FrancophonIA/ELRC3.0 huggingface dataset:
English: Mycamine 50 mg powder for solution for infusion micafungin
Estonian: Mycamine 50 mg infusioonilahuse pulber mikafungiin
English: Mycamine contains sodium
Estonian: Mycamine sisaldab naatriumi
English: - Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
Estonian: Söögitoru kandidiaasi ravi patsientidel, kellel on sobilik kasutada veenisisest ravi.
English: decreased albumin in the blood (hypoalbuminaemia) - hypersensitivity - increased sweating - decreased sodium in the blood (hyponatraemia); increased potassium in the blood
Estonian: vereliistakute arvu langus (trombotsütopeenia), teatud tüüpi valgete vereliblede (eosinofiilide) arvu suurenemine, albumiini sisalduse langus veres (hüpoalbumineemia) - ülitundlikkus - suurenenud higistamine - naatriumi sisalduse vähenemine veres (hüponatreemia), kaaliumi sisalduse suurenemine veres
English: The solution must not be used if it is cloudy or has precipitated.
Estonian: Lahust, mis on hägune või milles on sade, ei tohi kasutada.
English: Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Estonian: Lahjendatuna naatriumkloriidi 9 mg/ml (0,9%) infusioonilahusega või glükoosi 50 mg/ml (5%) infusioonilahusega on ravimi kasutusaegne keemilis-füüsikaline stabiilsus tõestatud kuni 96 tunni jooksul temperatuuril 25°C, valguse eest kaitstult.
English: Renal effects
Estonian: C. tropicalis
English: General disorders and administration site conditions pyrexia, rigors injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Estonian: manustamiskoha reaktsioonid tromboos, põletik infusioonikohas, valu süstekohas, perifeerne turse
English: After reconstitution each ml contains 20 mg of micafungin (as sodium).
Estonian: Pärast lahustamist sisaldab üks milliliiter 20 mg mikafungiini (naatriummikafungiinina).
English: Each vial contains 100 mg micafungin (as sodium).
Estonian: Üks viaal sisaldab 100 mg mikafungiini (Micafunginum) (naatriummikafungiinina).
English: Therefore, please discard unused reconstituted concentrate immediately.
Estonian: Seetõttu tuleb kasutamata jäänud kontsentraat kohe minema visata.
English: Reconstituted concentrate in vial
Estonian: Lahustatud kontsentraat viaalis:
English: Common (may affect up to 1 in 10 people) - abnormal blood tests (decreased white blood cells [leucopenia; neutropenia]); decreased red blood cells (anaemia) - decreased potassium in the blood (hypokalaemia); decreased magnesium in the blood
Estonian: [leukopeenia, neutropeenia]), punaste vereliblede arvu vähenemine (aneemia ehk kehvveresus) - kaaliumi vähesus veres (hüpokaleemia), magneesiumi vähesus veres (hüpomagneseemia),
English: Hepatobiliary disorders common hyperbilirubinaemia, hepatomegaly
Estonian: Maksa ja sapiteede häired sage hüperbilirubineemia, hepatomegaalia
English: Each vial contains: 100 mg micafungin (as sodium).
Estonian: Üks viaal sisaldab: 100 mg mikafungiini (naatriummikafungiinina).
English: • To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
Estonian: • Raske seennakkusega, mida nimetatakse invasiivseks kandidiaasiks (kehas levinud nakkus), täiskasvanute, noorukite ja laste sealhulgas vastsündinute raviks.
English: The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats.
Estonian: Pärast 3 kuu pikkust või pikemat ravi uuriti rottidel muundunud hepatotsüütidega kollete ja hepatotsellulaarsete kasvajate teket.
English: Each vial contains 50 mg micafungin (as sodium).
Estonian: Üks viaal sisaldab 50 mg mikafungiini (Micafunginum) (naatriummikafungiinina).
English: Hepatic impairment
Estonian: Neutropeenia puudumine ravieelselt
English: After reconstitution each ml contains 10 mg of micafungin (as sodium).
Estonian: Pärast lahustamist sisaldab üks milliliiter 10 mg mikafungiini (naatriummikafungiinina).
English: Metabolism and nutritional disorders hypokalaemia, hypomagnesaemia, hypocalcaemia hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
Estonian: Ainevahetus- ja toitumishäired hüpokaleemia, hüpomagneseemia,
English: (hypomagnesaemia); decreased calcium in the blood (hypocalcaemia) - headache - inflammation of the vein wall (at injection-site) - nausea (feeling sick); vomiting (being sick); diarrhoea; abdominal pain - abnormal liver function tests (increased alkaline phosphatase; increased aspartate aminotransferase, increased alanine aminotransferase) - increased bile pigment in the blood (hyperbilirubinaemia) - rash - fever - rigors (shivering)
Estonian: ikterus (maksa- või vereprobleemide tõttu tekkinud naha või silmavalgete kollasus), soolde jõudva sapi hulga vähenemine (kolestaas), maksa suurenemine, maksapõletik - sügelev lööve (urtikaaria), sügelemine, nahapunetus (erüteem) - normist kõrvalekalletega neerufunktsiooni testid (kreatiniini sisalduse suurenemine veres, uurea sisalduse suurenemine veres), neerupuudulikkuse süvenemine - laktaatdehüdrogenaasi nimelise ensüümi aktiivsuse suurenemine - vere hüübimine süstekoha veenis, põletik süstekohas, valu süstekohas, vedeliku kogunemine kehas
English: Each vial contains: 50 mg micafungin (as sodium).
Estonian: Üks viaal sisaldab: 50 mg mikafungiini (naatriummikafungiinina).
English: Cardiac disorders common tachycardia
Estonian: Südame häired sage tahhükardia
English: An intact cell wall is necessary for the fungus to continue living and growing.
Estonian: Seene eluks ja kasvuks on vajalik terve rakusein.
English: Although a possible effect in decreasing gingivitis was observed, information on how the study was conducted is incomplete, so firm conclusions could not be drawn.
Estonian: Kuigi täheldati võimalikku mõju gingiviidi vähenemisele, ei olnud piisavalt teavet, kuidas uuring läbi viidi ja ei saa teha kindlaid järeldusi.
English: 31 May 2016 EMA/270540/2016
Estonian: EMA/270540/2016
English: Knotgrass herb medicines should only be used in adults and adolescents over the age of 12 years.
Estonian: Linnurohuürti sisaldavaid ravimeid tohivad kasutada üksnes täiskasvanud ja vähemalt 12 aasta vanused noorukid.
English: Knotgrass herb EMA/270540/2016
Estonian: Linnurohuürt EMA/270540/2016
English: Further information on the risks associated with knotgrass herb medicines, including the appropriate precautions for their safe use can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave linnurohuürti sisaldavate ravimitega kaasnevate riskide, sh nende ohutu kasutamise ettevaatusabinõude kohta, on taimse aine monograafias Euroopa Ravimiameti veebilehe jaotises „All documents“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of knotgrass herb medicines, including details of the Committee's conclusions can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave linnurohuürti sisaldavate ravimite hindamise kohta, sh komitee kokkuvõtte üksikasjalik kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing knotgrass herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Estonian: Linnurohuürti sisaldavate ravimite müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimsete ravimite müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslikke järeldusi.
English: Detailed instructions on how to take knotgrass herb medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: Üksikasjalik teave, kuidas võtta linnurohuürti sisaldavaid ravimeid ja kes neid tohib kasutada, on ravimi pakendi infolehel.
English: In its assessment, the HMPC considered a clinical study in men with gingivitis (inflammation of the gum).
Estonian: Taimsete ravimite komitee uuris hinnangu andmisel ka kliinilist uuringut gingiviidiga (igemepõletikuga) meestel.
English: Information on the use and licensing of knotgrass herb medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab linnurohuürti sisaldavate ravimite kasutamise ja müügilubade teavet asjakohastelt riiklikelt ravimiametitelt.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing knotgrass herb.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad linnurohuürti sisaldavate taimsete ravimite müügilubade taotlusi.
English: However, because of the limitations with the available data, the HMPC conclusions on the use of these knotgrass herb medicines are based on their long-standing use.
Estonian: Kuid kuna saada on ainult piiratud andmed, põhineb taimsete ravimite komitee järeldus linnurohuürti sisaldavate ravimite kasutamise kohta nende pikaajalisel kasutamisel.
English: Knotgrass herb preparations may also be found in combination with other herbal substances in some herbal medicines.
Estonian: Mõnes taimses ravimis võib esineda linnurohuürdi valmistisi ka kombinatsioonis teiste taimsete ainetega.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of knotgrass herb.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb linnurohuürdi meditsiinilisi kasutusviise.
English: This summary is not intended to provide practical advice on how to use medicines containing knotgrass herb.
Estonian: Kokkuvõttes ei anta linnurohuürti sisaldavate ravimite kasutamise praktilisi nõuandeid.
English: The HMPC concluded, that on the basis of its long-standing use, these knotgrass herb preparations can be used for the relief of symptoms of common cold, for treating symptoms of minor mouth or throat inflammation and for minor problems affecting the urinary tract (structures that carry urine) to increase the production of urine in order to achieve flushing of the urinary tract.
Estonian: Taimsete ravimite komitee järeldas, et lähtudes pikaajalisest kasutamisest tohib seda linnurohuürdi valmistist kasutada külmetuse sümptomite, kergete suu või kurgu põletiku sümptomite ja kergete kuseteede probleemide (et suurendada uriini tootmist ja saavutada kuseteid loputav toime) leevendamiseks.
English: If symptoms last longer than two weeks or worsen during the use of the medicine for minor urinary tract problems a doctor or qualified healthcare practitioner should be consulted.
Estonian: kasutamise ajal kauem kui kaks nädalat või halvenevad selle aja jooksul, tuleb konsulteerida arsti või pädeva tervishoiuteenuse osutajaga.
English: The HMPC also considered studies in laboratory tests which support anti-inflammatory and antibacterial effects of knotgrass herb medicines.
Estonian: Taimsete ravimite komitee uuris hinnangu andmisel ka laborikatseid, mis toetavad linnurohuürdi põletikuvastast ja bakterivastast toimet.
English: The HMPC conclusions on the use of these knotgrass herb medicines for common colds, minor mouth or throat inflammation and minor problems affecting the urinary tract are based on their ‘traditional use'.
Estonian: Taimsete ravimite komitee järeldused nende linnurohuürti sisaldavate ravimite kasutamise kohta külmetuse, kergete suu või kurgu põletike ja kergete kuseteede probleemide leevendamiseks põhinevad nende traditsioonilisel kasutamisel.
English: Herbal medicines containing these knotgrass herb preparations are usually available as herbal material that is used to make herbal teas to be drunk or added to water to produce a liquid (decoction) to be applied to the lining of the mouth.
Estonian: Taimsed ravimid, mis sisaldavad linnurohuürdi valmistisi, turustatakse tavaliselt taimeteena, mida juuakse või mida lisatakse vette, et saada vedelik, mida manustatakse suu limaskestale.
English: If symptoms last longer than one week or worsen during the use of the medicine for common cold symptoms or for minor mouth or throat inflammation, a doctor or qualified healthcare practitioner
Estonian: Kui külmetuse või kerge suu või kurgu põletiku sümptomid kestavad ravimi kasutamise ajal kauem kui ühe nädala või halvenevad selle aja jooksul, tuleb konsulteerida arsti või pädeva tervishoiuteenuse osutajaga.
English: For more information about treatment with knotgrass herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate linnurohuürti sisaldavate ravimitega toimuva ravi kohta lisateavet, lugege palun ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: What is knotgrass herb?
Estonian: Mis on linnurohuürt?
English: What evidence supports the use of knotgrass herb medicines?
Estonian: Mis tõendid toetavad linnurohuürti sisaldavate ravimite kasutamist?
English: What are the risks associated with knotgrass herb medicines?
Estonian: Mis riskid linnurohuürti sisaldavate ravimitega kaasnevad?
English: For practical information about using knotgrass herb medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Estonian: Kui vajate linnurohuürti sisaldavate ravimite kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Other information about knotgrass herb medicines
Estonian: Muu teave linnurohuürti sisaldavate ravimite kohta
English: How are knotgrass herb medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus linnurohuürti sisaldavate ravimite müügiluba?
English: What are the HMPC conclusions on its medicinal uses?
Estonian: Mis on taimsete ravimite komitee järeldused linnurohuürdi meditsiiniliste kasutusalade kohta?
English: Knotgrass herb is the common name for the flowering aerial parts of the plant Polygonum aviculare L. The HMPC conclusions only cover knotgrass herb preparations which are obtained by drying and comminuting (reducing into tiny pieces) the flowering aerial parts.
Estonian: Linnurohuürt on taime Polygonum aviculare L. maapealsete õitsvate osade üldnimetus.
English: Neupro is applied once a day at about the same time every day.
Estonian: Neuprot kasutatakse üks kord ööpäevas, iga päev ligikaudu samal ajal.
English: Neupro rotigotine
Estonian: Neupro rotigotiin
English: Neupro is used when a specific cause for the disorder cannot be identified.
Estonian: Neuprot kasutatakse, kui selle häire konkreetset põhjust ei ole võimalik kindlaks määrata.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neupro on 15 February 2006.
Estonian: Euroopa Komisjon andis Neupro müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. veebruaril
English: The full EPAR for Neupro can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Neupro kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Neupro
Estonian: Muu teave Neupro kohta
English: Neupro is used to treat the symptoms of the following diseases in adults:
Estonian: Neuprot kasutatakse järgmiste haiguste sümptomite ravimiseks täiskasvanutel:
English: The backing layer of Neupro contains aluminium.
Estonian: Neupro aluskiht sisaldab alumiiniumi.
English: The CHMP decided that Neupro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Neupro kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: This is a summary of the European public assessment report (EPAR) for Neupro.
Estonian: See on ravimi Neupro Euroopa avaliku hindamisaruande kokkuvõte.
English: What is Neupro?
Estonian: Mis on Neupro?
English: In the smaller studies completed later, the effectiveness of Neupro was found to be comparable with ropinirole.
Estonian: Hiljem tehtud väiksemates uuringutes oli Neupro efektiivsus võrreldav ropinirooli efektiivsusega.
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 Neupro.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For more information about treatment with Neupro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Neuproga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The decrease seen with Neupro was similar to that seen with pramipexole (2.8 h).
Estonian: Neuproga saavutatud vähenemine oli sarnane pramipeksooliga saavutatuga (2,8 h).
English: Neupro must not be used in people who are hypersensitive (allergic) to rotigotine or any of the other ingredients.
Estonian: Neuprot ei tohi kasutada patsiendid, kes on rotigotiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Neupro was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole.
Estonian: Neupro oli ropiniroolist vähem efektiivne: ropinirooliga vähenesid sümptomid 70%-l patsientidest.
English: Neupro is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson's disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective;
Estonian: Neuprot kasutatakse ainsa ravimina varases järgus Parkinsoni tõve raviks või koos levodopaga (samuti Parkinsoni tõve ravim) haiguse mis tahes järgus, sealhulgas hilisstaadiumis, mil levodopa efektiivsus hakkab vähenema;
English: Neupro was more effective than placebo in treating Parkinson's disease.
Estonian: Neupro oli Parkinsoni tõve ravis efektiivsem kui platseebo.
English: Neupro delivers a constant supply of rotigotine through the skin into the bloodstream.
Estonian: Neupro eraldab läbi naha vereringesse pidevalt rotigotiini.
English: Two of these studies also compared Neupro with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Estonian: Neist kahes uuringus võrreldi Neuprot ka dopamiini teiste agonistidega (haiguse varajase järgu korral ropinirooliga ja hilise järgu korral pramipeksooliga).
English: In moderate to severe restless legs syndrome, Neupro has been compared with placebo in two main studies involving a total of 963 patients.
Estonian: Rahutute jalgade mõõduka kuni raske sündroomi korral võrreldi Neuprot platseeboga kahes põhiuuringus, milles osales kokku 963 patsienti.
English: Why has Neupro been approved?
Estonian: Miks Neupro heaks kiideti?
English: In Parkinson's disease, Neupro has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease.
Estonian: Parkinsoni tõve ravis võrreldi Neuprot platseeboga (näiv ravim) neljas uuringus, milles osales 830 haiguse varajases ja 842 hilises järgus patsienti.
English: What is the risk associated with Neupro?
Estonian: Mis riskid Neuproga kaasnevad?
English: For the full list of all side effects reported with Neupro, see the package leaflet.
Estonian: Neupro kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The most common side effects with Neupro in patients with Parkinson's disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin.
Estonian: Parkinsoni tõvega patsientidel olid Neupro kasutamise kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) unisus, peapööritus, peavalu, iiveldus, oksendamine ja manustuskoha reaktsioonid, näiteks punetus, sügelus ja naha ärritus.
English: In early-stage disease, 48 to 52% of the patients using Neupro had an improvement in symptoms, compared with 19 to 30% of those using placebo.
Estonian: Haiguse varajases järgus leevenesid sümptomid Neupro kasutamisel 48-52%-l patsientidest, platseebo kasutamisel aga 19-30%-l patsientidest.
English: Neupro is a range of transdermal patches (patches that deliver a medicine across the skin).
Estonian: Neuprot turustatakse mitmesuguste transdermaalsete plaastritena (plaaster, millest ravim imbub organismi läbi naha).
English: To avoid skin burns, Neupro must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart's normal rhythm).
Estonian: Kui patsiendile on vaja teha magnetresonantstomograafia (MRI) või kardioversioon (südame normaalse rütmi taastamise protseduur), tuleb Neupro nahapõletuste vältimiseks eemaldada.
English: The medicine can only be obtained with a prescription.
Estonian: Neupro on retseptiravim.
English: The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Estonian: Neupro toimeaine rotigotiin on dopamiini agonist, st sellel on dopamiiniga analoogne toime.
English: What benefit has Neupro shown during the studies?
Estonian: Milles seisneb uuringute põhjal Neupro kasulikkus?
English: In advanced Parkinson's disease, patients using Neupro had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo).
Estonian: Haiguse hilises järgus Neuprot kasutanud patsientidel vähenes passiivses seisundi kestus rohkem kui platseebot saanud patsientidel (Neuproga 2,1-2,7 h ja platseeboga 0,9 h).
English: In restless legs syndrome, patients using doses of Neupro between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Estonian: Rahutute jalgade sündroomi ravis paranesid Neuprot annuses 1 ja 3 mg/24 h võtnud patsientide näidud mõlemal sümptomite skaalal rohkem kui platseebot saanud patsientidel.
English: How does Neupro work?
Estonian: Kuidas Neupro toimib?
English: How is Neupro used?
Estonian: Kuidas Neuprot kasutatakse?
English: What is Neupro used for?
Estonian: Milleks Neuprot kasutatakse?
English: Two smaller studies comparing Neupro with ropinirole were completed after the medicine's authorisation.
Estonian: Pärast müügiloa saamist tehti kaks väiksemat uuringut, milles võrreldi Neuprot ropinirooliga.
English: How has Neupro been studied?
Estonian: Kuidas Neuprot uuriti?
English: It is used in patients who are at risk of fractures (broken bones), including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Estonian: Seda kasutatakse patsientidel, kellel on luumurru risk, sealhulgas patsientidel, kellel on hiljuti saanud väikese trauma (nt kukkumise) tagajärjel puusamurru, samuti patsientidel, kelle osteoporoos on seotud pikaajalise glükokortikoidraviga (teatud steroidraviga).
English: The full EPAR for Zoledronic acid Teva Pharma 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 Zoledronic acid Teva Pharma kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.