natgillin/translations-raw huggingface dataset:
Combisyn is intended for the treatment of mastitis in lactating cows caused by the major pathogens commonly occurring from the bovine udder (Staphylococci, Streptococci and Escherichia coli). 
Combisyn on ette nähtud sageli lehma udaras esinevate peamiste patogeenide (stafülokokid, streptokokid ja bakter Escherichia coli) põhjustatud mastiidi raviks lakteerivatel veistel.
Appropriate clinical data should be provided to confirm the efficacy of Combisyn Lactating Cow Intramammary Suspension. 
Lakteerivate veiste intramammaarsuspensiooni Combisyn efektiivsuse tõendamiseks tuleb esitada asjakohased kliinilised andmed.
There was discussion by the CVMP on applying the same pharmacokinetic parameters from classical plasma bioequivalence studies to comparative data in milk. 
Veterinaarravimite komiteega toimunud arutelus käsitleti samade farmakokineetiliste näitajate mõõtmist nii klassikalistes bioekvivalentsusuuringutes plasmaga kui ka võrdlevates uuringutes piimaga.
Grounds for refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation 
Müügiloa andmisest keeldumise ja kehtiva müügiloa peatamise alused
In support of Combisyn, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products. 
Combisyni taotluse toetuseks esitati andmed uuringute kohta, kus võrreldi geneerilise ravimi ja võrdlusravimite farmakokineetikat piimas ja plasmas.
• A comparative milk study was carried out to measure milk concentrations of prednisolone following intramammary infusion. 
• Tehti võrdlev piimauuring, kus mõõdeti prednisolooni kontsentratsiooni plasmas pärast intramammaarset infundeerimist.
• A comparative plasma study was carried out to measure plasma concentrations of amoxicillin, clavulanate and prednisolone following intramammary infusion. 
• Tehti võrdlev plasmauuring, kus mõõdeti amoksitsilliini, klavulanaadi ja prednisolooni kontsentratsiooni plasmas pärast intramammaarset infundeerimist.
Three comparative pharmacokinetic studies were carried out with Combisyn and the reference product, all with a two-period cross-over design. 
Combisyni ja võrdlusravimit uuriti kolmes võrdlevas farmakokineetika uuringus, mis kõik olid kaheperioodilised ristuuringud.
The dissolution data in particular were inconclusive due to limitations of the study design. 
Uuringu ülesehituse puuduste tõttu osutusid ebaselgeks just lahustuvuse andmed.
• A comparative milk study was carried out to measure milk concentrations of amoxicillin and clavulanic acid. 
• Tehti võrdlev piimauuring, kus mõõdeti amoksitsilliini ja klavulaanhappe kontsentratsiooni piimas.
Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin. 
Organismis looduslikult esinev aine klavulaanhape on beetalaktamaasi inhibiitor ja amoksitsilliini sünergist.
Combisyn is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route. 
Combisyni turustatakse süstaldes, mis sisaldavad ühikannust õlisuspensioonina intramammaarseks manustamiseks.
Grounds for the lifting of the suspension of the Marketing Authorisation 
Müügiloa peatamise lõpetamise alused
The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combisyn. 
Taotleja esitas Combisyni vana ja uue ravimvormi võrdlevad viskoossusandmed.
Strengths 
Lakteerivad veised
At the last sampling timepoint (108 hours), half of the quarter milk samples had amoxicillin concentrations above the MRL. All quarter milk samples from 84 hours onwards had clavulanic acid concentrations below the milk MRL. For prednisolone, the data showed that the levels were well below the milk MRL of 6 µg/kg from 24 hours onwards. 
Viimases proovivõtmise ajapunktis (108 tundi) ületas amoksitsilliini kontsentratsioon ravimijääkide piirnormi pooltes udaraveerandi piimaproovides.
This can happen during the treatment, or after it has been stopped. 
See võib toimuda ravi ajal või pärast selle lõppu.
Baraclude is taken once a day. 
Baracludet võetakse üks kord ööpäevas.
The full EPAR for Baraclude can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Euroopa avaliku hindamisaruande täistekst Baraclude kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
A risk management plan has been developed to ensure that Baraclude is used as safely as possible. 
Töötati välja riskijuhtimiskava, et tagada Baraclude võimalikult ohutu kasutamine.
The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude on 26 June 2006. 
Euroopa Komisjon andis Baraclude müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. juunil
What measures are being taken to ensure the safe and effective use of Baraclude? 
Mis meetmed võetakse, et tagada Baraclude ohutu ja efektiivne kasutamine?
Baraclude entecavir 
Baraclude entekaviir
Patients also need to know that they may also suffer a worsening of their liver disease. 
Patsiente tuleb ka hoiatada, et nende maksahaigus võib süveneda.
Viral suppression has also been shown in children. 
Viirust pärssivat toimet on näidatud ka laste puhul.
Other information about Baraclude 
Muu teave Baraclude kohta
The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal. 
0,5 mg annust võib võtta koos toiduga või ilma, kuid 1 mg annus tuleb võtta vähemalt 2 tundi enne või 2 tundi pärast sööki.
It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml). 
Seda turustatakse tablettidena (0,5 mg ja 1 mg) ja suukaudse lahusena (0,05 mg/ml).
The decision to start a child on treatment should be based on careful consideration of their individual needs, as not all children with chronic hepatitis B infection require treatment. 
Lapse ravi alustamise otsus peaks põhinema tema individuaalsete vajaduste hoolikal kaalumisel, sest kõik kroonilise B-hepatiidi nakkusega lapsed ei pruugi vajada ravi.
The CHMP concluded that Baraclude's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Inimravimite komitee järeldas, et Baraclude kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
This is a summary of the European public assessment report (EPAR) for Baraclude. 
See on ravimi Baraclude Euroopa avaliku hindamisaruande kokkuvõte.
When treatment is considered appropriate in children, the dose depends on their body weight. 
Kui laste ravi peetakse vajalikuks, sõltub annus nende kehakaalust.
Children weighing less than 32.6 kg should be given the oral solution, while those weighing 32.6 kg and above can also be given the 0.5 mg tablets. 
Vähem kui 32,6 kg kaaluvatele lastele tuleb anda suukaudset lahust, 32,6 kg ja rohkem kaaluvatele lastele võib anda ka 0,5 mg tablette.
The treatment duration is determined by how the patient responds. 
Ravi kestus määratakse vastavalt patsiendi ravivastusele.
Two of the studies were carried out in 1,363 patients who had not been treated with nucleoside analogues before. 
Kaks uuringut viidi läbi 1363 patsiendil, keda ei olnud nukleosiidianaloogidega varem ravitud.
Entecavir stops the virus making DNA, and prevents it from multiplying and spreading. 
Entekaviir peatab viiruse DNA moodustumise ning takistab selle replikatsiooni ja levikut.
This study looked at the reduction in viral DNA in the blood after 24 weeks. 
Selles uuringus jälgiti viiruse DNA sisalduse vähenemist veres 24 nädala jooksul.
For the full list of side effects and restrictions with Baraclude, see the package leaflet. 
Baraclude kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
The third study was carried out in 293 patients whose infection was no longer responding to lamivudine treatment. 
Kolmas uuring viidi läbi 293 patsiendil, kelle nakkus ravile lamivudiiniga enam ei allunud.
The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients. 
1 mg ööpäevast annust kasutatakse ka dekompenseeritud maksahaigusega patsientidel ja nendel patsientidel ei soovitata ravi katkestada.
It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease). 
Seda kasutatakse täiskasvanutel, kellel on jätkuva maksakahjustuse sümptomid (nagu põletik ja fibroos), kui maksatalitlus on veel korras (kompenseeritud maksahaigus) ja kui maksatalitlus ei ole enam korras (dekompenseeritud maksahaigus).
The most common side effects seen with Baraclude are headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%). 
Baraclude kõige sagedamad kõrvalnähud on peavalu (esinenud 9%-l patsientidest), väsimus (6%), peapööritus (4%) ja iiveldus (3%).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Baraclude, including the appropriate precautions to be followed by healthcare professionals and patients. 
Selle alusel lisati Baraclude omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease. 
Baraclude kasutamist võib kaaluda ka 2-18-aastastel lastel, kuid üksnes kompenseeritud maksahaiguse korral.
Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose. 
Patsientidel, keda ei ole varem nukleosiidianaloogiga ravitud, kasutatakse 0,5 mg annust, kuid nendel varem lamivudiiniga ravitud patsientidel, kelle nakkus ravile enam ei allu, kasutatakse 1 mg annust.
The study looked at the reductions in levels of the virus in the blood and the number of patients who developed antibody to a viral protein (known as e-antigen) and no longer had e-antigen in their blood after 48 weeks of treatment. 
Uuringus vaadeldi viiruse hulga vähenemist veres ja nende patsientide arvu, kelle organismis tekkis viirusproteiini (e-antigeeni) vastu antikeha ja kelle veres pärast 48-nädalast ravi e-antigeeni enam ei olnud.
Baraclude was also shown to be effective in the children's study: 24% of children in the Baraclude group achieved the primary goal of having a viral DNA level of less than 50 IU/ml plus production of antibody to e-antigen and no e-antigen in their blood compared with 2% of children in the placebo group. 
Baraclude osutus efektiivseks ka lastega läbiviidud uuringus: 24% Baraclude ravirühma lastest saavutas peaeesmärgi: viiruse DNA hulga vähenemine veres alla 50 IU/ml, lisaks e-antigeeni antikeha tootmine ning e-antigeeni puudumine veres võrreldes 2%-ga platseeborühma lastest.
Baraclude has been shown to be effective at suppressing the virus in adults with both compensated and decompensated liver disease. 
Baraclude on osutunud efektiivseks viiruse pärssimisel nii kompenseeritud kui ka dekompenseeritud maksahaigusega täiskasvanutel.
For more information about treatment with Baraclude, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate Baracludega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Baraclude. 
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
In a children's study, 180 children aged 2 to 18 years who had chronic hepatitis B were randomly selected to be given either Baraclude or placebo (a dummy treatment). 
Kroonilise B-hepatiidiga 2-18-aastaste lastega tehtud uuringus valiti juhuvalikuga 180 last, kellele manustati kas Baracludet või platseebot (näiv ravim).
For more information on the use of the medicine in children, see the summary of product characteristics (also part of the EPAR). 
Kui vajate lisateavet ravimi kasutamise kohta lastel, lugege palun ravimi omaduste kokkuvõtet (mis on samuti Euroopa avaliku hindamisaruande osa).
Baraclude is an antiviral medicine that contains the active substance entecavir. 
Baraclude on viirusevastane ravim, mis sisaldab toimeainena entekaviiri.
In adults with decompensated liver disease, there was a greater reduction in viral DNA with Baraclude than with adefovir dipivoxil. 
Dekompenseeritud maksahaigusega täiskasvanutel vähendas Baraclude viiruse DNA sisaldust veres rohkem kui adefoviirdipivoksiil.
Baraclude is used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus). 
Baracludet kasutatakse kroonilise (pikaajalise) B-hepatiidi (B-hepatiidi viiruse põhjustatud nakkuslik maksahaigus) raviks.
What is the risk associated with Baraclude? 
Mis riskid Baracludega kaasnevad?
Baraclude was compared with lamivudine in three main studies in adults with chronic hepatitis B who had compensated liver disease. 
Baracludet võrreldi lamivudiiniga kolmes põhiuuringus, milles osalesid kroonilise B-hepatiidiga ja kompenseeritud maksahaigusega täiskasvanud.
The active substance in Baraclude, entecavir, is an antiviral belonging to the class of the nucleoside analogues. 
Baraclude toimeaine entekaviir on nukleosiidianaloogide klassi kuuluv viiruseravim.
What is Baraclude? 
Mis on Baraclude?
Why has Baraclude been approved? 
Miks Baraclude heaks kiideti?
Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B. 
Ravi Baracludega peab alustama kroonilise B-hepatiidi ravis kogenud arst.
For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Baraclude 
Kompenseeritud maksahaigusega täiskasvanutel sõltub annus sellest, kas patsienti on või ei ole varem ravitud ravimiga, mis kuulub Baracludega samasse rühma (nukleosiidianaloogiga, näiteks lamivudiiniga).
In adults with compensated liver disease, Baraclude was more effective than lamivudine in patients who had not been treated with nucleoside analogues before: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine. 
Kompenseeritud maksahaigusega täiskasvanutel oli Baraclude lamivudiinist efektiivsem patsientidel, keda ei olnud varem nukleosiidianaloogidega ravitud: nende patsientide osakaal, kelle maksa seisund paranes, oli Baracludega ravitute hulgas veidi üle 70% ja lamivudiiniga ravitute hulgas veidi üle 60%.
Baraclude was also more effective than lamivudine in patients refractory to lamivudine: 55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine. 
Baraclude oli lamivudiinist efektiivsem ka varem ravimata patsientidel: nende patsientide osakaal, kelle maksa seisund paranes, oli Baracludega ravitute hulgas 55% ja lamivudiiniga ravitute hulgas 28%.
The studies looked at how the liver damage had evolved after 48 weeks treatment by examining samples of liver tissue and measuring signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA in the blood. 
Uuringutes vaadeldi, kuidas maksakahjustus oli arenenud pärast 48 ravinädalat, uurides maksakoe proove ja mõõtes maksaensüümi ALT ja viiruse DNA sisaldust veres.
What benefit has Baraclude shown during the studies? 
Milles seisneb uuringute põhjal Baraclude kasulikkus?
Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA. 
Entekaviir häirib viiruse DNA moodustumisel osaleva viiruseensüümi DNA-polümeraasi toimet.
What is Baraclude used for? 
Milleks Baracludet kasutatakse?
How is Baraclude used? 
Kuidas Baracludet kasutatakse?
How has Baraclude been studied? 
Kuidas Baracludet uuriti?
At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, while 4% of those treated with lamivudine showed the same results. 
Uuringu lõpuks oli patsiente, kelle vere ALT-sisaldus oli normaalne ja viiruse DNA veres puudus, Baracludega ravitute hulgas 55% ja lamivudiiniga ravitute hulgas 4%.
Baraclude was also compared with another medicine, adefovir dipivoxil, in 195 patients with chronic hepatitis B with decompensated liver disease. 
Baracludet võrreldi 195 B-hepatiidi ja dekompenseeritud maksahaigusega patsiendil ka teise ravimi adefoviirdipivoksiiliga.
Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients. 
Patsientidel, kelle haigus ei allu ravile lamivudiiniga, on esinenud resistentsust entekaviiri suhtes (viirus ei allu viirusevastase ravimi toimele).
How does Baraclude work? 
Kuidas Baraclude toimib?
The medicine can only be obtained with a prescription. 
Baraclude on retseptiravim.
The EU Member States shall ensure that: 
EL liikmesriik peab tagama:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
TINGIMUSED VÕI PIIRANGUD, MIS PUUDUTAVAD RAVIMI OHUTUT JA TÕHUSAT KASUTAMIST LIIKMESRIIKIDE POOLT RAKENDAMISEKS
• Use of antibiotics 
• Antibiootikumide kasutamine
• Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection 
• Steriilsed tehnikad, sealhulgas periokulaarne ja okulaarne desinfektsioon võimalike infektsioonide riski vähendamiseks
The physician information should contain the following key elements: 
Informatsioon arstile peab sisaldama järgmisi põhielemente:
The Marketing Authorisation Holder (MAH) shall ensure that updated physician information packs are provided to all ophthalmology clinics where Lucentis is expected to be used. 
Müügiloa hoidja peab tagama kõikidele oftalmoloogia kliinikute arstidele, kes eeldatavasti võiksid Lucentis't ordineerida/kasutada uuendatud arsti teabematerjali.
• How to prepare for Lucentis treatment 
• Kuidas valmistuda Lucentis-raviks
The patient information pack should be provided in the form of both patient information booklets and audio-CD that contain following key elements: 
Informatsioon patsiendile peab koosnema nii kirjalikust materjalist kui ka audio CD-st ning need peavad sisaldama järgmisi põhielemente:
• Intravitreal injection procedure video 
• Intravitreaalse süste protseduuri video
• What are the steps following treatment with Lucentis 
• Mida tuleb teada sellest, mis järgneb Lucentis-ravile
• Key signs and symptoms of serious adverse events 
• Tõsiste kõrvaltoimete põhilised nähud ja sümptomid
• Intravitreal injection procedure pictogram 
• Intravitreaalse süste protseduuri piktogramm
• Use of povidone iodine or equivalent 
• Povidoonjodiidi või sellele ekvivalentse vahendi kasutamine
The physician information pack should contain the following: 
Arstile vajalik teabematerjal peaks sisaldama järgmises mahus informatsiooni:
• Physician information 
• Informatsioon arstile
• Key signs and symptoms of IVT injection related adverse events 
• IVT süstega seotud kõrvaltoimete põhilised nähud ja sümptomid
• Patient information leaflet 
• Informatsioon patsiendile
• Management of IVT injection related adverse events 
• IVT süstega seotud kõrvaltoimete käsitlemine
• Techniques for the intravitreal injection 
• Intravitreaalse süste tehnika
10 mg/160 mg Film-coated tablet 
280 x 1 tablett
Package size 
ManustamisteePakendi iseloomustus Pakendi suurus
This summary was last updated in 08-2011. 
Kokkuvõtte viimane uuendus: 08-2011
Patients were followed up for at least two years. 
Patsiente jälgiti kuni vähemalt kahe aasta jooksul.
A similar difference was seen between the two groups after two years. 
Samalaadset erinevust kahe rühma vahel täheldati ka kahe aasta pärast.
The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr on 25 March 2004. 
Euroopa Komisjon väljastas PhotoBarri müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. märtsil 2004.
The type of apparatus used, as well as the duration of the illumination, depends on how large the disease area is. 
Kasutatava seadme liik ning valgustamise kestus sõltuvad haigestunud piirkonna suurusest.
This will ensure that all doctors and pharmacists who will prescribe or dispense the medicine are provided with information packs for healthcare workers and patients. 
Sellega tagatakse, et kõik ravimit määravad arstid ja ravimit väljastavad apteekrid varustatakse tervishoiutöötajatele ja patsientidele ettenähtud teabepakmega.
The company that makes PhotoBarr is preparing educational materials in agreement with medicines regulatory authorities in Member States. 
PhotoBarri tootja koostab teabematerjalid kooskõlas liikmesriikide reguleerivate meditsiiniasutustega.
Other information about PhotoBarr 
Muu teave PhotoBarri kohta
What measures are being taken to ensure the safe use of PhotoBarr? 
Mis meetmeid võetakse, et tagada PhotoBarri kasutamise ohutus?
The main measure of effectiveness was the number of patients who had no high-grade dysplasia left at least six months after the first course of treatment. 
Efektiivsuse põhinäitaja oli nende patsientide arv, kellel puudus tugev düsplaasia pärast vähemalt kuue kuu möödumist esimesest ravikuurist.
If necessary, patients may receive a second, shorter laser treatment two to three days later. 
Vajaduse korral võib patsient saada kahe-kolme päeva pärast teist korda lühemaajalist laserravi.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA. 
Need hävitavad rakke, reageerides rakukomponentidega, näiteks valkude ja DNAga, ning neid komponente hävitades.
The CHMP decided that PhotoBarr's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Inimravimite komitee otsustas, et PhotoBarri kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine. 
PhotoBarri saavale patsiendile tuleb anda ka spetsiaalne hoiatuskaart, millel on ravimi kokkuvõtlik ohutusteave.
As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection. 
Et kõikidel patsientidel, kellele manustatakse PhotoBarri, suureneb valgustundlikkus, peavad nad hoolikalt hoiduma naha ja silmade sattumisest eredasse valgusesse vähemalt kolme kuu jooksul pärast süstimist.
The summary of the opinion of the Committee for Orphan Medicinal Products for PhotoBarr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Harvikravimite komitee arvamuse kokkuvõte PhotoBarri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Because it causes difficulty swallowing, including pain, nausea and vomiting, patients should only take liquid food for a few days after laser treatment, and for up to four weeks in some cases. 
Et ravim põhjustab neelamishäireid, sealhulgas valu, iiveldust ja oksendamist, peavad patsiendid sööma mõne päeva, mõnel juhul ka kuni nelja nädala jooksul pärast laserravi ainult vedeltoitu.
The full EPAR for PhotoBarr can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Euroopa avaliku hindamisaruande täistekst PhotoBarri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.