FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Lilly, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Duloxetine Lilly omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Estonian: Neurotransmitterite tagasihaarde pärssimise kaudu suurendab duloksetiin nende arvu närvirakkude vahel, suurendades rakkudevahelist signaalivahetust.
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Estonian: Duloxetine Lilly toimeaine duloksetiin on serotoniini ja noradrenaliini tagasihaarde inhibiitor.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Lilly.
Estonian: See on ravimi Duloxetine Lilly Euroopa avaliku hindamisaruande kokkuvõte.
English: Duloxetine Lilly duloxetine
Estonian: Duloxetine Lilly duloksetiin
English: For neuropathic pain, Duloxetine Lilly has been compared with placebo in two 12-week studies in 809 diabetic adults.
Estonian: Neuropaatilise valu uuringus võrreldi Duloxetine Lillyt platseeboga kahes 12 nädalat kestnud uuringus, milles osales 809 diabeediga täiskasvanud patsienti.
English: In patients who respond to Duloxetine Lilly, treatment should continue for several months, to prevent the disorder coming back.
Estonian: Patsiendid, kellel tekib Duloxetine Lillyle ravivastus, peavad jätkama ravimi võtmist mitu kuud, et ennetada haiguse taastumist.
English: Other information about Duloxetine Lilly
Estonian: Muu teave Duloxetine Lilly kohta
English: Duloxetine Lilly must also not be used in patients with reduced liver function or patients with severely reduced kidney function.
Estonian: Duloxetine Lillyt ei tohi kasutada ka maksapuudulikkusega patsientidel ega väga raske neerupuudulikkusega patsientidel.
English: In the two studies where the approved dose of Duloxetine Lilly was compared with placebo, Duloxetine Lilly was more effective.
Estonian: Mõlemas uuringus, kus heakskiidetud annuses Duloxetine Lillyt võrreldi platseeboga, oli Duloxetine Lilly efektiivsem.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Estonian: Gastroresistentne tähendab, et kapslid ei lagune maos, vaid alles sooles.
English: For practical information about using Duloxetine Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Duloxetine Lilly kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Why is Duloxetine Lilly approved?
Estonian: Miks Duloxetine Lilly heaks kiideti?
English: For more information about treatment with Duloxetine Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Duloxetine Lillyga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What are the risks associated with Duloxetine Lilly?
Estonian: Mis riskid Duloxetine Lillyga kaasnevad?
English: For generalised anxiety disorder, Duloxetine Lilly has been compared with placebo in five studies involving a total of 2,337 patients.
Estonian: Generaliseerunud ärevushäire ravis võrreldi Duloxetine Lillyt platseeboga viies uuringus, milles osales kokku 2337 patsienti.
English: Although the results of the depression studies varied, Duloxetine Lilly was more effective than placebo in four of the studies.
Estonian: Kuigi depressiooniuuringute tulemused varieerusid, oli Duloxetine Lilly neljas uuringus efektiivsem kui platseebo.
English: These studies showed that Duloxetine Lilly was more effective at reducing pain than placebo.
Estonian: Need uuringud näitasid, et Duloxetine Lilly on valu vähendamisel efektiivsem kui platseebo.
English: It is not intended to provide practical advice on how to use Duloxetine Lilly.
Estonian: Hindamisaruandes ei anta Duloxetine Lilly kasutamise praktilisi nõuandeid.
English: The dose of Duloxetine Lilly should be reduced gradually when stopping treatment.
Estonian: Ravi katkestamisel tuleb Duloxetine Lilly annust vähendada järk-järgult.
English: For major depression, Duloxetine Lilly has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Estonian: Raske depressiooni uuringutes võrreldi Duloxetine Lillyt platseeboga (näiva ravimiga) kaheksas põhiuuringus, milles osales kokku 2544 patsienti.
English: How does Duloxetine Lilly work?
Estonian: Kuidas Duloxetine Lilly toimib?
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Duloxetine Lilly.
Estonian: Uuringus osales 429 patsienti, kellel oli esialgu tekkinud Duloxetine Lillyle ravivastus.
English: Duloxetine Lilly was shown to be more effective than placebo at treating the disorder and preventing symptoms returning.
Estonian: Duloxetine Lilly osutus häire ravis ja sümptomite taastekke vältimises efektiivsemaks kui platseebo.
English: For the full list of all side effects reported with Duloxetine Lilly, see the package leaflet.
Estonian: Duloxetine Lilly kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: How is Duloxetine Lilly used?
Estonian: Kuidas Duloxetine Lillyt kasutatakse?
English: In patients who respond to Duloxetine Lilly, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Estonian: peavad jätkama ravimi võtmist mitu kuud, et ennetada haiguse taastumist; samuti peavad ravimi võtmist jätkama patsiendid, kellel on varem olnud korduvaid depressiooniepisoode.
English: What benefits of Duloxetine Lilly have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Duloxetine Lilly kasulikkus?
English: It also took longer for symptoms to return in patients taking Duloxetine Lilly than in those taking placebo.
Estonian: Duloxetine Lillyt saanud patsientidel kulus sümptomite taastumiseni rohkem aega kui platseebot saanud patsientidel.
English: The patients were treated for eight weeks.
Estonian: Patsiente raviti kaheksa nädalat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasitrio on 22 November 2011.
Estonian: Euroopa Komisjon andis Rasitrio müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 22. novembril
English: It is available as tablets in the following strengths: 150 /5/12.5 mg; 300/5/12.5 mg; 300/5/25 mg; 300/10/12.5 mg; and 300/10/25 mg.
Estonian: Ravimit turustatakse järgmiste tugevustega tablettidena: 150/5/12,5 mg; 300/5/12,5 mg; 300/5/25 mg; 300/10/12,5 mg ja 300/10/25 mg.
English: The patient should take one tablet once a day with a light meal, preferably at the same time each day.
Estonian: Patsient peab võtma ühe tableti üks kord ööpäevas koos kerge einega, eelistatavalt iga päev samal kellaajal.
English: The full EPAR for Rasitrio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Rasitrio kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The tablet should be swallowed whole with water.
Estonian: Tablett tuleb neelata tervelt koos veega.
English: Other information about Rasitrio
Estonian: Muu teave Rasitrio kohta
English: The Committee therefore decided that Rasitrio's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu otsustas komitee, et Rasitrio kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: This is a summary of the European public assessment report (EPAR) for Rasitrio.
Estonian: See on ravimi Rasitrio Euroopa avaliku hindamisaruande kokkuvõte.
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 Rasitrio.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: It should not be taken together with grapefruit juice.
Estonian: Tabletti ei tohi võtta koos greibimahlaga.
English: The CHMP noted that taking the three active substances in one tablet, as opposed to taking separate tablets, may lead to better compliance with treatment.
Estonian: Inimravimite komitee märkis, et kolme toimeaine manustamine eraldi tablettide asemel ühe tabletina võib aidata paremini järgida raviskeemi.
English: For more information about treatment with Rasitrio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Rasitrioga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.
Estonian: Ettevõte esitas ka uuringud, mis tõendavad, et kõiki kolme toimeainet sisaldav tablett imendub organismis samamoodi kui eraldi tabletid.
English: 'Essential' means that the hypertension has no obvious cause.
Estonian: Essentsiaalne tähendab, et kõrgvererõhutõbe ei põhjusta ükski teine haigus.
English: After eight weeks, patients treated with Rasitrio had an average reduction in sitting systolic blood pressure of 37.4 mmHg.
Estonian: Pärast kaheksat ravinädalat oli Rasitriot võtnud patsientide istudes mõõdetud süstoolne vererõhk vähenenud keskmiselt 37,4 mmHg.
English: The main measure of effectiveness was the reduction in the average systolic blood pressure (blood pressure when the heart is contracting) measured when the patients were seated.
Estonian: Efektiivsuse põhinäitaja oli patsiendi istudes mõõdetud keskmise süstoolse ehk nn ülemise vererõhu alanemine (vererõhk südame kokkutõmbumise ajal).
English: Patients should be switched to the fixed combination tablet of Rasitrio that contains the same component doses as previously used individually.
Estonian: Patsient tuleb üle viia ravile Rasitrio fikseeritud annustega kombineeritud tabletiga, mis sisaldab komponente samas annuses kui varem eraldi võetuna.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Estonian: Angiotensiin I muundub hormooniks angiotensiin II, mis on tugeva toimega vasokonstriktor (ahendab veresooni).
English: For the full list of all side effects reported with Rasitrio, see the package leaflet.
Estonian: Rasitrio kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What is Rasitrio?
Estonian: Mis on Rasitrio?
English: The most frequent adverse reactions for Rasitrio are hypotension and dizziness.
Estonian: Rasitrio kõige sagedamad kõrvalnähud on hüpotensioon ja peapööritus.
English: By blocking the activity of renin, levels of both, angiotensin I and angiotensin II, fall.
Estonian: Reniini toime blokeerimisega väheneb nii angiotensiin I kui ka angiotensiin II sisaldus veres.
English: What is the risk associated with Rasitrio?
Estonian: Mis riskid Rasitrioga kaasnevad?
English: By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure.
Estonian: Vähendades kaltsiumi sissevoolu rakkudesse, ennetab amlodipiin rakkude kokkutõmbumist, mis alandab vererõhku.
English: EPAR summary for the public aliskiren / amlodipine / hydrochlorothiazide
Estonian: Kokkuvõte üldsusele aliskireen / amlodipiin / hüdroklorotiasiid
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Estonian: Kui kaltsiumiioonid sisenevad veresoonte seinte lihaste rakkudesse, tõmbuvad rakud kokku.
English: Studies also showed that the active substances in Rasitrio are absorbed in the body in the same way as the active substances when given as separate tablets.
Estonian: Uuringud tõendasid ka, et Rasitrio toimeained imenduvad organismis samamoodi kui eraldi võetud tablettide korral.
English: In a main study in 1,191 patients with moderate or severe hypertension, Rasitrio combinations containing the three active substances were compared with combinations containing only two active substances: aliskiren plus amlodipine, amlodipine plus hydrochlorothiazide, and aliskiren plus hydrochlorothiazide.
Estonian: Põhiuuringus võrreldi 1191 mõõduka või raske hüpertensiooniga patsiendil kolme toimeainet sisaldavaid Rasitrio kombineeritud tablette ainult kaht toimeainet sisaldavate tablettidega: aliskireen koos amlodipiiniga, amlodipiin koos hüdroklorotiasiidiga ja aliskireen koos hüdroklorotiasiidiga.
English: Rasitrio must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine, or hydrochlorothiazide, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine) or sulphonamide (includes hydrochlorothiazide).
Estonian: Rasitriot ei tohi kasutada patsiendid, kes on aliskireeni, amlodipiini või hüdroklorotiasiidi või selle ravimi mis tahes muu koostisaine või muude dihüdropüridiiniderivaatide (ravimirühm, kuhu kuulub amlodipiin) või sulfoonamiidide (sh hüdroklorotiasiidi) suhtes ülitundlikud (allergilised).
English: Why has Rasitrio been approved?
Estonian: Miks Rasitrio heaks kiideti?
English: Rasitrio is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose.
Estonian: Rasitriot kasutatakse essentsiaalse hüpertensiooni (kõrgvererõhutõve) raviks täiskasvanutel, kelle vererõhk allub piisavalt kombineeritud ravile aliskireeni, amlodipiini ja hüdroklorotiasiidiga, mida manustatakse samaaegselt samas annuses.
English: The combination of these three active substances reduces blood pressure more than either medicine acting alone.
Estonian: Kolme toimeaine kombinatsioon alandab vererõhku rohkem kui iga ravim eraldi.
English: The main study showed a greater reduction in blood pressure with Rasitrio than with combinations of two active substances.
Estonian: Põhiuuring näitas, et Rasitrio vähendas vererõhku rohkem kui kaht toimeainet sisaldavad kombineeritud tabletid.
English: Rasitrio is a medicine that contains the active substances aliskiren, amlodipine and hydrochlorothiazide.
Estonian: Rasitrio on ravim, mis sisaldab toimeainetena aliskireeni, amlodipiini ja hüdroklorotiasiidi.
English: Rasitrio contains three active substances, aliskiren, amlodipine, and hydrochlorothiazide.
Estonian: Rasitrio sisaldab kolme toimeainet: aliskireeni, amlodipiini ja hüdroklorotiasiidi.
English: The strength of the Rasitrio tablet that the patient takes depends on the doses of aliskiren, amlodipine and hydrochlorothiazide that they received previously.
Estonian: Võetava Rasitrio tableti tugevus sõltub patsiendi varasemast aliskireeni, amlodipiini ja hüdroklorotiasiidi annusest.
English: How has Rasitrio been studied?
Estonian: Kuidas Rasitriot uuriti?
English: It blocks the activity of an enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Estonian: Aliskireen on reniini inhibiitor, mis blokeerib organismis angiotensiin I tekkes osaleva ensüümi reniini toime.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter.
Estonian: Amlodipiin on kaltsiumikanali blokaator ehk aine, mis blokeerib rakupinnal olevaid teatud kanaleid (kaltsiumikanaleid), mille kaudu kaltsiumiioonid tavaliselt sisenevad rakku.
English: What benefit has Rasitrio shown during the studies?
Estonian: Milles seisneb uuringute põhjal Rasitrio kasulikkus?
English: This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.
Estonian: Selle tulemusena veresooned laienevad ja vererõhk langeb.
English: How is Rasitrio used?
Estonian: Kuidas Rasitriot kasutatakse?
English: How does Rasitrio work?
Estonian: Kuidas Rasitrio toimib?
English: What is Rasitrio used for?
Estonian: Milleks Rasitriot kasutatakse?
English: It works by increasing urine production, reducing the volume of fluid in the blood and lowering the blood pressure.
Estonian: Hüdroklorotiasiid on diureetikum ehk aine, mis suurendab uriinieritust, vähendades vedeliku hulka veres ja alandades vererõhku.
English: The Rasitrio combination was more effective than the double combinations at reducing systolic blood pressure.
Estonian: Rasitrio kombineeritud tablett vähendas süstoolset vererõhku efektiivsemalt kui kaht toimeainet sisaldavad tabletid.
English: Reductions of 28.2 mmHg, 30.6 mmHg and 30.8 mmHg were seen for aliskiren plus hydrochlorothiazide, aliskiren plus amlodipine and amlodipine plus hydrochlorothiazide respectively.
Estonian: Patsientidel, kes võtsid aliskireeni koos hüdroklorotiasiidiga, aliskireeni koos amlodipiiniga ja amlodipiini koos hüdroklorotiasiidiga, oli vererõhk langenud vastavalt 28,2 mmHg, 30,6 mmHg ja 30,8 mmHg.
English: The medicine can only be obtained with a prescription.
Estonian: Rasitrio on retseptiravim.
English: London, 26 June 2008 Doc.
Estonian: London, 26. juuni 2008 Dok.
English: On 13 June 2008, Novartis Vaccines and Diagnostics S.r.l.
Estonian: 13. juulil 2008. aastal teavitas Novartis Vaccines and Diagnostics S.r.l.
English: Ref. EMEA/306731/2008
Estonian: viide: EMEA/545116/2008
English: Consequently, the study results could not be considered reliable and could not be used for the evaluation of the vaccine.
Estonian: Seega ei ole uuringu tulemusi võimalik pidada usaldusväärseks ja neid ei saa kasutada vaktsiini hindamisel.
English: What is Aflunov?
Estonian: Mis on Aflunov?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete ravimi kliinilises uuringus ja vajate oma ravi kohta rohkem teavet, pöörduge palun arsti poole, kes teile ravi määras.
English: The virus used in the vaccine was first inactivated (killed) so that it does not cause any disease.
Estonian: Vaktsiinis kasutatav viirus esmalt inaktiveeriti (hävitati), seega ei põhjusta see enam haigust.
English: The main clinical study of Aflunov involved over 4,000 adults.
Estonian: Aflunovi peamises kliinilises uuringus osales üle 4000 täiskasvanu.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Estonian: Pärast inimravimite komitee otsust kulub Euroopa Komisjonil müügiloa andmiseks ligikaudu kaks kuud.
English: The application was at day 190 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 190 päeva, kui ettevõtte taotluse tagasi võttis.
English: This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Estonian: See on spetsiaalset tüüpi vaktsiin, mis on mõeldud kaitseks sellise gripiviiruse tüve vastu, mis võib tuleviks põhjustada pandeemiat.
English: As a result, the size of the clinical database for the assessment of the vaccine's safety was not sufficient to fulfil the requirements of the EMEA's guidelines on prepandemic vaccines.
Estonian: Selle tulemusena ei ole vaktsiini ohutuse hindamiseks vajaliku kliinilise andmebaasi suurus küllaldane Euroopa Ravimiameti suuniste täitmiseks prepandeemiliste vaktsiinide kohta.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Estonian: Kui ettevõte on küsimustele vastanud, vaatab inimravimite komitee need üle ja võib enne otsuse tegemist küsida 180. päeval veel küsimusi.
English: Aflunov also contains an ‘adjuvant' (a compound containing oil), which is expected to stimulate a better response.
Estonian: Aflunov sisaldab ka adjuvanti (õli sisaldavat ühendit), mille eesmärgiks on stimuleerida immuunvastust.
English: Aflunov was expected to provide protection against this strain, so that it could be used before or during a flu pandemic.
Estonian: Aflunov pidi eeldatavalt kaitsma selle tüve eest nii, et seda oleks võimalik kasutada enne gripipandeemiat või selle ajal.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Estonian: Pärast seda, kui inimravimite komitee oli hinnanud ettevõttele esitatud küsimuste vastuseid, jäid siiski lahendamata mõned olulised probleemid.
English: What were the reasons given by the company to withdraw the application?
Estonian: Mis põhjustel ettevõtte taotluse tagasi võttis?
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Estonian: Esialgsete dokumentide analüüsi tulemuste põhjal koostab inimravimite komitee 120. päeval küsimuste loetelu, mis saadetakse ettevõttele.
English: The comparator vaccine contained different strains of seasonal flu virus, but the rest of the components were the same as in Aflunov.
Estonian: Võrdlusvaktsiin sisaldas sesoonse gripiviiruse erinevaid tüvesid, kuid ülejäänud komponendid olid samad mis Aflunovis.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)
Estonian: TEAVE MÜÜGILOA TAGASIVÕTMISE KOHTA AFLUNOV Geneeriline nimetus: prepandeemiline gripivaktsiin (H5N1) (pinnaantigeen, inaktiveeritud, adjuvandiga) (A/VietNam/1194/2004)
English: It compared Aflunov's safety and its ability to stimulate the production of antibodies (‘immunogenicity') with those of a similar vaccine against seasonal flu.
Estonian: Selles võrreldi Aflunovi ohutust ja võimet stimuleerida antikehade tootmist (immunogeensust) võrreldes sarnase sesoonse gripi vaktsiiniga.
English: An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘good clinical practice' (GCP).
Estonian: Mõnede uuringukeskuste kontroll näitas, et uuringu tegemisel ei järgitud häid kliinilisi tavasid.
English: Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Estonian: Terviseeksperdid on mures, et uue gripipandeemia põhjuseks võib olla viiruse H5N1 tüvi.
English: Aflunov is a vaccine.
Estonian: Aflunov on vaktsiin.
English: Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov.
Estonian: Seega ei olnud taotluse tagasivõtmise ajal võimalik inimravimite komiteel teha otsust Aflunovi kasulikkuse ja riski tasakaalu kohta.
English: Aflunov contains small parts of the H5N1 strain of the flu virus.
Estonian: Aflunov sisaldab gripiviiruse H5N1 tüve väikseid osakesi.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Estonian: Vaktsiinide toime on „õpetada” immuunsüsteemile (organismi loomuomasele kaitsesüsteemile) enda kaitsmist haiguse eest.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Estonian: Uue taotluse hindamiseks kulub inimravimite komiteel enamasti 210 päeva.
English: Aflunov is a ‘prepandemic' vaccine.
Estonian: Aflunov on prepandeemiline vaktsiin.