FrancophonIA/ELRC3.0 huggingface dataset:
English: This veterinary medicinal product does not require any special storage condition.
Slovenian: Za shranjevanje ni posebnih navodil.
English: cabergoline
Slovenian: Kabergolin
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label of 5 ml vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection for cattle (dairy cows).
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Velactis 1,12 mg/ml raztopina za injiciranje za govedo (krave molznice).
English: PACKAGE LEAFLET FOR Velactis 1.12 mg/ml solution for injection for cattle.
Slovenian: NAVODILO ZA UPORABO Velactis 1,12 mg/ml raztopina za injiciranje za govedo
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection for cattle
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Velactis 1,12 mg/ml raztopina za injiciranje za govedo
English: Therefore, the product should only be administered to dairy cows at the time of drying-off.
Slovenian: Zato zdravilo dajajte le kravam molznicam v času presušitve.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection cabergoline
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Velactis 1,12 mg/ml raztopina za injiciranje kabergolin
English: Label of 25 ml vial
Slovenian: Nalepka na 5 ml viali Nalepka na 25 ml viali Nalepka na 50 ml viali
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emend on 11 November 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Emend, veljavno po vsej Evropski uniji, izdala dne 11. novembra 2003.
English: What measures are being taken to ensure the safe and effective use of Emend?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Emend?
English: The full EPAR for Emend can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Emend je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It stops a chemical in the body (substance P) from binding to the NK1 receptors.
Slovenian: Preprečuje, da bi se kemična snov v telesu (substanca P) vezala na receptorje za NK1.
English: • terfenadine, astemizole (commonly used to treat allergy symptoms - these medicines may be available without a prescription);
Slovenian: • terfenadinom, astemizolom (navadno se uporabljata za zdravljenje simptomov alergije - ti zdravili sta na voljo brez recepta);
English: When substance P attaches to these receptors, it causes nausea and vomiting.
Slovenian: Če se substanca P veže na te receptorje, to povzroči slabost in bruhanje.
English: • pimozide (used to treat mental illness);
Slovenian: • pimozidom (uporablja se za zdravljenje duševnih bolezni);
English: Other information about Emend
Slovenian: Druge informacije o zdravilu Emend
English: Emend is a neurokinin 1 (NK1) receptor antagonist.
Slovenian: Emend je antagonist nevrokinin-1 receptorjev (NK1).
English: This is a summary of the European public assessment report (EPAR) for Emend.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Emend.
English: A risk management plan has been developed to ensure that Emend is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Emend je bil pripravljen načrt obvladovanja tveganj.
English: In the chemotherapy studies in adults, adding Emend to the standard combination was more effective than the standard combination alone.
Slovenian: V študijah kemoterapije pri odraslih je bilo dodajanje zdravila Emend standardni kombinaciji učinkovitejše od same standardne kombinacije.
English: For more information about treatment with Emend, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Emend preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effect of Emend at all doses in adults (seen in between 1 and 10 patients in 100) is increased liver enzymes.
Slovenian: Najpogostejši neželeni učinek zdravila Emend pri odraslih v vseh odmerkih (opažen pri 1 do 10 bolnikih od 100) je povečana raven jetrnih encimov.
English: What benefit has Emend shown during the studies?
Slovenian: Kakšne koristi je zdravilo Emend izkazalo med študijami?
English: What is the risk associated with Emend?
Slovenian: Kakšna tveganja so povezana z zdravilom Emend?
English: The dose of Emend oral suspension to be given depends on the patient's bodyweight.
Slovenian: Odmerek peroralne suspenzije zdravila Emend, ki ga je treba dati, je odvisen od bolnikove telesne mase.
English: Emend 80 mg and 125 mg must not be taken with the following medicines:
Slovenian: Zdravilo Emend v odmerku 80 mg in 125 mg se ne sme jemati sočasno z naslednjimi zdravili:
English: • cisapride (used to relieve certain stomach problems).
Slovenian: • cisapridom (zdravilom za ublažitev nekaterih težav z želodcem).
English: The first two studies involved a total of 1,094 adults receiving chemotherapy including cisplatin, and the third involved 866 adults with breast cancer who were receiving cyclophosphamide, with or without doxorubicin or epirubicin.
Slovenian: Prvi dve študiji sta vključevali skupaj 1 094 odraslih, ki so se zdravili s kemoterapijo, vključno s cisplatinom, tretja študija pa je vključevala 866 odraslih z rakom dojke, ki so prejemali ciklofosfamid, z doksorubicinom ali epirubicinom ali brez njiju.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Emend, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Emend in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: 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 Emend.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Emend, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: In PONV, two studies were carried out in a total of 1,727 adult patients, most of whom were women undergoing gynaecological operations.
Slovenian: V zvezi s postoperativno slabostjo sta bili izvedeni dve študiji pri skupno 1 727 odraslih bolnikih, med katerimi so bile večinoma ženske, ki so imele ginekološko operacijo.
English: Emend was also shown to be effective in the first 24 hours after chemotherapy.
Slovenian: Zdravilo Emend se je izkazalo za učinkovito tudi v prvih 24 urah po kemoterapiji.
English: Emend is a medicine containing the active substance aprepitant.
Slovenian: Emend je zdravilo, ki vsebuje zdravilno učinkovino aprepitant.
English: It is used with chemotherapy that is a moderate or high trigger of nausea and vomiting such as cisplatin, cyclophosphamide, doxorubicin or epirubicin.
Slovenian: Uporablja se skupaj s kemoterapevtiki, ki so zmerni ali močni povzročitelji slabosti in bruhanja, kot so cisplatin, ciklofosfamid, doksorubicin ali epirubicin.
English: The effectiveness of Emend was also seen during a further five cycles of chemotherapy.
Slovenian: Učinkovitost zdravila Emend se je pokazala tudi v nadaljnjih petih ciklih kemoterapije.
English: The CHMP decided that Emend's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Emend večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The main measure of effectiveness was based on how many patients had a ‘complete response', which was defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy (delayed phase).The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy (acute phase).
Slovenian: Glavno merilo učinkovitosti je temeljilo na številu bolnikov s popolnim odzivom, kar pomeni, da niso bruhali, jih ni sililo na bruhanje oziroma se jim ni spahovalo in niso potrebovali drugega zdravila za obvladanje slabosti in bruhanja v 25 do 120 urah po začetku kemoterapije (zapoznela faza).V študiji so ugotavljali tudi, koliko bolnikov je doseglo popoln odziv v prvih 24 urah po kemoterapiji (akutna faza).
English: It is only given on the first day of the chemotherapy and is followed by treatment involving a corticosteroid and a 5HT3 antagonist.
Slovenian: Daje se samo prvi dan kemoterapije, čemur sledi zdravljenje, ki vsebuje kortikosteroide in antagoniste 5-HT3.
English: In children between 6 months and 12 years of age, Emend oral suspension is given together with a 5HT3 antagonist.
Slovenian: Pri otrocih, starih od 6 mesecev do 12 let, se peroralna suspenzija zdravila Emend daje skupaj z antagonistom 5-HT3.
English: Emend oral suspension is given one hour before the start of chemotherapy, and for the next 2 days.
Slovenian: Peroralna suspenzija zdravila Emend se daje eno uro pred začetkom kemoterapije in naslednja dva dni.
English: In chemotherapy, three main studies have been carried out for Emend 80 and 125 mg capsules.
Slovenian: Pri kemoterapiji so bile izvedene tri glavne študije zdravila Emend v obliki 80- in 125-miligramskih kapsul.
English: In children, the most common side effects are hiccups and flushing.
Slovenian: Pri otrocih so najpogostejši neželeni učinki kolcanje in vročinski oblivi.
English: The main measure of effectiveness was the number of patients who had no nausea and vomiting in the five days after receiving chemotherapy.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se v petih dneh po kemoterapiji nista pojavili slabost in bruhanje.
English: After chemotherapy, one 80 mg capsule is taken each day for the next two days.
Slovenian: Po kemoterapiji je treba naslednja dva dni vzeti po eno 80-miligramsko kapsulo.
English: It must be given with other medicines that also prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5-HT3 antagonist' (such as ondansetron).
Slovenian: Zdravilo je treba jemati z drugimi zdravili za preprečevanje slabosti in bruhanja, vključno s kortikosteroidi (kot je deksametazon) in antagonisti ‘5HT3 (kot je ondansetron).
English: The studies measured how many patients had a complete response, which was defined as no vomiting and no need for any other medication to control nausea and vomiting in the 24 hours after the operation.
Slovenian: študijah so beležili, pri koliko bolnikih je prišlo do popolnega odziva, kar pomeni, da niso bruhali oziroma niso potrebovali nobenih zdravil za obvladanje slabosti in bruhanja v 24 urah po operaciji.
English: All three studies compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron.
Slovenian: V vseh treh študijah so učinkovitost zdravila Emend, jemanega v kombinaciji z deksametazonom in ondansetronom, primerjali z učinkovitostjo standardne kombinacije deksametazona in ondansetrona.
English: Emend is used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer).
Slovenian: Zdravilo Emend se uporablja skupaj z drugimi zdravili za preprečevanje slabosti in bruhanja, ki sta posledica kemoterapije (zdravil za zdravljenje raka).
English: By blocking the receptors, Emend can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.
Slovenian: Zdravilo Emend lahko z blokiranjem receptorjev prepreči slabost in bruhanje, do česar pogosto pride po kemoterapiji ali zaradi zapletov pri operacijah.
English: Why has Emend been approved?
Slovenian: Zakaj je bilo zdravilo Emend odobreno?
English: It is available as capsules (40, 80, 125 and 165 mg) and as a powder to be made up into an oral (by mouth) suspension (125 mg).
Slovenian: Na voljo je v obliki kapsul (40, 80, 125 in 165 mg) in praška za pripravo peroralne suspenzije (125 mg).
English: A fourth study has been carried out with Emend (125 mg capsules or 125 mg oral solution) in 307 children from 6 months to 17 years of age, where Emend, taken with ondansetron (with or without dexamethasone), was compared with ondansetron alone (with or without dexamethasone).
Slovenian: Četrto študijo z zdravilom Emend (125 mg v obliki kapsul ali 125 mg v obliki peroralne raztopine) so izvedli pri 307 otrocih, starih od 6 mesecev do 17 let, kjer so zdravilo Emend, ki so ga bolniki prejemali skupaj z ondansetronom (z deksametazonom ali brez njega), primerjali s samim ondansetronom (z deksametazonom ali brez njega).
English: Emend makes chemotherapy more tolerable for the patient.
Slovenian: Z uporabo zdravila Emend je kemoterapija za bolnike znosnejša.
English: Emend 165 mg capsules were shown to be bioequivalent to Ivemend 150 mg, which means that like Ivemend it can also be used to prevent nausea and vomiting caused by chemotherapy.
Slovenian: Zdravilo Emend v 165-miligramskh kapsulah je bilo dokazano biološko enakovredno zdravilu Ivemend 150 mg, kar pomeni, da se lahko tako kot zdravilo Ivemend uporablja za preprečevanje slabosti in bruhanja, ki sta posledica kemoterapije.
English: Emend 80, 125 and 165 mg capsules are used in adults; children from 12 years of age may be given the 80- or 125-mg capsules and children between 6 months and 12 years of age are given the oral suspension.
Slovenian: Zdravilo Emend v 80-, 125- in 165-miligramskih kapsulah se uporablja pri odraslih, otroci, starejši od 12 let, lahko prejemajo 80- ali 125-miligramske kapsule, otroci, stari od 6 mesecev do 12 let, pa prejemajo peroralno suspenzijo.
English: Emend is an antiemetic, a medicine that prevents nausea (feeling sick) and vomiting.
Slovenian: Zdravilo Emend je antiemetik, tj. zdravilo, ki preprečuje navzejo (slabost) in bruhanje.
English: In chemotherapy, the usual dose of Emend in adults and children from 12 years of age is one 125 mg capsule by mouth one hour before the start of chemotherapy.
Slovenian: Pri kemoterapiji je običajni odmerek zdravila Emend pri odraslih in otrocih, starejših od 12 let, ena 125-miligramska kapsula peroralno eno uro pred začetkom kemoterapije.
English: At a dose of 80, 125 and 165 mg, the other side effects seen in between 1 and 10 patients in 100 are headache, hiccups, constipation, dyspepsia (indigestion), loss of appetite, and fatigue (tiredness).
Slovenian: Drugi neželeni učinki pri odmerkih 80, 125 in 165 mg, opaženi pri 1 do 10 bolnikih od 100, so glavobol, kolcanje, zaprtje, dispepsija (prebavne motnje), izguba teka in utrujenost.
English: Two doses of Emend (40 and 125 mg as capsules) were compared with ondansetron given as an injection.
Slovenian: V študijah so dva odmerka zdravila Emend (40 in 125 mg v obliki kapsul) primerjali z ondansetronom, danim v obliki injekcije.
English: In PONV, the usual dose is one 40 mg capsule given to adults within the three hours before the patient is anaesthetised (‘put to sleep').
Slovenian: Pri postoperativni slabosti in bruhanju je običajni odmerek za odrasle 40-miligramska kapsula, ki jo bolnik prejme tri ure pred anestezijo („preden ga uspavajo“).
English: Tests were performed to determine that Emend 165 mg produces the same amount of aprepitant in the body as a single dose of 150 mg Ivemend.
Slovenian: Opravljeni preskusi so pokazali, da se s 165-miligramskim odmerkom zdravila Emend v telesu proizvede enaka količina aprepitanta kot ob prejemu enkratnega 150-miligramskega odmerka zdravila Ivemend.
English: For the full list of all side effects reported with Emend, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Emend, glejte navodilo za uporabo.
English: Looking at the results of both studies together, 55% of the patients (298 out of 541) taking Emend capsules at a dose of 40 mg had a complete response, compared with 49% of the patients who received ondansetron (258 out of 526).
Slovenian: Skupna analiza rezultatov obeh študij je pokazala, da je do popolnega odziva prišlo pri 55 % (298 od 541) bolnikov, ki so prejeli kapsule zdravila Emend v odmerku 40 mg, v primerjavi z 49 % (258 od 526) bolnikov, ki so prejeli ondansetron.
English: In the study in children, around 51% (77 out of 152) of children given Emend with ondansetron had a complete response 25 to 120 hours after beginning chemotherapy, compared with 26% (39 out of 150) of children given ondansetron alone.
Slovenian: V študiji pri otrocih je popoln odziv v 25 do 120 urah po začetku kemoterapije doseglo približno 51 % (77 od 152) otrok, ki so prejeli zdravilo Emend z ondansetronom, v primerjavi s 26 % (39 od 150) otrok, ki so prejeli samo ondansetron.
English: Emend 165 mg is given to adults only once, one hour before the start of chemotherapy.
Slovenian: 165-miligramska kapsula zdravila Emend je namenjena samo odraslim za uporabo eno uro pred začetkom kemoterapije.
English: In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
Slovenian: V študiji kemoterapije, ki je zmerna povzročiteljica slabosti in bruhanja, se ta neželena učinka nista pojavila pri 51 % (pri 220 od 433) bolnikov, ki so jemali zdravilo Emend, v primerjavi s 43 % (180 od 424) bolnikov, ki zdravila Emend niso jemali.
English: For the full list of restrictions with Emend, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Emend glejte navodilo za uporabo.
English: Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523).
Slovenian: Skupna analiza rezultatov obeh študij cisplatina je pokazala, da se slabost in bruhanje v petih dneh nista pojavila pri 68 % (352 od 520) bolnikov, ki so jemali zdravilo Emend, v primerjavi z 48 % (250 od 523) bolnikov, ki zdravila Emend niso jemali.
English: Emend 40 mg capsules are used to prevent postoperative nausea and vomiting (PONV) in adults.
Slovenian: 40-miligramske kapsule zdravila Emend se pri odraslih uporabljajo za preprečevanje postoperativne slabosti in bruhanja, ki ju bolnik lahko doživi po prestani operaciji.
English: How is Emend used?
Slovenian: Kako se zdravilo Emend uporablja?
English: What is Emend used for?
Slovenian: Za kaj se zdravilo Emend uporablja?
English: How has Emend been studied?
Slovenian: Kako je bilo zdravilo Emend raziskano?
English: How does Emend work?
Slovenian: Kako zdravilo Emend deluje?
English: In PONV, Emend was as effective as ondansetron.
Slovenian: V študiji postoperativne slabosti in bruhanja je bilo zdravilo Emend enako učinkovito kot ondansetron.
English: What is Emend?
Slovenian: Kaj je zdravilo Emend?
English: Emend 165 mg capsules were compared with the authorised intravenous medicine Ivemend 150 mg. Ivemend contains a substance called fosaprepitant which is converted in the body into aprepitant.
Slovenian: Zdravilo Ivemend vsebuje snov, imenovano fosaprepitant, ki se v telesu pretvori v aprepitant.
English: EU/1/17/1232/001 Miglustat Gen.Orph
Slovenian: EU/1/17/1232/001 Miglustat Gen.Orph 100 mg kapsula, trda peroralna uporaba pretisni omot (OPA/alu/PVC)
English: 100 mg Capsule, hard
Slovenian: 84 kapsul
English: The main measure of effectiveness was based on the proportion of patients who responded to treatment.
Slovenian: Glavno merilo učinkovitosti je temeljilo na deležu bolnikov, ki so se na zdravljenje odzvali.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Folotyn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Folotyn je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The CHMP therefore confirmed its initial negative opinion.
Slovenian: Zato je potrdil svoje prvotno negativno mnenje.
English: Moreover, there was no clear improvement seen in the condition of the patients, as the study looked at the patients' response to treatment but did not further allow the Committee to assess the effect on overall survival (how long the patients lived) or progression free survival (how long the patients lived without their disease getting worse).
Slovenian: Poleg tega ni bilo opaziti jasnih znakov izboljšanja stanja bolnikov, saj je študija opazovala odziv bolnikov na zdravljenje, vendar Odboru ni omogočala oceniti učinka na skupno preživetje (kako dolgo so bolniki živeli) ali preživetje brez napredovanja bolezni (kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala).
English: The effects of Folotyn were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Folotyn so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Pralatrexate is an ‘antimetabolite' medicine.
Slovenian: Pralatreksat je „antimetabolično“ zdravilo.
English: In this study, Folotyn was not compared with any other treatment.
Slovenian: V tej študiji zdravila Folotyn niso primerjali z nobeno drugo obliko zdravljenja.
English: Response to treatment ranged from having improvements in the disease to having no sign of cancer.
Slovenian: Razpon odziva na zdravljenje je bil od izboljšanja bolezni do izostanka znakov raka.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 April 2012.
Slovenian: Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 19. aprila 2012 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
English: During the re-examination in April 2012, the CHMP's concerns were not resolved.
Slovenian: Ponovni pregled aprila 2012 ni odpravil pomislekov Odbora.
English: Refusal of the marketing authorisation for Folotyn (pralatrexate)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Folotyn (pralatreksat)
English: The company presented the results of one main study involving a total of 115 adults with peripheral Tcell lymphoma which kept coming back or did not respond to previous treatments.
Slovenian: Družba je predstavila rezultate ene glavne študije, v katero je bilo vključenih skupaj 115 odraslih bolnikov s perifernim T-celičnim limfomom, ki se je ponavljal ali se ni odzival na prejšnja zdravljenja.
English: In January 2012, the CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not compared with any other treatment or placebo (a dummy treatment) in another group of patients.
Slovenian: CHMP je bil januarja 2012 zaskrbljen, da je bila glavna študija zasnovana na način, ki Odboru ni omogočal oceniti koristi zdravila, zlasti zato, ker zdravila Folotyn niso primerjali z nobeno drugo obliko zdravljenja ali s placebom (zdravilom brez zdravilne učinkovine) v drugi skupini bolnikov.
English: Refusal of the marketing authorisation for Folotyn (pralatrexate) EMA/CHMP/255106/2012
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Folotyn (pralatreksat) EMA/CHMP/255106/2012