FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking these channels, zonisamide prevents the nerve cells from synchronising their activity and prevents abnormal electrical activity spreading through the brain.
Estonian: Kanalite blokeerimisega takistab sonisamiid närvirakkude talitluse sünkroniseerimist ja elektrilise talitluse häire levikut ajus.
English: Zonegran must not be used in people who are hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Estonian: Zonegrani ei tohi kasutada patsiendid, kes on sonisamiidi või selle ravimi mis tahes muu koostisaine või sulfoonamiidide (näiteks teatud antibiootikumid) suhtes ülitundlikud (allergilised).
English: What is Zonegran?
Estonian: Mis on Zonegran?
English: For the full list of all side effects reported with Zonegran, see the package leaflet.
Estonian: Zonegrani kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The percentage of patients on carbamazepine who were seizure-free for six months was 74.7%.
Estonian: Karbamasepiini saavatel patsientidel ei esinenud kuue kuu jooksul episoode 74,7% patsientidest.
English: In the study involving adults, the main measure of effectiveness was the change in the frequency of partial seizures between the 12 weeks before treatment started and the 18-week period when a stable dose was used.
Estonian: Täiskasvanute uuringus oli efektiivsuse põhinäitaja partsiaalsete episoodide sageduse muutus: võrreldi episoodide sagedust 12 nädala jooksul enne ravi algust ja 18-nädalasel püsiannusega perioodil.
English: Zonegran used on its own was compared with carbamazepine, another anti-epileptic medicine, in a main study involving 583 adults newly diagnosed with partial epilepsy.
Estonian: Ainuravimina kasutatud Zonegrani võrreldi karbamasepiiniga (teise epilepsiaravimiga) põhiuuringus, milles osales 583 patsienti, kellel oli äsja diagnoositud partsiaalne epilepsia.
English: Epileptic fits are caused by abnormal electrical activity in the brain.
Estonian: Epilepsiaepisoode põhjustab aju elektrilise talitluse häire.
English: The main measure of effectiveness was the proportion of patients who were seizure-free for a period of six months.
Estonian: Efektiivsuse põhinäitaja oli patsientide osakaal, kellel ei esinenud epilepsiaepisoode kuue kuu jooksul.
English: When Zonegran is used as an ‘add-on' to existing treatment in children aged 6 years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Estonian: Kui Zonegrani kasutatakse lisaks olemasolevale ravile vähemalt 6-aastastel lastel, sõltub annus kehakaalust; soovitatav algannus on 1 mg kehakaalu kg kohta ööpäevas.
English: Severe rashes have occurred in patients taking Zonegran, including cases of Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction affecting the skin and mucous membranes).
Estonian: Stevensi-Johnsoni sündroomi juhtumeid (naha ja limaskesta raske eluohtlik allergiline reaktsioon).
English: In children, the number of seizures was at least halved in 50% of the patients taking Zonegran, compared with 31% of those taking placebo.
Estonian: Laste uuringus vähenes episoodide arv vähemalt kaks korda Zonegrani ravi rühmas 50%-l ning platseebo rühmas 31%-l patsientidest.
English: In the study in children, the main measure of effectiveness was the proportion of patients in whom the number of seizures was at least halved between the 8 weeks before treatment started and the 12-week period when a stable dose was used.
Estonian: Lasteuuringus oli efektiivsuse põhinäitaja nende patsientide osakaal, kelle episoodide arv vähenes vähemalt poole võrra, kui võrreldi nende esinemist 8 nädala jooksul enne ravi ja 12-nädalasel stabiilse annuse kasutamise perioodil.
English: The active substance in Zonegran, zonisamide, is an anti-epileptic.
Estonian: Zonegrani toimeaine sonisamiid on epilepsiaravim.
English: Zonisamide works by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels.
Estonian: Sonisamiidi toime seisneb närvirakkude pinnal olevate spetsiifiliste naatriumi- ja kaltsiumikanalite blokeerimises.
English: What benefit has Zonegran shown during the studies?
Estonian: Milles seisneb uuringute põhjal Zonegrani kasulikkus?
English: When Zonegran is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Estonian: Kui Zonegrani kasutatakse äsja diagnoositud patsientidel ainuravimina, on soovitatav algannus 100 mg ööpäevas kahe nädala jooksul ning seejärel tohib annust iga kahe nädala tagant 100 mg kaupa suurendada.
English: When Zonegran is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Estonian: Kui Zonegrani kasutatakse lisaks täiskasvanud patsiendi olemasolevale ravile, on soovitatav algannus 25 mg kaks korda ööpäevas.
English: Zonegran can be given once or twice a day after an appropriate dose is reached.
Estonian: Pärast sobiva annuse saavutamist tohib Zonegrani manustada üks või kaks korda ööpäevas.
English: This reduces the chances of an epileptic fit. Zonegran also acts on the neurotransmitter gamma-aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Estonian: Zonegran mõjub ka neurotransmitterile gamma-aminovõihappele (GABA), mille abil toimub signaalivahetus närvirakkude vahel.
English: How is Zonegran used?
Estonian: Kuidas Zonegrani kasutatakse?
English: How does Zonegran work?
Estonian: Kuidas Zonegran toimib?
English: What is Zonegran used for?
Estonian: Milleks Zonegrani kasutatakse?
English: The medicine can only be obtained with a prescription.
Estonian: Zonegran on retseptiravim.
English: How has Zonegran been studied?
Estonian: Kuidas Zonegrani uuriti?
English: MA (EU) number (Invented) name
Estonian: MA (EU) number (Väljamõeldud) nimetus
English: Immediate Packaging
Estonian: Manustamisviis Sisepakend
English: Questions and answers
Estonian: Küsimused ja vastused
English: Outcome of re-examination
Estonian: Uue läbivaatamise tulemused
English: There are no consequences on the use of these medicines in their approved indications, for which the balance of benefits and risks remains unchanged.
Estonian: Puuduvad tagajärjed nende ravimite kasutamisele heakskiidetud näidustustel, mille puhul kasulikkuse ja riski tasakaal jääb endiseks.
English: The full European Public Assessment Report for Ariclaim, Cymbalta and Xeristar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ariclaimi, Cymbalta ja Xeristari kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: There was also insufficient evidence that its effect could be maintained over time, which is important when treating a long-term condition.
Estonian: Samuti ei olnud piisavalt tõendeid, et toime aja jooksul püsiks, mis on pikaaegse häire ravimisel oluline.
English: In addition, more information was needed on the effects of duloxetine in elderly patients and its safety in the intended patients including the elderly.
Estonian: Lisaks on vaja rohkem teavet duloksetiini toimete kohta eakatele patsientidele ja selle ohutuse kohta sihtrühma patsientidele, sealhulgas eakatele.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Estonian: Neurotransmitterid on keemilised ühendid, mis võimaldavad närvirakkudel omavahel suhelda.
English: The company that applied for the change to the authorisation is Eli Lilly.
Estonian: Müügiloa muutmist taotles ettevõte Eli Lilly.
English: They are available as gastroresistant capsules.
Estonian: Need on müügil gastroresistentsete kapslitena.
English: The Committee concluded however that its concerns had still not been adequately addressed and confirmed its initial negative opinion recommending the refusal of a change to the marketing authorisations.
Estonian: Kuid komitee järeldas, et neile probleemidele ei ole veel piisavalt tähelepanu pööratud, ja kinnitas oma esialgset negatiivset arvamust, soovitades müügilubade muutmisest keelduda.
English: The main measure of effectiveness was the change in the severity of pain, as recorded by the patients on an 11-point scale after 12 or 13 weeks of treatment.
Estonian: Efektiivsuse põhinäitaja oli muutus valu tugevuses, mille patsient märkis üles 11-pallisel skaalal pärast 12 või 13 ravinädalat.
English: Somatic pain is from the body surfaces (such as skin) or musculoskeletal tissues (such as skeletal muscles, bone and joints).
Estonian: Somaatiline valu pärineb keha pinnalt (näiteks nahk) või lihas-skeleti kudedest (näiteks skeletilihased, luud ja liigesed).
English: What were the medicines expected to be used for?
Estonian: Milleks kavatseti ravimeid kasutada?
English: After considering the grounds for this request, the CHMP re examined the initial opinion, and confirmed the refusal of the change to the marketing authorisations on 17 November 2011.
Estonian: Pärast taotluse põhjenduste kaalumist vaatas inimravimite komitee esialgse arvamuse uuesti läbi ja kinnitas keeldumist müügilubade muutmisest 17. novembril 2011.
English: The medicines are expected to work in the same way they do in diabetic peripheral neuropathy.
Estonian: Ravimite toime on eeldatavasti samasugune kui diabeetilise perifeerse neuropaatia korral.
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Estonian: 21. juulil 2011 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades duloksetiini sisaldavate ravimite Ariclaimi, Cymbalta ja Xeristari müügilubade muutmisest keelduda.
English: The CHMP noted that the studies had not proven that duloxetine would provide a relevant benefit in the indication applied for.
Estonian: Inimravimite komitee märkis, et uuringud ei ole tõestanud duloksetiini kasulikkust taotletava näidustuse korral.
English: In addition to pain due to diabetic peripheral neuropathy, Cymbalta and Xeristar are also used in major depression and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Estonian: Diabeetilisest perifeersest neuropaatiast tingitud valu ravi kõrval kasutatakse Cymbaltat ja Xeristari ka depressiooni ning generaliseerunud ärevushäire (pikaaegne ärevus või närvilisus igapäevaste asjade pärast) puhul.
English: What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisations?
Estonian: Mis olid peamised probleemid, mille tõttu soovitas inimravimite komitee müügilubade muutmisest keelduda?
English: Ariclaim, Cymbalta and Xeristar are medicines containing the active substance duloxetine.
Estonian: Ariclaim, Cymbalta ja Xeristar on ravimid, mis sisaldavat toimeainena duloksetiini.
English: What are Ariclaim, Cymbalta and Xeristar?
Estonian: Mis on Ariclaim, Cymbalta ja Xeristar?
English: The company informed the CHMP that there are currently no ongoing clinical trials with Ariclaim, Cymbalta and Xeristar in chronic somatic pain patients in Europe.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu ei ole Euroopas pooleli ühtegi Ariclaimi, Cymbalta ja Xeristari kliinilist uuringut kroonilise somaatilise valuga patsientidel.
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: Nende tagasihaarde pärssimisega suurendab duloksetiin nende neurotransmitterite arvu närvirakkude vahel, suurendades rakkudevahelist infovahetust.
English: It does not include pain from internal organs such as the stomach and intestines.
Estonian: See ei hõlma siseorganitest (nt maost ja soolestikust) pärinevat valu.
English: During the re-examination, the Committee considered the use of duloxetine in a smaller group of patients: patients with chronic low back pain or osteoarthritis (swelling and pain in the joints) of at least moderate severity who cannot use NSAIDS.
Estonian: Uue läbivaatamise ajal kaalus komitee duloksetiini kasutamist väiksemal patsientide rühmal: patsiendid, kellel on vähemalt mõõduka tugevusega krooniline alaseljavalu või osteoartriit (liigeste turse ja valu) ja kes ei saa kasutada mittesteroidseid põletikuvastaseid ravimeid.
English: Since these neurotransmitters are involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may improve the symptoms of pain.
Estonian: Et need neurotransmitterid osalevad valuaistingu vähendamises, võib nende närvirakkudesse tagasihaarde pärssimine leevendada valusümptomeid.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Estonian: Ariclaimi kasutatakse diabeetilisest perifeersest neuropaatiast (jäsemete närvide kahjustus, mis võib esineda diabeediga patsientidel) tingitud valu raviks.
English: Patients in the studies were treated with duloxetine or placebo (a dummy treatment) with some patients taking them in combination with NSAIDs.
Estonian: Nendes uuringutes osalevaid patsiente raviti kas duloksetiini või platseeboga (näiv ravim) ja osad patsiendid said neid kombinatsioonis mittesteroidsete põletikuvastaste ravimitega.
English: In addition to their approved uses, the three medicines were expected to be used to treat moderate to severe chronic (long-term) somatic pain in patients not regularly taking NSAID pain killers (non steroidal anti-inflammatory drugs).
Estonian: Lisaks heakskiidetud kasutamisviisidele kavatseti kolme ravimit kasutada ka mõõduka kuni raske kroonilise (pikaajalise) somaatilise valu raviks patsientidel, kes ei võta regulaarselt NSAID-i tüüpi valuvaigisteid (mittesteroidsed põletikuvastased ravimid).
English: The CHMP therefore concluded that the benefits of duloxetine in the treatment of moderate to severe chronic somatic pain in patients not regularly taking NSAIDs had not been shown to outweigh its risks.
Estonian: Seetõttu järeldas inimravimite komitee, et ei ole näidatud, et duloksetiini kasulikkus mõõduka kuni raske kroonilise somaatilise valu ravis patsientidel, kes ei võta regulaarselt mittesteroidseid põletikuvastaseid ravimeid, kaaluks üles ravimiga kaasnevad riskid.
English: The change concerned the addition of a new indication, the treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly.
Estonian: Muudatuse põhjus oli uue näidustuse lisamine, milleks oli mõõduka kuni tugeva kroonilise somaatilise valu ravi patsientidel, kes ei võta regulaarselt mittesteroidseid põletikuvastaseid ravimeid.
English: How are they expected to work?
Estonian: Milline on nende ravimite eeldatav toime?
English: What is happening with Ariclaim, Cymbalta and Xeristar for in their approved indications?
Estonian: Mis toimub Ariclaimi, Cymbalta ja Xeristari kasutamisel heakskiidetud näidustusteks?
English: The company presented results of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in patients with chronic low back pain.
Estonian: Kaks uuringut viidi läbi osteoartriidist (liigeste turse ja valu) tingitud põlvevaluga patsientidel ja kolm uuringut kroonilise alaseljavaluga patsientidel.
English: The active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Estonian: Toimeaine duloksetiin on serotoniini ja noradrenaliini tagasihaarde inhibiitor, mis pärsib neurotransmitterite 5hüdroksütrüptamiini (serotoniin) ning noradrenaliini tagasihaaret peaaju ja seljaaju närvirakkudesse.
English: Pharmaceutical Form
Estonian: Ravimvorm Manustamiste e
English: Pack size
Estonian: Sisepakendi iseloomustu s
English: The trials and programmes will continue as planned.
Estonian: Uuringud ja programmid jätkuvad kavandatud viisil.
English: They looked at the short- and long-term effectiveness of the medicine (short-term studies lasting 6-8 weeks and the longterm studies lasting up to a year).
Estonian: Uuringutes vaadeldi ravimi lühi- ja pikaajalist tõhusust (lühiajalised uuringud kestsid 6-8 nädalat ja pikaajalised kuni ühe aasta).
English: • The long-term study did not show that the medicine was effective.
Estonian: • Pikaajaline uuring ei näidanud ravimi tõhusust.
English: International Non-proprietary Name (INN): agomelatine
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): agomelatiin
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui te osalete kliinilises uuringus või ravimi eriloaga kasutamise programmis ja soovite oma ravi kohta lisateavet, võtke palun ühendust teile selle ravi määranud arstiga.
English: In major depressive disorder, patients have disturbances of mood that interfere with their everyday life.
Estonian: Raske depressiooni korral esinevad patsientidel meeleoluhäired, mis häirivad nende igapäevaelu.
English: The key symptoms are depressed mood and loss/diminished interest or pleasure.
Estonian: Võtmesümptomid on masendus ja huvi või naudingu kadumine/vähenemine.
English: The applicant requested a reexamination of the opinion, but withdrew this request before the CHMP completed the re-examination.
Estonian: Taotleja soovis arvamuse uut läbivaatamist, kuid võttis selle taotluse tagasi enne seda, kui inimtervishoius kasutavate ravimite komitee oli uue läbivaatamise lõpetanud.
English: All patients treated suffered from a major depressive disorder, the severity of which was assessed using a standard rating scale (the Hamilton Rating Scale for Depression, HAM-D).
Estonian: Kõik ravi saanud patsiendid kannatasid raske depressiooni all, mille raskusastet hinnati tavapärase hindamisskaalaga (Hamiltoni depressiooni hindamisskaala, HAM-D).
English: Some studies included a control group where patients were treated with fluoxetine or paroxetine (other medicines used in depression).
Estonian: Mõni uuring sisaldas ka kontrollrühma, kuhu kuuluvaid patsiente raviti fluoksetiini või paroksetiiniga (teised depressiooniravimid).
English: They may suffer from deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Estonian: Patsientidel võivad esineda suur kurbus, väärtusetustunne, huvipuudus meeldivate tegevuste vastu, unehäired, aeglustumistunne, ärevustunne ja kehakaalu muutused.
English: Patients often suffer relapses (when the disease comes back after it has been treated).
Estonian: Sageli esineb retsidiive (haigus naaseb pärast ravi).
English: The company that applied is Les Laboratoires Servier.
Estonian: Müügiluba taotles ettevõte Les Laboratoires Servier.
English: The main studies involved more than 2,400 patients that took Valdoxan/Thymanax.
Estonian: Põhiuuringud hõlmasid enam kui 2400 patsienti, kes võtsid Valdoxan/Thymanaxi.
English: What were the major concerns that led to the CHMP to recommend a refusal of the marketing authorisation?
Estonian: Mis olid peamised probleemid, mille tõttu inimtervishoius kasutatavate ravimite komitee soovitas müügiloa väljastamisest keelduda?
English: This means that agomelatine stimulates the melatonin receptors MT1 and MT2 (these receptors are normally activated by a natural hormone, melatonin) and it blocks the 5-HT2C receptors (these receptors are normally activated by a chemical messenger, serotonin).
Estonian: See tähendab, et agomelatiin stimuleerib melatoniini retseptoreid MT1 ja MT2 (neid retseptoreid aktiveerib tavaliselt kehaomane hormoon melatoniin) ja blokeerib 5-HT2C-retseptoreid (neid retseptoreid aktiveerib tavaliselt virgatsaine serotoniin).
English: The effectiveness was measured by looking at the score in the HAM-D rating scale before and at the end of the study.
Estonian: Tõhususe hindamiseks määrati depressiooni raskus HAM-D-skaalal enne uuringu algust ja pärast uuringu lõppu.
English: What documentation has been presented by the company to support the application to the CHMP?
Estonian: Mis dokumendid esitas ettevõte inimtervishoius kasutatavate ravimite komiteele oma taotluse toetuseks?
English: EMEA/37021/2007 - update
Estonian: London, 16/01/2007 Viitedokument EMEA/522434/2006 - uuendus
English: On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a marketing authorisation for the medicinal product Valdoxan/Thymanax, 25 mg film-coated tablets intended for the treatment of major depressive disorder.
Estonian: 27. juulil 2006 võttis inimtervishoius kasutatavate ravimite komitee vastu eitava otsuse, soovitades keelduda müügiloa andmisest õhukese polümeerkattega tablettravimile Valdoxan/Thymanax 25 mg, mille kavatsetud kasutusnäidustus oli raske depressioon.
English: Valdoxan/Thymanax are orange-yellow tablets containing 25 mg of the active substance agomelatine.
Estonian: Valdoxan/Thymanax on oranžikaskollane tablett, mis sisaldab 25 mg toimeainet agomelatiini.
English: What is Valdoxan/Thymanax?
Estonian: Mis on Valdoxan/Thymanax?
English: See here for information on the outcome of the resubmission
Estonian: Informatsiooni lõpptulemuse leiate siit.
English: The effects of agomelatine were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti agomelatiini toimet muude katsetega.
English: Valdoxan/Thymanax was expected to be used in adult patients to treat major depressive disorder.
Estonian: Valdoxan/Thymanaxi kavatseti kasutada raske depressiooni raviks täiskasvanud patsientidel.
English: The active substance in Valdoxan/Thymanax, agomelatine, is a ‘melatonergic agonist' and a ‘5-HT2C antagonist'.
Estonian: Valdoxan/Thymanaxi toimeaine agomelatiin on melatoniiniprotsessi agonist ja 5-HT2C-antagonist.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING AUTHORISATION for VALDOXAN/THYMANAX
Estonian: TEAVE SOOVITUSE KOHTA KEELDUDA VÄLJASTAMAST MÜÜGILUBA ravimile VALDOXAN/THYMANAX
English: Valdoxan/Thymanax was compared with a placebo (a dummy treatment).
Estonian: Valdoxan/Thymanaxi võrreldi platseeboga (näiv ravim).
English: At this point in time, the CHMP was of the opinion that the benefits of Valdoxan/Thymanax did not outweigh its risks.
Estonian: Sel ajal arvas inimtervishoius kasutatavate ravimite komitee, et Valdoxan/Thymanaxi kasulikkus ei ületa ravimi kasutamisega seotud riske.
English: The major concern of the CHMP was that the effectiveness of Valdoxan/Thymanax had not been sufficiently shown:
Estonian: Inimtervishoius kasutatavate ravimite komitee põhiarvamus oli, et Valdoxan/Thymanaxi tõhusus ei ole küllaldaselt tõestatud.
English: The Company has informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Valdoxan/Thymanax.
Estonian: Ettevõte teatas inimtervishoius kasutatavate ravimite komiteele, et hetkel Valdoxan/Thymanaxi kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele keeldumise otsusel tagajärgi ei ole.
English: What are the consequences of the refusal for patients undergoing clinical trials/compassionate use programmes with Valdoxan/Thymanax?
Estonian: Mis on keeldumise tagajärjed Valdoxan/Thymanaxi kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele?
English: • The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine's effectiveness The CHMP had no special concerns regarding the side effects associated with Valdoxan/Thymanax, as these could have been managed using the standard risk management tools.
Estonian: • Lühiajalised uuringud näitasid, et ravim toimis, kuid toime ulatuse alusel ei saanud komitee teha kindlat otsust ravimi tõhususe kohta.