natgillin/translations-raw huggingface dataset:
Do not store this medicine above 25 °C. 
Zdravilo shranjujte pri temperaturi do 25 C.
Always take this medicine exactly as your doctor has told you. 
Pri jemanju tega zdravila vedno natančno upoštevajte navodila zdravnika.
Efficacy and safety of sevelamer hydrochloride has not been studied in patients with: 
Učinkovitost in varnost sevelamerijevega klorida nista bili preučevani pri bolnikih s/z:
The safety of Tasermity has not been established in pregnant or breast-feeding women. 
Varnosti zdravila Tasermity pri nosečnicah ali doječih ženskah niso ugotavljali.
Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient. 
Čeprav med kliničnimi študijami ni bilo opaziti klinično pomembnega porasta koncentracije klorida v serumu, je potrebno klorid v serumu spremljati kot pri postopku pri bolniku na dializi.
The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class. 
Povzetek varnostnega profila Najpogostejši neželeni učinki (≥ 5 % bolnikov) so bili vsi v organskem sistemu bolezni prebavil.
Iron oxide black (E172) Propylene glycol Hypromellose (E464) 
Tiskarsko črnilo: črni železov oksid (E172), propilenglikol, hipromeloza (E464).
Serum phosphate level in patients not on 
Raven fosfata v serumu pri bolnikih, ki ne
You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis. 
Pri vas se lahko razvije peritonitis (okužba vaše trebušne tekočine) zaradi peritoenalne dialize.
Sevelamer hydrochloride has no or negligible influence on the ability to drive and use machines. 
Sevelamerijev klorid nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood. 
Odrasli bolniki z odpovedjo ledvic, ki so na hemodializi ali peritonealni dializi, ne morejo uravnavati ravni serumskih fosfatov v krvi.
Tasermity tablets are film-coated, off-white, oval tablets with “SH800” imprinted on one side. 
Zdravilo Tasermity tablete so sivo-bele, ovalne, filmsko obložene tablete z natisnjeno oznako "SH800” na eni strani.
Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia. 
Pri bolnikih z ledvično okvaro lahko pride do hipokalciemije ali hiperkalciemije.
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate. 
V 12 tedenski študiji, ki je zajemala bolnike, ki so prejemali peritonealno dializo pa se je pokazala primerljivost zmajšanja iPTH-ja z bolniki, ki so prejemali kalcijev acetat.
Tasermity contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium. 
Zdravilo Tasermity vsebuje sevelamer, neabsorbiran polimer (alilaminijev klorid), ki veže fosfate, brez kovine in kalcija.
• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Tasermity. 
• Učinke zdravil kot so ciklosporin, mofetilmikofenolat in takrolimus (zdravila, ki zavirajo odziv imunskega sistema), lahko zdravilo Tasermity zmanjša.
Patients taking Tasermity should adhere to their prescribed diet and liquid intake. 
Bolniki, ki jemljejo zdravilo Tasermity, se morajo držati predpisane diete.
Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal products. 
Zato se pri bolnikih, ki jemljejo obe zdravili, priporoča skrbno nadziranje ravni TSH.
• develop a low or high level of calcium in your blood. 
• koncentracija kalcija v krvi pade ali naraste.
• if you have undergone major surgery on your stomach or bowel. 
• ste prestali zahtevnejše operacije želodca ali črevesja.
Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed. 
V številnih študijah so poročali o poslabšanju acidoze po prehodu iz drugih vezalcev fosfata na sevelamer, kjer so opazili nižje ravni hidrogenkarbonata pri bolnikih, zdravljenih s sevelamerom v primerjavi z bolniki, zdravljenimi z vezalci na osnovi kalcija.
Closer monitoring of patients with hypothyroidism co-administered with sevelamer hydrochloride and levothyroxine is recommended (see section 4.5). 
Priporoča se skrbno nadziranje bolnikov s hipotiroidizmom, ki dobivajo sevelamerijev klorid sočasno z levotriroksinom (glejte poglavje 4.5).
The safety and efficacy of this product have not been established in patients below the age of 18 years. 
Pediatrična populacija Varnost in učinkovitost tega zdravila pri otrocih, mlajših od 18 let, nista bili ugotovljeni.
Sevelamer hydrochloride should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus (see section 5.3). 
Sevelamerijev klorid naj nosečnice jemljejo le, če ga nujno potrebujejo, in po skrbni analizi tveganja/koristi za mater in zarodek (glejte poglavje 5.3).
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with sevelamer hydrochloride without any clinical consequences (i.e graft rejection). 
Ciklosporin, mofetilmikofenolat in takrolimus pri bolnikih po presaditvi Pri bolnikih po presaditvi, ki so sočasno prejemali sevelamerijev klorid, so poročali o zmanjšanih koncentracijah ciklosporina, mikofenolat mofetila in takrolimusa, vendar brez kakršnihkoli kliničnih posledic (npr. zavrnitev presadka).
Sevelamer hydrochloride alone is not indicated for the control of hyperparathyroidism. 
Sevelamerijev klorid samo ni namenjeno za nadzorovanje hiperparatiroidizma.
Therefore Tasermity is not recommended for use in this population. 
Zato uporaba zdravila Tasermity pri otrocih ni priporočljiva.
Patients who are constipated should be monitored carefully while being treated with sevelamer hydrochloride. 
Zaprte bolnike je potrebno med zdravljenjem s sevelamerijevim kloridom skrbno spremljati.
Sevelamer hydrochloride does not contain calcium. 
Sevelamerijev klorid ne vsebuje kalcija.
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride. 
V zelo redkih primerih je bilo pri bolnikih med zdravljenjem s sevelamerijevim kloridom opaziti črevesno zaporo in ileus/subileus.
Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “SH800” on one side. 
filmsko obložena tableta (tableta) Sivobele ovalne tablete imajo na eni strani natisnjeno oznako “SH800”.
- If you get any side effects talk to your doctor or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
• gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis, 
• gastrointestinalnimi motnjami, vključno z nezdravljeno ali hudo gastroparezo, divertikulozo in zastajanjem hrane v želodcu in nenormalnim ali nepravilnim gibanjem črevesja
HDPE bottles, with a child resistant polypropylene closure and a foil induction seal. 
HDPE plastenke s pokrovom iz polipropilena, ki otrokom onemogoči odpiranje, in indukcijskim tesnilom iz folije.
Folate deficiency 
Pomanjkanje folatov
Caution should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal products. 
Pri predpisovanju sevelamerijevega klorida bolnikom, ki jemljejo tudi omenjena zdravila, je potrebna previdnost.
In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper was detected. 
V raziskavah na podganah so pri dajanju sevelamera v 15 do 30-krat večjem odmerku kot za ljudi zabeležili porast bakra v serumu.
• if you are not on dialysis 
• se ne zdravite z dializo
In a clinical trial of one-year duration, sevelamer hydrochloride had no adverse effect on bone turnover or mineralisation compared to calcium carbonate. 
V enoletnih kliničnih preskusih sevelamerijev klorid na obnovo in mineralizacijo kosti v primerjavi s kalcijevim karbonatom ni imelo neugodnih učinkov.
By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum. 
Ker veže fosfate v prebavilih, sevelamer znižuje koncentracijo fosfata v serumu.
Hypromellose (E464) Diacetylated monoglycerides 
Hipromeloza (E464),
In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients) and that were spontaneously reported from post-marketing experience are listed by frequency in the table below. 
Neželeni učinki iz teh študij (299 bolnikov), iz nekontroliranih kliničnih preskušanj (384 bolnikov) in tisti, o katerih so spontano poročali po začetku trženja, so glede na pogostost našteti v spodnji preglednici.
• if you have symptoms of delayed emptying of stomach contents such as feeling of fullness, 
• imate simptome zapoznelega praznjenja želodčne vsebine, ki se občutijo kot polnost v želodcu, slabost in/ali bruhanje
The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal. 
Tablete so pakirane v plastenkah iz polietilena visoke gostote, s pokrovčkom iz polipropilena, ki je varen za otroke, in indukcijskim tesnilom.
In the event of a possible overdose you should contact your doctor immediately. 
Če ste vzeli večji odmerek zdravila Tasermity, kot bi smeli V primeru prevelikega odmerka se takoj posvetujte z vašim zdravnikom.
Serum chloride may increase during sevelamer hydrochloride treatment as chloride may be exchanged for phosphorus in the intestinal lumen. 
Med zdravljenjem s sevelamerijevim kloridom lahko pride do porasta koncentracije klorida v serumu, ker lahko fosfor zamenja klorid v črevesnem lumnu.
Do not crush, chew or break into pieces prior to swallowing. 
Tablet ne drobite, ne žvečite in ne lomite na koščke.
Tasermity 800 mg film-coated tablets 
IME ZDRAVILA Tasermity 800 mg filmsko obložene tablete
Tasermity is unlikely to affect your ability to drive or to use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Tasermity vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood. 
Zdravilo Tasermity veže fosfate iz hrane v prebavnem traktu in tako zniža koncentracijo serumskega fosfata v krvi.
• If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor before taking Tasermity. 
• Če jemljete zdravila zaradi težav s srčnim ritmom ali zaradi epilepsije, se o jemanju zdravila
Dialysis Interaction studies have not been conducted in patients on dialysis. 
Dializa Pri bolnikih, ki se zdravijo z dializo, študij medsebojnega delovanja niso izvedli.
• have a low amount of vitamin D in your blood. 
• vsebnost vitamina D v krvi pade, odvisno od vrste ledvičnih težav.
During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. 
V izkušnjah po začetku trženja so poročali o zelo redkih primerih zvišanih ravni tiroideo stimulirajočega hormona (TSH) pri bolnikih, ki so sočasno jemali sevelamerijev klorid in levotiroksin.
Tasermity contains sevelamer as the active ingredient. 
Zdravilo Tasermity vsebuje zdravilno učinkovino sevelamer.
The safety of sevelamer hydrochloride has not been established in pregnant women. 
Varnosti sevelamerijevega klorida pri nosečnicah niso ugotavljali.
How to take Tasermity 
Kako jemati zdravilo Tasermity
Tasermity 800 mg film-coated tablets sevelamer hydrochloride 
Tasermity 800 mg filmsko obložene tablete sevelamerijev klorid
In clinical trials, sevelamer hydrochloride has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis. 
Klinične študije dokazujejo učinkovitost sevelamerijevega klorida pri zmanjševanju serumskega fosfata pri bolnikih, ki prejemajo hemodializo oziroma peritonealno dializo.
Starting dose of Sevelamer hydrochloride 800 mg tablets 
Začetni odmerek sevelamerijevega klorida 800 mg tablete
Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. 
Zdravilo Tasermity je namenjen uravnavanju hiperfosfatemije pri zdravljenju odraslih bolnikov, ki prejemajo hemodializo oziroma peritonealno dializo.
Talk to your doctor before taking Tasermity if any of the following applies to you: 
Opozorila in previdnostni ukrepi Če karkoli od naštetega velja za vas, se pred začetkom jemanja zdravila Tasermity posvetujte z zdravnikom:
In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels. 
Pri bolnikih s sekundarnim hiperparatiroidizmom je treba sevelamerijev klorid uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1,25 - dihidroksi vitamin D3 ali kakšen njegov analog, za znižanje koncentracije intaktnega paratiroidnega hormona (iPTH).
In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the iPTH levels. 
Pri bolnikih s sekundarnim hiperparatiroidizmom je treba sevelamerijev klorid uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1,25 - dihidroksi vitamin D3 ali kakšen njegov analog, za znižanje koncentracije iPTH.
What you need to know before you take Tasermity Do not take Tasermity: 
Kaj morate vedeti, preden boste vzeli zdravilo Tasermity
Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 
Študije na živalih so pokazale, da sevelamer ne vpliva na plodnost pri samcih in samičkah podgan pri izpostavljenosti primerjalnemu odmerku pri človeku, dvakrat večjemu od največjega odmerka v kliničnem preskušanju 13 g/dan, na osnovi relativne površine telesa.
During post-marketing experience, very rare cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with sevelamer hydrochloride. 
Med izkušnjami v obdobju trženja so poročali o zelo redkih primerih zvišanih ravni fosforja pri bolnikih, ki so sočasno jemali sevelamerijev klorid in zaviralce protonske črpalke.
Patients should take sevelamer hydrochloride with meals and adhere to their prescribed diets. 
Bolniki morajo jemati sevelamerijev klorid ob obroku in se držati predpisanih diet. Tablete je treba pogoltniti cele.
If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental 
Zato utegne vaš zdravnik nadzirati koncentracijo vitamina D v krvi in vam po potrebi predpisati dodatek vitamina D. Če ne jemljete multivitaminskih dodatkov, vam lahko pade tudi koncentracija vitaminov A, E, K in folne kisline v krvi, zato utegne vaš zdravnik nadzirati tudi te koncentracije in vam po potrebi predpisati dodatne vitamine.
Each tablet contains 800 mg sevelamer hydrochloride. 
Ena tableta zdravila Tasermity vsebuje 800 mg sevelamerijevega klorida.
Tasermity is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment. 
Zdravilo Tasermity se uporablja za uravnavanje koncentracije fosfatov v krvi pri odraslih bolnikih s kronično ledvično odpovedjo, ki se zdravijo s hemodializo oziroma peritonealno dializo.
The effects on phosphate and calcium were proven to be maintained throughout a study with one year follow-up. 
V enoletni raziskavi so dokazali, da se učinki na fosfat in kalcij ohranijo.
Therefore your doctor may monitor the levels of TSH in your blood more closely. 
Zato se lahko vaš zdravnik odloči za skrbno nadziranje
Renal impairment The safety and efficacy of this product have not been established in predialysis patients. 
Varnosti in učinkovitosti tega zdravila pri bolnikih z ledvično okvaro, ki niso na dializi, niso ugotavljali.
Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease. 
Sevelamerijev klorid je treba uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1,25 - dihidroksi vitamin D3 ali kakšen njegov analog, za nadziranje razvoja renalne osteodistrofije.
Fat-soluble vitamins 
V maščobi topni vitamini
The safety of sevelamer hydrochloride has not been established in breast-feeding women. 
Varnosti sevelamerijevega klorida pri doječih ženskah niso ugotavljali.
Check with your doctor if you are not sure. 
Če niste prepričati, se posvetujte z zdravnikom.
Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels. 
Glede na vnos hrane in naravo končne odpovedi ledvic se lahko pri dializnih bolnikih pojavijo nizke ravni vitaminov A, D, E in K. Ni mogoče izključiti, da lahko sevelamerijev klorid veže v maščobi topne vitamine v zaužiti hrani.
Tasermity may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease. 
Zdravilo Tasermity se lahko uporablja sočasno s terapijo preprečevanja razvoja bolezni kosti, v sklopu katere se dodaja kalcij in vitamin D.
Gastrointestinal disorders 
Zaviralci protonske črpalke
He/she will base the dose on your serum phosphate level. 
Zdravnik bo odmerek določil glede na koncentracijo fosfata v serumu.
How to store Tasermity 
Shranjevanje zdravila Tasermity
Uncommon reports of difficulty swallowing the sevelamer hydrochloride tablet have been reported. 
Občasno so poročali o težavah s požiranjem tablet s sevelamerijevim kloridom.
Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence. 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): driska, slaba prebava, bolečine v trebuhu, zaprtost, nabiranje plinov v želodcu in črevesju Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): povečana kislost krvi
- The active substance is sevelamer hydrochloride. 
- Zdravilna učinkovina je sevelamerijev klorid.
Therefore caution should be exercised when sevelamer hydrochloride is used in patients with these disorders. 
Zato je treba biti pri teh bolnikih z uporabo sevelamerijevega klorida zelo pazljiv.
• if you have bowel obstruction. 
• če imate zaporo črevesja,
Acidosis, increased chloride 
Presnovne in prehranske motnje acidoza, zvišana vrednost klorida v serumu
Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms. 
Pri bolnikih, ki imajo hudo zaprtje ali druge hude gastrointestinalne simptome, je treba ponovno pretehtati smiselnost zdravljenja s sevelamerijevim kloridom.
Posology 
Levotiroksin
• if you have problems with motility (movement) in your stomach and bowel 
• imate težave z nenormalno ali nepravilno gibljivostjo želodca in črevesja
Sevelamer hydrochloride is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic study in healthy volunteers. 
Glede na farmakokinetične raziskave zdravih prostovoljcev z enim samim odmerkom se sevelamerijev klorid ne absorbira iz gastrointestinalnega trakta.
• Bowel obstruction. 
Okvara ledvic
Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms. 
Pri bolnikih, ki se jim pojavijo hudi simptomi povezani s prebavili, je treba zdravljenje s sevelamerijevim kloridom znova oceniti.
49 x 1 tablets (unit dose) 
196 (2 x 98) tablet
l t o r 
Pot uporabe
Target Species 
Ciljna živalska
Packaging 
Farmacevtska
EU Number 
EU številka Izmišljeno ime Jakost
Package size 
Ovojnina Velikost pakiranja Karenca
London, 19 July 2007 Doc. 
London, 19. julij 2007 Sklic na dok.
The Committee also had concerns over the ways in which the study had been carried out, which made it difficult to interpret the results. 
Odbor je imel tudi pomisleke v zvezi z načinom izvedbe študije, zaradi česar je bilo rezultate težko interpretirati.
The letter from the company notifying the EMEA of the withdrawal of the application is available here. 
Dopis podjetja, v katerem je agencijo EMEA obvestilo o umiku vloge, je na voljo tukaj.
The main measure of effectiveness was how long the patients survived after the first operation. 
Glavno merilo učinkovitosti je bil čas preživetja bolnikov po prvi operaciji.
Ref. EMA/318692/2007 
EMA/382244/2007
Cerepro was designated an orphan medicinal product on 6 February 2002. 
Zdravilo Cerepro je bilo dne 6. februarja 2002 določeno kot zdravilo sirota.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew. 
Podjetje je zahtevalo ponovno preučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je podjetje odločilo za umik svoje vloge.
The effects of Cerepro were first tested in experimental models before being studied in humans. 
Učinki zdravila Cerepro so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for CEREPRO 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo CEREPRO
It was concerned over the low number of patients included in the main study of Cerepro, which prevented a benefit of the medicine being demonstrated. 
Zaskrbljen je bil glede majhnega števila bolnikov, vključenih v glavno študijo zdravila Cerepro, zaradi česar koristi zdravila ni bilo mogoče dokazati.
What are the consequences of the withdrawal for patients in clinical trials with Cerepro? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila Cerepro?
Cerepro has also been studied in 36 patients with high-grade glioma. 
Zdravilo Cerepro so preučevali tudi pri 36 bolnikih z visoko malignimi gliomi.
The study compared the effects of adding Cerepro and ganciclovir sodium to standard treatment with the effects of standard treatment alone. 
V okviru študije so primerjali učinek dodajanja zdravila Cerepro in ganciklovir natrija k standardnemu zdravljenju z učinkom standardnega zdravljenja samega.
Cerepro injection was to be followed by a two-week course of treatment with ganciclovir sodium, starting five days after the operation. 
Injiciranju zdravila Cerepro bi naj sledilo dvotedensko zdravljenje z ganciklovir natrijem, ki bi se pričelo pet dni po operaciji.
On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma. 
Podjetje Ark Therapeutics je dne 13. julija 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Cerepro, namenjenim zdravljenju bolnikov z operabilnimi visoko malignimi gliomi.