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CQNG HOA xA HOI CHU NGHiA VI:E:TNAMDQc l~p - Tl}'do - Hanh phuc
phil quy dinh chuc nang nhiem v¥, quyen han va co cdu t6 chuc cua B(J Y ti;Thea dJ nghi cua Cue truong Cue Quan If Dirac,B(J truong B(J Y ti ban hanh Thong tu quy dinh vJDanh muc thu6c hiim.
Di~u 1. Pham vi di~u chinhThong tu nay ban hanh Danh muc thu6c hiem, quy dinh muc dich ban hanh,
nguyen t~c xay dung va tieu chi lira elton thuoc vao Danh muc thu6c hiem.
Di~u 2. Danh muc thu8c hi~mDanh muc thuoc hiSm diroc bah hanh tai Phu luc kern thea Thong tir nay
bao g6m:1. Danh muc thuoc dS phong, ch§.ndmln, diSu tri b~nh hiSm g?p.
2. Danh m\lc thu6c khong s~n co.Di~u 3. Muc dich ban himh Danh muc thu8c hi~m. .1. Danh m\lc thu6c dS phong, ch§.ndo{m,diSu tri b~nh hiSm g?P la co sa dS:a) Co quan nha nuac co th§.m quySn xem xet mi@n,giam du li~u Himsang,
mi@nmQt ho?c mQt s6 giai dOC;lnthir thu6c tren Himsang truac khi c~p phep luuhanh d6i vai thu6c thea quy dinh tC;liKhoan 3 DiSu 18 Thong tu s6 32/2018/TTBYT ngay 12 thang 11 nam 2018 cua BQ twang BQY tS quy dinh vi~c dang kythu6c, nguyen li~u lam thu6c (sau day gQit~t la Thong tu s6 32/2018/TT-BYT);
b) Co quan nha nuac co th§.mquySn xem xet du li~u nghien Clm dQ6n dinh d6ivai thu6c thea quy dinh tC;lidiSm a Khoan 2 DiSu 25 Thong tu s6 3212018/TT-BYT;
c) Co quan quan ly nha nuac uu tien trong trinh t\f, thu Wc trong dang ky luuhanh thu8c theo quy dinh tC;likhoan 1 Di~u 34 Thong tu s8 32/2018/TT-BYT;
d) Co quan qmin ly nha nuac c~p phep nh~p khAu thu6c thea quy dinh cuaphap lu~t;
d) Th\fc hi~n vi~c thanh toan chi phi hao h\lt thu6c thea quy dinh vS ti l~ haoh\lt thu6c va vi~c thanh toan chi phi hao h\lt thu6c tC;lico sa kham b~nh, chua b~nh.
BO YTE CONG HOA xA HOI CHU NGHiA VI:eT NAMDQc l~p - Tl}' do - Hanh phiic
s6:2.6 12019/TT-BYT Ha N(ji, ngay30thang8 ndm 2019
THONGTUQuy djnh v~ Danh ml}c thuBc hi~m
Can cu Ludt duac s6 105120161QH13 ngay 06 thong 4 ndm 2016,'Can cu Nght dinh s6 75120171ND-CPngay 20 thong 6 ndm 2017 cua Chinh
phil quy dinh chtec nang nhiem v¥, quyen han va CCl cdu ta chuc cua Bo Y ti;Thea a~nghi cua Cue truong Cue Quan If Duoc,so truong so Y ti ban hanh Thong tu quy dinh' v~Danh muc thu6c hiim.
I)i~u 1. Pham vi di~u chinhThong tir nay ban hanh Danh muc thuoc hiern, quy dinh muc dich ban hanh,
nguyen t~c xay dung va tieu chi Iva elton thuoc vao Danh muc thu6c hiem,
I)i~u 2. Danh muc thuBc hi~mDanh muc thu6c hiSm diroc bah hanh tai Phu luc kern thea Thong nr nay
bao g6m:1. Danh muc thuoc dS phong, ch~n doan, diSu tri b~nh hiSm g?p.
2. Danh m\lc thu6c khong s~n co.I)i~u 3. Ml}c dich ban hanh Danh ml}c thuBc hi~m1. Danh m\lc thu6c dS phong, ch~n doan, diSu tri b~nh hiSm g?P la co sa dS:a) Co quan nha nuac co thAm quySn xem xet miSn, giam du li~u lam sang,
miSn m9t ho?c m9t s6 giai do?n thir thu6c tren lam sang twac khi cftp phep luuhanh d6i vai thu6c thea quy dinh t?i Khoan 3 DiSu 18 Thong tu s6 32/2018/TTBYT ngay 12 thang 11 nam 2018 cua B9 twang B9 Y tS quy dinh vi~c dang kythu6c, nguyen li~u lam thu6c (sau day gQit~t la Thong tu s6 32/20 18/TT-BYT);
b) Co quan nha nuac co th~m quySn xem xet du li~u nghien Clmd9 6n dinh d6ivai thu6c thea quy dinh t?i diSm a Khoan 2 DiSu 25 Thong tu s6 32/2018/TT-BYT;
c) Co quan quan ly nha nuac uu tien trong trinh tv, thu t\lCtrong dang kY luuhanh thu6c thea quy dinh t?i khoan 1 DiSu 34 Thong tu s6 32/2018/TT-BYT;
d) Co quan quan ly nha nuac cftp phep nh~p khAu thu6c thea quy dinh cuaphap lu~t;
d) Thvc hi~n vi~c thanh toan chi phi hao h\lt thu6c thea quy dinh vS ti l~ haoh\lt thu6c va vi~c thanh toan chi phi hao h\lt thu6c t?i co sa kham b~nh, chua b~nh.
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2. Danh muc thuoc khong s~n co Ia co sa dS co quan, t6 chirc co lien quanthirc hien quy dinh tai cac diem c, d va d Khoan 1 DiSu nay.
Di~u 4. Nguyen t~c xay d\fng Danh muc thu8c hi~mDanh muc thuoc hiem duoc xay dung dua tren cac nguyen t~c sau day:1. Can cir vao cac huang d~n ch~n doan va diSu tri, cac quy trinh chuyen
mon ky thuat do B9 Y t@,T6 chirc Y t@th@gioi (WHO), co quan quan ly thamchieu (bao g6m: Co quan quan ly Dtroc pham Chau Au (EMA), My, Nhat Ban,Anh, Thuy Sy, Dc) hoac cac Hiep h9i y khoa co uy tin trong nuoc, khu vue hoactren th@gioi (bao g6m: H9i Tim mach Vi~t Nam; Hiep hoi gan mat Chau A, chauAu; H9i Th~p khop hoc Hoa Ky va Lien doan chong Th~p khop Chau Au; Hieph9i Tim mach Chau Au; Hi~p h9i Tim m~ch Hoa Ky; Hi~p h9i n9i ti@t,dai thaodUOngHoa Ky va cac Hi~p h9i y khoa uy tin khac) ban hanh.
2. Ra soat, k@thua danh m\lc thu6c hi@mdff dugc ban hanh truac day theaquy dinh cua B9 truang B9 Y t@.
3. Tham khao quy dinh vS phan lo~i b~nh hi@mg~p, phan lo~i va danh m\lcthu6c hi@mcua T6 chuc Y t@th@giai, co quan quan ly tham chi@uva cac co quanquan ly khac co lien quan.
doan, diSu tri b~nh hi@mg~p khi dap Ung m9t trong cac tieu chi sau day:
a) Thu6c dS phong, ch~n doan, diSu tri b~nh hi@mg~p thea quy dinh cua B9truang B9 Y t@;
b) Thu6c co chi dinh dugc phan lo~i va c~p phep luu hanh la thu6c hi@mbaim9t trong cac co quan quan ly tham chi@u.
2. M9t thu6c dugc xem xet dS Iva chQn vao Danh m\lc thu6c khong s~n cola thu6c rna tren thi truOng Vi~t Nam chua co s~n cac thu6c khac co kha nang thayth@ho~c thu6c co tai li~u chUng minh mang l~i 19i ich dang kS vS m~t ch~t luqng,an toan, hi~u qua so vai cac thu6c khac co kha nang thay th@tren thi truOng trongnuac va qu6c t@va thu9c m9t trong cac trucmg hqp sau day:
a) Thu6c dS phong, ch~n doan, diSu tri cac b~nh co ty l~ ca b~nh hi~n luuhanh trong m9t qufin thS ngay t~i m9t thai diSm th~p khong qua 0,05% dan s6(Prevalence rate - ty l~ luu hanh) va thu9Cm9t trong cac truOng hqp sau day: B~nhthu9C vS gen; b~nh b~m sinh; ung thu; tv mi@n;truySn nhi@m;b~nh nhi@mtrimgnhi~t dai va b~nh khac do B9 truang B9 Y t@quy@tdinh thea tu v~n cua H9i d6ngchuyen mon do B9 truang B9 Y t@thanh l~p;
b) V~c xin, thu6c ch~n doan ho~c thu6c phong b~nh co ty l~ su d\lng u6ctinh khong qua 8.000 truOng hqp m6i nam t~i Vi~t Nam;
c) Thu6c phong x~, ch~t danh d~u;
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d) Viec kinh doanh thuoc khong tao ra 19i nhuan du Ian dS bu dip chi phid~u tir, tiSp thi thuoc tai thi tnrong Vi~t Nam.
Di~u 6. Hi~u ll}'cthi hanh1. Thong tu nay co hieu luc thi hanh kS tir ngay 15 thang 10 nam 2019.2. Quyet dinh s6 37/200S/QD-BYT ngay 20 thang 11 nam 200S vS viec ban
hanh Danh muc thuoc hiSm thea yeu c~u diSu tri (sau day goi tit la Quyet dinh s637/200S/QD-BYT) hSt 4i~u hrc thi hanh kS tu ngay Thong tir nay c6 hieu lire.
Di~u 7. Di~u khoan chuyen ti~pViec thanh tom chi phi hao hut ;t~i co sa kham benh, chua 'benh d6i voi
thu6c thuoc Danh muc thuoc hiSm ban hanh thea Quyet dinh s6 371200S/QDBYT nhung khong thuec Danh muc thuoc hiSm ban hanh kern thea Thong nr nayduoc tiSp tuc ap dung thea quy dinh d6i vai thu6c hiSm trong truang hQ'Pthu6cd6 da dugc co sa kham b~nh, chua b~nh nh?P truac thai diSm Thong tu nay c6hi~u Ivc.
Di~u 8.Di~u Khmin tham cbi~uTrong truang hQ'Pcac van b~mquy ph~m phap lu?t va cac quy dinh duQ'c
vi~n dftn trong Thong tu nay c6 SlJthay d6i, b6 sung ho~c dugc thay th@thi apd\1ngtheo van b::mquy ph~m phap lu?t mai.
\ Di~u 9. T8 cbrrc thl}'c hi~n1. Can cu nguyen t~c xay dlJng, tieu chi IlJa Ch9n thu6c hi@mva tren co sa
dS xu~t cua cac dan vi quy dinh t~i Khoin 2 DiSu 10 Thong tu nay, cua cac t6chuc, ca nhan khac c6 lien quan ho~c tren co sa kSt lu?n cua HQi d6ng tu v~nc~p gi~y dang ky lUll hanh thu6c, nguyen li~u lam thu6c, C\1CQuin ly Dugc dSxu~t danh m\1e cac thu6c hiSm c~n C?Pnh?t b6 sung ho~c lo~i b6 cho phli hQ'Ptinh hinh thlJc tS, xin y ki@nrQng rai cac co quan, t6 chuc, dan vi lien quan, cosa l<4amb~nh, chua b~nh, doanh nghi~p va dS nghi V\1Phap ch@'t6 chuc th§.mdinh tr:uac khi trinh BQ truang B9 Y tS ban hanh Quy@tdinh sua d6i, b6 sungDanh m\1cthu6c hiSm. '
2. Truang hQ'PBQ Y tS ban hanh QuySt dinh sua d6i, b6 sung Danh m\1cthu6c hi@mthea quy dinh t~i Khoin 1 DiSu nay, vi~c thanh toan chi phi ha() h\1tt~i co sa kham b~nh, chua b~nh d6i vai thu6c thuQc Danh m\1c thu6c hi@mduQ'cban hanh liSn kS truac d6 nhung khong thuQc Danh m\1c thu6c hiSm sua d6i, b6sung dugc thlJc hi~n thea quy dinh d6i vai thu6c hiSm trong truang hQ'Pthu6c d6da dugc co sa kham b~nh, chua b~nh nh?P truac thai diSm QuySt dinh sua d6i, b6sung Danh m\1cthu6c hiSm c6 hi~u IlJc.
Di~u 10. Tnich nhi~m thi h~mh1. C\1CQuan ly Dugc c6 trach nhi~m chu tri, ph6i hQ'Pvai cac co quan chuc
nang thlJc hi~n Thong tu nay va C?Pnh?t Quy@tdinh sua d6i, b6 sung Danh m\1ethu6c hi@mtren C6ng thong tin di~n ill cua BQY t~ va Trang thong tin di~n ill cuaC\1CQuan ly Dugc trong thai h~ 03 ngay kS illngay BQ truang BQY t@kY quy@tdinh.
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2. CO'sa diroc, co sa kham benh, chua benh co trach nhiem:a) Thirc hien cac quy dinh tai Thong tu nay;
b) D@xufit sua d6i, b6 sung Danh muc thuoc hiSm cho phil hop tinh hinh thirctS, bao dam dap irng kip thai thuoc phuc vu cho cong tac phong benh, chua benh,
3. Chanh van phong B9, Chanh thanh tra B9, Vu tnrong, C\lC tnrong, T6ngC\lC tnrong thuoc B9 Y tS, Thu tnrong cac co quan, dan vi true thuoc B9, Giamd6c Sa Y tS cac tinh, thanh ph6 tnrc thuoc Trung uong, Thu tnrong co quan y tScac B9, nganh va cac t6 chirc, ca nhan lien quan chiu trach nhiem thi hanh Thongtu nay.
Trong qua trinh thuc hien nSu co vfin d@vuong mac, d@nghi cac co quan, t6chirc, ca nhan kip thai phan anh v@C\lC Quan Iy Diroc dS xem xet, giai quyet.'. ¥NO'inhljn: , , ,- Uy ban cac van de xii hQi cua Quoc hQi;- Van phong Chinh phu (V\) KGVX, Cong bao, C6ng TTDT CP- BQtfU&ngNguy€n Thi Kim Ti8n (d8 bao cao);- Cac Thu tfU&ngBYT;- BQTu phap (C\lCKi8m tra van ban QPPL);- Cac BQ, cO'quan ngang BQ, CO' quan thuQCCP;- UBND cac tinh, thimh ph6 tr\)"cthuQc TW;- Ki8m toan Nha nuac;- Uy ban TW M~t tr~n T6 qu6c Vi~t Nam;- CO'quan Trung UO'llgcua cac doim th8;- Sa Tai chinh, SaY t8 cac tinh, TP tn,rc thuQc TW;- Phong ThuO'llg m~i va Cong nghi~p Vi~t Nam;- Cac dO'llvi thuQc, tr\)"cthuQc Be)Y t8;- Bao hi8m xii hQi Vi~t Nam;- Y t8 ngimh (QP, CA, BCVT, GTVT):- Hi~p hQi DN DuQ'cVi~t Nam;- Hi~p hQiB~nh vi~n tu nhan Vi~t Nam;- T6ng Cong ty DuQ'c Vi~t Nam;- C6ng ThOng tin di~n illBQY t8;- Trang Thong tin di~n tu C\lCQLD;- Luu: VT, QLD(02),PC(02).
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BQYTE CONG HoA xA HOI CHU NGHiA VIET NAM. . .DQc l~p - Tl}'do - H~nh plnic
Chi dinh phong, chin doan, di~u. tr] b~nh hi~m g~p
--- - Dieu tri benh bach diu donglympho t~ bao B man tinh rnatnroc do benh nhan da duoc di~utri voi tac nhan alkyl hoa va nhfrngbenh nhan di~u tri th~t bai voifludarabine.
- Chi dinh cho benh nhan ngiroi Ianmac benh X(J cirng rai rae th~ taiphat - thuyen giam (RRMS), cobenh dang hoat dong dua tren lamsang hoac chan dean hinh anh.
- Di~u tri benh du trtr glycogen typeII (Benh Pompe). Chi dinh trenbenh nhan ngiroi Ian va tre emmoi dQtu6i.
- Yeu to ire che alphal-proteinaseduoc chi dinh cho li~u phap di~utri duy tri va b6 sung lau dai chob~nh nhan nguai Ian co tri~uchUng khi ph~ thfing do b~nh thi~ualpha I-proteinase bfrm sinh
- Di~u tri c~p tinh va di~u tri dlJphong nhip nhanh thfit ho~c rungth~t de dQa tinh m~ng.
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Anagrelid
Antihemophilic factor(recombinant), Fcfusion protein
Chi dinh tren nguai Ian va tre emm~c b~nh Hemophilia A (thi~u y~ut6 VIII bfrm sinh) d~:- Di~u tri, ki~m soM theo nhu c~ucac dqt chay mau;
- Xu tri chay mau khi ph~u thu~t;- Di~u tri dlJ phong thuang quy d~giam t~n suM cac dqt chay mau.
- Chi dinh cho can cap chay maucua b~nh nhan nguai Ian bi b~nhhemophilia A m~c phai.
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DU'Ong dung, dangbao ch~, nAng dQ,ham hrong cuathuBc hi~m
Chi djnh phong, chin doan, diSutr] b~nh hi~m g~p
TT Ten hoat chit
- Su dung du phong de giam matmau trong phfru thuat va yeu c.lutruyen mau nrong d6ng tren benhnhan trai qua phfru thuat b~c c.lumach vanh trong qua trinh phfruthuat ghep d9ng mach vanh laplai, va trong mot s6 twang hQ'Pduoc Iva chon phfru thuat ghepdong mach vanh sa cfrp, nguy cochay mau d~c biet cao (earn maubi suy yeu) hoac noi truyen maukhang co s~n ho~c khang duQ'cchfrp nhan.
- Dieu tri benh bach cau tien mybao cfrp tinh
15 Aprotinin Tiem: Dung dichtiem
- De dieu tri nhiem trung doPfalciparum hoac nhiem trimgh6n hQ'Pbao g6m P. falciparum
- Dieu trt ung thu phai te bao nh6(SCLC).
- Di~u trt b~nh nhan giai do?n lIb,IIc, III va IV u ac tinh.
- Chi dinh dieu tri cho benh nhantnrong thanh bi u lym pho baoHodgkin (HL) +CD30 tal phathoac khang tri: Sau cdy ghep t~bao g6c tI;r than (ASCT); hoac sauit nhdt 2 IAndi~u tri khi ASCTho~c da h6a Ii~uphap khong phaiIamot my chon di~utrio
- Chi dinh di~u tri cho benh nhantnrong thanh bi CD30+HL c6nguy co cao tai phat hoac ti~ntrien sau khi cdy ghep t~ bao g6ctt.r than (ASCT).
- Chi dinh di~u tri cho benh nhantnrong thanh bi u Iym pho t~ bao100 thoai bi~n tom than (sALCL)c6 nguy co tai phat hoac khang trio
- Chi dinh di~u tri cho benh nhantnrong thanh bi CD30 + U lympho bao t~ bao T da (CTCL) sau itnhdt I IAndi~utri tom than.
- Li~u phap chuan bi trong di~u trikh6i u ac tinh kern thea cdy gheptUyxuang.
- Dieu tri thubng qui phong ngiracac can cdp phil quincke cho b~nhnhan nguOi 100 va vi Thanh nienm~c b~nh phil quincke di truy~n(HereditaryAngioedema).
- Dieu tri b~nh Roi lo~ dong mauA ho~c B, c6 ho~c khong co yeut6 khang l~iphuc hgp uc ch€ dongmau, c6 ho~c khong c6 b~nh vonWillebrand.
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TT
TiI~m:Cac dang
-' Duong dung, dangb' h~ l. eeao c e, nong Q,ham hreng ciiathu8c hi~m
Chi djnh phong, chin doan, di~utr] b~nh hi~m g~p
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Ten hoat chit
Cac yeu to khang yeut6 chay mau(Antihemophilic factor).Cac y€u t6 khang laiphirc hop ire ch€ dongmau (Resistance factorsfor inhibitingcoagulation complexesanti-inhibitors)
Cafein citrat
- Dieu tri benh R6i loan dong mauA hoac B co hoac khong co y€u t6khang lai plnrc hop trc ch€ dongmau, co hoac khong co benh vonWillebrand.
- Dieu tri ngan han clnrng ngirngtha a tre sinh non tuan ill28 d€n33
- Dieu tri hQi chtrng thtrong ky lienquan d€n y€u t6 receptor kh6i uhoai tir
- Dieu tri ban xuat huyet giam tieuAcau.
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Canakinumab
Caplacizumab
41 Carfilzomib
42 Carglumic acid U6ng:200mg
- Dieu tri benh da u my
- Dieu tri thieu hut N-acetyl glutamate synthetase
43 Celiprolol Uong: cac dang
44 Ceritinib
45 choiic acid U6ng: Cac d~g
46 Cic1osporin(Cyclosporin)
Tiem, dungtiem50mg/lml);
. U6ng: dung dich
dich(6ng - Dieu tri tbn thuang nao do chdn
thuang ill trung binh d€n n?ng
47 Cinacalcet U6ng: Cac d~g
- Dieu tri h9i chUng Ehlers-Danlos- Dieu tri ung thu phoi khong te baonh6 (NSCLC) rna anaplasticlymphoma kinase (ALK) duangtinh
- Dieu tri cac 16i bam sinh trongtbng hgp acid m~t chu dap Ung vaidieu tri bAng axit cholic.
- Dieu tri tang calci-hUyet a nhilngb~nh nhan tang nang tuy€n c~giap rna dugc chi diM c~t b6tuy€n c~ giap dva tren n6ng dQcalci huy€t thanh tuy nhien khongco khlt nang ph~u thu~t.
- Dieu tri tang calci huy€t a nhilngb~nh nhan ung"thu bi€u mo tuy€nc~giap
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TT
Duong dung, dangbao eh~, nAng dl),ham IUQ'Ilg ellathu6e hi~m
Chi djnh phong, ehAn doan, di~utr] b~nh hi~m g~p
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Cladribin
Cladribin
Clofazimin
Clonidin
Coagulation factor IX(recombinant), Fcfusion protein
Tiem: Cac dang
U6ng: Cac dang
U6ng: Cac dang
U6ng: Cac dangTiem: Dung dichtiem
Tiem: Cac d~ng
- Di~u tri benh bach cAut€ bao long
- Di~u tri benh da xa cirng tai phatd~ giam tAn su~t tai phat Himsangva tri hoan SlJti€n trien cua khuyett~t th~ chat.
- Dieu tri benh u phong, bao gam uphong khang dapsone va u phongbi bien chirng boi hong ban nutphong
- Dung dirong tiem ngoai mangcimg lien tuc nhu mot phac d6phoi hop voi opiat c<)tsong trongdi~u tri dau tren benh nhan ungthu dung nap hoac khong dap irngvoi opiat dirong c<)ts6ng.
- Phong ngua viem niem m~c mi~ng6 b~nh nhan ung thu c6 va dAudang dUQ"cti€n hanh x~ tri
Yeu to dong mau IX (Tai to hqp),Protein dung hqp FC, la m<)ty€ut6 dong mau IX tai t6 hqp congu6n g6c DNA, dUQ"cchi dinhtren nguai l6n va tre em m~c b~nhHemophilia B d~:
- Di~u tri, ki~m soat thea nhu cAucac dqt chay mau.
- Xu tri chay mau khi phftu thu~t- Di~u tri dv phong thuOng quy d~giam tAnsu~t cac dqt chay mau.
- Dieu tri viem mang m~ch nho toan74 Difluprednat Nho m~t: Cae d~ng bQ ho~c mQt ph:1n ben trong va
phia tru6c do ch§n thuang- Dieu tri la xe m! kinh dong
75 Duvelisib U6ng: Cae d~ng lympho va u lympho t~ bao nho.Di€u tri u lympho th~ nang.
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TT
Estradiol
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Duong dung, dangbao ch~, nAng d(},ham hrong ellathu8c hi~m
Tiem:tiem
dung dich
Ten hoat chit
Ecallantid
77 Edaravon Truyen tinh mach
Chi djnh phong, ch§n doan, di~utr] b~nh hi~m g~p
- Dieu tri phil mach di truyen,- Yeu t5 ire che kallikrein huyetthanh duoc chi dinh cho dieu trican c§.pcua phil quincke di truyen(Hereditary angioedema) 0 benhnhan 12 tu6i va Ian han.
- Dieu tri benh xo cimg teo co motben (ALS)
79 Eliglustat U5ng: Cac dang
78 EfavirenzUong: Vien nang _ Di~u tri nhiem HIV-l 0 tre em va50mg, 200mg; thanh thieu nien tren 3 tuoi,Vien nen 600mg
- Duoc chi dinh de dieu tri lau daicho benh nhan ngiroi 100 macbenh Gaucher loai 1 (GDI), langiroi chuyen h6a cao, chuyen h6atrung binh hoac chuyen h6a kernCYP2D6 (EMs) duoc phat hienboi xet nghiem da: duoc FDAthong qua.
80 Elotuzumab Tiem: Cac dc;tng - Dieu tri benh da u my.
81 Elotuzumab Tiem: Cac dc;tng
82 Eltrombopag U5ng: Cac dc;tng
- Di~u tri b~nh da u my.
- Dieu tri thi~u mau b~t san.- Di~u tri xu~t huy~t giam ti~u d.utv phat.
83 Emicizumab Tiem duai da - Di~u tri b~nh chciymau A
84 Erwinia L-asparaginase Tiem: Cac dc;tng
85
86 Everolimus
Fibrinogen87 (Dan thanh ph~n ho~c
ph5i hgp)
H~ dieu tri qua da: _ Phac d6 thay the estrogen tren ph\!mi~ng dan chuathu5c nfr c6 hQi chling Turner
Tiem: BQt pha - Di~u tri tren b~nh nhan thieudung dich tiem fibrinogen
U5ng: Cac dc;tng
- Di~u tri u lympho ac tinh
- Dieu tri b~nh xa cling cu (TSC)bao g6m u sao bao t~ bao kh6ng 16duai mang 5ng nQi my lien quanden TSC (SEGA), u ma-ca-mc;tchmau th~n lien quan den TSC vab~nh u ca tran-mc;tch bc;tchhuy~tlien quan d~n TSC (LAM).
- Di~u tri b~nh u th~n kinh nQi ti~t.
" "
r-
11
DuOng dung, dang
TT Ten hoat chat bao ch~, nAng dQ, Chi djnh phong, chin doan, di~uham Iuong cua tr] b~nh hi~m g~pthuBc hi~m
- Dieu tri tren b~nh nhan
88 Fitusiran Tiem: Cac dang hemophilia A hoac B trung binhd~n nang, c6 hoac khong c6 chatUC ch~
- S1,l'kich thich sinh tinh trung aFollitropin alfa/ benh nhan nam thi~u nang sinh
89 Follitropin beta tai t6 Tiem: tiem diroi da, due nguyen phat va thir phat tren
hQ'P tiem tinh mach nhimg nguoi c6 nguyen nhan vosinh khong phai do suy tinh hoannguyen phat
90 Fosfomycin trometamol Uong: Com pha - Dieu tri nhiern trung phoi liendung dich uong quan d~n xo nang
91 Fostamatinib Uong: Cac dang - Dieu tri ban xuat huyet giam tieudiu mien dich.
92 Gilteritinib U6ng: Cac dang - Dieu tri La xe mi cApdong tuy
93 Glasdegib Uong: Cac dang - Dieu tri La xe mr cap dongtuyChun
94 Glatiramer Tiem: Bot pha dung - Di~u tri benh da xo cirngdich tiem
95 Glucarpidas Tiem: Cac dl;lng - Tri nhiem d(>cMethotrexate
96 Glycerol phenylbutyrat U6ng: Cac dl;lng - Dieu tri duy tri b~nh nhan thieuh\lt enzym trong chu ky ure
U6ng: Cac dl;lng - Di~u tri s6t ret c~p nhy d~n trung97 Halofantrin hydroclorid ." binh do cac chung nhl;ly cam v6i
Vlen P.falciparum and P. vivax- Dieu tri suy thuQ11gth~n a nguai100.
98 Hydrocortison U6ng: Cac dl;lng - Li~u phap thay th~ trong di~u trisuy thuQ11gth~n a tre em, nguai100 va thanh thi~u nien (du6i <18tu6i).
99 Hydroxycarbamid U6ng: Cac dl;lng- Dieu tri b~nh te bao hinh liem trenb~nh nhan du6i 18 tu6i.
Duong dung, dangbao ch~, nang dQ,ham IUQ11g ciiathu8c hi~m
U6ng: Cac dang
Tiem: Cac dang
Tiem, truyen diroidaDang dung: dungdich tiem truyen
Tiem: Cac d(;lng
Tiem: Cac d(;lllg
Chi djnh phong, chin doan, di~utr] b~nh hi~m g~p
- U lympho te bao B 16n Ian toa.- U lympho t~ bao ao nang.- U lympho t~ bao nho (SLL).- U lympho vung ria hach,- U lympho th~ nang.- U lympho vung ria lach,- Dieu tri benh bach cftu lymphobao man tinh (CLL).
- Dieu tri ung thu tuyen tuy.- Dieu tri benh ghep chong chu mantinh.
- Dieu tri clnrng macroglobulin mauWaldenstrom.
- Dieu tri ung thu da day, bao g6mung thu bieu rna tuyen n6i da daythuc.
- Phong ngira va dieu tri benh con6ng dong mach
- Dieu tri cac dot dip cua phuquincke di truyen (HereditaryAngioedema) a benh nhan ngiroi16n 18 tu6i va tren 18 tu6i.
- Dieu tri b~nh b(;lch cau cap dongtUy, tham khao b~nh b(;lch d.ukhong tang lympho bao c~p tinh.
Chi dinh cho b~nh nhan da dieu trib~ng Pradaxa (dabigatran) khi cfrnh6a giai nhanh ch6ng tac dVngch6ng dong cua dabigatran:
- Trong tru<'mg hqp phftu thu~t c~pc(mlthu thu~t khAnc~p.
- Trong tru<'mg hQ'p chay mau dedQa tinh m(;lng hoi).c khong ki~msoM duQ'c.
- Dieu tri u 1ympho the nang;Dieu tri La xe m! kinh donglympho va u lympho t~ bao nhO.
- Phac do thay the enzym lau daicho b~nh mucopolysaccharid (HQichUng Hunter)
146 Nintedanib U6ng: Cac dang- Dieu tri xo h6a phoi tv phat (xoph6i vo din)
147 Nitric oxide Khi tho- Di€u tri tang huyet ap ph6i daidang 0 tre sa sinh
- Dieu tri ung thu bieu mo te baogan;
148 Nivolumab Tiem: Cac d?llg- Di€u tri u lympho Hodgkin;- Di€u tri ung thu h~c t6 giai do?nlIb d~n IV;
- Di€u tri ung thu ph6i t~ bao nho.- Dieu tri u lympho the nang;
149 Obinutuzumab Tiem: Cac d?ng Di€u tri La xe mt kinh donglympho.
150 Ofatumumab Tiem: Cac d?ng- Dieu tri La xe mt kinh donglympho.
18
DU'Ong dung, dang
TT Ten hoat chAt bao ch~, nAng dQ, Chi djnh phong, chin doan, di~uham IU'Q11gella tr] b~nh hi~m g~pthu6c hi~m
- Dieu tri duy tri cho benh nhannguoi ,I6n bi t~i phat ung, thu !~bao bieu rna buong tnrng, ong dantnrng ho~c ung thu phuc macnguyen phat, cho nhilng b~nhnhan dap ling hoan toan hoac mot
U6ng: Dang ." phAn ' . h6a tri li~u c6 chuaVIen vO'!151 Olaparib 100mg, 150mg platinum; va di~u tri cho b~nh
nhan nguoi 1611diroc chAn doanung thu buong tnrng ti~n trien dQtbien gen ~RCA hoac ng~i ngoung thu buong tnrng dQt bien genBRCA da: duoc di~u tri bang bahoac nhi~u dong h6a tri li~u truced6.
152Omacetaxin Tiem: Cac dang
- Dieu tri benh La xe mi kinh dongmepesuccinat tuy
153 Panobinostat U6ng: Cac dang - Di~u tri benh da u my.
- H6c m?n tuyen c~ giap duoc chi
Parathyroid Hormonedinh de dieu chinh SlJ phoi hop
154 Tiem: Cac dl;!ng canxi va vitamin D nham kiem(1-84) human soat hl;!canxi trong cac b~nh nhan
suy c~n giap.
155 Pasireotide Tiem: Cac dl;!ng - Di~u tri b~nh to ClJC;- Di~u tri b~nh Cushing
156 Pazopanib U6ng: Cac dl;!ng - Dieu tri ung thu buang trirng;- f)i~u tri ung thu rna m~m- La li~u phap thay the enzyme cho
157 Pegademase bovine Tiem: Cac dl;!ng SlJ thi~u hvt ADA a nhilng b~nhnhan suy giitm mi~n dich n?ng k~thqp.
158 Pegaspargase Tiem: Cac dl;!ng - Dieu tri ~ng thu dong bl;!ch caulympho cap tinh
- De tang khit nang sinh tan cua cac
159 Pegfilgrastim Tiem: Cac dl;!ng b~nh nhan c6 nguy ca bi suy tuyd.p sau khi mot vv n6 ph6ng Xl;!ho~c hl;!tnhan
" 19
DU'Ongdung, dang
TT Ten hoat chit bao ch~, nAng dQ, Chi djnh phong, chAn doan, di~uham lU'Q'Dgella tr] b~nh hi~m g~pthucJc hi~m
- Dieu tri ung thu da ac tinh giaidoan lIB den giai doan IV;
- DiSu tri u lympho t~ bao B trungth~t nguyen phat;
- Dieu tri thieu hut hoc-men tangtnrong 6 ngiroi 1611.
- Di~u tri thieu hut hoc-men tangtnrong 6 ngiroi 1611.
- Di~u tri chirng thdp lim do h(>ichirng Noonan.
- Dung trong di~u tri lau dai a trecham 1611 do thieu hut hoc-mentang tnrong.
- Di~u tri chirng thdp lun 6 tre nhodo thieu hut gen (SHOX).
- Dan tri hoac k€t hQ'P voiglutamine trong di~u tri hci chirngruot ngan.
- Di~u tri giam can/di hoa lien quand€nAIDS.
- Di~u tri cham phat trien lien quand€n suy than man,
- La li~u phap thay th€ cho SlJ thieuhut hormone tang tnrong 6 nguai1611 sau khi xuang ngimg phattriSn.
- Dieu tri ch~m phat triSn 6 tre sinhnon.
- Di~u tri ch(mg thdp lun do h(>ich(mg_Prader- Willi
- Dieu tri ung thu te bao th~n.- Di~u tri ung thu t€ bao gan.- Di~u tri ung thu tuy€n giap thStuy, ling thu tuy€n giap anaplastic,va ung thu tuy€n giap d~ng nangho~c di can tai phat ho~c di can.
- Doi vai nhip nhanh that, rung that,ho~c duy tri nhip xoang 6 b~nhnhan chuySn d6i til rung tam nhlho~c rung tam nhl khi dung duQ'cthu6c u6ng.
191 Succimer Tiem: Cac d~ng - Di~u tri ng(>d(>cchi 6 tre em.
192 TacrolimusH6n dich nh6 m~t - Dieu tri viem ket giac m~c mua
xuan khi su d\lng thu6c khang di(mg khong hi~u_gmt0,1%
23
TT
193 Talc
Ten hoat chit
194 Temolozomid
DuOng dung, dangbao eh~, nAng c.tQ,ham hrong cuathudc hi~m
Bot vo trung
Tiem: Cac dang
Chi djnh phong, eh§n doan, c.ti~utr] b~nh hi~m g~p
- Dieu tri trim khi mang phoi.- Di~u tri SlJ chay dich mang phoiac tinh
- Dieu tri benh nhan bi u te bao hinhsao b~t thirong va u nguyen baothan kinh dern da dang.nlnr, benhnhan tai phat Iftn dftu dff trai quati~n trien benh tren mot ch~ d('>di~u tri chuan,
195
196
197
Temsirolimis
Thalidomid
Thiotepa
198 Tiaprid
199
200
Tisagenlecleucel- T
Tobramycin
Tiem: Dung dich _ Di~u tri h('>ichung Tourettetiem
Tiem: Cac dang
Uong: Vien nangcirng
Tiem: Cac dang
B('>thit
- Di~u tri u lympho t~ bao lap phil
- Dieu tri benh da u my.- Di~u tri hong ban nut phong(erythema nodosum leprosum)
- Di~u tri co dieu kien tnroc khighep t~ bao g6c tao mau
- Di~u tri u lympho t~ bao B 100 Iantoa
- Dieu tri b~nh nhan giffn phe quannhi€m Pseudomonas aeruginosa
201
202
Tocilizumab
Trametinib U6ng: Cac dc;mg
- Viem d('>ngm~ch te bao khong 10(GCA)
- Dieu tri ung thu hac to giai do~n IIb tai giai do~n IV
203 Trametinib +DabrafenibTretinoin
204 (All-Trans RetinoicAcid)
U6ng: Cac d~ng
U6ng: Cac d~ng
- Dieu tri ung thu hac t6 giai do~n IIb tai giai do~n IV
- Di~u tri b~nh b~ch caupromyelocytic
205 Triclabendazol U6ng: Cac d~ng - Di~u tri san la gan
206 TrientinTiem: Cac d~ng;U6ng: Cac d~ng
- Dieu tri b~nh nhan mac b~nhWilson
207 Velaglucerase alfa
208 Venetoclax
209 Vigabatrin
U6ng: Cac d~ng
U6ng: cac d~ng
- Di~u tri b~nh Gaucher tuyp 1 va 3
- Dieu tri b~nh b~ch cau m~n donglympho (CLL).
- f)i~u tri b~nh b~ch du c~p dongmy
- Di~u tri co thAta tre sa sinh
24
DU'Ong dung, dangChi djnh phong, ch§n doan, di~u
TT Ten hoat chAtbao ch~, nAng dQ,ham IU'Q'Dgcua tr] b~nh hi~m g~pthu8c hi~m
210 Vincristin Tiem: Cac dang- Dieu tri benh bach diu tao lymphoc~p
211 Vincristin sulfat Tiem: Cac dang - Bi~u tri La xe mi dp lympho bao.Liposome
B<)t dong kho pha - Bieu tft ung thu h~ch khong212 Vorinostat Hodgkin cua t~ bao T.
tiem - U lympho t~ bao T ada.
213 Xanh methyl en Tiem: Dung dich - Bi~u tri thieu mau methemoglobin(Methylen Blue) tiem 6ng mac phai va do di truyen.
Uong: Cac dang214 Zidovudin Tiem: Dung dich - Dieu tri AIDS
tiem
II. Danh muc thu8c khdng sin co
Ten hoat chAt Ghi chuTTDU'Ong dung, dang bao ch~, nAngdo, ham IU'O'n~cua thudc hi~m
I.Nhom thudc hoa dU'Q'Cva sinh ph§m
1 Acid folic dan thanhph~n (Vitamin B9)
2 Acid Fusidic
U6ng: cac dang
Uong: Cac dang
3 Acid Paraaminobenzoic U6ng: Cac dang
4 Acid valproic Tiem: Bot pha tiem
5 Acitretin U6ng: Cac dang
6 Adenosin Tiem: Cac d~ng
7 Altretamin U6ng: Cac d~ng
8 Ambenonium U6ng: Cac d~ng
9 Aminolevulinic acid U6ng: Cac d~ng
10 Amitriptylin clorhydrat Tiem: Cac d~ng
11 Anetholtrihion U6ng: Cac d~ng
12 Anti thymocyteimmunoglobulin Tiem: Cae d~ng
Anti-Dimmunoglobulinehuman
13
25
TT Ten hoat ehit Dueng dung, dang bao eh~, nAng Ghi chudo, ham luong ciia thudc hi~m14 Apomorphin U6ng: Cac dang
15 Artesunat Tiem: Cac dang
16 Artesunate 100mg +Uong: Cac dangMefloquin base 200mg
17 Atenolol Tiem: Dung dich tiem
18 Atomoxetine U6ng: 10mg; 40mg
19 Atropin Tiem: Dung dich tiem lmg/rnl;Nh6 mat: Dung dich nho mat 1%
20 Azacitidine Tiem: Cac dang
21 Betaxolol Nh6 m~t: Dung dich nho mat
22 Bromocriptin Uong: Cac dang
23 Buspiron clorhydrat U6ng: Cac dang
24 Calciclorid Tiem: Dung dich tiem truyen nangd910%
25 Calci heparinat Tiern: Dung dich tiem
26 Carbidopa U6ng: Vien nen d€ be
27 Cariprazin U6ng: Cac dang
28 Cethexonium bromid Nh6 mat: Dung dich nho mat
29 Cibenzolin U6ng: Cac dang
30 Citrat de cafe inDung dich tiem 25mg/ml;U6ng: Cac dang
Ghi chu:1. Ten hoat chat ghi trong cac Bang nay: cung mot hoat ch~t co th@co
nhieu each viSt khac nhau (ten g6c, ten khoa hoc, ten chung quoc tS (INN) ...).Cac ten nay co th@duoc dung thay thS cho nhau.
2. Dang tiem ghi trong cac Bang nay: bao g6m ca dang truyen (neu co).
3. D6i voi thuoc thuoc Danh muc thuoc d@phong, chuan doan, dieu tribenh hiem g~p: Chi dinh duoc phe duyet khi dang ky luu hanh hoac c~p phepnh~p kh:1u thu6c chua co gi~y dang ky luu hanh co th@la chi dinh dugc ghi C\lth@han ho~c gi6i h~n l~i han so v6i cach ghi chi dinh trong C9t "Chi dinhphong, ch:1ndoan, diSu tri b~nh hiSm g~p" trong Bang t~i M\lc I Ph\ll\lc nay.
4. Danh m\lc nay bao g6m ca:a) Cac mu6i cua cac ch~t ghi trong cac Bang nay, khi cac mu6i do co th@
hinh thanh va t6n t~i;
-------- - --------- -
36
, b) Cac th,u6c ph6~g xa hi d6ng vi phong x~ n~ trong Bang nay diroc g~nket voi cac chat drum dau khac nhau.!.~,;.Y