FrancophonIA/ELRC3.0 huggingface dataset:
English: It attaches to excess iron in the body to form a compound called a ‘chelate' that can be removed by the body, mainly in the stool.
Estonian: See seondub organismis liigse rauaga, moodustades kelaadi (teatav ühend), mis eritub organismist põhiliselt roojaga.
English: Non-transfusion-dependent thalassaemia syndromes are blood disorders similar to beta thalassaemia major but which do not require blood transfusions.
Estonian: Vereülekandest sõltumatud talasseemiasündroomid on verehäired, mis sarnanevad suuremale beetatalasseemiale, kuid ei vaja vereülekandeid.
English: • patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin - the protein that carries oxygen around the body - in the blood) and who receive frequent blood transfusions;
Estonian: • vähemalt 6-aastased patsiendid, kellel on suurem beetatalasseemia (pärilik verehaigus, mille korral ei ole veres piisavalt normaalset hemoglobiini - valku, mis kannab organismis hapnikku laiali) ja kes saavad sageli vereülekandeid;
English: As for every medicine, the company provided studies on the quality of Deferasirox Mylan.
Estonian: Nagu iga ravimi korral, esitas ettevõte Deferasirox Mylani kvaliteedi uuringud.
English: What is Deferasirox Mylan and what is it used for?
Estonian: Mis on Deferasirox Mylan ja milleks seda kasutatakse?
English: Why is Deferasirox Mylan authorised in the EU?
Estonian: Miks Deferasirox Mylan ELis heaks kiideti?
English: Deferasirox Mylan contains the active substance deferasirox and is a ‘generic medicine'.
Estonian: Deferasirox Mylan sisaldab toimeainena deferasiroksi ja on geneeriline ravim.
English: Other information about Deferasirox Mylan
Estonian: Muu teave Deferasirox Mylani kohta
English: Deferasirox Mylan is a medicine used to treat chronic iron overload (an excess of iron in the body) in:
Estonian: Deferasirox Mylan on ravim, mida kasutatakse kroonilise raualiigsuse raviks järgmistel patsiendirühmadel:
English: An overview of Deferasirox Mylan and why it is authorised in the EU
Estonian: Ülevaade ravimist Deferasirox Mylan ja ELis müügiloa väljastamise põhjendus
English: How has Deferasirox Mylan been studied?
Estonian: Kuidas Deferasirox Mylanit uuriti?
English: How is Deferasirox Mylan used?
Estonian: Kuidas Deferasirox Mylanit kasutatakse?
English: The starting dose of Deferasirox Mylan depends on the patient's body weight, what the medicine is used for, and on the level of iron overload.
Estonian: Deferasirox Mylani algannus sõltub patsiendi kehamassist, ravitavast seisundist ja raualiigsuse tasemest.
English: • children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;
Estonian: • 2-5-aastased suurema beetatalasseemiaga lapsed, kes saavad sageli vereülekandeid, kui ravi deferoksamiiniga (samuti raualiigsuse ravim) on vastunäidustatud või ebapiisav;
English: Deferasirox Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload.
Estonian: Ravi peab algama ja toimuma kroonilise raualiigsuse ravis kogenud arsti järelevalve all.
English: The active substance in Deferasirox Mylan, deferasirox, is an ‘iron chelator'.
Estonian: Deferasirox Mylani toimeaine deferasiroks on rauda kelaativ aine.
English: • patients from 2 years of age with beta thalassaemia major who receive infrequent blood transfusions, when deferoxamine cannot be used or is inadequate;
Estonian: • vähemalt 2-aastased suurema beetatalasseemiaga patsiendid, kes saavad harva vereülekandeid, kui ravi deferoksamiiniga on vastunäidustatud või ebapiisav;
English: • patients from 10 years of age with non-transfusion-dependent thalassaemia syndromes, when deferoxamine cannot be used or is inadequate.
Estonian: • vähemalt 10-aastased vereülekandest sõltumatute talasseemiasündroomidega patsiendid, kui ravi deferoksamiiniga on vastunäidustatud või ebapiisav.
English: • patients from 2 years of age who suffer from other types of anaemia (low levels of haemoglobin in the blood) and who receive blood transfusions, when deferoxamine cannot be used or is inadequate;
Estonian: • muud tüüpi aneemiaga (vere väike hemoglobiinisisaldus) vähemalt 2-aastased patsiendid, kes saavad vereülekandeid, kui ravi deferoksamiiniga on vastunäidustatud või ebapiisav;
English: How does Deferasirox Mylan work?
Estonian: Kuidas Deferasirox Mylan toimib?
English: What are the benefits and risks of Deferasirox Mylan?
Estonian: Milles seisneb Deferasirox Mylani kasulikkus ja mis riskid ravimiga kaasnevad?
English: Trydonis received a marketing authorisation valid throughout the EU on 26 April 2018.
Estonian: Trydonis on saanud müügiloa, mis kehtib kogu ELis, 26. aprillil 2018.
English: Other information about Trydonis
Estonian: Muu teave Trydonise kohta
English: What measures are being taken to ensure the safe and effective use of Trydonis?
Estonian: Mis meetmed võetakse, et tagada Trydonise ohutu ja efektiivne kasutamine?
English: Further information on Trydonis can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/trydonis.
Estonian: Lisateave Trydonise kohta on ameti veebilehel: https://www.ema.europa.eu/en/medicines/human/EPAR/trydonis.
English: The company that makes Trimbow has agreed that its scientific data can be used for Trydonis (‘informed consent').
Estonian: Trimbowi tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka Trydonise toetuseks (teabel põhinev nõusolek).
English: As for all medicines, data on the use of Trydonis is continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Trydonise kasutamise kohta pidevat järelevalvet.
English: What is Trydonis and what is it used for?
Estonian: Mis on Trydonis ja milleks seda kasutatakse?
English: Trydonis (beclometasone / formoterol / glycopyrronium bromide)
Estonian: Trydonis (beklometasoon/formoterool/glükopürrooniumbromiid)
English: For more information about using Trydonis, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Trydonise kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Side effects reported with Trydonis are carefully evaluated and any necessary action taken to protect patients.
Estonian: Trydonise kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: The European Medicines Agency therefore decided that Trydonis's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Trydonise kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: What are the risks associated with Trydonis?
Estonian: Mis riskid Trydonisega kaasnevad?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trydonis have been included in the summary of product characteristics and the package leaflet.
Estonian: Trydonise ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: How is Trydonis used?
Estonian: Kuidas Trydonist kasutatakse?
English: In the first study lasting a year, after 26 weeks of treatment, Trydonis improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose.
Estonian: Esimeses uuringus, mis kestis ühe aasta, parandas Trydonis 26 ravinädala järel patsientide forsseeritud esimese sekundi ekspiratoorset mahtu (FEV1, suurim õhumaht, mida inimene suudab 1 sekundi jooksul välja hingata) 82 ml võrra enne annust ja 261 ml võrra pärast annust.
English: Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs..
Estonian: Beeta-2-agonistid ja muskariiniretseptori antagonistid laiendavad hingamisteid, kortikosteroidid vähendavad põletikku hingamisteedes ja kopsudes.
English: In this study, Trydonis was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.
Estonian: Selles uuringus oli Trydonis ägenemiste arvu vähendamisel sama efektiivne kui tiotroopium koos beklometasooni ja formoterooli kombinatsiooniga.
English: Trydonis is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist.
Estonian: Trydonist kasutatakse säilitusraviks (tavaraviks) patsientidel, kelle haigus ei allu piisavalt ravile vaatamata kombinatsioonravile kahe KOK-ravimiga, beeta-2-agonisti ja kas inhaleeritava kortikosteroidi või pikatoimelise muskariiniretseptori antagonistiga.
English: What benefits of Trydonis have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Trydonise kasulikkus?
English: For the full list of side effects and restrictions with Trydonis, see the package leaflet.
Estonian: Trydonise kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Trydonis is available as a liquid in a portable inhaler device.
Estonian: Trydonist turustatakse vedelikuna kaasaskantavas inhalaatoris.
English: No major safety concerns have been reported with Trydonis, with side effects being manageable and similar to other COPD medicines.
Estonian: Trydonisega seoses ei ole teatatud olulistest ohutusprobleemidest ning ravimi kõrvalnähte peetakse hallatavateks ja sarnasteks teiste kroonilise obstruktiivse kopsuhaiguse ravimite kõrvalnähtudega.
English: Trydonis is a medicine used in adults to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Estonian: Trydonis on ravim, mida kasutatakse mõõduka kuni raske kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamiseks täiskasvanutel.
English: In the third study lasting a year, patients treated with Trydonis had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.
Estonian: Kolmandas uuringus, mis kestis ühe aasta, oli Trydonist kasutanud patsientidel sümptomite ägenemiste arv aastas 15% väiksem kui patsientidel, kes kasutasid indakaterooli (pikatoimeline beeta2-agonist) ja glükopürrooniumbromiidi kombinatsiooni.
English: Trydonis contains the active substances beclometasone, formoterol and glycopyrronium bromide.
Estonian: Trydonis sisaldab toimeainetena beklometasooni, formoterooli ja glükopürrooniumbromiidi.
English: In the second study lasting a year, patients treated with Trydonis had 20% fewer exacerbations (flareups of symptoms) per year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist).
Estonian: Teises uuringus, mis kestis ühe aasta, oli Trydonist kasutanud patsientidel sümptomite ägenemiste arv aastas 20% väiksem kui patsientidel, kes kasutasid tiotroopiumi (pikatoimeline muskariiniretseptori antagonist).
English: Side effects with Trydonis include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth.
Estonian: Trydonise kõrvalnähud on suuõõne kandidoos (pärmseene Candida põhjustatud seeninfektsioon suuõõnes), lihasespasmid ja suukuivus.
English: An overview of Trydonis and why it is authorised in the EU
Estonian: Ülevaade ravimist Trydonis ja ELis müügiloa väljastamise põhjendus
English: The three active substances in Trydonis work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.
Estonian: Trydonise kolmel toimeainel on eri toimemehhanismid, mis aitavad vähendada põletikku ja hoida hingamisteed avatuna, võimaldades patsiendil kergemini hingata.
English: How does Trydonis work?
Estonian: Kuidas Trydonis toimib?
English: Trydonis is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD.
Estonian: Trydonis on efektiivne ägenemiste esinemissageduse vähendamisel ja kopsutalitluse parandamisel kroonilise obstruktiivse kopsuhaigusega patsientidel.
English: Beclometasone belongs to anti-inflammatory medicines known as corticosteroids.
Estonian: Beklometasoon kuulub põletikuvastaste ravimite kortikosteroidide rühma.
English: It opens the airways by blocking muscarinic receptors in muscle cells in the lungs.
Estonian: See blokeerib kopsus lihasrakkude muskariiniretseptorid, mistõttu hingamisteed avanevad.
English: Trydonis has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a muscarinic receptor antagonist alone.
Estonian: Kolmes põhiuuringus, milles osales üle 5500 patsiendi, kelle sümptomid ei allunud piisavalt kas kombinatsioonravile kahe muu KOK-ravimiga või ravile üksnes muskariiniretseptori antagonistiga, tõendati, et Trydonis on efektiivne kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamisel.
English: By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Trydonis (beclometasone plus formoterol).
Estonian: Patsientidel, kes kasutasid ravimit, mis sisaldas üksnes kaht Trydonise toimeainet (beklometasoon ja formoterool), suurenes FEV1 vastavalt 1 ja 145 ml enne ja pärast annuse manustamist.
English: The medicine can only be obtained with a prescription.
Estonian: Trydonis on retseptiravim.
English: This summary was last updated in 05-2015.
Estonian: Kokkuvõtte viimane uuendus: 03-2015.
English: The full EPAR for Fasturtec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Dutrebise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Fasturtec
Estonian: Muu teave Dutrebise kohta
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fasturtec on 23 February 2001.
Estonian: Euroopa Komisjon andis Dutrebise müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. märtsil
English: This is a summary of the European public assessment report (EPAR) for Fasturtec.
Estonian: See on ravimi Dutrebis Euroopa avaliku hindamisaruande kokkuvõte.
English: The CHMP decided that Fasturtec's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Dutrebise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
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 Fasturtec.
Estonian: Selles selgitatakse, kuidas amet hindas ravimit, et soovitada müügiloa andmist Euroopa Liidus ja kasutustingimusi.
English: What benefit has Fasturtec shown during the studies?
Estonian: Milles seisneb uuringute põhjal Dutrebise kasulikkus?
English: For more information about treatment with Fasturtec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Dutrebisega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What is the risk associated with Fasturtec?
Estonian: Mis riskid Dutrebisega kaasnevad?
English: Why has Fasturtec been approved?
Estonian: Miks Dutrebis heaks kiideti?
English: Fasturtec rasburicase
Estonian: Dutrebis lamivudiin/raltegraviir
English: How is Fasturtec used?
Estonian: Kuidas Dutrebist kasutatakse?
English: For the full list of all side effects reported with Fasturtec, see the package leaflet.
Estonian: Dutrebise kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What is Fasturtec used for?
Estonian: Mis on Dutrebis ja milleks seda kasutatakse?
English: The most common side effects with Fasturtec (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache, fever and diarrhoea.
Estonian: Lamivudiini ja raltegraviiri kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu ja iiveldus.
English: Two of the studies were designed to define the best dose to use.
Estonian: Töötati välja riskijuhtimiskava, et tagada Dutrebise võimalikult ohutu kasutamine.
English: The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which transforms uric acid into another chemical called allantoin, which can easily be excreted by the kidneys in the urine.
Estonian: Teine toimeaine, raltegraviir, on integraasiinhibiitor, mis blokeerib HIVi paljunemisel vajaliku ensüümi integraasi.
English: This helps to reduce the levels of uric acid in the blood, thereby reducing the load on the kidney and preventing any damage.
Estonian: Dutrebis vähendab HIV-i kogust veres ja hoiab selle sisalduse väikese.
English: How does Fasturtec work?
Estonian: Kuidas Dutrebis toimib?
English: For the full list of restrictions, see the package leaflet.
Estonian: Üksikasjalik teave on pakendi infolehel.
English: Fasturtec must not be used in patients with a deficiency in (low levels of) glucose 6 phosphate dehydrogenase (G6PD) or other metabolic disorders known to cause haemolytic anaemia (low haemoglobin levels caused by the abnormal breakdown of red blood cells).
Estonian: Dutrebis on ravim, mida kasutatakse omandatud immuunpuudulikkuse sündroomi (AIDS) põhjustava inimese I tüüpi immuunpuudulikkuse viiruse (HIV-1) infektsiooniga patsientide raviks.
English: In the comparative study, Fasturtec was more effective than allopurinol: over the first 96 hours after treatment, patients treated with Fasturtec had a lower average blood level of uric acid than the patients treated with allopurinol (128.1 and 328.5 mg.h/dl, respectively).
Estonian: Efektiivsuse põhinäitaja oli nende patsientide osakaal, kelle vere viirusesisaldus vähenes alla 50 HIV RNA koopia/ml ehk 68,8%.
English: The dose-finding studies showed that, after 48 hours, Fasturtec at a daily dose of 0.2 mg per kg reduced the uric acid levels to normal in 95% of patients.
Estonian: Dutrebist turustatakse tablettidena, mis sisaldavad 150 mg lamivudiini ja 300 mg raltegraviiri, ning soovitatav annus on üks tablett kaks korda ööpäevas.
English: The medicine can only be obtained with a prescription.
Estonian: Ravi tohib määrata ainult HIV-infektsiooni ravis kogenud arst.
English: The enzyme was originally extracted from a fungus, but in Fasturtec it is produced by a method known as ‘recombinant DNA technology': it is made by a yeast into which a gene (DNA) has been introduced that makes it able to produce urate oxidase.
Estonian: See blokeerib pöördtranskriptaasi toime; pöördtranskriptaas on ensüüm, mida inimese immuunpuudulikkuse viirus (HIV) vajab, et saada pärast raku nakatamist geneetilist informatsiooni viiruse paljundamiseks.
English: Fasturtec is a medicine that contains the active substance rasburicase.
Estonian: Üks toimeaine, lamivudiin, on nukleosiidne pöördtranskriptaasi inhibiitor (NRTI).
English: The benefits of Fasturtec were first studied in three main studies involving a total of 293 patients, including adults and children.
Estonian: Et lamivudiin ja raltegraviir on HIV-infektsiooni ravis juba eraldi heaks kiidetud, esitas ettevõte nende ravimite heakskiitmiseks kasutatud uuringute andmed, sh uuringuandmed, milles osales 160 patsienti, kes said kokku 240 nädalat raltegraviiri koos lamivudiiniga (lisaks teisele HIV-ravimile tenofoviirile).
English: Fasturtec was not compared with another medicine in this study.
Estonian: Dutrebist tuleb kasutada kombinatsioonis teiste HIVravimitega.
English: The duration of treatment is adjusted depending on the patient's blood levels of uric acid and the doctor's judgment.
Estonian: Selle alusel lisati Dutrebise ravimi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Patients undergoing chemotherapy may be at risk of rapid tumour lysis, where many cancer cells are broken down at once causing a sudden rise of uric acid in the blood which can cause damage to the kidneys.
Estonian: Uuringute tulemused näitasid, et Dutrebis tekitas organismis sarnase lamivudiini sisalduse kui lamivudiini eraldi manustamisel; kuigi raltegraviiri sisaldus erines veidi, tõendati, et Dutrebis tekitab raltegraviiri sisalduse, mis reguleerib on viirust sarnase efektiivsusega.
English: The recommended dose is 0.2 mg per kilogram body weight in both children and adults, given as a daily infusion for up to seven days.
Estonian: Seda kasutatakse koos teiste HIV-ravimitega ning seda tohib kasutada ainult vähemalt 6-aastastel ja vähemalt 30 kg kaaluvatel patsientidel.
English: 1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3
Estonian: 1 doos (0,5 ml) sisaldab: B-hepatiidi pinnaantigeen 1, 2, 3
English: 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Estonian: 2adsorbeeritud alumiiniumfosfaadil (kokku 0,5 milligrammi Al3+) Valmistatud pärmirakkudes (Saccharomyces cerevisiae) rekombinantse DNA tehnoloogiaga.
English: 1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
Estonian: 1adjuvandina on kasutatud AS04C, mis sisaldab: - 3-O-desatsüül-4'- monofosforüüllipiid A (MPL) 2
English: 1 pre-filled syringe + 1 needle
Estonian: 1 eeltäidetud süstal + 1 nõel
English: 10 pre-filled syringes
Estonian: 10 eeltäidetud süstalt
English: Content (concentration)
Estonian: Sisaldus
English: Immediate Packaging
Estonian: Ravimvorm Manustamisviis Pakend
English: • The Committee considered the notification of the referral triggered by the Germany under Article 29(4) of Directive 2001/83/EC;
Estonian: • inimravimite komitee arutas esildist, mille algatas Saksamaa direktiivi 2001/83/EÜ artikli 29 lõike 4 kohaselt;
English: Overall summary of the scientific evaluation of Nanotop and associated names (see Annex I)
Estonian: Ravimi Nanotop ja sarnaste nimetuste (vt I lisa) teadusliku hindamise üldkokkuvõte
English: In addition the MAH has provided data on Nanocoll and Nanotop batches that were analysed on four days (six batches), and on the same day.
Estonian: Peale selle esitas müügiloa hoidja andmed Nanocolli ja Nanotopi partiide kohta, mida analüüsiti neljal päeval (kuus partiid) ning samal päeval.
English: If the subcutaneously injected particles are too small they “run” through the lymphatic system too quickly and disappear before imaging techniques can be applied.
Estonian: Kui subkutaanselt manustatud osakesed on liiga väikesed, liiguvad lümfisüsteemist läbi liiga kiiresti ja kaovad, enne kui saab kasutada piltdiagnostikat.
English: The legal basis for the submitted marketing authorisation application (MAA) was Article 10a "well established use", relying on appropriate scientific literature data of another similar product, Nanocoll.
Estonian: Esitatud müügiloa taotluse õiguslik alus oli artikkel 10a („hästi tõestatud meditsiiniline kasutus”), mis põhines teise sarnase toote Nanocolli kohta avaldatud teaduslikel andmetel.
English: The data provided by the MAH support the notion that variability may decrease when batches are analysed over a shorter period of time.
Estonian: Müügiloa hoidja esitatud andmed kinnitavad arvamust, et partiidevaheline varieeruvus võib väheneda, kui partiisid analüüsitakse lühema aja vältel.