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to urTlt rl6uuuilarlnu'l#rfl utrjnuRsEAN G uider.i ne on submission of
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ar fr nrjr i o I ra:*o qun r :ar 6 m
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*firr'izu6nr-nnfrun-rurrirdrun'urirf,o:-r:o.r cEP uave'iei6nzufrnniruq{urdx6.r


UIOU

dorirvuor r n:otutor':-nq6u O'r urrirriry6u ( utiu U SP, J P, I n-house rfl udu)


rizufr rr zufr n
!U d'ruviu r o v 6'or duriol ado 54. 1 fi { 54. 5
nr:uffhuJduuudauonar:rirriuurtrin:.rflruronar:rirrYuurvrttriiuoqrylnoln

drrinq ru n ru v n::il n1: o1 14 1 i ua vu 1

Auy_ y a X
rtttunr: 1. ro n al:n1 n! ulvt lo:1J0u! n 01nalun{''lun 6uu n::! n1:0114'15 ltau ul Fl0.iil tuo141
d,\,vod4dl
Jq
uuljoun tfl rlju LU Fl',tlJ10 n1uuo01 t{ uu 14:0 tvl u1j tvll
z. rflunr:rui'lrur.Jduurula.:fif;urflo.rlra']nn1:tileuutda{Lona1:rirfiiurtotar
rujdtruurilar
v,
fiutiuu (origina[ drugs)
3. n:fironar:rirfiuorro.r{zufinlurJ:vtvrfi (vrvtf,uuzu6nviour-jr!:rnu16'utt1JlJ
(original. drugs) raion:firy'rira''rr firfluvrvrCuuer'rr-uurfifido4arrafiousir:nurfitdil
! a A qv v q
f,uvrvrflauliudr'Luf,onr:rirlvri to{urfrurlu (originaI drugs) rirvunrl#tonar:
YA
n r n u u'r Fr o.r r1iil o u n ull n | 5un1 : un t{ufi onr : firlrailtu vr v tfi u u u r

1 . a a 1 n rra u ro n a r : rir rYu u r arir fi t6':-r o ututu'r Ft ru rJ t o


i
liu
JJ 2. aa1n tta v ro n a 1 : ril nl1l u r fi t o ff1t uJ 6 u u ini a I
uu[v'l0 ur

3. ro n a1 : uta a { ru r] r,r alunl i? o rLfi'[r rl 6u u utl ar


rJ:vnounr: I

4. ronar:rirfi!ur (Package insert) doqaalJtolzu6nfiruc{mr:JLL!I..J Summary of


v{Q15[U1
Product Characteristtcs (SmPC) u6oronar:rirnluurdrvir{thu fiLil:-loqtu'lnto.i
dou
yrvrtousiriuurduuur (original.) rravdrrurrirtoiui'hui6uuru.Ja'rfi16'ilo1.{ry1rrx1n

drrinrrunruv nr:! nlio'r1i1: lrau u'r


s. vrir f; o 0 u u o l.r a 1 n ri"rr o': zu fr n rYrucfll#dr r 6 t ro nar : rir riu u r

14lJ''ru[14sr n:finr:eir:ru{lurJanlrai?aaoun?r}Jnn6'ottorn:vurunr:26n (Process val.idation


t!
report) r,ld'.rornkiiuhrirrYrynr:rsuvrrru^uuuru#r trid'qr{Ju nr:uritturJf;uuutla.i:1unr:vvuiuum"r:-uur
trin'ruflunr:lirrari.rf;ofi.rrirrinur rvl'orir:rurrurianl:n:?aaounrunn6'o.rllo.iniu!?unr:26n (Process
Val'idation report)

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