FrancophonIA/ELRC3.0 huggingface dataset:
English: The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
Danish: In vitro har det vist sig, at dannelsen af O-desmethyl-gefitinib sker via CYP2D6.
English: A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Danish: Der blev observeret en reduktion i fertiliteten i hunrotter ved en dosis på 20 mg/kg/dag.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Phenytoin or carbamazepine (for epilepsy).
Danish: Hvis du tager nogen af disse lægemidler, skal du især huske at fortælle det til din læge eller på apoteket: - Phenytoin eller carbamazepin (mod epilepsi) - Rifampicin (mod tuberkulose) - Itraconazol (mod svampeinfektion)
English: Overall
Danish: Total
English: Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8).
Danish: Unormale værdier ved leverfunktionsundersøgelser (inklusive øget alaninaminotransferase, aspartataminotransferase, bilirubin) blev observeret og blev registreret som hepatitis med frekvensen "ikke almindelig" (se pkt.
English: At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval.
Danish: Ved steady-state er den cirkulerende plasmakoncentration fastholdt, så Cmax typisk er 2-3 gange højere end Cmin inden for doseringsintervallet på 24 timer.
English: Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Danish: Behandling med itraconazol (en potent CYP3A4-hæmmer) forud for gefitinib resulterede i en gennemsnitlig AUC-forøgelse på 80 % hos raske frivillige.
English: CYP2D6 poor metabolisers
Danish: Patienter med ringe CYP2D6-aktivitet
English: IRESSA contains sodium
Danish: IRESSA indeholder natrium
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Danish: Titandioxid (E171) Jernoxid, gul (E172) Jernoxid, rød (E172)
English: INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Danish: Der er rapporteret INR-forøgelse og/eller blødningstilfælde hos nogle patienter, som tager warfarin samtidig (se pkt.
English: Very common: side effects (may affect more than 1 in 10 people) Diarrhoea
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer
English: Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4).
Danish: Behandling med rifampicin (en potent CYP3A4-inducer) forud for gefitinib reducerede den gennemsnitlige AUC for gefitinib med 83 % hos raske frivillige (se pkt.
English: Pack size of 30 film-coated tablets.
Danish: Pakningsstørrelse: 30 filmovertrukne tabletter.
English: Asians
Danish: Asiatere
English: Therefore, concomitant administration of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum) may reduce efficacy of the treatment and should be avoided (see section 4.5).
Danish: Derfor kan samtidig administration af CYP3A4inducere (fx phenytoin, carbamazepin, rifampicin, barbiturater eller planteformuleringer indeholdende perikon/hypericum perforatum) reducere behandlingseffekten og bør derfor undgås (se pkt.
English: N Number of patients evaluable for quality of life analyses QoL Quality of life
Danish: N Antal patienter, der kan evalueres ved livskvalitetsanalyser.
English: Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Danish: Tabel 5 Data for virkning af gefitinib versus docetaxel fra INTEREST-studiet
English: If you take more IRESSA than you should If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Danish: Hvis du har taget for mange IRESSA tabletter Kontakt din læge eller apoteket straks, hvis du har taget flere tabletter end du må.
English: Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib (see section 5.2).
Danish: Nedsat leverfunktion, på grund af cirrose, er vist at medføre øgede plasmakoncentrationer af gefitinib (se pkt.
English: At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5).
Danish: Ved påbegyndelse af behandling med en CYP3A4-hæmmer skal patienterne monitoreres tæt for bivirkninger relateret til gefitinib (se pkt.
English: Substances that inhibit CYP3A4 may decrease the clearance of gefitinib.
Danish: Substanser, der hæmmer CYP3A4, kan nedsætte gefitinibs clearance.
English: Hepatic impairment
Danish: Hepatisk insufficiens
English: The recommended dose is one 250mg tablet per day.
Danish: • Den sædvanlige dosis er én tablet på 250 mg daglig.
English: The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated).
Danish: Hvis tabletten ikke kan synkes hel, kan den gives som opslæmning i vand (uden kulsyre).
English: Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2).
Danish: Antacida, som administreres tidsmæssigt tæt på gefitinib, kan have samme effekt (se pkt.
English: Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Danish: Aktive substanser, hvis plasmakoncentration kan ændres gefitinib In vitro-studier har vist, at gefitinib potentielt hæmmer CYP2D6 i et begrænset omfang.
English: Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Danish: • Dehydrering (almindelig) som følge af længerevarende diarré, opkastning, kvalme eller appetitløshed.
English: This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
Danish: Eksponeringsforøgelsen kan være klinisk relevant, da uønskede hændelser er relaterede til dosis og eksponering af gefitinib.
English: Keep this leaflet.
Danish: Se punkt.
English: Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Danish: Tabel 4 Resultatet for livskvalitet for gefitinib versus carboplatin/paclitaxel fra IPASSstudiet
English: Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1)
Danish: Konjunktivit, øjenlågsbetændelse og tørre øjne*, hovedsageligt lette (CTC-grad 1)
English: Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Danish: Substanser, der forårsager signifikant vedvarende forhøjet gastrisk pH kan reducere gefitinibs plasmakoncentration og derved reducere effekten af gefitinib.
English: EGFR mutationunknown
Danish: EGFR-mutation ukendt
English: Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Danish: Aktive substanser der kan reducere gefitinibs plasmakoncentration Substanser, der inducerer CYP3A4-aktivitet, kan forøge metaboliseringen og nedsætte gefitinibs plasmakoncentration og derved reducere gefitinibs effekt.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
English: Inflammation of the liver.
Danish: • Betændelse (inflammation) i hudens blodkar.
English: In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Danish: I situationer med samtidig behandling med en potent CYP3A4-hæmmer skal patienten monitoreres tæt for bivirkninger forårsaget af gefitinib.
English: Table 1 Adverse reactions
Danish: Tabel 1 Bivirkninger
English: Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened.
Danish: Hos 652 ud af 1.060 screenede patienter var både ctDNA- og tumorprøverne vurderbare.
English: IRESSA contains lactose.
Danish: IRESSA indeholder lactose.
English: IRESSA contains lactose
Danish: IRESSA indeholder lactose
English: Gastrointestinal perforation
Danish: • Gastrointestinel perforation.
English: Pretreated patients
Danish: Tidligere behandlede patienter
English: Corneal erosion, reversible and sometimes in association with aberrant eyelash growth Keratitis (0.12%)
Danish: Hornhindeerosion, reversibel og til tider i forbindelse med abnorm øjenvippevækst
English: This may give the appearance of bruising or patches of non-blanching rash on the skin.
Danish: Det kan fremtræde som blå mærker eller plettet hududslæt, der ikke forsvinder ved fingertryk.
English: Loss of appetite
Danish: • Appetitmangel
English: EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Danish: Status for EGFR-mutation og kliniske karakteristika I en multivariat analyse med 786 kaukasiske patienter fra gefitinib-studierne* (se tabel 7) har kliniske karakteristika i form af aldrig at have røget, at have en adenocarcinom histologitype og at være kvinde vist sig at være uafhængige indikatorer for positiv EGFR-mutation.
English: Elevations in total bilirubin, mainly mild to moderate
Danish: Forøgelse af aspartataminotransferase, hovedsagligt let til moderat Forøgelse af total bilirubin, hovedsagligt let til moderat
English: IRESSA 250 mg tablets gefitinib
Danish: IRESSA 250 mg tabletter gefitinib
English: A 2-year carcinogenicity study in rats resulted in a small but statistically significant increased incidence of hepatocellular adenomas in both male and female rats and mesenteric lymph node haemangiosarcomas in female rats at the highest dose (10 mg/kg/day) only.
Danish: Et 2-årigt carcinogenicitetsstudie i rotter resulterede i en lille, men signifikant øget forekomst af hepatocellulære adenomer i både han- og hunrotter.
English: IRESSA 250 mg film-coated tablets gefitinib
Danish: IRESSA 250 mg filmovertrukne tabletter gefitinib
English: Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration
Danish: - corneaepitel atrofi og translucens af cornea - nyrepapilnekrose - hepatocellulær nekrose og eosinofil sinusoidal makrofag infiltration
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Danish: Tabel 6 Data for virkning af gefitinib versus placebo fra ISEL-studiet
English: Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Danish: Tabel 3 Virkningen af gefitinib versus carboplatin/paclitaxel fra IPASS-studiet
English: Haemorrhagic cystitis
Danish: Hæmoragisk cystitis
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate)
Danish: • Forhøjet niveau af bilirubin og det andet leverenzym, som kaldes aspartat-aminotransferase, i en blodprøve; hvis antallet er for højt, vil din læge muligvis fortælle dig, at du skal stoppe med at tage IRESSA.
English: Anorexia mild or moderate (CTC grade 1 or 2)
Danish: Opkastning, hovedsageligt let eller moderat (CTC grad 1 eller 2)
English: In a phase III open-label clinical trial (IPASS) in 1217 patients comparing IRESSA to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the IRESSA treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
Danish: I et åbent, klinisk fase III-forsøg (IPASS) med 1.217 patienter, blev IRESSA sammenlignet med kemoterapi med to lægemidler, carboplatin og paclitaxel, som førstelinjebehandling hos udvalgte patienter med avanceret NSCLC i Asien.
English: Weakness
Danish: • Svaghed
English: Primary endpoint overall survival ab
Danish: Primært endepunkt total overlevelse ab
English: For patients unable to tolerate treatment after a therapy interruption, gefitinib should be discontinued and an alternative treatment should be considered.
Danish: Gefitinib-behandlingen skal ophøre, og en alternativ behandling bør overvejes til de patienter, der ikke tåler behandlingen efter det korte behandlingsophør.
English: PC: {number} SN: {number} NN: {number}
Danish: PC: SN: NN:
English: Ever smoker
Danish: Har røget på et eller andet tidspunkt
English: Numbers in square brackets are 95% confidence intervals for HR c Stratified log-rank test for overall; otherwise cox proportional hazards model d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth
Danish: Tal i de kvadratiske parenteser er 95 % konfidensinterval (CI) for HR. c Stratificeret log-rank test for samlede resultater ellers er Cox Proportional Hazard Model anvendt.
English: HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m
Danish: HR 0,82 [0,70 til 0,96] 18,9 m vs. 17,2 m a Værdier for IRESSA versus carboplatin/paclitaxel.
English: Common: side effects (may affect up to 1 in 10 people) Dry mouth
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 personer)
English: What IRESSA is and what it is used for What you need to know before you take IRESSA How to take IRESSA
Danish: Det skal du vide, før du begynder at tage IRESSA Sådan skal du tage IRESSA Bivirkninger
English: If it is less than 12 hours until your next dose: skip the missed tablet.
Danish: • Hvis der er mindre end 12 timer til din næste dosis: Spring den glemte tablet over, og tag den næste tablet på samme tid, som du plejer.
English: Uncommon: side effects (may affect up to 1 in 100 people) Inflammation of the pancreas.
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 personer
English: 23.7 v. 13.3 Never-smoker
Danish: 23.7 v. 13.3 Har aldrig røget 3.9 v. 6.5 Har røget på et eller andet tidspunkt
English: IRESSA 250 mg film-coated tablets
Danish: IRESSA 250 mg, filmovertrukne tabletter
English: Primary endpoint Progression free survival (PFS)
Danish: Primært endepunkt Progressionsfri overlevelse ab
English: During treatment with gefitinib, asthenia has been reported.
Danish: Asteni er rapporteret under behandling med gefitinib.
English: Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Danish: - Barbiturater (en type af medicin, der bruges mod søvnproblemer) - Naturlægemidler, som indeholder perikon (Hypericum Perforatum, mod depression og angst) - Protonpumpe-hæmmere, H2-antagonister og antacida (mod mavesår, sure opstød, halsbrand og til at mindske syre i maven)
English: EGFR mutation-positive
Danish: EGFR-mutation positiv
English: CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
Danish: Substanser, der inducerer CYP3A4-aktiviteten, kan forårsage en øget metabolisering af gefitinib og dermed reducere gefitinibs plasmakoncentration.
English: Nausea
Danish: • Kvalme
English: EGFR mutation-negative
Danish: EGFR-mutation negativ
English: When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day.
Danish: Der sås en reduktion i overlevelsen hos unger af drægtige og fødende rotter ved administration af en dosis på 20 mg/kg/dag.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ALUMINIUM FOIL LAMINATE FLOW WRAP
Danish: BLISTER/ALUMINIUMFOLIE-LAMINATINDPAKNING
English: Red and sore eyelids
Danish: • Røde og ømme øjenlåg
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Danish: Hos nogle patienter, som tager warfarin sammen med gefitinib, er der rapporteret forøget International Normaliseret Ratio (INR) og/eller blødningstilfælde (se pkt.
English: Vomiting
Danish: Neglelidelser
English: Odds of EGFR mutation
Danish: Sandsynlighed for EGFR-mutation
English: Hepatotoxicity and liver impairment
Danish: Blødning, så som epistaxis og hæmaturi
English: 6.1List of excipients
Danish: 6.1 Hjælpestoffer
English: Asthenia, predominantly mild (CTC grade 1)
Danish: Kvalme, hovedsageligt let (CTC grad 1) Stomatit, overvejende let (CTC grad 1)
English: Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1)
Danish: Meget almindelig Diarré, hovedsageligt let eller moderat (CTC grad 1 eller 2)
English: In this study IRESSA exposure did not increase with increasing dose, adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of IRESSA.
Danish: I et forsøg blev et begrænset antal patienter behandlet ugentligt med doser fra 1.500 mg til 3.500 mg. I dette forsøg øgedes IRESSAeksponeringen ikke med større doser, og bivirkningerne var for det meste lette til moderate i sværhedsgrad og i overensstemmelse med IRESSAs sikkerhedsprofil.
English: Stomatitis, predominantly mild in nature (CTC grade 1)
Danish: Meget almindelig Asteni, hovedsageligt let (CTC grad 1) Almindelig
English: 261 71.2% vs 47.3%
Danish: 261 71,2 % vs. 47,3 % [12,0 % vs. 34,9 %]
English: Adverse reactions by system organ class and frequency Metabolism and nutrition disorders
Danish: Bivirkninger efter systemorganklasse og frekvens Metabolisme og ernæring Meget almindelig Anoreksi, let eller moderat (CTC-grad 1 eller 2) Øjne
English: The proportion of ILD-type events with a fatal outcome was
Danish: Andelen af ILSbivirkninger med fatalt udfald var 38,6 %.
English: Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Danish: • Hæmoragisk blærebetændelse (blærebetændelse med blod i urinen).
English: Rare: side effects (may affect up to 1 in 1000 people) Inflammation of the blood vessels in the skin.
Danish: Sjælden: kan forekomme hos op til 1 ud af 1.000 personer
English: Vascular disorders
Danish: Kutan vaskulitis
English: 4m p=0.1087
Danish: 18,8 m vs. 17,4 m p=0,1087
English: Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia
Danish: Dehydrering, som følge af diarré, kvalme, opkastning eller anoreksi Tør mund*, hovedsageligt let (CTC grad 1)
English: In a trial in healthy volunteers where gastric pH was maintained above pH 5, gefitinib exposure was reduced by 47%, likely due to impaired solubility of gefitinib in the stomach (see sections 4.4 and 4.5).
Danish: Gefitinibs eksponering reduceredes med 47 % i et studie med raske frivillige forsøgspersoner, hvor gastrisk pH var fastholdt over 5.
English: Oral suspension
Danish: Oral suspension Oral anvendelse
English: 1 bottle +1 adaptor + 3 oral syringes
Danish: 1 flaske + 1 flaskeadapter + 3 orale sprøjter
English: Bottle (glass)
Danish: Flaske (glas)
English: EU/1/04/303/005 Orfadin 4 mg/ml
Danish: Orfadin 4 mg/ml
English: MA (EU) number Invented name
Danish: MF (EU)-nummer
English: London, 23 July 2009 Doc.
Danish: London, den 23. juli 2009 Dok.
English: Ref. EMEA/448660/2009 EMEA/H/C/1041
Danish: ref. EMA/123942/2010 EMEA/H/C/1041
English: The main measure of effectiveness was how long the patients lived.
Danish: Det primære mål for virkningen var, hvor længe patienterne overlevede.
English: In 2008, the CHMP had formulated a list of questions to be answered by the company.
Danish: I 2008 havde CHMP udarbejdet en liste over spørgsmål, som virksomheden skulle besvare.
English: Also, the company had not supplied enough evidence to demonstrate that the product was safe, that it could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Danish: Virksomheden havde heller ikke fremlagt tilstrækkelig dokumentation for, at lægemidlet var sikkert, at det kunne fremstilles på en pålidelig måde, eller at det ikke ville være skadeligt for miljøet eller for personer i tæt kontakt med patienten.
English: It was to be used when the cancer was refractory (does not respond to treatment) or recurrent (keeps coming back).
Danish: Det skulle anvendes, når kræften var refraktær (ikke responderer på behandling) eller recidiverende (bliver ved med at komme tilbage).
English: The company had to submit their responses to the Committee for Advanced Therapies (CAT) in line with new European Union regulations on advanced therapies.
Danish: Virksomheden skulle indsende sit svar til Udvalget for Avancerede Terapier (CAT) i overensstemmelse med de nye EUbestemmelser om avancerede terapier.
English: This is a type of medicine that works by delivering genes into the body.
Danish: Det er en lægemiddeltype, der virker ved at afgive gener til kroppen.
English: The new genes then make the body produce or stop the production of a protein which may help treat a disease.
Danish: De nye gener får så kroppen til at producere eller holde op med at producere et protein, der kan være med til at behandle en sygdom.
English: Finally, the CHMP noted that there was insufficient information on the product's toxicity, its distribution in the body and the role of some genes and impurities found in the product.
Danish: Endelig bemærkede CHMP, at der var utilstrækkelige information om lægemidlets toksicitet, dets fordeling i kroppen og den rolle, som visse gener og urenheder, der er fundet i lægemidlet, spiller.
English: The application was at day 120 of the procedure when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 120, da virksomheden trak sin ansøgning tilbage.
English: Questions and answers on the withdrawal of the marketing authorisation application for Contusugene Ladenovec Gendux contusugene ladenovec
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Contusugene Ladenovec Gendux contusugen ladenovec
English: The effects of Contusugene Ladenovec Gendux were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Contusugene Ladenovec Gendux blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Contusugene Ladenovec Gendux was expected to be used to treat squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Danish: Contusugene Ladenovec Gendux forventedes anvendt til behandling af pladecellekræft i hoved og hals (en kræfttype, der opstår i cellerne i mund, næse, hals eller øre).
English: Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
Danish: Eftersom kræftceller indeholder beskadiget DNA, bidrager p53-proteinet enten til at reparere DNA eller får cellerne til at dø.
English: The p53 protein also reduces the formation of blood vessels supplying the cancer cells.
Danish: P53-proteinet mindsker også dannelsen af blodkar, som forsyner kræftcellerne med blod.
English: In one main study involving 123 patients with refractory or recurrent squamous cell carcinoma of the head and neck, Contusugene Ladenovec Gendux was compared with methotrexate (another anti-cancer medicine).
Danish: I en hovedundersøgelse, der omfattede 123 patienter med recidiverende eller refraktært pladecellekræft i hoved og hals, blev Contusugene Ladenovec Gendux sammenlignet med methotrexat (et andet lægemiddel mod kræft).
English: But, the company withdrew its application before responding to the questions.
Danish: Virksomheden trak dog sin ansøgning tilbage inden.