FrancophonIA/ELRC3.0 huggingface dataset:
English: • insulin, either on its own or together with metformin.
Estonian: • insuliin ainsa ravimina või koos metformiiniga.
English: What is the risk associated with Trajenta?
Estonian: Mis riskid Trajentaga kaasnevad?
English: For the full list of all side effects reported with Trajenta, see the package leaflet.
Estonian: Trajenta kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: However the benefit of adding Trajenta to pioglitazone treatment was not considered to have been sufficiently established.
Estonian: Komitee leidis aga, et Trajenta pioglitasoonile lisamise kasulikkus ei ole piisavalt tõestatud.
English: Trajenta was shown to be more effective than placebo at reducing HbA1c levels in all combinations studied:
Estonian: Uuringute põhjal oli Trajenta HbA1c sisalduse vähendamisel efektiivsem kui platseebo kõikides uuritud kombinatsioonides:
English: Trajenta is also used on its own in patients whose blood sugar levels are not adequately controlled by diet and exercise alone and who cannot be treated with metformin because they cannot tolerate it or because they have kidney problems.
Estonian: Trajentat kasutatakse ka ainsa ravimina patsientidel, kelle vere glükoosisisaldus ei ole piisavalt reguleeritud ainuüksi dieedi ja füüsilise koormusega ning keda ei saa ravida metformiiniga, sest nad ei talu seda ravimit või neil on neeruprobleemid.
English: Trajenta was also compared with placebo when used on its own in 503 patients.
Estonian: Lisaks võrreldi Trajentat platseeboga, kasutades seda ainsa ravimina 503 patsiendil.
English: Hypoglycaemia was seen in around 15 out of 100 patients treated with the triple combination of Trajenta with metformin and a sulphonylurea (around twice as many as the placebo group).
Estonian: Hüpoglükeemiat esines umbes 15-l 100st patsiendist, kes said Trajentat koos metformiini ja sulfonüüluureravimiga (umbes kaks korda rohkem kui platseeborühmas).
English: Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Estonian: Linagliptiin vähendab ka maksas tekkiva glükoosi kogust, suurendades insuliini ja vähendades glükagooni (teatud hormoon) sisaldust.
English: When added to metformin the dose of metformin should remain unchanged, however when combined with a sulphonylurea or insulin, a lower dose of the sulphonylurea or insulin may be considered because of the risk of hypoglycaemia (low blood sugar).
Estonian: Kui Trajentat võetakse koos metformiiniga, siis peab metformiini annus jääma samaks, kuid kombineerituna sulfonüüluurearavimi või insuliiniga võib hüpoglükeemia (normaalsest väiksem glükoosisisaldus veres) riski tõttu kaaluda sulfonüüluurearavimi või insuliini annuse vähendamist.
English: Why has Trajenta been approved?
Estonian: Miks Trajenta heaks kiideti?
English: Trajenta on its own was also shown to be effective compared with placebo and was considered appropriate for patients who cannot take metformin either due to intolerance or because they have kidney problems.
Estonian: Uuringud näitasid, et Trajenta on efektiivsem kui platseebo ka ainsa ravimina ja seda peeti sobivaks ravimiks patsientidele, kes ei saa võtta metformiini kas talumatuse või neeruprobleemide tõttu.
English: Trajenta is used to treat type 2 diabetes with the following antidiabetes medicines when blood sugar levels are not already adequately controlled by diet, exercise and these antidiabetes medicines taken alone:
Estonian: Trajentat kasutatakse II tüüpi (insuliinisõltumatu) diabeedi raviks järgmiste diabeediravimitega, kui dieedi, füüsilise koormuse ja nimetatud diabeediravimitega ei ole vere glükoosisisaldus piisavalt reguleeritud:
English: Trajenta was also more effective than placebo when used on its own, reducing HbA1c levels by 0.46 percentage points compared with a rise of 0.22 percentage points seen with placebo.
Estonian: Trajenta oli efektiivsem kui platseebo ka kasutamisel ainsa ravimina, vähendades HbA1c sisaldust 0,46%, samas kui platseebo kasutamisel suurenes vastav näitaja 0,22%.
English: Linagliptin does not work when the blood glucose is low.
Estonian: Kui vere glükoosisisaldus on väike, linagliptiin ei toimi.
English: The active substance in Trajenta, linagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Estonian: Trajenta toimeaine linagliptiin on ensüümi dipeptidüülpeptidaas-4 (DPP-4) inhibiitor, mille toime seisneb inkretiinhormoonide organismis lagunemise blokeerimises.
English: What is Trajenta?
Estonian: Mis on Trajenta?
English: The medicine can only be obtained with a prescription.
Estonian: Trajenta on retseptiravim.
English: By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Estonian: Kui vere glükoosisisaldus on suur, stimuleerib linagliptiin kõhunääret tekitama rohkem insuliini, suurendades inkretiinhormoonide sisaldust veres.
English: How has Trajenta been studied?
Estonian: Kuidas Trajentat uuriti?
English: What benefit has Trajenta shown during the studies?
Estonian: Milles seisneb uuringute põhjal Trajenta kasulikkus?
English: Based on the results of the main studies, the CHMP concluded that significant benefits in controlling blood glucose levels were seen in the combinations of Trajenta with metformin, with metformin plus a sulphonylurea, and with insulin with or without metformin.
Estonian: Tuginedes põhiuuringute tulemustele, järeldas inimravimite komitee, et Trajenta kombineerituna metformiiniga ning Trajenta kombineerituna metformiini ja sulfonüüluurearavimiga ning Trajenta kombineerituna insuliiniga koos metformiiniga või ilma aitab reguleerida vere glükoosisisaldust olulisel määral.
English: How is Trajenta used?
Estonian: Kuidas Trajentat kasutatakse?
English: What is Trajenta used for?
Estonian: Milleks Trajentat kasutatakse?
English: • in combination with pioglitazone, a reduction of 1.25 percentage points was seen with Trajenta compared with a reduction of 0.75 percentage points with placebo;
Estonian: • Trajenta kasutamisel pioglitasooniga vähenes HbA1c sisaldus 1,25% ja platseebo kasutamisel pioglitasooniga vähenes HbA1c sisaldus 0,75%;
English: • in combination with insulin with or without metformin and/or pioglitazone, a reduction of 0.55
Estonian: • Trajenta kasutamisel insuliiniga koos metformiiniga või ilma ja/või pioglitasooniga vähenes HbA1c sisaldus 0,55% ning platseebo kasutamisel insuliiniga koos metformiiniga või ilma ja/või pioglitasooniga suurenes HbA1c sisaldus 0,10%.
English: This gives an indication of how well blood glucose is controlled.
Estonian: HbA1c näitab vere glükoosisisalduse reguleeritust.
English: • when used in combination with a metformin plus a sulphonylurea, a reduction of 0.72 percentage points was seen with Trajenta compared with a reduction of 0.10 percentage points with placebo;
Estonian: • Trajenta kasutamisel metformiini ja sulfonüüluureravimiga vähenes HbA1c sisaldus 0,72% ning platseebo kasutamisel metformiini ja sulfonüüluureravimiga vähenes HbA1c sisaldus 0,10%;
English: How does Trajenta work?
Estonian: Kuidas Trajenta toimib?
English: • when used in combination with metformin, a reduction of 0.56 percentage points was seen with
Estonian: • Trajenta kasutamisel metformiiniga vähenes HbA1c sisaldus 0,56% ja platseebo kasutamisel metformiiniga suurenes HbA1c sisaldus 0,10%;
English: • Educational brochure
Estonian: • Õppematerjali
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Estonian: • Toote omaduste kokkuvõtet, pakendi infolehte ja märgistust
English: Key elements to be included in the educational brochure
Estonian: Õppematerjalis sisalduvad põhielemendid
English: • The need to inform patients about the effects of food on Tasigna o Not to eat within two hours before and one hour after taking Tasigna o The need to avoid foods such as grapefruit juice which inhibit CYP3A4 enzymes
Estonian: • Informatsioon patsientidele toidu mõjust Tasigna'le o Ei tohi süüa kaks tundi enne ja üks tund peale Tasigna võtmist o Peab hoiduma CYP3A4 ensüümi inhibeeriva toimega toidust, nagu näiteks greipfruudimahl
English: • That Tasigna is metabolised by CYP3A4 and that strong inhibitors or inducers of this enzyme may significantly affect exposure to Tasigna.
Estonian: • Tasigna metabolism ensüümi CYP3A4 toimel ja selle tugevatoimeliste inhibiitorite või induktorite oluline mõju Tasigna toimele.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
Estonian: LIIKMESRIIKIDES RAKENDATAVAD TINGIMUSED VÕI PIIRANGUD, MIS PUUDUTAVAD RAVIMI OHUTUT JA TÕHUSAT KASUTAMIST
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Estonian: Liikmesriigid peavad tagama, et kõik allpoolkirjeldatud tingimused või piirangud, mis puudutavad ravimi ohutut ja tõhusat kasutamist oleksid rakendatud.
English: • Information on the cardiac risks associated with the use of Tasigna o That Tasigna can cause prolongation of the QT interval and that patients at risk of arrythmia, especially torsade de pointes, should not be prescribed Tasigna.
Estonian: • Tasigna kasutamisega seotud ohud südamele o Tasigna võib põhjustada QT intervalli pikenemist, seetõttu ei tohi Tasigna´t määrata arütmia, eriti torsade de pointes ohuga patsientidele.
English: o The need to avoid co-prescription with any other medicines that might prolong the QT interval o Caution in prescribing to patients with a history of or risk factors for coronary heart disease o That Tasigna may cause fluid retention, cardiac failure and pulmonary oedema
Estonian: o Peab hoiduma samaaegselt teiste ravimite määramisest, mis võivad pikendada QT intervalli o Varasemate koronaartõve riskifaktoritega patsientidele tuleb Tasigna't määrata ettevaatusega o Tasigna võib põhjustada vedelikupeetust, südamepuudulikkust ja kopsuturset
English: The MAH shall ensure that prior to launch, all doctors who intend to prescribe Tasigna, and all pharmacists who may dispense Tasigna, are provided with a healthcare professional information pack containing the following:
Estonian: Enne turustamist peab müügiloa hoidja varustama kõik Tasigna't väljastavad arstid ja apteekrid informatsiooniga, mis sisaldab:
English: o That inhibitors may increase the potential for adverse drug reactions in particular QT interval prolongation.
Estonian: o Inhibiitorid võivad suurendada kõrvaltoimete ohtu, eriti QT intervalli pikenemist o Hoiatus käsimüügiravimite, eriti naistepuna kasutamise kohta
English: • Brief background on Tasigna, its authorised indication and posology
Estonian: • Lühike Tasigna tutvustus, näidustused ja annustamine
English: The European Commission granted a marketing authorisation valid throughout the EU for Tandemact on 8 January 2007.
Estonian: Euroopa Komisjon andis Tandmacti müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 8. jaanuaril 2007.
English: The tablet should be swallowed whole with a little water.
Estonian: Tablett tuleb neelata tervelt koos vähese veega.
English: What measures are being taken to ensure the safe and effective use of Tandemact?
Estonian: Mis meetmed võetakse, et tagada Tandemacti ohutu ja efektiivne kasutamine?
English: The full EPAR for Tandemact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Tandemacti kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day.
Estonian: Tandemacti tavaline annus on üks tablett üks kord ööpäevas, mis võetakse vahetult enne päeva esimest söögikorda või selle ajal.
English: It is available as tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).
Estonian: Seda turustatakse tablettidena (30 mg pioglitasooni ja 2 või 4 mg glimepiriidi või 45 mg pioglitasooni ja 4 mg glimepiriidi).
English: Tandemact pioglitazone and glimepiride
Estonian: Tandemact pioglitasoon ja glimepiriid
English: Other information about Tandemact
Estonian: Muu teave Tandemacti kohta
English: The patients' HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%.
Estonian: Patsientide HbA1c-sisaldus, mis oli algselt üle 7,5%, vähenes 1,22-1,64% võrra.
English: Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature.
Estonian: Et pioglitasoon on Euroopa Liidus heaks kiidetud ravimina Actos alates aastast 2000 ja glimepiriidi juba kasutatakse Euroopa Liidus varem heaks kiidetud ravimites, esitas ettevõte andmed varasematest uuringutest ning avaldatud kirjandusest.
English: At least 64% of the patients treated were classified as ‘responders', since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.
Estonian: Ravivastus registreeriti vähemalt 64%-l ravitud patsientidest: nende HbA1c vähenes uuringute kestel algselt väärtuselt vähemalt 0,6% võrra või oli neil uuringute lõpus HbA1c-sisaldus 6,1% või alla selle.
English: Treatment with Tandemact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Estonian: Tandemacti ravivastus tuleb 3-6 kuu möödudes läbi vaadata ning lõpetada ravi patsientidel, kellele ravi ei ole piisavalt kasulik.
English: The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema (swelling).
Estonian: Tandemacti kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on ülemiste hingamisteede nakkused (nohu), hüpesteesia (vähenenud puutetundlikkus), luumurrud, kehakaalu suurenemine, peapööritus, kõhupuhitus ja ödeem (turse).
English: The company that markets Tandemact will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Estonian: Tandemacti turustav ettevõte koostab ravimit määravatele arstidele teabematerjalid , milles selgitatakse südamepuudulikkuse ja kusepõie vähi võimalikku riski pioglitasooni sisaldavate ravimite kasutamisel, patsientide valikukriteeriume ning vajadust ravi regulaarselt läbi vaadata ja lõpetada, kui see ei ole patsientidele enam kasulik.
English: Tandemact contains two active substances, each of which has a different mode of action.
Estonian: Tandemact sisaldab kaht toimeainet, mille toimemehhanismid on erinevad.
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Estonian: Pioglitasoon suurendab rakkude (rasva-, lihas- ja maksarakud) tundlikkust insuliini suhtes, mis tähendab, et organism kasutab enda toodetavat insuliini paremini ära.
English: For more information about treatment with Tandemact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Tandemactiga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Tandemact.
Estonian: See on ravimi Tandemact Euroopa avaliku hindamisaruande kokkuvõte.
English: Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride.
Estonian: Tandemact on ravim, mis sisaldab kaht toimeainet: pioglitasooni ja glimepiriidi.
English: These studies used pioglitazone and sulphonylureas given as separate tablets.
Estonian: Uuringutes manustati pioglitasooni ja sulfonüüluureat eraldi tablettidena.
English: The Committee decided that Tandemact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Tandemacti kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: It is used in patients for whom metformin (a type of diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances pioglitazone and glimepiride.
Estonian: Seda kasutatakse patsientidel, kellele metformiin (diabeediravimi liik) ei sobi ning keda juba ravitakse selliste tablettide kombinatsiooniga, mis sisaldavad toimeainena pioglitasooni ja glimepiriidi.
English: Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Estonian: Glimepiriid on sulfonüüluurearavim, mis stimuleerib kõhunääret tootma rohkem insuliini.
English: The CHMP concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed.
Estonian: Inimravimite komitee järeldas, et pioglitasooni ja glimepiriidi efektiivsus II tüüpi diabeedi ravis on tõendatud ning et Tandemact lihtsustab ravi ja parandab raviskeemi järgimist, kui tuleb kasutada kahe toimeaine kombinatsiooni.
English: What is the risk associated with Tandemact?
Estonian: Mis riskid Tandemactiga kaasnevad?
English: The company used three studies to support the use of Tandemact in the same indication.
Estonian: Ettevõte esitas Tandemacti toetuseks kolm sama näidustuse kohta tehtud uuringut.
English: As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.
Estonian: Mõlema toimeaine toimel vere glükoosisisaldus väheneb ning see aitab II tüüpi diabeeti reguleerida.
English: It must not be used in patients with type 1 diabetes, patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breastfeeding.
Estonian: Seda ei tohi kasutada I tüüpi diabeediga patsiendid, diabeedi tüsistustega (ketoatsidoos või diabeetiline kooma) patsiendid ega rasedad või imetavad naised.
English: The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Estonian: Uuringutel, mis kestsid 4 kuust 2 aastani, mõõdeti glükohemoglobiini (HbA1c) sisaldust veres, mis näitab, kui hästi organism vere glükoosisisaldust reguleerib.
English: Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i.e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact.
Estonian: Patsiendid, kes võtavad pioglitasooni koos mõne teise glimepiriidiga samasse klassi kuuluva ravimiga (st muu sulfonüüluurearavimiga), tuleb enne Tandemactile üleminekut viia teiselt sulfonüüluurearavimilt üle glimepiriidile.
English: Why has Tandemact been approved?
Estonian: Miks Tandemact heaks kiideti?
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 Tandemact.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Estonian: Actos on heaks kiidetud koos sulfonüüluurearavimiga kasutamiseks II tüüpi diabeediga patsientidel, kelle ravi ainult metformiiniga ei anna rahuldavat tulemust.
English: What is Tandemact?
Estonian: Mis on Tandemact?
English: The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea.
Estonian: Neis uuringutes osales 1390 patsienti, kelle sulfonüüluurearavile lisati pioglitasoon.
English: Tandemact must not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys.
Estonian: Tandemacti ei tohi kasutada patsientidel, kellel on südamepuudulikkus, maksaprobleemid või rasked neeruprobleemid.
English: In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose.
Estonian: Kõigis kolmes uuringus saavutati patsientidel, kes said pioglitasooni ja sulfonüüluurea kombineeritud ravi, vere glükoosisisalduse parem reguleeritavus.
English: Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.
Estonian: Patsiendid, kellel tekib Tandemactiga ravimisel hüpoglükeemia (veresuhkru vähesus), võivad vajada väiksemat annust või peavad hakkama taas võtma eraldi tablette.
English: The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.
Estonian: Ettevõte esitas andmeid selle kohta, et kahe toimeaine sisaldus veres oli Tandemacti kasutanud ning eraldi tablette võtnud patsientidel ühesugune.
English: For the full list of all side effects reported with Tandemact, see the package leaflet.
Estonian: Tandemacti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tandemact have also been included in the summary of product characteristics and the package leaflet.
Estonian: Tandemacti omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems.
Estonian: Tandemacti ei tohi kasutada patsiendid, kellel on raskeid neeruprobleeme või maksaprobleeme.
English: Tandemact is used to treat adult patients who have type 2 diabetes.
Estonian: Tandemacti kasutatakse II tüüpi diabeediga (suhkurtõvega) täiskasvanud patsientide ravimiseks.
English: What benefit has Tandemact shown during the studies?
Estonian: Milles seisneb uuringute põhjal Tandemacti kasulikkus?
English: How is Tandemact used?
Estonian: Kuidas Tandemacti kasutatakse?
English: How does Tandemact work?
Estonian: Kuidas Tandemact toimib?
English: The medicine can only be obtained with a prescription.
Estonian: Tandemact on retseptiravim.
English: What is Tandemact used for?
Estonian: Milleks Tandemacti kasutatakse?
English: How has Tandemact been studied?
Estonian: Kuidas Tandemacti uuriti?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012.
Estonian: Euroopa Komisjon andis Xalkori müügiloa, mis kehtib kogu Euroopa Liidus, 23. oktoobril 2012.
English: What measures are being taken to ensure the safe and effective use of Xalkori?
Estonian: Mis meetmed võetakse, et tagada Xalkori ohutu ja efektiivne kasutamine?
English: Xalkori crizotinib
Estonian: Xalkori krisotiniib
English: The full EPAR for Xalkori can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Xalkori kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.