natgillin/translations-raw huggingface dataset:
Other information about Fulphila
Druge informacije o zdravilu Fulphila
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulphila have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fulphila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Fulphila can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj ali krvnih bolezni.
It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Zdravilo se daje za skrajševanje trajanja nevtropenije in preprečevanje febrilne nevtropenije (nevtropenije, ki jo spremlja povišana telesna temperatura).
The reference medicine for Fulphila is Neulasta.
Referenčno zdravilo za zdravilo Fulphila je zdravilo Neulasta.
Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Filgrastim deluje tako, da spodbuja kostni mozeg k proizvodnji več belih krvnih celic, s čimer poveča število belih krvnih celic in zdravi nevtropenijo.
What are the risks associated with Fulphila?
Kakšna tveganja so povezana z zdravilom Fulphila?
What is Fulphila and what is it used for?
Kaj je zdravilo Fulphila in za kaj se uporablja?
All these data were considered sufficient to conclude that Fulphila will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Fulphila pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
The safety of Fulphila has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Varnost zdravila Fulphila je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neulasta.
The active substance in Fulphila, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Učinkovina zdravila Fulphila, pegfilgrastim, je sestavljena iz filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
Because Fulphila is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Fulphila.
Zdravilo Fulphila je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Fulphila ni treba ponavljati.
In addition, a study involving 194 patients who had chemotherapy before or after surgery for breast cancer showed that Fulphila was as effective as Neulasta in reducing the duration of neutropenia.
Poleg tega so v študiji, ki je vključevala 194 bolnic, ki so se s kemoterapijo zdravile pred kirurškim posegom zaradi raka dojk ali po njem, dokazali, da je zdravilo Fulphila pri skrajševanju trajanja nevtropenije enako učinkovito kot zdravilo Neulasta.
Fulphila is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Zdravilo Fulphila ni namenjeno uporabi pri bolnikih s krvnim rakom, tj. kronično mieloično levkemijo ali mielodisplastičnimi sindromi (boleznimi, pri katerih nastajajo velike količine nenormalnih krvnih celic, ki se lahko razvijejo v levkemijo).
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fulphila has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Fulphila po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neulasta in da se po telesu enako prenaša.
For the full list of side effects and restrictions with Fulphila, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Fulphila glejte navodilo za uporabo.
Fulphila is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Fulphila je zdravilo, ki se uporablja pri bolnikih z rakom za pomoč pri nevtropeniji (zmanjšanem številu nevtrofilcev, vrste belih krvnih celic), ki je pogost neželeni učinek pri zdravljenju raka, zaradi katerega pa so bolniki dovzetnejši za okužbe.
In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Fulphila is equivalent to that of Neulasta in reducing the duration of neutropenia.
Poleg tega so v študijah pri bolnicah z rakom dojke, ki so se zdravile s kemoterapijo, dokazali, da je učinkovitost zdravila Fulphila pri skrajševanju trajanja nevtropenije enakovredna učinkovitosti zdravila Neulasta.
Fulphila is a ‘biosimilar medicine'.
Zdravilo Fulphila je „podobno biološko zdravilo“.
In Fulphila, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
V zdravilu Fulphila je filgrastim „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
Therefore, the Agency's view was that, as for Neulasta, the benefit of Fulphila outweighs the identified risk and it can be authorised for use in the EU.
Agencija je menila, da koristi zdravila Fulphila enako kot pri zdravilu Neulasta odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How does Fulphila work?
Kako zdravilo Fulphila deluje?
Laboratory studies comparing Fulphila with Neulasta have shown that the active substance in Fulphila is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Fulphila primerjali z zdravilom Neulasta, so pokazale, da je učinkovina zdravila Fulphila po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neulasta.
How is Fulphila used?
Kako se zdravilo Fulphila uporablja?
Studies have also shown that giving Fulphila produces similar levels of the active substance in the body to giving Neulasta.
Študije so pokazale tudi, da zdravilo Fulphila vzpostavi podobne ravni učinkovine v telesu kot zdravilo Neulasta.
The full EPAR for Clopidogrel Apotex 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 Clopidogrel Apotex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Uporablja se pri tistih bolnikih, pri katerih obstaja vsaj en dejavnik tveganja za vaskularne dogodke, kot sta srčni napad ali kap, ki ne morejo jemati antagonistov vitamina K (drugih zdravil za preprečevanje krvnih strdkov) in pri katerih je tveganje za krvavitev majhno.
Previously known as Clopidogrel Mylan Pharma.
1 Prej znano kot Clopidogrel Mylan Pharma.
In acute coronary syndrome and atrial fibrillation, Clopidogrel Apotex is used together with aspirin, the dose of which should not be higher than 100 mg.
Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Clopidogrel Apotex uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Apotex.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel Apotex.
For more information about treatment with Clopidogrel Apotex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Clopidogrel Apotex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Pri akutnem koronarnem sindromu se zdravljenje na splošno začne z udarnim odmerkom štirih 75-miligramskih tablet.
This means that Clopidogrel Apotex is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan Pharma on 16 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Mylan Pharma, veljavno po vsej Evropski uniji, odobrila dne 16. oktobra 2009.
The name of the medicine was changed to Clopidogrel Apotex on 20 January 2010.
Ime zdravila je bilo 20. januarja 2010 spremenjeno v Clopidogrel Apotex.
Clopidogrel Apotex is used to prevent problems caused by blood clots in adults who have:
Zdravilo Clopidogrel Apotex se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih, ki:
The standard dose of Clopidogrel Apotex is one 75-mg tablet once a day.
Običajni odmerek zdravila Clopidogrel Apotex je ena 75-miligramska tableta enkrat dnevno.
Clopidogrel Apotex can be started between a few days and 35 days after the attack;
Zdravilo Clopidogrel Apotex se lahko začne jemati nekaj dni po napadu in do 35 dni po njem;
Because Clopidogrel Apotex is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Clopidogrel Apotex generično zdravilo in je biološko enakovredno referenčnemu zdravilu, šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
• atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
• imajo atrijsko fibrilacijo (neredno in hitro krčenje zgornjih preddvorov srca), pri katerem se mora zdravilo dajati skupaj z aspirinom.
The Committee recommended that Clopidogrel Apotex be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Clopidogrel Apotex odobri dovoljenje za promet.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Apotex.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel Apotex, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Clopidogrel Apotex:
Druge informacije o zdravilu Clopidogrel Apotex:
Clopidogrel Apotex can be started between seven days and six months after the stroke;
Zdravilo Clopidogrel Apotex se lahko začne jemati od sedem dni po kapi in do šest mesecev po njej;
Because Clopidogrel Apotex is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Clopidogrel Apotex generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Apotex has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Apotex primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
What are the benefits and risks of Clopidogrel Apotex?
Kakšne so koristi in tveganja, povezani z zdravilom Clopidogrel Apotex?
include heart attacks and unstable angina (a severe type of chest pain).
Akutni koronarni sindrom je skupina obolenj srca, ki zajema tudi srčni napad in nestabilno angino pektoris (hudo obliko bolečine v prsih).
Clopidogrel Apotex is a medicine that contains the active substance clopidogrel.
Clopidogrel Apotex je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
Clopidogrel Apotex is a ‘generic medicine'.
Zdravilo Clopidogrel Apotex je „generično zdravilo“.
The active substance in Clopidogrel Apotex, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel Apotex, klopidogrel, je zaviralec agregacije trombocitov.
Why has Clopidogrel Apotex been approved?
Zakaj je bilo zdravilo Clopidogrel Apotex odobreno?
How has Clopidogrel Apotex been studied?
Kako je bilo zdravilo Clopidogrel Apotex raziskano?
What is Clopidogrel Apotex?
Kaj je zdravilo Clopidogrel Apotex?
What is Clopidogrel Apotex used for?
Za kaj se zdravilo Clopidogrel Apotex uporablja?
How does Clopidogrel Apotex work?
Kako zdravilo Clopidogrel Apotex deluje?
How is Clopidogrel Apotex used?
Kako se zdravilo Clopidogrel Apotex uporablja?
Invented name Strength Pharmaceutical form Route of administration Packaging
Številka EU Zaščiteno ime Jakost
The side effects that were seen, which mainly affected the gut, did not raise major concerns and were considered mild and manageable.
Opaženi neželeni učinki, ki so prizadeli predvsem črevesje, niso vzbudili večjih pomislekov in so bili ocenjeni kot blagi in obvladljivi.
What measures are being taken to ensure the safe and effective use of Xermelo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xermelo?
These enzymes are needed for the production of serotonin.
Ti encimi so potrebni za tvorbo serotonina.
The European Medicines Agency therefore decided that Xermelo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Xermelo večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Xermelo.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xermelo.
The effects of Xermelo were seen from about 3 weeks after starting treatment.
Učinki zdravila Xermelo so bili vidni po približno 3 tednih zdravljenja.
The commonest side effect severe enough to cause treatment to be stopped is abdominal pain.
Najpogostejši neželeni učinek, ki je dovolj hud, da povzroči prekinitev zdravljenja, so bolečine v trebuhu.
Although small, this reduction was considered significant given that patients view the frequency of bowel movements as a symptom with an important impact on their quality of life.
Zmanjšanje je bilo sicer majhno, vendar ocenjeno kot pomembno, saj se bolnikom pogostnost odvajanja blata zdi simptom, ki pomembno vpliva na kakovost njihovega življenja.
Other information about Xermelo
Druge informacije o zdravilu Xermelo
The summary of the opinion of the Committee for Orphan Medicinal Products for Xermelo 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 Xermelo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The most common side effects with Xermelo (which may affect more than 1 in 10 people) are abdominal (belly) pain, increases in the liver enzyme gamma-glutamyl transferase, and tiredness, and are usually mild or moderate.
Najpogostejši neželeni učinki zdravila Xermelo (ki se lahko pojavijo pri več kot 1 bolniku od 10) so bolečine v trebuhu, zvišanje jetrnega encima gama-glutamiltransferaze in utrujenost, ki so ponavadi blagi do zmerni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xermelo have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xermelo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Xermelo was compared with placebo (a dummy treatment) and the main measure of effectiveness was the change in average number of daily bowel movements over the 12 weeks of the study.
Zdravilo Xermelo so primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bila sprememba povprečnega števila odvajanj blata na dan v 12 tednih študije.
Carcinoid syndrome occurs when certain tumours produce and release too much of a substance called serotonin into the blood.
Do karcinoidnega sindroma pride, kadar določeni tumorji proizvajajo in v kri sproščajo preveč snovi, imenovane serotonin.
The excess serotonin can cause severe diarrhoea as well as other symptoms such as flushing of the face and cramps.
Odvečni serotonin lahko povzroča hudo drisko in druge simptome, kot so vročinski oblivi obraza in krči.
Because the number of patients with carcinoid syndrome is low, the disease is considered ‘rare', and Xermelo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Ker je bolnikov s karcinoidnim sindromom malo, velja ta bolezen za redko, zato je bilo zdravilo Xermelo 8. oktobra 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What benefits of Xermelo have been shown in studies?
Kakšne koristi je zdravilo Xermelo izkazalo v študijah?
For more information about treatment with Xermelo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xermelo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
At the start, patients given Xermelo had an average of 6.1 bowel movements per day, and this went down over the 12 weeks to an average of 4.7 per day, a reduction of 1.4 movements.
Na začetku so bolniki, ki so prejemali zdravilo Xermelo, odvajali blato povprečno 6,1-krat na dan, v 12 tednih pa se je to zmanjšalo na 4,7-krat na dan, kar je zmanjšanje za 1,4 odvajanja.
What is Xermelo and what is it used for?
Kaj je zdravilo Xermelo in za kaj se uporablja?
What are the risks associated with Xermelo?
Kakšna tveganja so povezana z zdravilom Xermelo?
The benefits of adding Xermelo to treatment have been shown in one main study involving 135 patients with carcinoid syndrome whose diarrhoea had not been fully controlled with somatostatin analogues alone.
Koristi dodajanja zdravila Xermelo obstoječemu zdravljenju so dokazali v eni glavni študiji, ki je vključevala 135 bolnikov s karcinoidnim sindromom, pri katerih driska ni bila popolnoma nadzorovana samo z analogi somatostatina.
Why is Xermelo approved?
Zakaj je bilo zdravilo Xermelo odobreno?
For practical information about using Xermelo, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Xermelo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The full EPAR for Xermelo 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 Xermelo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Xermelo is used together with other medicines, called somatostatin analogues, when those medicines are not sufficient on their own to control the diarrhoea.
Zdravilo Xermelo se uporablja skupaj z drugimi zdravili, imenovanimi analogi somatostatina, kadar ta zdravila sama ne zadoščajo za obvladovanje driske.
It is not intended to provide practical advice on how to use Xermelo.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
By blocking the enzymes, telotristat reduces the production of serotonin in patients with carcinoid syndrome, and so relieves the symptoms of the condition.
Telotristat z zaviranjem encimov zmanjša nastajanje serotonina pri bolnikih s karcinoidnim sindromom in tako lajša simptome tega stanja.
For the full list of all side effects and restrictions with Xermelo, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Xermelo glejte navodilo za uporabo.
The active substance in Xermelo, telotristat, blocks the action of enzymes called L-tryptophan hydroxylases.
Zdravilna učinkovina v zdravilu Xermelo, telotristat, zavira delovanje encimov, imenovanih L-triptofanhidroksilaze.
Doctors may consider stopping treatment if patients do not benefit after 12 weeks.
Če zdravilo bolniku po 12 tednih še ne koristi, lahko zdravnik razmisli o prekinitvi zdravljenja.
Patients taking placebo were having an average of 5.2 bowel movements daily at the start, which fell to an average of 4.6 movements daily, a fall of 0.6 movements.
Bolniki, ki so prejemali placebo, so na začetku blato odvajali 5,2-krat, nato pa se je število zmanjšalo na 4,6 odvajanj na dan, kar je zmanjšanje za 0,6.
Xermelo contains the active substance telotristat.
Zdravilo Xermelo vsebuje zdravilno učinkovino telotristat.
Xermelo has been shown to produce a reduction in the number of bowel movements suffered by patients with carcinoid syndrome not fully controlled with other medicines.
Dokazali so, da zdravilo Xermelo povzroči zmanjšanje števila odvajanj blata, kar je stanje, ki se pojavi pri bolnikih s karcinoidnim sindromom, ki ni popolnoma nadzorovano z drugimi zdravili.
It is available as tablets containing 250 mg of telotristat and the recommended dose is one tablet three times a day.
Na volje je v obliki tablet, ki vsebujejo 250 mg telotristata, priporočeni odmerek pa je ena tableta trikrat na dan. Odmerek zdravila je morda treba zmanjšati pri bolnikih z lažjo ali zmerno okvaro jeter.
Xermelo is a medicine used to treat adults with severe diarrhoea associated with a condition called carcinoid syndrome.
Zdravilo Xermelo se uporablja za zdravljenje hude driske, povezane s stanjem, imenovanim karcinoidni sindrom, pri odraslih.
How does Xermelo work?
Kako zdravilo Xermelo deluje?
Xermelo can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Xermelo je le na recept.
How is Xermelo used?
Kako se zdravilo Xermelo uporablja?
29 May 2019
29. maj 2019
Doctors use this scale to rate how well patients can talk, breath, eat and perform other normal activities.
Zdravniki to lestvico uporabljajo za merjenje, kako dobro lahko bolniki govorijo, dihajo, jedo in opravljajo druga običajna opravila.
However, the study involved only a small number of patients and there was not enough evidence of improvements in other important measures, such as those related to survival, breathing and muscle strength.
Vendar je bilo v študijo vključeno le manjše število bolnikov, prav tako pa ni bilo dovolj dokazov o izboljšavah v zvezi z drugimi pomembnimi ukrepi, na primer v zvezi s preživetjem, dihanjem in močjo mišic.
Radicava was expected to be used to slow down the worsening of the disease in patients who can still perform normal daily activities.
Zdravilo Radicava naj bi se uporabljajo za upočasnitev poslabšanja bolezni pri bolnikih, ki lahko še vedno opravljajo običajna vsakodnevna opravila.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was based on the Committee's provisional opinion on the study data.
Podjetje je v dopisu, s katerim je agencijo obvestilo o umiku vloge, navedlo, da umik temelji na začasnem mnenju odbora o podatkih študije.