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CPR Ascorbic Acid Syr 100mg5mL (NOVACEE)
CPR Ascorbic Acid Syr 100mg5mL (NOVACEE)
CPR Ascorbic Acid Syr 100mg5mL (NOVACEE)
: I'ilt liilirltrr:
I )c1l:.tt llttc:tt rtl' I.l*ll !tlt
'l'he urarketing autlrorizutrul shall hc lalid until 0? ;lpril 2{}?6 suhjtct to thc
conrlilions listed on thu rcvcrsc sirir. Nn changc irr the t'ormulalinn. lahcllirrg and
comrncrcial prcscntaliorl nl'this product shall trc utade fil ntt-y timc tlurirtg the
ci'fce livity of lhis rcgistralion rvithout priur writtcn approval rtl'this O{'f ir:c.
.l
his nrarkeling authorization is sirh.i cct to su-spenston. clttce llttiun t)r rccall
should artv violation of I{,.A. }'io. 37:0. R.A. No. {r675 lrrl R.A. Np. t)7I I aIld",.tr
regulations issircd lhcrcundcr involvin* Ihc procluut bc con"ll'trittcd.
Provide{ that nuhing in the registration ul'tlrc product herein granted shall be intr:rpleted or constnted
as an e ndorsement or nipresentadon try FDA. lhat Registrant hns thc riglrt or priTilege to thr usc of'the narne or
blinel si:r regisrererl; Rcgis{rant }rrreby agrees anr} *t-tinns to indrrmnify an*or hald FDA free and harmless
againsr any an,J all thir{-par{y itlaiils on in&ingertturt tlf patent. tradenrark nr intellectual property right arising
lionr the registratir;n *l the product.
l*l;l I'hrs is rub;ccr ro conrplianee *,ith the rcquir*ments unqler fDA Circular No" l0ll-004 frrr [lonitor*ri
t-'rt Subjeet llr posl-marketing surveillancr ol'the markeling authori?ation h*lder's sti.rct ctl$pliance lo lht:
Ceneric I-alxiing Requirr.,mcnts folk-rrving the applicahh provisirrns r,rf A.{} No. 101(;-tX}fi8 fbrdmg
i.l'j prr:ducts lgr human use and A.{-). }I*. 105 t 1991 lbr veltrinary drug prn{ucts.
il;l Submit a $&tisfactory lSioequivrlencc Str.rtly Report ar Eiowaiver twhichcver is applicrrblc) within tho
validity o{ this CPR in accrtdalce r-v'ith IjI}A Circular No. 2016-019'
r--r- Dalgerous Drug - '[^o tre prescribed br* I]DEA 5-2 licc*sed practitioner in a personalizrtl oxfinar3
L l., prescripti*n. It is a habit-lirrnring drug.
i-l ,. ] eoti.nr lnlirnnation l-eatlet - Appropnat* infbnnarit:n firr the consumijrs shall be written in Filipino
I " I andior local clialects. as appropriate.
IL_]_"-_i
t..l'.* I Suh,r',,t a Ccrti{icate oI Co*r! Manularturing Practicr: {CI{P) f*mpiiance of' l'oreign Drug
t , f i lr,lanutacturer{s} rvlthin th* validity +f this CPR in a€cordattce with A.(]" n*o.:013-tl0l: and FDA
L .1
('rrcular No. l()l4-0I6.
' --l
[^l- Rcvicrt ol'the submitted llnequivalerree Study Report cr Biorvaiver" whiehever is applicahle- s]rall h.r
I J ct mplcrctl hv the FD-'\ rvithin the validity o{'this CPR: crrrrespondingly, this CPR shall he r*'oked il'
i I produqt uttcrchangealrility has nqt hren establirhed.
-l
I l, SuUi".t ro sxtisi'actory cr:nrpliance to the posi-apprr)\.al conrnritnrents dctailed in thc lettcr
I^ I o..on panving rhis CPR
Rf,}IARKS:
I'his Certiflcate of Product Registration {CPR} is r*newed to chirnge rsgistration numher frorn
tHRP-010 to IIRP-9740)"
Exluustiun up tc retail lcvel of all existing tnv(rntr'lry *f the previour iabelling malt'rial$ is allc'rvr'd r:nlv unti!
!S UeLI!?t. No tirrther exte*tiion shall be grantcd.