natgillin/translations-raw huggingface dataset:
The daily dose of levodopa should be reduced by about 10-30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient. 
Glede na bolnikovo klinično stanje je treba dnevni odmerek levodope zmanjšati za približno 10-30 %, in sicer s podaljšanjem časovnega presledka med posameznimi odmerki in/ali z zmanjšanjem količine levodope na odmerek.
Comtan is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations). 
Zdravilo Comtan se jemlje skupaj z zdravili, ki vsebujejo levodopo (bodisi pripravki levodope/karbidope bodisi pripravki levodope/benserazida).
The recommended dose of Comtan is one 200 mg tablet with each levodopa dose. 
Priporočeni odmerek zdravila Comtan je ena 200-miligramska tableta z vsakim odmerkom levodope.
• discolouration of the skin, hair, beard and nails. 
• sprememba barve kože, las, brade in nohtov.
Entacapone therapy should be administered cautiously to patients with ischaemic heart disease. 
Entakapon moramo uporabljati previdno pri zdravljenju bolnikov z ishemično boleznijo srca.
Comtan aids levodopa in relieving the symptoms of Parkinson's disease. 
Zdravilo Comtan pomaga levodopi pri lajšanju simptomov Parkinsonove bolezni.
How to take Comtan 
Kako jemati zdravilo Comtan
Brownish-orange, oval, biconvex film-coated tablet with “Comtan” engraved on one side. 
Rjavkastooranžna, ovalna, bikonveksna filmsko obložena tableta z vtisnjenim napisom “Comtan” na eni strani.
Comtan has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa. 
Zdravilo Comtan ne lajša simptomov Parkinsonove bolezni, če ga bolnik ne vzame skupaj z levodopo.
Table 2 Daily ON time (Mean ± SD) 
Preglednica 2 Dnevno obdobje ‘ON' (povprečje ± S.D.)
Usually side effects caused by Comtan are mild to moderate. 
Neželeni učinki, ki jih povzroča zdravilo Comtan, so navadno blagi do zmerni.
When stopping, your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson's disease. 
Pri prekinitvi jemanja vam bo zdravnik mogoče prilagodil odmerjanje drugih vaših zdravil za zdravljenje Parkinsonove bolezni.
White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60 or 100 tablets. 
Bele stekleničke iz polietilena visoke gostote (HDPE), z belim polipropilenskim (PP) pokrovčkom, odpornim proti nepooblaščenemu odpiranju, v katerih je po 30, 60 ali 100 tablet.
100 film-coated tablets (glass) 30 film-coated tablets (HDPE) 100 film-coated tablets (HDPE) 60 film-coated tablets (HDPE) 
100 filmsko obloženih tablet (HDPE) 60 filmsko obloženih tablet (HDPE)
• Excessive movements (hyperkinesias), worsening of symptoms of Parkinson's disease, 
• čezmerni gibi (hiperkinezije), poslabšanje simptomov Parkinsonove bolezni, dolgotrajni mišični krči (distonija);
Your doctor may advise you to slowly discontinue the treatment with Comtan and other medicines to treat Parkinson's disease. 
Zdravnik vam bo morda svetoval, da zdravilo Comtan in druga zdravila za zdravljenje Parkinsonove bolezni prenehate jemati postopoma.
Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60 or 100 tablets. 
Stekleničke iz temno obarvanega stekla (hidrolizni razred III) z belim pokrovčkom, odpornim proti nepooblaščenemu odpiranju, iz polipropilena, v katerih je po 30, 60 ali 100 tablet.
General characteristics of the active substance 
Splošne značilnosti učinkovine
In addition, Comtan taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep. 
Poleg tega lahko zdravilo Comtan, ki ga vzamete skupaj z levodopo, povzroči hudo zaspanost ali povzroči, da včasih nenadoma zaspite.
Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171) 
Filmska obloga hipromeloza polisorbat 80 glicerol 85 % saharoza rumeni železov oksid (E172) rdeči železov oksid (E172) titanov dioksid (E171) magnezijev stearat
See Section 4 Possible side effects for the characteristics of NMS; 
Za značilnosti NMS glejte poglavje 4 Možni neželeni učinki;
Comtan 200 mg film-coated tablets 
Comtan 200 mg filmsko obložene tablete
Comtan taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Comtan, ki ga jemljete skupaj z levodopo, vam lahko zniža krvni tlak, zaradi česar se vam lahko stemni pred očmi ali postanete omotični.
• Comtan taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep; 
• poredko se lahko zgodi, da zaradi zdravila Comtan, ki ga jemljete z levodopo, postanete čez dan izredno zaspani, lahko tudi povzroči, da nenadoma zaspite;
Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate 
Jedro tablete mikrokristalna celuloza manitol natrijev karmelozat, premreženi hidrogenirano rastlinsko olje magnezijev stearat
Comtan tablets contain sucrose. 
Tablete zdravila Comtan vsebujejo saharozo.
Comtan taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep. 
Zdravilo Comtan, ki ga vzamete skupaj z levodopo, lahko povzroča zaspanost ali povzroči, da včasih nenadoma zaspite.
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtan in association with levodopa (see section 4.4). 
Motnje pri obvladovanju impulzov: Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Comtan v povezavi z levodopo, lahko pride do patološkega hazardiranja, povečanega libida, hiperseksualnosti, kompulzivnega zapravljanja ali nakupovanja, prenajedanja ali kompulzivnega prenajedanja (glejte poglavje 4.4).
What Comtan looks like and contents of the pack Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with “Comtan” engraved on one side. 
Comtan 200 mg filmsko obložene tablete so rjavkastooranžne, ovalne tablete z vtisnjenim napisom “Comtan” na eni strani.
Comtan contains sucrose Comtan tablets contain a sugar called sucrose. 
Tablete Comtan vsebujejo sladkor, ki ga imenujemo saharoza.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtan in association with levodopa. 
Bolnike in njihove skrbnike je treba opozoriti, da pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Comtan v povezavi z levodopo, lahko pride do vedenjskih simptomov, ki so znak motenj pri obvladovanju impulzov, kar vključuje patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno zapravljanje ali nakupovanje, prenajedanje in kompulzivno prenajedanje.
Comtan 200 mg film-coated tablets entacapone 
Comtan 200 mg filmsko obložene tablete entakapon
Talk to your doctor or pharmacist before taking Comtan: 
Pred začetkom jemanja zdravila Comtan se posvetujte z zdravnikom ali farmacevtom:
1 tablet contains 200 mg of entacapone. 
1 tableta vsebuje 200 mg entakapona.
The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtan. 
Najvišji priporočeni odmerek je 10 tablet na dan, t.j.
maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited. 
Vendar so izkušnje s klinično uporabo entakapona z več zdravili, med drugim z zaviralci MAO-A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so desipramin, maprotilin in venlafaksin, in zdravili, ki jih presnavlja COMT (na primer spojine s kateholno skupino: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa, apomorfin in paroksetin), še omejene.
Therefore, the use of Comtan in children or adolescents cannot be recommended. 
Izkušenj z uporabo zdravila Comtan pri bolnikih, ki so stari manj kot 18 let, je malo, zato uporabe zdravila Comtan pri otrocih in mladostnikih ni mogoče priporočati.
How to store Comtan 
Shranjevanje zdravila Comtan
Cardiac disorders** Common: 
Srčne bolezni**
Marketing Authorisation Holder Orion Corporation Orionintie 1 
Imetnik dovoljenja za promet z zdravilom Orion Corporation
Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtan and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced. 
Do nje lahko pride zlasti pri nenadni prekinitvi zdravljenja z zdravilom Comtan in drugimi zdravili za zdravljenje Parkinsonove bolezni oziroma pri nenadnem znižanju odmerka teh zdravil.
Hepatitis with mainly cholestatic features (see section 4.4) Skin and subcutaneous tissue disorders Rare: 
hepatitis s prevladujočimi znaki holestaze (glejte poglavje 4.4)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
Izgled zdravila Comtan in vsebina pakiranja
The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Comtan. 
Morda bo ob uvedbi zdravila Comtan potrebno prilagoditi odmerke drugih zdravil za zdravljenje Parkinsonove bolezni.
General disorders and administration site conditions Common: 
sprememba barve urina Splošne težave in spremembe na mestu aplikacije pogosti:
It can be used in patients of all ages. 
Zdravilo se lahko uporablja pri bolnikih vseh starosti.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Alprolix's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Alprolix večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Alprolix. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Alprolix.
What measures are being taken to ensure the safe and effective use of Alprolix? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Alprolix?
A risk management plan has been developed to ensure that Alprolix is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Alprolix je bil pripravljen načrt obvladovanja tveganj.
Hypersensitivity (allergic) reactions are seen rarely with Alprolix and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing. 
Preobčutljivostne (alergijske) reakcije se pri zdravilu Alprolix redko pojavijo in vključujejo: oteklost, pekoč občutek in zbadanje na mestu injiciranja, mrzlico, vročinske oblive, srbeč izpuščaj, glavobol, koprivnico, nizek krvni tlak, letargijo, slabost in bruhanje, nemirnost, hiter srčni utrip, stiskanje v prsnem košu in sopenje.
Other information about Alprolix 
Druge informacije o zdravilu Alprolix
The summary of the opinion of the Committee for Orphan Medicinal Products for Alprolix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Alprolix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Patients or their carers may be able to inject Alprolix themselves at home once they have been trained appropriately. 
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Alprolix injicirajo sami doma.
It is not intended to provide practical advice on how to use Alprolix. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In addition, when bleeding did occur, around 90% of bleeding episodes resolved with one injection of Alprolix. 
Kadar se je pojavila krvavitev, pa so približno 90 % krvavitev obvladali z eno injekcijo zdravila Alprolix.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Alprolix, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In the second study in 30 children aged below 12 years, Alprolix was similarly effective: 2 bleeding episodes occurred per year on average and around 75% of bleeding episodes resolved with one injection. 
V drugi študiji s 30 otroki, mlajšimi od 12 let, je bilo zdravilo Alprolix podobno učinkovito: na leto sta se povprečno pojavili dve krvavitvi, pri čemer so 75 % krvavitev obvladali z eno injekcijo.
The active substance in Alprolix, eftrenonacog alfa, works in the body in the same way as human factor IX. 
Zdravilna učinkovina zdravila Alprolix, eftrenonakog alfa, deluje v telesu enako kot humani faktor IX.
The dose and frequency of treatment depend on the patient's bodyweight and whether Alprolix is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health. 
Odmerek in pogostnost injiciranja sta odvisna od bolnikove telesne mase in tega, ali se zdravilo Alprolix uporablja za zdravljenje ali preprečevanje krvavitve, ter resnosti bolnikovega pomanjkanja faktorja IX, obsega in mesta krvavitve ter bolnikove starosti in stanja.
In the first study involving 123 adults and adolescents aged 12 years or above, patients given Alprolix as a weekly preventive treatment had around 3 bleeding episodes a year, patients given Alprolix as an every 10 days preventive treatment had around 2 bleeding episodes per year, and patients given Alprolix for treating bleedings on demand had around 18 bleeding episodes a year. 
V prvi študiji, ki je vključevala 123 odraslih in mladostnikov, starih 12 let ali več, so bolniki, ki so prejemali zdravilo Alprolix kot tedensko preventivno zdravljenje, imeli približno 3 krvavitve na leto; bolniki, ki so prejemali zdravilo Alprolix kot 10-dnevno preventivno zdravljenje, so imeli približno 2 krvavitvi na leto; bolniki, ki so prejemali zdravilo Alprolix za zdravljenje krvavitev po potrebi, pa so imeli približno 18 krvavitev na leto.
What is Alprolix and what is it used for? 
Kaj je zdravilo Alprolix in za kaj se uporablja?
For the full list of all side effects and restrictions with Alprolix, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Alprolix glejte navodilo za uporabo.
The full EPAR for Alprolix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Alprolix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Why is Alprolix approved? 
Zakaj je bilo zdravilo Alprolix odobreno?
What benefits of Alprolix have been shown in studies? 
Kakšne koristi je zdravilo Alprolix izkazalo v študijah?
Alprolix can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia. 
Izdaja zdravila Alprolix je le na recept, zdravljenje z njim pa mora biti pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije.
Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Alprolix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2007. 
Ker je bolnikov s hemofilijo B malo, velja ta bolezen za redko, zato je bilo zdravilo Alprolix 8. junija 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What are the risks associated with Alprolix? 
Kakšna tveganja so povezana z zdravilom Alprolix?
Alprolix has been shown to be effective at both preventing and treating bleeding episodes in 2 main studies in patients with haemophilia B. 
Zdravilo Alprolix se je izkazalo za učinkovito tako pri preprečevanju kot pri zdravljenju krvavitev v dveh glavnih študijah pri bolnikih s hemofilijo B.
Alprolix is available as a powder and solvent that are mixed together to make a solution for injection into a vein. 
Zdravilo Alprolix je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
For more information about treatment with Alprolix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Alprolix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Alprolix, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Alprolix naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Alprolix contains the active substance eftrenonacog alfa. 
Zdravilo Alprolix vsebuje zdravilno učinkovino eftrenonakog alfa.
Studies show that Alprolix is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products. 
Študije kažejo, da je zdravilo Alprolix učinkovito pri preprečevanju in zdravljenju krvavitev pri bolnikih s hemofilijo B, varnost zdravila pa je primerljiva z drugimi zdravili, ki vsebujejo faktor IX.
Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels. 
Zdravila, ki vsebujejo faktor IX, lahko povzročijo težave zaradi tvorjenja krvnih strdkov v krvnih žilah.
Alprolix is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX. 
Zdravilo Alprolix se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B, prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor IX.
Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control. 
Pri nekaterih bolnikih, ki jemljejo zdravila s faktorjem IX, obstaja tudi tveganje, da se bodo pri njih pojavili zaviralci (protitelesa) faktorja IX, ki bodo izničili njegovo delovanje ter tako povzročili izgubo nadzora nad krvavitvijo.
How is Alprolix used? 
Kako se zdravilo Alprolix uporablja?
How does Alprolix work? 
Kako zdravilo Alprolix deluje?
Asparaginase has been used to treat cancer for many years and is authorised in EU countries under several trade names. 
Asparaginaza se že vrsto let uporablja za zdravljenje raka in je v EU odobrena pod različnimi trgovskimi imeni.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. 
Vlogo so umaknili po tem, ko je odbor CHMP že ocenil začetno dokumentacijo, ki jo je predložilo podjetje, in oblikoval seznam vprašanj.
Withdrawal of the marketing authorisation application for Graspa (L-asparaginase) EMA/431413/2018 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (L-asparaginaza) EMA/431413/2018
The company had not yet responded to the questions at the time of the withdrawal. 
Podjetje ob umiku vloge še ni odgovorilo na zastavljena vprašanja.
On 22 June 2018, Erytech Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia (ALL). 
Podjetje Erytech Pharma S.A. je 22. junija 2018 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Graspa, namenjenim zdravljenju akutne limfoblastne levkemije (ALL).
Asparagine is an amino acid produced by healthy cells in the body. 
Asparagin je aminokislina, ki jo proizvajajo zdrave celice v telesu.
Withdrawal of the marketing authorisation application for Graspa (L-asparaginase) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (L-asparaginaza)
The company provided data from a main study which compared Graspa with asparaginase (not enclosed in blood cells) in 80 patients aged 1 to 55 years with Philadelphia chromosome negative ALL whose disease had not improved with other treatment or had come back. 
Podjetje je predložilo podatke iz glavne študije, v kateri so zdravilo Graspa primerjali z asparaginazo (ki ni bila vključena v krvne celice) pri 80 bolnikih, starih od enega leta do 55 let, z akutno limfoblastno levkemijo, negativno za kromosom Philadelphia, pri katerih se bolezen z drugim zdravljenjem ni izboljšala ali se je ponovila.
Graspa was expected to be used in combination with other cancer medicines to treat adults and children with ALL that was not related to a particular genetic change (known as ‘Philadelphia chromosome negative'). 
Zdravilo Graspa naj bi se uporabljalo v kombinaciji z drugimi zdravili proti raku za zdravljenje odraslih in otrok z akutno limfoblastno levkemijo, ki ni povezana z določeno genetsko spremembo (znano kot „negativna za kromosom Philadelphia“).
However, lymphoblastic leukaemia cells cannot produce the amino acid and therefore they take it from the blood since they need it for their rapid growth. 
Limfoblastne levkemične celice pa te aminokisline ne morejo proizvajati in jo zato jemljejo iz krvnega obtoka, saj jo potrebujejo za hitro rast.
Also, data were too limited to show how much Graspa's effectiveness was reduced by antibodies or how safe it was in children or after repeated treatments. 
Podatki so bili tudi preveč omejeni, da bi z njimi lahko ugotovili, v kolikšnem obsegu protitelesa zmanjšajo učinkovitost zdravila Graspa in kako varno je zdravilo za otroke ali pri večkratnem zdravljenju.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Graspa. 
Podjetje je odbor CHMP obvestilo, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Graspa.
It was to be used if the ALL did not improve with standard treatment or if it had come back after such treatment. 
Uporabljalo naj bi se, kadar se akutna limfoblastna levkemija ne izboljša s standardnim zdravljenjem ali se po tovrstnem zdravljenju ponovi.
Graspa is a cancer medicine that contains the active substance L-asparaginase that has been enclosed in red blood cells. 
Graspa je zdravilo za zdravljenje raka, ki vsebuje učinkovino L-asparaginazo, vključeno v rdeče krvne celice.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the data provided were not sufficient to conclude on Graspa's benefit and risk. 
Podjetje je v dopisu, s katerim je agencijo obvestilo o umiku vloge, navedlo, da predloženi podatki ne zadoščajo za sklepanje o koristih in tveganjih zdravila Graspa.
What was Graspa expected to be used for? 
Za kaj naj bi se zdravilo Graspa uporabljalo?
The CHMP was concerned that the medicine contains a different type of asparaginase to that used in clinical studies and that the data provided were not sufficient to show how the medicine behaved in the body or how well it worked compared with other asparaginase medicines. 
Izrazil je zadržek, ker zdravilo vsebuje drugačno vrsto asparaginaze, kot so jo uporabljali v kliničnih študijah, in ker predloženi podatki niso zadoščali za prikaz obnašanja zdravila v telesu ali njegove učinkovitosti v primerjavi z drugimi zdravili z asparaginazo.