FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Fulphila is equivalent to that of Neulasta in reducing the duration of neutropenia.
Estonian: Peale selle tõendati keemiaravi läbinud rinnavähipatsientide uuringus, et Fulphila oli neutropeenia kestuse vähendamisel sama efektiivne kui Neulasta.
English: All these data were considered sufficient to conclude that Fulphila will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Estonian: Nende piisavate andmete põhjal järeldati, et Fulphila efektiivsus ja ohutus on heakskiidetud näidustustel võrreldav Neulasta efektiivsuse ja ohutusega.
English: Fulphila can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Estonian: Ravi peab algama ja toimuma vähi või verehäirete ravis kogenud arsti järelevalve all.
English: An overview of Fulphila and why it is authorised in the EU
Estonian: Ülevaade ravimist Fulphila ja ELis müügiloa väljastamise põhjendus
English: Fulphila is a ‘biosimilar medicine'.
Estonian: Fulphila on bioloogiliselt sarnane ravim.
English: Pain in muscles is also common.
Estonian: Sage kõrvalnäht on ka lihasevalu.
English: What benefits of Fulphila have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Fulphila kasulikkus?
English: Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Estonian: Filgrastiim soodustab leukotsüütide (vere valgeliblede) teket luuüdis, mis suurendab leukotsüütide sisaldust ja ravib sellega neutropeeniat.
English: In Fulphila, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Estonian: Fulphilas on filgrastiim pegüleeritud (seotud keemilise aine polüetüleenglükooliga).
English: Fulphila is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Estonian: Neutropeenia (neutrofiilide ehk teatud valgevereliblede vähesus) on vähiravi sage kõrvalnäht ja see võib suurendada patsientide vastuvõtlikkust infektsioonidele (nakkustele).
English: In addition, a study involving 194 patients who had chemotherapy before or after surgery for breast cancer showed that Fulphila was as effective as Neulasta in reducing the duration of neutropenia.
Estonian: Lisaks oli Fulphila neutropeenia kestuse vähendamisel sama efektiivne kui Neulasta uuringus, milles osales 194 patsienti, kes said pärast rinnavähi operatsiooni keemiaravi.
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Estonian: Seda turustatakse subkutaanse (nahaaluse) süstelahusena eeltäidetud süstlis.
English: Why is Fulphila authorised in the EU?
Estonian: Fulphila Euroopa Liidus heakskiitmise põhjused
English: The full EPAR for Clopidogrel Apotex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Clopidogrel Apotex kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The name of the medicine was changed to Clopidogrel Apotex on 20 January 2010.
Estonian: Ravimi nimetus muudeti 20. jaanuaril 2010 Clopidogrel Apotexiks.
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Estonian: Ravimit kasutatakse patsientidel, kellel on vähemalt üks vaskulaarhäiretegur, näiteks südameinfarkti või insuldi riskitegur, kes ei saa võtta K-vitamiini antagoniste (vere hüübimist pärssivad ravimid) ja kellel on väiksem verejooksu risk.
English: Previously known as Clopidogrel Mylan Pharma.
Estonian: Varasem nimetus Clopidogrel Mylan Pharma.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Estonian: Ägeda koronaarsündroomi korral algab ravi üldiselt küllastusannusega, kus võetakse neli 75 mg tabletti.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan Pharma on 16 October 2009.
Estonian: Euroopa Komisjon andis ravimi Clopidogrel Mylan Pharma müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. oktoobril 2009.
English: Clopidogrel Apotex clopidogrel
Estonian: Clopidogrel Apotex klopidogreel
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Apotex is used together with aspirin, the dose of which should not be higher than 100 mg.
Estonian: Ägeda koronaarsündroomi ja kodade virvenduse korral kasutatakse Clopidogrel Apotexi koos aspiriiniga, mille annus ei tohi ületada 100 mg.
English: For more information about treatment with Clopidogrel Apotex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Clopidogrel Apotex toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The standard dose of Clopidogrel Apotex is one 75-mg tablet once a day.
Estonian: Clopidogrel Apotexi tavaannus on üks 75 mg tablett üks kord ööpäevas.
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 Clopidogrel Apotex.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Clopidogrel Apotex is used to prevent problems caused by blood clots in adults who have:
Estonian: Ravimit Clopidogrel Apotex kasutatakse trombidest (soonesisestest verehüüvetest) põhjustatud probleemide ennetamiseks täiskasvanutel, kellel on:
English: Clopidogrel Apotex can be started between seven days and six months after the stroke;
Estonian: Apotexi manustamist tohib alustada 7 päeva kuni 6 kuu jooksul pärast insulti;
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Apotex.
Estonian: See on ravimi Clopidogrel Apotex Euroopa avaliku hindamisaruande kokkuvõte.
English: Because Clopidogrel Apotex is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Estonian: Et Clopidogrel Apotex on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: This means that Clopidogrel Apotex is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Clopidogrel Apotex on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Apotex has been shown to have comparable quality and to be bioequivalent to Plavix.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel Apotexi võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
English: Clopidogrel Apotex is a medicine that contains the active substance clopidogrel.
Estonian: Clopidogrel Apotex on ravim, mis sisaldab toimeainena klopidogreeli.
English: Because Clopidogrel Apotex is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Estonian: Et Clopidogrel Apotex on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Clopidogrel Apotexi bioekvivalentsust võrdlusravimiga Plavix.
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Estonian: • hiljuti olnud isheemiline insult (aju teatud osa verevarustushäiretest tingitud insult); Clopidogrel
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Plavixi korral, ületab ravimi Clopidogrel Apotexi kasulikkus sellega kaasnevad riskid.
English: Clopidogrel Apotex is a ‘generic medicine'.
Estonian: Clopidogrel Apotex on geneeriline ravim.
English: What is Clopidogrel Apotex?
Estonian: Mis on Clopidogrel Apotex?
English: Clopidogrel Apotex can be started between a few days and 35 days after the attack;
Estonian: • hiljuti olnud südameinfarkt; Clopidogrel Apotexi manustamist tohib alustada mõne kuni 35 päeva jooksul pärast infarkti;
English: The Committee recommended that Clopidogrel Apotex be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi müügiloa.
English: Why has Clopidogrel Apotex been approved?
Estonian: Miks Clopidogrel Apotex heaks kiideti?
English: Other information about Clopidogrel Apotex:
Estonian: Muu teave Clopidogrel Apotexi kohta
English: include heart attacks and unstable angina (a severe type of chest pain).
Estonian: Äge koronaarsündroom on südamehaiguste rühm, kuhu kuuluvad südameinfarkt ja ebastabiilne stenokardia (rinnaangiin, teatud tugev
English: How has Clopidogrel Apotex been studied?
Estonian: Kuidas Clopidogrel Apotexi uuriti?
English: How does Clopidogrel Apotex work?
Estonian: Kuidas Clopidogrel Apotex toimib?
English: The active substance in Clopidogrel Apotex, clopidogrel, is an inhibitor of platelet aggregation.
Estonian: Clopidogrel Apotexi toimeaine klopidogreel on trombotsüütide agregatsiooni (vereliistakute kokkukleepumise) inhibiitor, mis aitab ennetada trombide (soonesiseste verehüüvete) tekkimist.
English: How is Clopidogrel Apotex used?
Estonian: Kuidas Clopidogrel Apotexi kasutatakse?
English: What are the benefits and risks of Clopidogrel Apotex?
Estonian: Milles seisneb Clopidogrel Apotexi kasulikkus ja mis riskid ravimiga kaasnevad?
English: What is Clopidogrel Apotex used for?
Estonian: Milleks Clopidogrel Apotexi kasutatakse?
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Estonian: Pakendi iseloomustus Pakendi sisuPakendi suurus
English: These enzymes are needed for the production of serotonin.
Estonian: Neid ensüüme on vaja serotoniini tootmiseks.
English: What measures are being taken to ensure the safe and effective use of Xermelo?
Estonian: Mis meetmed võetakse, et tagada Xermelo ohutu ja efektiivne kasutamine?
English: The European Medicines Agency therefore decided that Xermelo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Xermelo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The side effects that were seen, which mainly affected the gut, did not raise major concerns and were considered mild and manageable.
Estonian: Täheldatud kõrvalnähud, mis piirdusid peamiselt seedetraktiga, ei tõstatanud erilisi probleeme ning neid peeti kergeks ja kontrolli all hoitavaks.
English: Xermelo telotristat
Estonian: Xermelo telotristaat
English: Other information about Xermelo
Estonian: Muu teave Xermelo kohta
English: The effects of Xermelo were seen from about 3 weeks after starting treatment.
Estonian: Xermelo ravitoimet täheldati umbes 3 nädala möödudes ravi alustamisest.
English: The most common side effects with Xermelo (which may affect more than 1 in 10 people) are abdominal (belly) pain, increases in the liver enzyme gamma-glutamyl transferase, and tiredness, and are usually mild or moderate.
Estonian: Xermelo kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on kõhuvalu, gamma-glutamüültransferaasi (maksaensüüm) aktiivsuse suurenemine ja väsimus ning enamasti on need kerged või mõõdukad.
English: It is available as tablets containing 250 mg of telotristat and the recommended dose is one tablet three times a day.
Estonian: Xermelot turustatakse tablettidena, mis sisaldavad 250 mg telotristaati, ning soovitatav annus on üks tablett kolm korda ööpäevas.
English: What is Xermelo and what is it used for?
Estonian: Mis on Xermelo ja milleks seda kasutatakse?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xermelo have been included in the summary of product characteristics and the package leaflet.
Estonian: Xermelo ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Doses may need to be reduced in patients with mildly or moderately reduced liver function.
Estonian: Annust võib olla vaja vähendada maksa kerge või mõõduka talitlushäirega patsientidel.
English: The excess serotonin can cause severe diarrhoea as well as other symptoms such as flushing of the face and cramps.
Estonian: Liiga suures koguses serotoniini võib põhjustada rasket kõhulahtisust ning ka muid sümptomeid, näiteks näoõhetus ja krambid.
English: Although small, this reduction was considered significant given that patients view the frequency of bowel movements as a symptom with an important impact on their quality of life.
Estonian: Kuigi muutus oli väike, peeti seda oluliseks, kuna patsientide arvates mõjutab sooletühjenduste sagedus oluliselt elukvaliteeti.
English: Why is Xermelo approved?
Estonian: Miks Xermelo heaks kiideti?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Xermelo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Xermelo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Xermelo.
Estonian: See on ravimi Xermelo Euroopa avaliku hindamisaruande kokkuvõte.
English: The benefits of adding Xermelo to treatment have been shown in one main study involving 135 patients with carcinoid syndrome whose diarrhoea had not been fully controlled with somatostatin analogues alone.
Estonian: Xermelo kasulikkust ravile lisamisel tõendati ühes põhiuuringus, milles osales 135 kartsinoidsündroomiga patsienti, kelle kõhulahtisus ei olnud täielikult allunud ravile üksnes somatostatiini analoogidega.
English: Xermelo was compared with placebo (a dummy treatment) and the main measure of effectiveness was the change in average number of daily bowel movements over the 12 weeks of the study.
Estonian: Xermelot võrreldi platseeboga (näiv ravim) ning efektiivsuse põhinäitaja oli ööpäevaste sooletühjenduste keskmise arvu muutus 12 uuringunädala jooksul.
English: The full EPAR for Xermelo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Xermelo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The commonest side effect severe enough to cause treatment to be stopped is abdominal pain.
Estonian: Kõige sagedam ravi lõpetamist põhjustav raske kõrvalnäht on kõhuvalu.
English: By blocking the enzymes, telotristat reduces the production of serotonin in patients with carcinoid syndrome, and so relieves the symptoms of the condition.
Estonian: Ensüümide toime blokeerimisega vähendab telotristaat kartsinoidsündroomiga patsientidel serotoniini teket ning leevendab seeläbi sümptomeid.
English: It is not intended to provide practical advice on how to use Xermelo.
Estonian: Hindamisaruandes ei anta Xermelo kasutamise praktilisi nõuandeid.
English: Xermelo contains the active substance telotristat.
Estonian: Xermelo sisaldab toimeainena telotristaati.
English: What are the risks associated with Xermelo?
Estonian: Mis riskid Xermeloga kaasnevad?
English: Because the number of patients with carcinoid syndrome is low, the disease is considered ‘rare', and Xermelo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Estonian: Et kartsinoidsündroomiga patsientide arv on väike ja see haigus esineb harva, nimetati Xermelo 8. oktoobril 2009 harvikravimiks.
English: Doctors may consider stopping treatment if patients do not benefit after 12 weeks.
Estonian: Kui patsiendil ei teki 12 nädala jooksul ravivastust, võib arst kaaluda ravi lõpetamist.
English: At the start, patients given Xermelo had an average of 6.1 bowel movements per day, and this went down over the 12 weeks to an average of 4.7 per day, a reduction of 1.4 movements.
Estonian: Uuringu alguses oli Xermelot saanud patsientidel keskmiselt 6,1 sooletühjendust ööpäevas ning 12 nädala möödudes keskmiselt 4,7 sooletühjendust ööpäevas (1,4 sooletühjendust vähem).
English: For practical information about using Xermelo, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Xermelo kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How does Xermelo work?
Estonian: Kuidas Xermelo toimib?
English: For more information about treatment with Xermelo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Xermeloga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Xermelo is used together with other medicines, called somatostatin analogues, when those medicines are not sufficient on their own to control the diarrhoea.
Estonian: Xermelot kasutatakse koos somatostatiini analoogidega (teist tüüpi ravimid), kui nendest ravimitest üksi kõhulahtisuse raviks ei piisa.
English: For the full list of all side effects and restrictions with Xermelo, see the package leaflet.
Estonian: Xermelo kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The active substance in Xermelo, telotristat, blocks the action of enzymes called L-tryptophan hydroxylases.
Estonian: Xermelo toimeaine telotristaat blokeerib L-trüptofaani hüdroksülaasideks nimetatavate ensüümide toime.
English: Patients taking placebo were having an average of 5.2 bowel movements daily at the start, which fell to an average of 4.6 movements daily, a fall of 0.6 movements.
Estonian: Platseebot saanud patsientidel oli uuringu alguses keskmiselt 5,2 sooletühjendust ööpäevas ning uuringu lõpus keskmiselt 4,6 sooletühjendust ööpäevas (0,6 sooletühjendust vähem).
English: How is Xermelo used?
Estonian: Kuidas Xermelot kasutatakse?
English: Xermelo is a medicine used to treat adults with severe diarrhoea associated with a condition called carcinoid syndrome.
Estonian: Xermelo on ravim, mida kasutatakse kartsinoidsündroomiga kaasneva raske kõhulahtisuse raviks täiskasvanutel.
English: What benefits of Xermelo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Xermelo kasulikkus?
English: Carcinoid syndrome occurs when certain tumours produce and release too much of a substance called serotonin into the blood.
Estonian: Kartsinoidsündroomi korral toodavad teatavad kasvajad liiga suures koguses serotoniini (teatavat tüüpi aine) ja eritavad seda verre.
English: Xermelo has been shown to produce a reduction in the number of bowel movements suffered by patients with carcinoid syndrome not fully controlled with other medicines.
Estonian: Uuringus tõendati, et Xermelo vähendab kartsinoidsündroomiga patsientidel sooletühjenduste arvu, kui kõhulahtisus ei ole täielikult allunud muudele ravimitele.
English: Xermelo can only be obtained with a prescription.
Estonian: Xermelo on retseptiravim.
English: 29 May 2019
Estonian: 29. mai 2019
English: What is Radicava?
Estonian: Mis on Radicava?
English: Doctors use this scale to rate how well patients can talk, breath, eat and perform other normal activities.
Estonian: mõõdavad selle skaala abil, kui hästi patsiendid suudavad rääkida, hingata, süüa ja sooritada muid tavatoiminguid.
English: Radicava is a medicine that contains the active substance edaravone.
Estonian: Radicava on ravim, mis sisaldab toimeainena edaravooni.
English: ALS is a disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.
Estonian: ALS on närvisüsteemi haigus, mille korral tahtlikke liigutusi reguleerivad pea- ja seljaaju närvirakud järk-järgult degenereeruvad, põhjustades lihasfunktsiooni vähenemist ja paralüüsi.
English: However, the study involved only a small number of patients and there was not enough evidence of improvements in other important measures, such as those related to survival, breathing and muscle strength.
Estonian: Uuringus osales aga üksnes väike arv patsiente ning see ei näidanud piisavalt muude oluliste näitajate, näiteks elumuse, hingamise ja lihasjõu paranemist.
English: Withdrawal of the marketing authorisation application for Radicava (edaravone) EMA/293450/2019
Estonian: Müügiloa taotluse tagasivõtmise teave: Radicava (edaravoon) EMA/293450/2019
English: Withdrawal of the marketing authorisation application for Radicava (edaravone)
Estonian: Müügiloa taotluse tagasivõtmise teave: Radicava (edaravoon)
English: On 24 May 2019, Mitsubishi Tanabe Pharma GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Radicava intended for the treatment of amyotrophic lateral sclerosis (ALS).
Estonian: Mitsubishi Tanabe Pharma GmbH teatas 24. mail 2019 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Radicava müügiloa taotlus.
English: The company will continue with its ongoing compassionate use programmes pending discussions with national authorities that have already granted approval for compassionate use.
Estonian: Ettevõte jätkab eriloaga kasutamise programme seni, kuni kestavad arutelud riiklike asutustega, kes on eriloaga kasutamise programmid juba heaks kiitnud.
English: The Committee considered the merits of such a study but had some objections, including the fact that the treatment for ALS had changed significantly over the past few years, rendering comparisons difficult.
Estonian: Komitee kaalus sellise uuringu eeliseid, kuid esitas ka vastuväiteid, osutades muu hulgas sellele, et ALSi ravi on viimastel aastatel oluliselt muutunud, mis raskendab võrdlemist.
English: Radicava was expected to be used to slow down the worsening of the disease in patients who can still perform normal daily activities.
Estonian: Radicavat kavatseti kasutada haiguse süvenemise aeglustamiseks patsientidel, kes saavad veel sooritada igapäevaseid tavatoiminguid.
English: Given the clear need for further evidence of Radicava's effectiveness, the Committee considered the possibility of a conditional approval, which would allow the company to provide more data at a later stage.
Estonian: Arvestades selget vajadust Radicava efektiivsuse lisatõendite järele, kaalus komitee tingimusliku heakskiidu andmist, et ettevõte saaks hiljem lisaandmeid esitada.
English: Furthermore, the CHMP noted important differences between the two groups which could have influenced the final results - such as the fact that a higher number of patients in the Radicava group had less severe disease.
Estonian: Peale selle täheldas inimravimite komitee kahe rühma vahel olulisi erinevusi, mis võisid mõjutada uuringu lõpptulemusi - näiteks asjaolu, et Radicava rühmas oli suurem arv kergema haigusega patsiente.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was based on the Committee's provisional opinion on the study data.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et taotluse tagasivõtmine põhines komitee esialgsel arvamusel uuringutulemuste kohta.