iYu(iMmtiThv($ewino'i tL · 2019. 8. 14. · 2' •v1 ¶J OñQGLW1 4 t, nLYYr1 ,ogoo fllflClP2i...
21
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Transcript of iYu(iMmtiThv($ewino'i tL · 2019. 8. 14. · 2' •v1 ¶J OñQGLW1 4 t, nLYYr1 ,ogoo fllflClP2i...
- -
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1581 iYu(iMmtiThv($ewino'i ~tL
0 148 nmtnm
t,irnjuavoàliJ tvn,iawnst
6). httpi/bitiy/2OMswrs ! .M4OØ41,LQP; , tc,
fr OR Code
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*uuhI7n4uvu1rJtriP*nThJRu5PnmJbio QIT1JLtJI3I flinolati btbb
cauit Sufaudi I er1Jinm#9n*n tnteti,mitrn ffrrnsi mhviiti
Mtho414fln1tJJ11atha1In1
V3M1flnUO1U UhVIiIhJ th,fl,12JtMOttftth5flDhJfl1ThQ17QflY1fiUft1%I%uifl1
ia1ntibiet t*VlflU1fl11iflMaP'tiUiJLUhlhi7fl4iJthv3J1N wswbb.go.th . 4,18fl(gVP
mimne A in odmsbhaot q MIU%$I31
I4IvutJ1I'otthmnm 4d w,3Jam44vthtj41u1uI4 iawe.iniivwist
niuwirnifri7p
(trtlNkø5 niiiii)
J,*wr4Amstmtnn;nrOnuf
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si.i'rn
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QyuLi2JL;v flfl1PJ t't tuiu - - • 4 -
a,, wni'u bluultvuPa n :tabm'JIlPQ 4tt42nrw uavvi,oø,brptFtui1ult
*n7fl4mJnLlna www.bb.ath 411 O-mijn-i jnvii w41um14nQ%i111In1*mn1\iiv11
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a%nhvnt4a i1Lnhr 1'3r1/i.n,uitMv c17tti3J nnrn1. ctt,ic, ttitt,tnaunn, ri
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tin. o VVbt flab UM o
Tm?i-) 0
urpuemmiums
The drniniuthantu
a QUU'%13J'rnI
2562
*1* rnnthe
'inhmlu c.....aa1JAo - (Vi)
02 *I1$n't1UV!II
0201 'spmvqtJninbnttrnn ..
1 02010015 Jitilntnn,gn,JeiC. (e tflwä 8b-extract)
1) tins 250 WARI 194.00
2) tvwi 500 fmh, ins 366.00
3) tins 1.000 DgiFicn
(Plant Bio-extract)
- tim 672.00 —
2 02010016
1) 'InS 250 frP&s, 194.00
2) tins 500 DalAvil ts 366.00
3) mn. i000Th'Pk, tip 672.00
oa*wt,S - —
O3Olvi -
3 03000 ntetukaflSodkjrn)
vORdmuvuJtn tins 5 flenTh (28 ul.) nSi 400.00,
itiflUt9: Mufli tgnii$fldsm ,iitnj ,irnkj 30
iu 8 s,iwivsejtit&thujtjnn,4u
q%fl.flT73JbUf441fl (O'.aufl1tn1 2561) tvinnRfr
l\wrn.nonai4Onii 5*C 11025 nniiñ*ns,i*sf mmiwu llneutM O11ZOVt9R111 tstuv (Montelucag
Sodium) urn
4 03010110 eitüilqift&wj 14944Da (Olniesattan mSoxcrnR)
:) tI*IsU'&UMJ 'Ins 20 Anu (30 A) 340.00
2) VOAdmmaetAh tins 40 fir&f* (30 A) flt4 590.00
M3JIrn%i11: vijtjniijniig1iiij 1) tills 20 Oeniis
5 03010142 eitsttna Eats,nst, (Donepext Hydrodilotide)
(tstiutiJi : DORACEPT)
1) ,c).uis 'Ins 5 fltiênjIj (30 uls) 450.00
2) yOsA tins 10 £rrSii (30 uls) M04 600.00
6 03010143 eit4niuiu (PregabaUn)
(tuul'lni PERVCA)
1) tOsun tins 26 £,eln*j (56 iu'nip) nec4 530.00
2) tOst&Mlye tins 75 £M&iiu (56 w'nJla) n6o4 663.00
3) tsniip tins 150 nean1z (56 amiJr) -- ntiei 1,060.00
Tt4smwtiw clYIni3jjw !nflpfli 2562
1'e M1J21$I7U (nirntiiu)
(trw)
1 03010144 -- deunvnlu (Olanzaphe) -
(te.iu OLAPPI)
itn.puiStniRñ'nrm ioOalnj(w OA) •! 1,750.00
0363 tqwNm
8 03030013 nnewrifàatn (TubercuLosis test kit)
torn (TB D.tect) in 96 test AiiM 70,900.00
9 03030014 II*e*IAI4U (Tub, for bLood coUectton) -
waen$uhø (rnome*j) trü,rnajn Am 300.00
13 EAWI Q4 75 fr&u,n (100 wIoWa4ffi)
Muwist,p llMldll3JAIrJd4 -
• . : .- . - . - .. U
'13 &114$tSlJflhtdWfl2fllU*4 -
- 'V 1302
-
10 13020006 Sn1 i4annqin!w7nun ,viu SA (BatUnic Vest
Llhtwe4gt'it level 3A)
$u2813 K, 23.54000
14kilu
I 100025 nD,tne (a ciimsi* pcoDucn
I) tuwtntflin 6 ovi 170.00
(1 n thtneutu uth.'*rywsei., t .Ai tex ujkatmean IutJu)
2) WRU 11" RZ 2 i* tel 66.00
(:it* jwnei,#,v Luu*srwve1m 1 iuhi 14(15
tsdijtieeen 1 uzha)
MflWPI: tJitecmim,i4i ueawswniiui&
tq6Iuitntw1se a A1d3J mnnaa 2562
3
U RflJflflW8 Law 1Z11Oflh1Ufl15*J 1110 I
I, tflUfl1'hflfl
Iii :02010015:. .:.?i; -:;..(•
4aeininaiiuu{prrnvtiw: Jn4ntrnwCnhJrS (Mile tila$ Bio-extract)
cnh11Ie4f1annrnmjlIIe: misromiuvii aiTh 1 (Natural éxtTact SPEED 1)
iflh1O41VU1: u%i b.,u t
4iisthe: u3ti tuei 4iV
1. ,jWii uiwciiw, tutacnø 4,&u
2.1fr 1 u54w1!uirn144l
3. uIthi usnIw( lu LviloifA
4. çnp ii zininksththtw4v ttTfi
5. e4i4ni,.e,rnatnvnrn
iwum Mn ia&tqhi'tinmhe: UWn1USI M.
mnoltw 2562 - rnnpni 2570(80)
titit i ThJiilntniiniiaicm 4twatwUiqkaTwis,ilntnq
tt4 u3ii 1u54 ti'm Mt flnM''Rl ,isavn,nnun,,rtk,'niurni tmu1iYquwnm 'daiGraø
u*imJnnaijvFn4iun,,4'u,e nuun,,,ip uhua aeitu,ui'rni4d, R1tisJ1P1gThfl1flil)bI14flhj
(Good Aquacuthre Practte GAP) nmthnn MetafrmNjSm6
s vi,i d ivianenttrnm'n 4itu.i,icw,v diwitjtfuriit4un,vtnin,,n thtneu*uj
wAgL$ ,,tuiS zfi ttniideuraiai'icqthnid flaii(thtnautm,rdtulrnm,m hilu bii
llll lq&alluTA Vto 1 aiithvnatoinfluu* 1ALU1 mal*J tAu)dn) 41mistleAu (Gtbereuit)
ttailtttstu (Cyto&th) LtitflcihGn (Hun* acid) *Jbnosg4 limaJu t1nnh1tIULu51qta%incJn lAiui
m1mv (Aa'sent As) uasirn (Cadmkam: Cd) trid1ua (Chromium: Cr) IW4U*14 (Copper; Cu) at M- (Lead. Pb)
thoi (Mercuiy. Hg) %a--Fml (Zinc Zn) i mMultulvAu (Sod,jrr: Na) 'IsitMairn: 1 VN16~ "LAO cthvneu,aniainiiJn tutnLate iicn4th twsnkh3J uavêinlui'*q tmduiumnpui4urnium
in,,nmnvul JnLnyJ-wnj)n -m rn*r'msuiu n,n,tmsIv Lnlnqnoi 4ianatrux4ivdlntnm
ngrGZIthtnaticJ d3mcuenioiwn vaThiui uain ,dui
fWKflbt4flQWW
i. diA4WTh,IiJLi-TGa 9Q1%42}b94WCn WffiWij 250, 500 ujit 1,000 üaict- .t
tajtfianniibm QLtisJ niniM 2562 hn.njthnjicu
z J'nilftPTh*thn*a £*nnjnneuvin u5mqiniJe,Thi MsoaIU M\i1c4
1V1JVfl11M U€mJUI ILfIVU5PfO$b1J, p-nun,,
(Good Aqacuttuce Practice: GAP) flThlJlvlFl
3. nUO 1PnMtfLfioNU1DrU,813flR,31UJ1MilnPTh ,IIItLGOUi,iUn , ,1 tkatuelflAeihhninnq
4. wmL Thimnivmqiiwntni mjtnniu
5. ni,14iJsvtnu d1tt n,1Lcit'Liutmte4ftv1u,zvtn1Lio4m iij&&eslutiiu thvum
Atli ttha 6i i-nlyin IOViU UatIJ,VLPWt$-Th A*i*tUC4i L5U U6U1J UP413J SkJIJVIP
tnmvl i&atnr94 iOuu nztmt,niiu,Jntu
....................
* tjqr IliN tiTh Q 0 5449 3030
I 7tjtimirsiAvo o1\Jn%msJ nirtptw 2562 eh'nnithtuiu
iliJflhlUlVn:
4BM1Iflh,1tB4ufI41 in
1MtI1V:
titt'.itJiv:
vthucntj uNr vw74uYqfra'Thniubw:
(PlantBb-extract)
z%Om 2 (NaturM extract SPEED 2)
iJ3n IIJfl t*
tAluz4 i fTA
1. VI& thcii,t34a lutania tt
2. UT 'itui 4s iuKMA shr
3 ut umuá % moth 4*
4. nthwnio thvumlwj iirti
5. siAniimai.i#tum.nn
R1u4tffi
ninnmi 2542. fnriQlfll 2570(80)
a,,aMmtnut-i cOi 2 iwYiii'ntuiiiqmtt (ff1194 L$tflhI ua:*uii:ui) 4itjauei4iu3t
594 tJtJII 11J4 4I5%
twa. tvWurint 3 ts (fn,ioi wn,c uaviinJns) thi4,uth:neusjFn ium1iuie4 m.gm
(Good AgricuLturaL Practice GAP) ,n,s%,nmn.,
*uwi*Onniit4ni!6wemiitn'ii4 5 i. dm5ovnm1un1tI4'n 44Iup7tQ1flv dlwfutitGutcn5d41u
n,nmtnnn th:ncuto i&u*t ii unS ,:fiviBavmtumuJounmuAiurqt5 i9o4Mhgn1DbIo4 inftutan. tIMIJ u'izhThj
VIMNRGIUVP i')n 2 G thtneuta4toibJw tri act CAu,&i) iuweinh (Groberetit)
htabtOis (Cytothin) unni.hThi (Hurnc acid) M2ninj4 li&ii e -rnj
(Arsenic: As) uirnuv (Cadmium: Cd) tn.ou (Chromium: Cr) 11841LP4 (Copper. Cu) mv (Lead! Pb) thmi
(Mercury-. Hg) u9Id4n4 (Zit Zn) aihJ%iwtti.ju (Sodium: Na) IIJIiUtCV*t 1 164diWGfl rns4i1
c4rhJnneusM1e1Y11M1n tutn,u WenluTh twia.on LLa ziuvilopiq trrntuezn.yMJttnii NI
iiwntnn thvnJm'ntjvm fll*Iflr.fl4i&t Vfltfll4tflbil ufl$Mn10
iwFnwne.it
1. t i'ntjvncnt CJtUVJIS4LMa Wniij 250, 500 iet 1 .000 EailuiSne viij
tu'nmnmncwz4
2. d'ntdntrnnt,*e flthtnJnneusin cirin*u 3 tOm (niiei LfflUl
tMjnnfu,e1 ,n4nmnbm,4R1MTU*t (Good
Agricultural Practice: GAP) niu%iniinmi
3. tUcNq1.n11wIfl3e4 1Urufl4U,M31Ulb%.nI).fl111 •ivl tLUuiiPhtr17U
tfe4sneTu,e4n1miJiV1nunh,u.m4nhi(nwn uvtutncn.e1hiMuPa1e
4. nh1u.,mn.nrJi1lntwa1 nmtnriu
Yj%u.niiutn, oiyuttan n1nn 2562 di.~n4wil-rI.I tu
5. niilfintuvd thLni Jfl1IL3gIiU1.IO4I ,VtJA1flQ1114,ONLfWc1O tk,i *Jnu,,i
St iii initiwi LThJ*J ninutsi*tn n *r%?tcit St uiàu anLi iTutitift
teimi uat*ma4 iMt
.................... It++++++t++
* uithi tu4
i)'ØAmnmilwi Q1Jtaau IflflQ1$1 2562
V Of
W)UflhIL&1N%1U
4U1 tUtV4Ma41l4Ulfl1ThtMO:
4flh4flhl4fl94Rtl4tfla5NflThJtfl
04%4funtuhvnm:
ILM1441Wi1v:
Ithun4 3thi %ie4tia7qftwThn1nbi8
vipt,jti,n114 tttmi (Montettflst Sodium)
uvaavifte4m 5 pn.(ASTftJR CHEWABLE 5 MG)
13im UlKIn,,Vfl1IJ,tfiI4 4,
¶J3tn mhn,,aar1th:4 4,M.i u.ber
t1 tfläVfl773J,Ith:4 4,5 uiVitiii 2561 - I3jVThts 2569 (8 t)
¶UfllflThwTflml:
raVULIlQAlNc lU3J P'vlfl14n,1Yi, ASTM CHEWABLE 5 MG &uviStg 2thswv 1 ttmio cat o4uuadntnsw1Jtlttgtv11 1ti4 vie i.iRu Thb11Vt1MltUflQ1flfldII9$hIitj
tntnq 6 tov&ttl 1 nmrelrnieql4nentmxm aut)4nu1nr4uuaznr14u itzngnncuc,n
2 O4ut*J
neiq 6 LicufAU tsvu1ivauuluon1!1 Singutafr 5 m Ew,c1n*i4iJnLr1,a1 u5i41i Wtji&rt4,ihnaui,iu fl lWfl$Jfi'UU11WVB4VI flU)t4fll7RflWl
CttJ1VULWJ1JlJg1'JU1fJ tøvuW'ii 4e{LtjuLtun bile ts43i ditTh 4*njpwm J,vfi,i%nii unwnuiiae& l.rntifueurtaCuuv1t,n*11nmwgnfl2Jn1fl,tn,ufltEj1tuTfl
f$4'IlbcUtLQIflZ
1. b,e4A½Jurtinw,t1,weugM:vvun ,4l94Uflh1LiiflQ1flh1M9UtlJt4v3e1
2. tfnvi Tin 1J%1,q,nn1iLILflali%% L4avh4'un1n%thsnuJMpiLGe4,n
esn6,in,o
S. ttt1,,e,nh1 eqIJnnLmJq,n utt4L1nwl41'tsnr,4gu 40engnt5u
iLfidi*tiqnis
4. LVI3JPt1JAL&J M1vg1s unILev it
stu'rnWuC*utonitethitli4tudn
S. Litn1uas(uluthn,ab,o lnun,,gnviinuve (Bioequival.ent study) nJkutvuiu
tn.wij'u 43pnn, oun, thta,i3nz, atwrwUeocuThkthtxnAasuu tSthimnsth
sis11unls: uurn4iyt4vTn,,itg 11 111AULAIJ uiYIv%a 2561
- wnnuaM ni,trrqflu3'in,sübiu cinj 3 10 uTh 8 V t1nni u5oin,iuiius3'4uin (telawreu 2561) dievainuNwi lMun,ifrnei
en*)rn, ISCVEC 17025 9,nn,1Jwn,nrm{n,,tnmt5 tuveu,u u euitpnt!t ttJIrnj
(MonteLu$st Sodiun'i) aAt1M)ivlm1ülm Q17uttLit fliflinu 2562
* iAth'i U Ifl1 th,4 f'iN* Q 02420 1632-S
fi i7zu%viimtyu uucvis mnoini 2562 *flfl4%Jthvv,cJ
8
11Jflh1Lnfl'ti: 61
W
nj1u4mRm1:
uiiiini,d,nien
1iifl:
IflhBtiti u1 otmnnijtrni:
SJtrnUl*flhlU:
tntatfl,,iasiu fl$enho (Qmewtan med oxoqnhl)
kiUlfi 20 (ESATEC 20), %tn 40 (ESATEC 40)
UQ+J4*
Geu 4* uim umw 411T
sAt j1Wv 4*
n1esj 2561- &Mft 2564 (3 10)
1. fnwItmwrnhiuteM4
2. Ui ESATEC CO nMgn UAJCWA V1?1JCnUILu\J iifl,nissithtuuXuaimtuu
tpuWtsniineiueni,nwihnn9t N1nim,1wiw,n*n7n4,u,clanmJn -ueiMi1%Letui
ant
3. tthz81tnn&awaamluthvtw'i1iuj
Unnmubsa aa4eiii'uwintncu,1 ie Ptwmaceutca( Inspection
Co-operation Scheme (PICA)
1. in ESATEC 20 iunflqiJnau p4 mhuiai, *nth3tn, o.i InkluAZLem 20
1 Ui ESATEC 40 Ouuiui.pfi pa OM Snkmwd4um 40
3. in ESATEC 40 9nTAnVYj=qM n.oututAuenisasuu Mutt &ins*vn,fnw,tm
øfl14MUV1UUd1Vi11ifl,ii4tJ1Xfl,ø *ftfl1itfle4T1fflhfl41UflQjtflh1Ifl,,
4. Package dtt14theaaz.iain,s,in,iuin6 un,notj %v4im IuOmmotalq anji
5.in ESATE C 20, ESATEC 40
tUIIBLMPI: thtfløfU+3jntAMV QIT1JLUL2J KtTWi2i 2561 - 1) IU-114 20 Dflif& 10Qu5mrrn3JtwJ giYw,101aia 2562
+++++++9-+++*+14t.t++ +
* u3 tik4& tuTh C 3856 4.930 - 2
I7UJUTmn,IIJtnU Q1t%tkU flfl1R1i 2562
vi
,4W
anLJtouze41uwnh1uhv:
4aininiiA,tinns5inimbio:
inhb41s4!wwwt:
u5thqfuni,thura,
rnhenu uWii laØuiTnflunm4iie:
oitnuMa Mmwal, (Donepezil HydrochLoride)
tntM coolw:EPT)
vAriunthmim
2562 - mnola 2565 (3 t)
1. tin 0CR5'T twnCsi&ntuthn
on OCRPCEPT (5 MG) thtn *.v*rntiA% go Donepezit hydrochloride 5 iiafin3i
in DCRiEPT (10 MG) thvneu*30*xndnieJ go Conepezit hydroch(oide 10 in&thi 2. si Donepezi twni,m,e,ni,I,agetvuja1 eenqMb13Jnnnh41un41r.uulJlnrIM
chotherr tfuJnhlItMllvLiviute4flu, acety(choUne QiflnulôlJt4flfl,*W'flJtU4taUlti
acetytchotne esterase tniiisn& thlm,1vtnlaianiai, acetylcholine
in Donepezil. WiaAMd 2.1 nrurnb1a, m4tutGøhUJc415iuOotJE4%Jmnnh4 Isvfuthmzs'wnnrntii
5 %5O 10 fPnTU ikii'It i
12 fuInwintvtwevutts,u,e4,t'u1uu,i tufuthniuuipnivtni 10 flenTh
If4d al
144
DORfiCEPT ana5,thnnwfmn&biMiffveismffI
3. on DOWCW (10 MG) Cn,,gnv,tnsginjuuttjuffijv,iirniju (kicept Evess 10 mg)
tpesian1,niwjiivi44 2 110fl15 flvniszninte3jffu1n4iiw1rn,Tn1 (Therapeutic
equivaence) i4& lii 0ORCEPT (5 mg) 1eonIunMnv1hn3qetuuv6.n2nKn dose
propotbnaVty ifutil DORACEPT (10 mg) tdonin.
3.1 01 DORACEPT (5 me) tOu,wumt.ucr,o,u,/n,n,,unitua,t*j,jIvifu
01 DOR°CEPT (10 me) 32 u4IQoucqiemfee.uj, DORACEPT øi,ju,4 $ iaanfn LVIt 10 flnfi ATflIKR*u
3.3 in OCR$CS'T (5 me) fit vni1vbe4d1mhvneufflJSnqr1 (vndd) nd)ou*u Ui DOR10EPT (10 rn& t a.'w 4r04t tantuiTiiiuin 'I
(<5%)
3.4 rnnivmiu (OissoLution proilte) 10401 DORACEPT (5 mg)1uinaitiI*i p14 1.2. pH 43
&az pH 6.8 4Das,fleuiTtnhlnavJto4t1 00EPT (10 mg) (sinilurcty factor ((2)>
50
* 84#flThP*tflI5IJ Q 0 2203 8600- 3
i7qrMormulmi; QtTtJL42JLiIJ mMlmv 2562
10
illJfllWYfljli: in
e dniltfle4nr 41UUPflUt1: tnii5rntniiu (Pregabalin)
4nn4nhl4lnlua.aluu5fInnvtsm: Ram 25 (NERY1CA 25), wa'n1 75 (NERVICA 75),
%thtflhlA)TqflJl:
tLMU411I1J1O:
whena ut3j, e4ij1Ycu5mn,ml%m:
t1vm141J1WLUu14;
PITh:
te{ifn 150 (\ERVCA 150)
uii ijG€u 411T
uTh Ciu 4*
¶JWY usitail 41
titi iu dtTh
nThisii 2562- fl$fl1S3J 2565(30)
,j-mniut (Pregabelin) rntAitwwirnAi tuo43rn 25 (NE&A 25 nzn1 75 (NEW)CA 75), ua
taflr, 150 (NEWICA 150) tOwntncbiü tuci I fliiJ ti,:neu,a Pregaba!ki 25mg PregabaUn 75 mg.
Ptegabaun :so mg
tjm5n,uiv (PregabSJn)mItnI4I1h4m18 GABA tsmtjliiiA GASA MO benzodiazepne
receptors vltJ4tA apta2-deUa subunit 'ii vottage-gated cadum channels tsnutThjins:j4bw
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