FrancophonIA/ELRC3.0 huggingface dataset:
English: Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin) EMA/610519/2019
Estonian: Müügiloa taotluse tagasivõtmise teave: Linhaliq (tsiprofloksatsiin) EMA/610519/2019
English: Therefore, at the time of the withdrawal, the Agency's opinion was that the benefits of Linhaliq did not outweigh its risks.
Estonian: Seetõttu oli amet müügiloa taotluse tagasivõtmise ajal arvamusel, et Linhaliqi eelised ei kaalu üles selle riske.
English: In each study Linhaliq was compared with placebo (a dummy treatment).
Estonian: Igas uuringus võrreldi Linhaliqi platseeboga (näiv ravim).
English: The company informed the Agency that there are no ongoing clinical trials or compassionate use programmes with Linhaliq.
Estonian: Ettevõte teatas ametile, et Linhaliqi kliinilisi uuringuid või eriloaga kasutamise programme praegu ei toimu.
English: The main measure of effectiveness was the time it took until patients had a flare-up of bronchiectasis.
Estonian: Efektiivsuse põhinäitaja oli aeg, mille järel patsientide bronhoektaasiatõbi ägenes.
English: Linhaliq was developed for patients with ‘non-cystic fibrosis bronchiectasis', which means it was not intended for patients with bronchiectasis due to cystic fibrosis.
Estonian: Linhaliq töötati välja mittetsüstilise fibroosiga bronhoektaasiatõvega patsientidele, st see ei olnud näidustatud tsüstilisest fibroosist tingitud bronhoektaasiatõvega patsientidele.
English: The active substance in Linhaliq, ciprofloxacin, is an antibiotic belonging to a group called fluoroquinolones.
Estonian: Linhaliqi toimeaine tsiprofloksatsiin on fluorokinoloonide rühma kuuluv antibiootikum.
English: Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin)
Estonian: Müügiloa taotluse tagasivõtmise teave: Linhaliq (tsiprofloksatsiin)
English: Bronchiectasis is a long-term condition in which the airways have widened and become flabby and scarred, with a build-up of mucus.
Estonian: Bronhoektaasiatõbi on pikaajaline seisund, mille korral hingamisteed laienevad, lõõgastuvad ja armistuvad, mis soodustab lima kogunemist.
English: Linhaliq contains the active substance ciprofloxacin and was to be available for inhalation using an inhaler device.
Estonian: Linhaliq sisaldab toimeainena tsiprofloksatsiini ja seda kavatseti turustada inhaleeritavana inhalaatori abil.
English: Based on the review of the data, at the time of the withdrawal, the Agency had several concerns and its provisional opinion was that Linhaliq could not have been authorised for treating or preventing flare-ups in adults with non-cystic fibrosis bronchiectasis who have long-term lung infection with Pseudomonas aeruginosa.
Estonian: Andmete läbivaatamise tulemusena nägi amet taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et Linhaliqi kasutamist mittetsüstilise fibroosiga bronhoektaasiatõve ägenemise ennetamiseks ja vähendamiseks bakteri Pseudomonas aeruginosa põhjustatud pikaajalise kopsuinfektsiooniga patsientidel ei saa heaks kiita.
English: Linhaliq was developed as a medicine for preventing and reducing exacerbations (flare-ups) of bronchiectasis in adults who have long-term lung infection with Pseudomonas aeruginosa bacteria.
Estonian: Linhaliq töötati välja ravimina bronhoektaasiatõve ägenemise ennetamiseks ja vähendamiseks bakteri Pseudomonas aeruginosa põhjustatud pikaajalise kopsuinfektsiooniga patsientidel.
English: In Linhaliq, some of the active substance is enclosed in tiny fat particles called liposomes.
Estonian: Linhaliqis on osa toimeainest ümbritsetud väikeste rasvaosakeste liposoomidega, et aeglustada ravimi vabanemist kopsudesse, mis pikendab toimeaega.
English: Aradigm Pharmaceuticals Limited withdrew its application for a marketing authorisation of Linhaliq for treating and preventing flare-ups of bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria.
Estonian: Aradigm Pharmaceuticals Limited võttis tagasi ravimi Linhaliq müügiloa taotluse.
English: In all studies the vaccinated sheep and cattle were compared with unvaccinated animals (controls).
Estonian: Kõikides uuringutes võrreldi vaktsineeritud lambaid ja veiseid vaktsineerimata loomadega (kontrollrühm).
English: The full EPAR for Bovilis Blue-8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst vaktsiini Bovilis Blue-8 kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The most common side effect with Bovilis Blue-8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Estonian: Vaktsiini Bovilis Blue-8 kõige sagedam kõrvaltoime (võib esineda kuni 1 loomal 10st) on kehatemperatuuri tõus 0,5-1,0 ˚C võrra, mis ei kesta enam kui paar päeva.
English: It is also the time required after administration of a medicine before milk may be used for human consumption.
Estonian: See on ka aeg, mis peab vaktsiini manustamisest mööduma, enne kui piima tohib inimtoiduks tarvitada.
English: The first injection is given from two and a half months of age and a second injection is given three weeks later.
Estonian: Esimene süst tehakse loomadele alates 2,5 kuu vanusest ja teine 3 nädalat hiljem.
English: This medicine is the same as Bluevac BTV8, which is already authorised in the EU.
Estonian: See vaktsiin on samane vaktsiiniga Bluevac BTV8, millel juba on Euroopa Liidus müügiluba.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovilis Blue-8's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et vaktsiini Bovilis Blue-8 kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas vaktsiini kasutamise Euroopa Liidus heaks kiita.
English: The European Commission granted a marketing authorisation valid throughout the EU for Bovilis Blue-8 on 21 November 2017.
Estonian: Euroopa Komisjon andis vaktsiinile Bovilis Blue-8 müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 21/11/2017.
English: Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep.
Estonian: Haiguse kliinilised sümptomid on palavik, nahahaavandid ja ka turse ning vahel keele sinakaks muutumine, mida on peamiselt täheldatud lammastel.
English: bluetongue virus vaccine, serotype 8 (inactivated)
Estonian: lammaste katarraalse palaviku viirus, serotüüp 8 (inaktiveeritud)
English: This authorisation was based on the authorisation granted to Bluevac BTV8 in 2011 (‘informed consent').
Estonian: Müügiluba põhineb 2011. aastal antud vaktsiini Bluevac BTV8 müügiloal (teabel põhinev nõusolek).
English: Bovilis Blue-8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Estonian: Bovilis Blue-8 sisaldab lammaste katarraalse palaviku viirust, mis on inaktiveeritud ega suuda seetõttu haigust tekitada.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.
Estonian: Samuti sisaldab vaktsiin parema immuunvastuse tekitamiseks adjuvante (toimet tugevdavaid aineid) alumiiniumhüdroksiidi ja saponiini.
English: The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Estonian: Vaktsiini efektiivsuse põhinäitajad olid vireemia (BTV8 esinemine veres) ja lammaste katarraalse palaviku viiruse nakkuse kliinilised sümptomid.
English: The company that makes Bluevac BTV8 has agreed that its scientific data can be used for Bovilis Blue-8 (‘informed consent').
Estonian: Vaktsiini Bluevac BTV8 tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka vaktsiini Bovilis Blue-8 toetuseks (teabel põhinev nõusolek).
English: What is Bovilis Blue-8 and what is it used for?
Estonian: Mis on Bovilis Blue-8 ja milleks seda kasutatakse?
English: This is a summary of the European public assessment report (EPAR) for Bovilis Blue-8.
Estonian: See on vaktsiini Bovilis Blue-8 Euroopa avaliku hindamisaruande kokkuvõte.
English: For practical information about using Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad vaktsiini Bovilis Blue-8 kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: Bovilis Blue-8 contains bluetongue viruses of one type (‘serotype 8').
Estonian: Bovilis Blue-8 sisaldab lammaste katarraalse palaviku viiruse ühte teatud vormi (serotüüpi 8).
English: The withdrawal period for meat and milk from cattle and sheep treated with Bovilis Blue-8 is ‘zero' days, which means there is no mandatory waiting time.
Estonian: Vaktsiiniga Bovilis Blue-8 vaktsineeritud veiste ja lammaste liha ja piima keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
English: Bovilis Blue-8 is a vaccine.
Estonian: Bovilis Blue-8 on vaktsiin.
English: It is not intended to provide practical advice on how to use Bovilis Blue-8.
Estonian: Hindamisaruandes ei anta vaktsiini Bovilis Blue-8 kasutamise praktilisi nõuandeid.
English: The vaccine is given to cattle and sheep as two injections under the skin.
Estonian: Vaktsiini manustatakse veistele ja lammastele kahe nahaaluse süstiga.
English: Why is Bovilis Blue-8 approved?
Estonian: Miks Bovilis Blue-8 heaks kiideti?
English: The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Estonian: Uuringutes tõendati, et vaktsiin takistab lammaste katarraalse palaviku viiruse serotüübi 8 nakkuse korral vireemia teket lammastel ja veistel ning vähendab kliinilisi sümptomeid lammastel.
English: The vaccine contains inactivated (killed) bluetongue virus, serotype 8.
Estonian: Vaktsiin sisaldab lammaste katarraalse palaviku inaktiveeritud (hävitatud) viiruse serotüüpi 8 (BTV8).
English: For the full list of restrictions and all side effects reported with Bovilis Blue-8, see the package leaflet.
Estonian: Vaktsiini Bovilis Blue-8 kohta teatatud piirangute ja kõrvaltoimete täielik loetelu on pakendi infolehel.
English: What are the risks associated with Bovilis Blue-8?
Estonian: Mis riskid vaktsiiniga Bovilis Blue-8 kaasnevad?
English: How does Bovilis Blue-8 work?
Estonian: Kuidas Bovilis Blue-8 toimib?
English: Bovilis Blue-8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Estonian: Bovilis Blue-8 on vaktsiin, mida kasutatakse veiste ja lammaste kaitsmiseks lammaste katarraalse palaviku eest.
English: Other information about Bovilis Blue-8:
Estonian: Muu teave vaktsiini Bovilis Blue-8 kohta
English: What benefits of Bovilis Blue-8 have been shown in studies?
Estonian: Milles seisneb uuringute põhjal vaktsiini Bovilis Blue-8 kasulikkus?
English: How is Bovilis Blue-8 used?
Estonian: Kuidas vaktsiini Bovilis Blue-8 kasutatakse?
English: The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
Estonian: Tablett tuleb alati võtta siis, kui patsient ei ole vähemalt kuue tunni jooksul öösel midagi söönud ning vähemalt 30 minutit enne päeva esimest toiduja joogikorda.
English: This leads to less bone loss.
Estonian: See vähendab luukadu.
English: The full EPAR for Ibandronic Acid Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ibandronic Acid Sandozi kohta on Euroopa Ravimiameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The patient must also not lie down for one hour after taking the tablets.
Estonian: Pärast tableti võtmist ei tohi patsient ühe tunni jooksul pikali heita.
English: Ibandronic Acid Sandoz is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Estonian: Ibandronic Acid Sandozit kasutatakse luukahjustuste (luumurrud või ravi vajavad luutüsistused) ennetamiseks rinnavähi ja luumetastaasidega (kui vähk on levinud luudesse) patsientidel.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Estonian: Luukao vähenemine muudab luud murdudele vastupidavamaks ning sel viisil saab ennetada luumurdude tekkimist vähipatsientidel, kellel on luumetastaasid.
English: A risk management plan has been developed to ensure that Ibandronic Acid Sandoz is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Ibandronic Acid Sandozi võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Sandoz on 26 July 2011.
Estonian: Euroopa Komisjon andis Ibandronic Acid Sandozi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. juulil 2011.
English: For more information about treatment with Ibandronic Acid Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ibandronic Acid Sandoziga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This means that Ibandronic Acid Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU).
Estonian: See tähendab, et Ibandronic Acid Sandoz on sarnane võrdlusravimiga, millel juba on Euroopa Liidus müügiluba.
English: What measures are being taken to ensure the safe and effective use of Ibandronic Acid Sandoz?
Estonian: Mis meetmed võetakse, et tagada Ibandronic Acid Sandozi ohutu ja efektiivne kasutamine?
English: Because Ibandronic Acid Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Ibandronic Acid Sandoz on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Sandoz has been shown to have comparable quality and to be bioequivalent to Bondronat.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Ibandronic Acid Sandoz võrreldav kvaliteet ja bioekvivalentsus ravimiga Bondronat.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ibandronic Acid Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Ibandronic Acid Sandozi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
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 Ibandronic Acid Sandoz.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The Committee recommended that Ibandronic Acid Sandoz be given marketing authorisation.
Estonian: Komitee soovitas anda Ibandronic Acid Sandozi müügiloa.
English: Ibandronic Acid Sandoz must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Estonian: Ibandronic Acid Sandozit tuleb võtta klaasitäie veega (v.a mineraalvesi) seistes või istudes.
English: Because Ibandronic Acid Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine.
Estonian: Et Ibandronic Acid Sandoz on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Ibandronic Acid Sandozi bioekvivalentsust võrdlusravimiga.
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Estonian: Seetõttu oli inimravimite komitee arvamusel, et nagu ka Bondronati korral, ületab Ibandronic Acid Sandozi kasulikkus sellega kaasnevad riskid.
English: This document is a summary of the European public assessment report (EPAR) for Ibandronic Acid Sandoz.
Estonian: See on ravimi Ibandronic Acid Sandoz Euroopa avaliku hindamisaruande kokkuvõte.
English: Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid.
Estonian: Ibandronic Acid Sandoz on ravim, mis sisaldab toimeainena ibandroonhapet.
English: Ibandronic Acid Sandoz is a ‘generic medicine'.
Estonian: Ibandronic Acid Sandoz on geneeriline ravim.
English: Other information about Ibandronic Acid Sandoz:
Estonian: Muu teave Ibandronic Acid Sandozi kohta
English: Ibandronic Acid Sandoz ibandronic acid
Estonian: Ibandronic Acid Sandoz ibandroonhape
English: What is Ibandronic Acid Sandoz?
Estonian: Mis on Ibandronic Acid Sandoz?
English: Why has Ibandronic Acid Sandoz been approved?
Estonian: Miks Ibandronic Acid Sandoz heaks kiideti?
English: The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate.
Estonian: Ibandronic Acid Sandozi toimeaine ibandroonhape on bisfosfonaat.
English: The reference medicine for Ibandronic Acid Sandoz is Bondronat.
Estonian: Ibandronic Acid Sandozi võrdlusravim on Bondronat.
English: How does Ibandronic Acid Sandoz work?
Estonian: Kuidas Ibandronic Acid Sandoz toimib?
English: How has Ibandronic Acid Sandoz been studied?
Estonian: Kuidas Ibandronic Acid Sandozit uuriti?
English: How is Ibandronic Acid Sandoz used?
Estonian: Kuidas Ibandronic Acid Sandozit kasutatakse?
English: What is Ibandronic Acid Sandoz used for?
Estonian: Milleks Ibandronic Acid Sandozit kasutatakse?
English: What is Nenad?
Estonian: Mis on Nenad?
English: 17 December 2009 EMA/830685/2009 EMEA/H/C/1020
Estonian: 17. detsember 2009 EMA/830685/2009 EMEA/H/C/1020
English: Idiopathic means that the disease has no obvious cause.
Estonian: Idiopaatiline tähendab, et haigusel ei ole ilmset põhjust.
English: The company withdrew before the European Commission had issued a decision on this opinion.
Estonian: Ettevõte võttis taotluse tagasi enne Euroopa Komisjoni otsust käesoleva arvamuse kohta.
English: The 210 patients who completed the first 12 weeks were also offered the opportunity to continue treatment in an extension study.
Estonian: 210 patsiendile, kes läbisid uuringu esimesed 12 nädalat, pakuti võimalust osaleda ka jätku-uuringus.
English: Since restless legs syndrome is often a lifelong disease, long-term data were considered essential.
Estonian: Et rahutute jalgade sündroom on sageli eluaegne haigus, peeti pikaajalisi andmeid hädavajalikeks.
English: The company had also provided results on studies involving patients with Parkinson's disease.
Estonian: Ettevõte esitas tulemused ka Parkinsoni tõvega patsientide uuringutest.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Nenad be refused.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, oli komitee andnud taotluse tagasivõtmise ajal negatiivse arvamuse ega soovitanud anda Nenadi müügiluba.
English: The company presented results of one main study of 309 patients with moderate-to-severe restless legs syndrome.
Estonian: Ettevõte esitas ühe põhiuuringu tulemused, mis tehti mõõduka kuni raske rahutute jalgade sündroomiga 309 patsiendil.
English: The Committee was also concerned that a large proportion of patients in the study stopped treatment with Nenad because of skin irritation, making the patch unsuitable for long-term use.
Estonian: Komitee avaldas kahtlust ka seoses sellega, et suur hulk uuringus osalenud patsiente lõpetas ravi Nenadiga nahaärrituse tõttu, mis muutis plaastri pikaajaliseks kasutamiseks sobimatuks.
English: There were also problems with the patches not sticking well enough to the skin.
Estonian: Samuti ilmnes probleeme, et plaastrid ei kinnitunud korralikult nahale.
English: The CHMP noted that, while the short-term effectiveness of Nenad for the treatment of restless legs syndrome had been shown, there was not enough evidence to demonstrate its long-term effectiveness.
Estonian: Inimravimite komitee märkis, et kuigi on näidatud Nenadi lühiajalist efektiivsust rahutute jalgade sündroomi ravis, ei olnud pikaajalise efektiivsuse tõendeid piisavalt.
English: However, the syndrome is thought to be caused by problems in the way dopamine works in the brain, which was expected to be corrected by lisuride.
Estonian: Arvatakse, et sündroom on tingitud dopamiini toime häiretest ajus, ning eeldati, et lisuriid võib neid korrigeerida.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Nenad?
Estonian: Kuidas mõjutab tagasivõtmine praegu Nenadi kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: The patients were given Nenad, ropinirole (another medicine for restless legs syndrome) or placebo (a dummy medicine).
Estonian: Patsientidele manustati Nenadit, ropinirooli (samuti rahutute jalgade sündroomi ravim) või platseebot (näiv ravim).
English: The way lisuride was expected to work in restless legs syndrome is not fully understood.
Estonian: Lisuriidi toimemehhanism rahutute jalgade sündroomi korral ei ole täielikult teada.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Nenad in the treatment of restless legs syndrome did not outweigh its risks.
Estonian: Inimravimite komitee oli tagasivõtmise ajal seepärast arvamusel, et Nenadi kasulikkus rahutute jalgade sündroomi ravis ei ole suurem kui sellega kaasnevad riskid.
English: On 30 November 2009, Axxonis Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Nenad, for the treatment of the signs and symptoms of moderate-to-severe idiopathic restless legs syndrome in adults.
Estonian: 30. novembril 2009 teatas Axxonis Pharma AG ametlikult inimravimite komiteele, et soovib tagasi võtta Nenadi müügiloa taotluse.
English: However, during the CHMP evaluation, the company withdrew its application for Nenad to be used for this disease.
Estonian: Inimravimite komitee hindamismenetluse ajal võttis ettevõte oma taotluse Nenadi kasutamiseks selle näidustuse korral aga tagasi.
English: Nenad is a transdermal patch (patch that delivers a medicine across the skin) that contains the active substance lisuride.
Estonian: Nenad on transdermaalne plaaster (plaaster, millest ravim imbub organismi läbi naha), mis sisaldab toimeainena lisuriidi.
English: What was Nenad expected to be used for?
Estonian: Milleks kavatseti Nenadit kasutada?
English: The company informed the CHMP that there are no consequences for patients using Nenad in clinical trials or compassionate use programmes.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Nenadi kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele tagasivõtmine mõju ei avalda.
English: The effects of Nenad were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Nenadi toimet muude katsetega.