sulfat 5 14 Lactic acid bacillus 6 n cht hoc phi hp vi cc Vitamin 14 Lactitol 7 TT Thnh phn hot cht Dng ngoi Dng ngoi

Dng ngoi Thuc tra mt Ung: cc dng

Ung: cc dng ng dng, dng bo ch, gii hn hm lng, nng

Ghi ch

14 Lactobacllus acidophilus Ung: cc dng 8 14 Lactobacllus acidophilus Ung: cc dng 9 n cht hoc phi hp vi cc Vitamin 15 Lactoserum atomisate 0 (Lactacyd) 15 Lactulose 1 15 Levocetirizin 2 15 Levonorgestrel n 3 cht hoc phi hp vi Ethylestradiol Dng ngoi Ung: cc dng Ung: cc dng Ung: cc dng Ch nh trnh thai

15 Lindan (Benhexachlor, Dng ngoi vi nng 4 666, Gamma-BHC) n Lindan 1% cht hoc phi hp vi Lidocain 15 Loperamid 5 15 Loratadin n cht Ung: cc dng vi gii hn hm lng chia liu Loperamid 2mg Ung: cc dng vi gii hn
17

Thnh phm

hoc phi hp Pseudoephedrin HCl

hm lng nh sau (tnh theo dng base): - chia liu: Loratadin 10mg/n v; Pseudoephedrin 120mg/n v - Cha chia liu: Loratadin 0,1% Pseudoephedrin 0,5% Ung: cc dng Ung: cc dng Dng ngoi

cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng.

15 Loxoprofen 7 15 Lysozym n cht 8 hoc phi hp vi Tocopherol, Nicotinate, Carbazochrom, Inositol Cetylpyridinium,... 15 Macrogol 9 16 Magaldrat n cht 0 hoc phi hp vi cc hot cht Nhm, Magnesi, Acid Alginic (hay dng mui Alginat). 16 Mangiferin 1 TT Thnh phn hot cht 16 Mebendazol 2

Ung: cc dng Thuc tht trc trng Ung: cc dng

Dng ngoi ng dng, dng bo ch, gii hn hm lng, nng Ung: cc dng, vi gii hn hm lng nh sau: - Dng chia liu 500mg/n v - Cha chia liu 2% Ung: dng chia liu 200mg/n v Ung: cc dng

Ghi ch

16 Mebeverin 3 16 Men nm (cellulase 4 fongique)

16 Menthol phi hp vi mt Ung: cc dng

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s hot cht khc nh hn Dng ngoi: cc dng hp tinh du, Methyl Salycilat.... 16 Mequinol 6 16 Mequitazin 7 16 Mercurocrom (Thuc 8 ) Dng ngoi Ung: cc dng Dng ngoi Dng ngoi vi quy cch ng gi 30ml Bn khng n mi ln khng qu 2 n v ng gi

16 Methyl salicylat phi hp Dng ngoi 9 trong cc thnh phm Ming dn vin ngm, dng ngoi Ung: vin ngm (phi hp vi tinh du...) 17 Metronidazol 0 17 Miconazol 1 17 Miconazole phi hp vi 2 Hydrocortison Dng ngoi Dng ngoi Thuc bi m o 2% Dng ngoi Thuc bi m o Miconazol 2%; Hydrocortison 0,05% Dng ngoi: cc dng nng 5% Thuc tra mi: 50 mcg/ln xt vi quy cch ng gi 200 liu/hp; Dng ngoi. Dng ngoi

17 Minoxidil 3 17 Mometasone 4

17 Mupirocin 5 17 Myrtol n cht hoc Ung: cc dng 6 phi hp trong cc thnh Dng ngoi phm vin ngm

TT Thnh phn hot cht 17 Naphazolin n cht

ng dng, dng bo ch, gii hn hm lng, nng Thuc tra mi vi nng

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Ghi ch

hoc phi hp trong thnh phm thuc mi nh Diphenylhydramin v/hoc Procain

Naphazolin 0,05%

17 Naphazolin phi hp Thuc tra mt: cc dng 8 trong thnh phm thuc vi nng Naphazolin tra mt (Pheniramin; 0,1%, Vitamin glycyrhizinat, Dexpanthenol...) 17 Naproxen 9 18 Natri benzoat n cht 0 hoc phi hp 18 Natri bicacbonat n 1 cht hoc phi hp 18 Natri carbonat n 2 cht hoc phi hp 18 Natri 3 Carboxymethylcellulose (Na CMC) 18 Natri clorid n cht 4 hoc phi hp vi cc mui Kali Citrat, Natri citrat... 18 Natri Docusat 5 18 Natri Fluorid dng phi 6 hp 18 Natri Hyaluronat (Acid 7 Hyaluronic) 18 Natri 8 Monofluorophosphat 18 Natri Salicylat dng phi 9 hp 19 Neomycin sulfat phi 0 hp trong cc thnh phm vin ngm (Km; Bacitracin; Ung: cc dng chia liu Naproxen 250mg/n v Ung: cc dng

Ung: cc dng Ung: cc dng Thuc tra mt

Ung: cc dng Dng ngoi Thuc tra mt, tra mi Ung: cc dng Dng ngoi: nh rng, xc ming Dng ngoi Dng ngoi: nh rng, xc ming Ung: dng phi hp trong cc vin ngm Dng ngoi Ung: vin ngm Dng ngoi
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Amylocain...), cc thnh phm dng ngoi ng dng, dng bo ch, gii hn hm lng, nng

TT Thnh phn hot cht

Ghi ch

19 Nomahydrated Natri Ung: cc dng 1 Sulfid + Saccharomyces Dng ngoi Cerevisiae 19 Noscarpin 2 19 Nystatin n cht 3 hoc phi hp 19 Orlistat 4 19 Ossein hydroxy apatit 5 19 Oxeladin 6 19 Oxymemazin 7 19 Oxymetazolin 8 Ung: cc dng Dng ngoi Ung: cc dng Ung: cc dng Ung: cc dng Ung: cc dng Thuc tra mi vi nng 0,5% .

19 Pancreatin n cht Ung: cc dng 9 hoc phi hp vi Simethicon v/hoc cc men tiu ho v/hoc cc Vitamin nhm B v/hoc Azintamid 20 Panthenol 0 20 Paracetamol 1 Dng ngoi Thuc tra mt Ung: cc dng Thuc t hu mn

Dng phi hp quy nh c th trong danh mc

20 Paracetamol phi hp vi 2 Ibuprofen v/hoc Cafein 20 Paracetamol phi hp vi 3 Loratadin v/hoc

Ung: cc dng

Ung: cc dng
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Dextromethorphan HBr 20 Paracetamol phi hp vi 4 Promethazin HCl Ung: cc dng vi gii hn hm lng, nng nh sau (tnh theo dng base): - chia liu: Promethazin 12,5mg/n v; - Cha chia liu: Promethazin 0,1% Thuc t hu mn Paracetamol phi hp vi Ung: cc dng vi gii hn Codein Codein (tnh theo dng base) nh sau: - Dng chia liu 30mg/n v; - Dng cha chia liu 2,5% ng dng, dng bo Thnh phn hot cht ch, gii hn hm lng, nng Paracetamol phi hp vi Ung: cc dng vi gii hn Pseudoephedrin HCl nh sau (tnh theo dng v/hoc Vitamin C base): v/hoc mt trong cc hot cht sau: - Dng chia liu: Brompheniramin Pseudoephedrin maleat; Clorpheniramin 120mg/n v; maleat; Pheniramin Dextromethophan maleat; 15mg Dexclorpheniramin - Dng cha chia liu: maleat; Pseudoephedrin 0,5% Dexbrompheniramin Dextromethophan 0,6% maleat; Dextromethorphan HBr; Phenylephrin HCl Pentoxyverin Ung: cc dng Thuc tra mt, nh mi nng 1% .

20 5

Thnh phm cha Codein c bn khng cn n vi s lng ti a cho 10 ngy s dng. Ghi ch Thnh phm cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng.

TT 20 6

20 7

20 Phenylephrin HCl 8

20 Phenylephrin HCl phi Dng ngoi 9 hp trong cc thnh phm dng ngoi (nh Petrolatum sperti yellow; Mineral oil light;
22

Shark liver oil...)

21 Phenylephrin HCl phi 0 hp trong cc thnh phm thuc ho, h nhit, gim au 21 Phospholipid 1 21 Picloxydin 2 21 Piracetam 3 21 Piroxicam 4 21 Policresulen 5 (Metacresolsulphonic acid-formaldehyd)

Ung: cc dng Thuc t hu mn

Ung: cc dng Thuc tra mt Ung: cc dng Dng ngoi: cc dng vi nng 1% Dng ngoi Thuc t trc trng

21 Polymethylen glycol 400 Thuc tra mt 6 n cht hoc phi hp vi Propylen glycol 21 Polysacharid 7 Ung: cc dng

21 Polytar n cht hoc Dng ngoi 8 phi hp trong cc thnh phm dng ngoi (nh Km Pyrithion...) 21 Povidon Iodin 9 Dng ngoi: cc dng, bao gm dung dch xc ming vi nng 1%. Thuc tra mt ng dng, dng bo ch, gii hn hm lng, nng Ung: cc dng vi gii hn hm lng, nng Promethazin nh sau (tnh theo dng base): - chia liu 12,5mg/
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TT Thnh phn hot cht 22 Promethazin HCl n 0 cht hoc phi hp trong cc thnh phm thuc ho, h nhit, gim au (vi Carbocystein; Paracetamol...)

Ghi ch

n v; - Cha chia liu 0,1% Dng ngoi: nng 2% 22 Pseudoephedrin HCl 1 phi hp vi Cetirizin Ung: cc dng vi gii hn Pseudoephedrin nh sau (tnh theo dng base): - Dng chia liu 120mg/n v; - Dng cha chia liu 0,5% Ung: cc dng vi gii hn Pseudoephedrin nh sau (tnh theo dng base): - Dng chia liu 120mg/ n v; - Dng cha chia liu 0,5% Ung: cc dng Ung: cc dng chia liu 75mg Thnh phm cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng. Thnh phm cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng. Ch nh tr giun Bn ti a khng c n cho 15 ngy s dng.

22 Pseudoephedrin HCl 2 phi hp trong cc thnh phm thuc ho, h nhit, gim au,

22 Pyrantel 3 22 Ranitidin 4

22 Rotundin n cht 5 hoc phi hp vi cc cao, dch chit t dc liu 22 Rutin n cht hoc 6 phi hp vi Vitamin C v/hoc cc cao, dch chit t dc liu 22 Saccharomyces 7 boulardic 22 Saccharomyces 8 cerevisiae + Trihydrat Magnesi Sulfat 22 Hyocine (Scopolamin) 9 butylbromid n cht hoc phi hp vi

Ung: cc dng

Ung: cc dng

Ung: cc dng Ung: cc dng

Ung: cc dng, bao gm c vin nhai vi gii hn hm lng chia liu

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Meclizin hydrochlorid 23 Selen hu c dng phi 0 hp trong cc thnh phm cha Vitamin, khong cht TT Thnh phn hot cht 23 Selen sulfid 1 23 Silymarin n cht 2 hoc phi hp vi cc Vitamin v/hoc cc cao, dch chit t dc liu. 23 Simethicon n cht 3 hoc phi hp vi Pancreatin v/hoc Acid Desoxycholic v/hoc cc Vitamin nhm B v/hoc cc men tiu ho 23 Simethicon phi hp vi 4 cc hp cht nhm, magnesi, v/hoc Dicyclomin v/hoc than hot

20mg Ming dn Ung: cc dng vi gii hn hm lng nh sau: - Dng chia liu Selen 50mcg/ n v ng dng, dng bo ch, gii hn hm lng, nng Dng ngoi Ung: cc dng Ghi ch

Ung: cc dng

Ung: cc dng

23 Sorbitol n cht hoc Ung: cc dng 5 phi hp 23 Sterculia (gum 6 sterculia) 23 Sucralfat 7 23 Sulbutiamin 8 Ung: cc dng Thuc tht trc trng Ung: cc dng Ung: cc dng

23 Sulfogaiacol n cht Ung: cc dng 9 hoc phi hp trong cc thnh phm h nhit, gim au, chng ho (nh phi hp vi Natri
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Benzoat, Dextromethophan...) 24 Terbinafin 0 24 Terpin n cht hoc 1 phi hp vi Codein Dng ngoi: cc dng vi nng 1% Ung: cc dng. Dng phi hp Codein (tnh theo dng base) gii hn hm lng nh sau: - Dng chia liu 30mg/n v; - Dng cha chia liu 2,5% Thuc tra mi Ung: cc dng Thnh phm cha Codein c bn khng cn n vi s lng ti a cho 10 ngy s dng.

24 Tetrahydrozolin 2 24 Than hot n cht 3 hoc phi hp vi Simethicon

ng dng, dng bo TT Thnh phn hot cht ch, gii hn hm lng, nng 24 Tioconazol n cht Dng ngoi: cc dng vi 4 hoc phi hp vi nng nh sau: Hydrocortison - Tioconazol 1,00% - Hydrocortison 0,05% 24 Tolnaftat Dng ngoi 5 24 Tretinoin Dng ngoi: cc dng vi 6 nng 0,05% 24 Triclosan n cht Dng ngoi 7 hoc phi hp trong cc thnh phm dng ngoi 24 Triprolidin n cht Ung: cc dng vi gii hn 8 hoc phi hp trong cc Pseudoephedrin nh sau thnh phm thuc ho, (tnh theo dng base): h nhit, gim au (nh - Dng chia liu 120mg/ vi: Guaiphenesin, n v; Paracetamol, - Dng cha chia liu Pseudoephedrin HCl, 0,5% Dextromethophan HBr...) 24 Trolamin n cht Dng ngoi
26

Ghi ch

Thnh phm cha Pseudoephedri n c bn khng cn n vi s lng ti a cho 15 ngy s dng.

hoc phi hp trong cc thnh phm dng ngoi (vi Triclosan v/hoc Tyrothricin) 25 Tyrothricin dng phi 0 hp (vi Benzalkonium, Benzocain, Formaldehyd, Trolamin, tinh du...) 25 Urea n cht hoc 1 phi hp vi Vitamin E v/hoc Bifonazol v/hoc cc dc liu (cao L hi...) 25 Vitamin A v tin 2 Vitamin A (Betacaroten)

Ung: vin ngm Dng ngoi: dung dch xc ming, xt ming Dng ngoi

25 Vitamin nhm B, 3 Vitamin PP n cht hoc phi hp. 25 Vitamin v tin Vitamin 4 dng n cht (tr Vitamin A v Vitamin D) hoc phi hp cc Vitamin, khong cht, acid amin, Taurin, acid bo. 25 Xanh Methylen 5 25 Xylometazolin n 6 cht hoc phi hp vi Benzalkonium.

Ung: cc dng vi Vitamin A 5000 IU /n v chia liu. Dng ngoi Thuc tra mt Thuc tra mt

Ung: Vitamin A dng phi hp 5000 IU/n v chia liu Dng ngoi

Vi tc dng b sung Vitamin, khong cht v dinh dng.

Dng ngoi Thuc tra mi vi nng Xylometazolin 1%

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2. DANH MC Thuc c ngun gc t dc liu: Thuc c ngun gc t dc liu trong thnh phn khng cha cc dc liu c c tnh cao (v d: M tin, ph t, l ngn, trc o, hong nn,...), dc liu c nhng tc dng c hi nghim trng c bit v/hoc khuyn co c tc dng ny c phn loi l thuc khng k n. Thuc c ngun gc t dc liu trong thnh phn c cha cc dc liu c c tnh cao (v d: m tin, ph t, l ngn, trc o, hong nn,...), dc liu c nhng tc dng c hi nghim trng c bit v/hoc khuyn co c tc dng ny c xem xt phn loi theo tng trng hp c th. B Y t s ban hnh danh mc cc dc liu c c tnh cao, c nhng tc dng c hi nghim trng c bit v/hoc khuyn co c tc dng ny.
KT. B TRNG TH TRNG ( k)

Cao Minh Quang

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