FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects when used to treat diabetic neuropathic pain (seen in more than 1 patient 10) are headache, somnolence (sleepiness), dizziness, nausea and dry mouth.
Estonian: Kõige sagedamad kõrvalnähud diabeetilise neuropaatilise valu ravis (esinenud enam kui ühel patsiendil kümnest) on peavalu, unisus, peapööritus, iiveldus ja suukuivus.
English: For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Estonian: Diabeetilise neuropaatilise valu ravis kasutamiseks uuriti Duloxetine Boehringer Ingelheimi kahes 12nädalases uuringus 809 diabeediga täiskasvanud patsiendil, kellel oli olnud valu iga päev vähemalt kuue kuu jooksul.
English: Duloxetine Boehringer Ingelheim must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Estonian: Duloxetine Boehringer Ingelheimi ei tohi kasutada koos monoamiini oksüdaasi inhibiitoritega (teatud antidepressandid), fluvoksamiiniga (samuti antidepressant) või tsiprofloksatsiini või enoksatsiiniga (teatud antibiootikumid).
English: The company that makes Ariclaim has agreed that its scientific data can be used for Duloxetine Boehringer Ingelheim.
Estonian: Ariclaimi tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka Duloxetine Boehringer Ingelheimi toetuseks.
English: Duloxetine Boehringer Ingelheim was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Estonian: Duloxetine Boehringer Ingelheim oli platseebost efektiivsem ainult neil rõhkinkontinentsiga patsientidel, kellel esines uuringu alguses üle 14 kusepidamatuse episoodi nädalas (mõõdukas kuni raske rõhkinkontinents).
English: The European Commission granted a marketing authorisation valid throughout the EU for Duloxetine Boehringer Ingelheim to Boehringer Ingelheim International GmbH on 8 October 2008.
Estonian: Muu teave Duloxetine Boehringer Ingelheimi kohta Euroopa Komisjon andis Duloxetine Boehringer Ingelheimi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Boehringer Ingelheim International GmbH 8. oktoobril 2008.
English: • moderate to severe stress urinary incontinence (SUI) in women.
Estonian: • mõõdukas kuni raske rõhkinkontinents naistel.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DULOXETINE BOEHRINGER INGELHEIM EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE DULOXETINE BOEHRINGER INGELHEIM Kokkuvõte üldsusele
English: The four main studies involved 1,913 women and lasted 12 weeks, comparing Duloxetine Boehringer Ingelheim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
Estonian: Neljas 12 nädalat kestnud põhiuuringus osales 1913 naist ning nendes võrreldi Duloxetine Boehringer Ingelheimi (enamasti 40 mg annus kaks korda ööpäevas) toimet platseeboga (näiva ravimiga).
English: Duloxetine Boehringer Ingelheim is a medicine that contains the active substance duloxetine.
Estonian: Duloxetine Boehringer Ingelheim on ravim, mis sisaldab toimeainena duloksetiini.
English: The active substance in Duloxetine Boehringer Ingelheim, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Estonian: Duloxetine Boehringer Ingelheimi toimeaine duloksetiin on serotoniini ja noradrenaliini tagasihaarde inhibiitor.
English: For the treatment of SUI, Duloxetine Boehringer Ingelheim has been studied in a total of 2,850 women.
Estonian: Rõhkinkontinentsi ravis kasutamiseks uuriti Duloxetine Boehringer Ingelheimi kokku 2850 rõhkinkontinentsiga naisel.
English: In all four studies of SUI, the patients treated with Duloxetine Boehringer Ingelheim had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Estonian: Kõigis neljas rõhkinkontinentsi uuringus esines Duloxetine Boehringer Ingelheimiga ravitud patsientidel 12 nädala pärast kusepidamatuse episoode vähem: uuringueelse ajaga võrreldes ligikaudu neli või viis kusepidamatuse episoodi nädalas vähem.
English: Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Estonian: Mõnel patsiendil saab vähendada tekkivat iiveldust või peapööritust nii, et enne annuse suurendamist 40 mg-ni ööpäevas alustatakse ravi annusega 20 mg, mida manustatakse kaks korda ööpäevas esimese kahe nädala jooksul.
English: Combining Duloxetine Boehringer Ingelheim with pelvic floor muscle training may provide additional benefit.
Estonian: Duloxetine Boehringer Ingelheimi kombineerimine vaagnapõhjalihaste harjutustega võib anda täiendavaid soodsaid tulemusi.
English: For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Estonian: Diabeetilise neuropaatilise valu ravis vähendas Duloxetine Boehringer Ingelheim annuses 60 mg üks või kaks korda ööpäevas valu efektiivsemini kui platseebo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Boehringer Ingelheim's benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Estonian: Inimravimite komitee otsustas, et Duloxetine Boehringer Ingelheimi kasulikkus mõõduka kuni raske rõhkinkontinentsi ja diabeetilise perifeerse neuropaatilise valu ravimisel täiskasvanutel on suurem kui sellega kaasnevad riskid.
English: Duloxetine Boehringer Ingelheim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Estonian: Duloxetine Boehringer Ingelheimi ei tohi kasutada patsiendid, kes võivad olla duloksetiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The Committee recommended that Duloxetine Boehringer Ingelheim be given marketing authorisation.
Estonian: Komitee soovitas anda Duloxetine Boehringer Ingelheimile müügiloa.
English: The IEF decreased by 52% in the Duloxetine Boehringer Ingelheim group, compared with a decrease of 33% in the placebo-treated group.
Estonian: Duloxetine Boehringer Ingelheimi rühmas vähenes kusepidamatuse episoodide sagedus 52% võrra ja platseeborühmas 33% võrra.
English: The effectiveness of three different doses of Duloxetine Boehringer Ingelheim was compared with that of placebo.
Estonian: Duloxetine Boehringer Ingelheimi kolme eri annuse efektiivsust võrreldi platseebo efektiivsusega.
English: Duloxetine Boehringer Ingelheim must not be used in patients with certain types of liver disease or with severe kidney disease.
Estonian: Duloxetine Boehringer Ingelheimi ei tohi kasutada teatud maksahaiguse või raske neeruhaigusega patsiendid.
English: The most common side effects with Duloxetine Boehringer Ingelheim when used to treat SUI (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
Estonian: Duloxetine Boehringer Ingelheimi kõige sagedamad kõrvalnähud rõhkinkontinentsi ravis (esinenud enam kui ühel patsiendil kümnest) on iiveldus, suukuivus, kõhukinnisus ja väsimus.
English: The I-QOL questionnaire scores were also improved in the Duloxetine Boehringer Ingelheim group compared with the placebo group.
Estonian: Ka I-QOLküsimustiku punktisummad olid Duloxetine Boehringer Ingelheimiga ravitud rühmas suuremad kui platseeborühmas.
English: For SUI, the recommended dose of Duloxetine Boehringer Ingelheim is 40 mg twice a day.
Estonian: Duloxetine Boehringer Ingelheimi soovituslik annus rõhkinkontinentsi raviks on 40 mg kaks korda ööpäevas.
English: For the full list of all side effects reported with Duloxetine Boehringer Ingelheim, see the Package Leaflet.
Estonian: Duloxetine Boehringer Ingelheimi kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Duloxetine Boehringer Ingelheim should be used with caution in elderly patients.
Estonian: Ettevaatlik tuleb olla Duloxetine Boehringer Ingelheimi kasutamisel eakatel patsientidel.
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Duloxetine Boehringer Ingelheim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
Estonian: Duloxetine Boehringer Ingelheimi kasutanud patsientide valuskaala punktisumma oli 1,17 kuni 1,45 punkti võrra väiksemad kui platseebot kasutanud patsientidel.
English: What is Duloxetine Boehringer Ingelheim?
Estonian: Mis on Duloxetine Boehringer Ingelheim?
English: Why has Duloxetine Boehringer Ingelheim been approved?
Estonian: Miks Duloxetine Boehringer Ingelheim heaks kiideti?
English: The full EPAR for Duloxetine Boehringer Ingelheim is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Duloxetine Boehringer Ingelheimi kohta leiate siit.
English: What is the risk associated with Duloxetine Boehringer Ingelheim?
Estonian: Mis riskid Duloxetine Boehringer Ingelheimiga kaasnevad?
English: How has Duloxetine Boehringer Ingelheim been studied?
Estonian: Kuidas Duloxetine Boehringer Ingelheimi uuriti?
English: How does Duloxetine Boehringer Ingelheim work?
Estonian: Kuidas Duloxetine Boehringer Ingelheim toimib?
English: How is Duloxetine Boehringer Ingelheim used?
Estonian: Kuidas Duloxetine Boehringer Ingelheimi kasutatakse?
English: What is Duloxetine Boehringer Ingelheim used for?
Estonian: Milleks Duloxetine Boehringer Ingelheimi kasutatakse?
English: Duloxetine Boehringer Ingelheim is used to treat:
Estonian: Duloxetine Boehringer Ingelheimi kasutatakse järgmiste haiguste ja sümptomite raviks:
English: What benefit has Duloxetine Boehringer Ingelheim shown during the studies?
Estonian: Milles seisneb uuringute põhjal Duloxetine Boehringer Ingelheimi kasulikkus?
English: 5 April 2016 EMA/823974/2015
Estonian: 5. aprill 2016 EMA/823974/2015
English: Detailed
Estonian: Üksikasjalik teave,
English: If symptoms persist during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Estonian: Kui sümptomid ravimi kasutamise ajal püsivad, tuleb pöörduda arsti või pädeva tervishoiutöötaja poole.
English: Although a possible effect in relief of lower urinary tract symptoms related to BHP was observed, there were shortcomings in the studies such as too few patients and too short a treatment period.
Estonian: Kuigi täheldati võimalikku mõju eesnäärme healoomulise hüperplaasiaga seotud kuseteede alumise osa sümptomite leevendamisele, ilmnesid uuringus puudused, näiteks liiga vähe patsiente ja liiga lühike raviaeg.
English: Saw palmetto fruit should only be used in male adults and the elderly.
Estonian: Serenoapalmivilja tohivad kasutada üksnes täiskasvanud ja eakad mehed.
English: Common side effects (seen between 1 and 10 patients in 100) reported with saw palmetto fruit are abdominal (belly) pain and headache.
Estonian: Serenoapalmivilja kohta teatatud sagedad kõrvalnähud (esinenud 1-10 patsiendil 100st) on kõhuvalu ja peavalu.
English: Further information on the risks associated with saw palmetto fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave serenoapalmivilja sisaldavate ravimitega kaasnevate riskide, sh nende ohutu kasutamise ettevaatusabinõude kohta, on taimse aine monograafias Euroopa Ravimiameti veebilehe jaotises „All documents“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of saw palmetto fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave serenoapalmivilja sisaldavate ravimite hindamise kohta, sh komitee kokkuvõtte üksikasjalik kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing saw palmetto fruit have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Estonian: Serenoapalmivilja sisaldavate ravimite müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimsete ravimite müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslikke järeldusi.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom instructions on how to take saw palmetto fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing saw palmetto fruit.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad serenoapalmivilja sisaldavate taimsete ravimite müügilubade taotlusi.
English: Information on the use and licensing of saw palmetto fruit medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab serenoapalmivilja sisaldavate ravimite kasutamise ja müügilubade teavet riiklikelt asjakohastelt ravimiametitelt.
English: Saw palmetto fruit is the common name for the fruit of the plant Serenoa repens (W. Bartram) Small.
Estonian: Serenoapalmivili on taime Serenoa repens (W. Bartram) Small vilja üldnimetus.
English: Other information about saw palmetto fruit medicines
Estonian: Muu teave serenoapalmivilja sisaldavate ravimite kohta
English: In its assessment, the HMPC considered a number of clinical studies with saw palmetto fruit hexane extract some of which showed that it is as effective as finasteride and tamsulosin (other medicines approved to treat BPH) at treating BPH symptoms for periods up to 1 year.
Estonian: Taimsete ravimite komitee uuris hinnangu andmisel mitut kliinilist uuringut serenoapalmivilja heksaani ekstrakti kohta, mis tõendasid, et see on eesnäärme healoomulise hüperplaasia sümptomite ravis kuni 1 aasta jooksul sama efektiivne kui finasteriid ja tamsulosiin (heaks kiidetud ravimid eesnäärme healoomulise hüperplaasia korral).
English: Herbal medicines containing saw palmetto fruit are usually available in solid forms to be taken by mouth.
Estonian: Serenoapalmivilja sisaldavaid taimseid ravimeid turustatakse tavaliselt suukaudsete tahkete ravimvormidena.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of saw palmetto fruit.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb serenoapalmivilja meditsiinilisi kasutusviise.
English: What evidence supports the use of saw palmetto fruit medicines?
Estonian: Mis tõendid toetavad serenoapalmivilja sisaldavate ravimite kasutamist?
English: The way saw palmetto fruit acts is not fully known, but from laboratory studies it is thought to work by reducing the action of male sex hormones such as testosterone, which play a role in causing enlargement of the prostate gland in BPH; and it may also have anti-inflammatory effects.
Estonian: Serenoapalmivilja toimemehhanism ei ole täielikult teada, kuid laboriuuringute põhjal arvatakse, et see vähendab meessuguhormoonide (testosteroon) toimet eesnäärme suurenemisele healoomulise eesnäärme suurenemise korral ja et sellel ravimil võib olla ka põletikuvastane toime.
English: BPH is a non-cancerous increase in size of the prostate gland which surrounds the urethra, the tube that carries urine from the bladder out of the body.
Estonian: Eesnäärme healoomuline hüperplaasia on eesnäärme mõõtmete mittekasvajaline suurenemine; eesnääre ümbritseb kusitit, mis viib uriini põiest välja.
English: For more information about treatment with saw palmetto fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate serenoapalmivilja sisaldavate ravimitega toimuva ravi kohta lisateavet, lugege palun ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: In its assessment, the HMPC also considered clinical studies with saw palmetto fruit ethanol extract.
Estonian: Taimsete ravimite komitee uuris hinnangu andmisel ka mitmeid serenoapalmivilja etanooli ekstraktiga tehtud kliinilisi uuringuid.
English: The HMPC concluded that saw palmetto fruit (extracted with hexane) can be used to treat the symptoms of benign prostatic hyperplasia (BPH).
Estonian: Taimsete ravimite komitee järeldas, et serenoapalmivilja (heksaaniga ekstraheeritud) võib kasutada eesnäärme healoomulise hüperplaasia sümptomite raviks.
English: Saw palmetto fruit preparations may be obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (hexane or ethanol), which is then partially evaporated to obtain a soft extract.
Estonian: Serenoapalmivilja valmistisi saadakse taimeosade asetamisel lahustisse (nt heksaani või etanooli), et ekstraheerida ühendid.
English: The HMPC also concluded that, on the basis of its long-standing use, saw palmetto fruit (extracted with ethanol) can be used for the relief of lower urinary tract symptoms (such as difficulty starting urination or a frequent need to urinate) related to BPH, after serious conditions have been excluded by a doctor.
Estonian: Taimsete ravimite komitee järeldas, et lähtudes pikaajalisest kasutamisest tohivad eesnäärme healoomulise hüperplaasiaga patsiendid kasutada serenoapalmivilja kuseteede alumise osa sümptomite, näiteks urineerimisraskuse või sageda urineerimise leevendamiseks juhul, kui arst on välistanud rasked seisundid.
English: What are the risks associated with saw palmetto fruit medicines?
Estonian: Mis riskid serenoapalmivilja sisaldavate ravimitega kaasnevad?
English: For practical information about using saw palmetto fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Estonian: Kui vajate serenoapalmivilja sisaldavate ravimite kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How are saw palmetto fruit medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus serenoapalmivilja sisaldavate ravimite müügiluba?
English: What are the HMPC conclusions on its medicinal uses?
Estonian: Mis on taimsete ravimite komitee järeldused serenoapalmivilja meditsiiniliste kasutusalade kohta?
English: The HMPC conclusions on the use of ethanol-extracted saw palmetto fruit medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Estonian: Taimsete ravimite komitee järeldused nende serenoapalmivilja etanooli ekstrakti sisaldavate ravimite kasutamise kohta eesnäärme healoomulise hüperplaasiaga seotud alumiste kuseteede sümptomite leevendamiseks põhinevad nende traditsioonilisel kasutamisel selle seisundi korral.
English: This summary is not intended to provide practical advice on how to use medicines containing saw palmetto fruit.
Estonian: Kokkuvõttes ei anta serenoapalmivilja sisaldavate ravimite kasutamise kohta praktilisi nõuandeid.
English: Therefore, the HMPC conclusions on the use of saw palmetto medicines are based on their long-standing use.
Estonian: Seetõttu põhineb taimsete ravimite komitee järeldus serenoapalmivilja sisaldavate ravimite kasutamise kohta nende pikaajalisel kasutamisel.
English: What is saw palmetto fruit?
Estonian: Mis on serenoapalmivili?
English: The HMPC conclusions on the use of hexane-extracted saw palmetto fruit medicines for the symptomatic treatment of BPH are based on their ‘well-established use' in this condition.
Estonian: Taimsete ravimite komitee järeldused serenoapalmivilja sisaldavate ravimite kasutamise kohta eesnäärme healoomulise hüperplaasia sümptomite leevendamiseks põhinevad nende tõendatud kasutusel selle seisundi korral.
English: How does saw palmetto fruit work as a medicine?
Estonian: Kuidas serenoapalmivili ravimina toimib?
English: Saw palmetto fruit
Estonian: Serenoapalmivili
English: 23 January 2015
Estonian: 23. jaanuar 2015
English: Teysuno has been authorised in the EU since March 2011.
Estonian: Teysunol on Euroopa Liidus müügiluba alates 2011. aasta märtsist.
English: The full European Public Assessment Report for Teysuno can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Teysuno kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The withdrawal letter is available here.
Estonian: Müügiloa taotluse tagasivõtmise kiri on siin.
English: On 6 January 2015, Nordic Group BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the indication for Teysuno.
Estonian: Nordic Group BV teatas 6. jaanuaril 2015 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Teysuno näidustuse muutmise taotlus.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Teysuno contains the active substances tegafur, gimeracil and oteracil.
Estonian: Teysuno sisaldab toimeainena tegafuuri, gimeratsiili ja oteratsiili.
English: It is available as capsules.
Estonian: Seda turustatakse kapslitena.
English: As a result, it prevents the growth of cancer cells and eventually kills them.
Estonian: Selle tulemusena pärsib 5-FU vähirakkude kasvu ja lõpuks hävitab need.
English: The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU, and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Estonian: Teised kaks Teysuno toimeainet võimaldavad tegafuuril toimida väiksemas koguses ja vähemate kõrvalnähtudega: gimeratsiil takistab 5-FU lagunemist ja oteratsiil vähendab 5-FU toimet tervetes, vähita soolekudedes.
English: The company presented data from two studies involving a total of 43 patients with advanced gastric cancer or other tumours, in which Teysuno was used in combination with oxaliplatin and other cancer medicines.
Estonian: Ettevõte esitas andmed kahest uuringust, kus osales kokku 43 kaugelearenenud maovähi või muude kasvajatega patsienti ning kus Teysunot kasutati kombinatsioonis oksaliplatiini ja muude vähiravimitega.
English: There are no consequences on the use of Teysuno in its authorised indication.
Estonian: Tagasivõtmine ei mõjuta Teysuno kasutamist heakskiidetud näidustusel.
English: In particular very limited data were provided on the combination of Teysuno with oxaliplatin and no data were provided on the use with carboplatin.
Estonian: Eelkõige olid piiratud Teysuno ja oksaliplatiini kombinatsioonravi andmed ning puudusid koos karboplatiiniga kasutamise andmed.
English: How far into the evaluation was the application when it was withdrawn?
Estonian: Mis järgus oli müügiloa muutmise taotluse hindamine, kui see tagasi võeti?
English: How is Teysuno expected to work?
Estonian: Milline on Teysuno eeldatav toime?