FrancophonIA/ELRC3.0 huggingface dataset:
English: An observation period of 30 - 60 minutes is recommended after completion of each infusion.
Estonian: Pärast iga infusiooni lõpetamist on soovitatav patsienti 30...60 minutit jälgida.
English: • Trastuzumab plus docetaxel
Estonian: • Trastuzumab pluss dotsetakseel
English: (median number of cycles of Perjeta was 4, across all treatment arms) and TRYPHAENA (median number of cycles of Perjeta was 3 - 6 across treatment arms) and from the treatment period of APHINITY (median number of cycles of Perjeta was 18).
Estonian: ^ Tabelis 2 on toodud uuringu CLEOPATRA kogu raviperioodi jooksul saadud (andmete kuupäev 11. veebruar 2014; Perjeta-ravi tsüklite arvu mediaan oli 24) ja uuringute NEOSPHERE (Perjeta-ravi tsüklite arvu mediaan oli 4 kõikide ravirühmade lõikes) ja TRYPHAENA (Perjeta-ravi tsüklite arvu mediaan oli 3...6 ravirühmade lõikes) neoadjuvantravi perioodi jooksul saadud koondandmed ning APHINITY raviperioodi andmed (Perjeta tsüklite arvu mediaan oli 18).
English: 0.81; 95% CI 0.66, 1.00 p-value 0.0446) reduction in risk of recurrence or death in patients randomised to receive Perjeta compared with patients randomised to receive placebo.
Estonian: Pärast mediaanselt 45,4-kuulist järelkontrolli vähenes uuringus APHINITY Perjeta ravirühma randomiseeritud patsientide puhul retsidiveerumise või surma oht 19% (riskitiheduste suhe [HR] =0,81; 95% CI 0,66; 1,00 p-väärtus 0,0446), võrreldes platseebot saama randomiseeritud patsientidega.
English: The incidence of symptomatic LVD (congestive heart failure) was 1.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC (this excludes a patient who experienced symptomatic LVD
Estonian: Sümptomaatilise LVD (südame paispuudulikkuse) esinemissagedus oli 1,3% FEC-ravi järgselt kasutatud Perjeta pluss trastuzumabi ja dotsetakseeli rühmas (välja arvatud patsient, kellel tekkis sümptomaatiline LVD FEC-ravi ajal enne Perjeta pluss trastuzumabi ja dotsetakseeli saamist) ning samuti 1,3% Perjeta ja TCH kombinatsiooni rühmas.
English: Each vial contains a total of 420 mg pertuzumab at a concentration of 30 mg/ml
Estonian: Iga viaal sisaldab kokku 420 mg pertuzumabi kontsentratsioonis
English: † Evaluated in patients with Best Overall Response of CR or PR. ^ Objective response rate and duration of response are based on IRF-assessed tumour assessments.
Estonian: ^ Objektiivse ravivastuse määr ja ravivastuse kestus põhinevad sõltumatu hindamiskogu poolt antud hinnangul.
English: Nodal status Positive
Estonian: Sõlmede staatus Positiivne Negatiivne Hormoonretseptori staatus Negatiivne Positiivne
English: Treat diarrhoea according to standard practice and guidelines.
Estonian: Kõhulahtisust tuleb ravida vastavalt kehtivatele ravijuhenditele.
English: Fever
Estonian: Kuumahood
English: Left ventricular dysfunction
Estonian: Vasaku vatsakese düsfunktsioon
English: There was one case of symptomatic LVD in the Perjeta and trastuzumab-treated group.
Estonian: Perjeta- ja trastuzumabravi rühmas täheldati ühte sümptomaatilise LVD juhtu.
English: p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI] Overall Survival (OS)3
Estonian: Tüsistusega patsientide arv (%) HR [95% CI] p-väärtus (logaritmiline astaktest, stratifitseeritud1) 0,0327 3 aasta episoodideta elulemuse määr 2 [95% CI] Üldine elulemus (OS)3
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Perjeta 420 mg concentrate for solution for infusion pertuzumab
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Perjeta 420 mg infusioonilahuse kontsentraat pertuzumab i.v.
English: Leucopenia
Estonian: Trastuzumab
English: Cough Epistaxis Dyspnoea
Estonian: Köha Epistaks Düspnoe
English: Mus culoskeletal and connective tissue disorders
Estonian: Lihas-skeleti ja sidekoe kahjustused
English: Pertuzumab displayed linear pharmacokinetics within the recommended dose range.
Estonian: Lineaarsus/mittelineaarsus Soovitatud annusevahemiku piirides oli pertuzumabi farmakokineetika lineaarne.
English: Dose adjustments of pertuzumab are not needed in patients with mild or moderate renal impairment.
Estonian: Kerge või keskmise raskusega neerukahjustuse korral ei ole vaja pertuzumabi annust muuta.
English: Hepatic impairment
Estonian: Külmavärinad Valu
English: No dose adjustment is necessary in the elderly population ≥ 65 years of age.
Estonian: 65-aastastel ja vanematel patsientidel ei ole vaja annust muuta.
English: pCR rate in the breast (ypT0/is)
Estonian: Täiendavad uurivad pCR määrad sisaldasid lümfisõlmede staatust (ypT0/isN0 ja ypT0N0).
English: No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic breast cancer.
Estonian: Metastaatilise rinnanäärmevähi randomiseeritud keskse uuringu CLEOPATRA lisauuringus, kus osales 37 patsienti, ei täheldatud farmakokineetilisi koostoimeid pertuzumabi ja trastuzumabi või pertuzumabi ja dotsetakseeli vahel.
English: Febrile neutropenia*
Estonian: Febriilne neutropeenia* Neutropeenia Leukopeenia Aneemia
English: NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion pertuzumab
Estonian: RAVIMPREPARAADI NIMETUS Perjeta 420 mg infusioonilahuse kontsentraat pertuzumab
English: p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI]
Estonian: pCR määr rinnanäärmes (ypT0/is) n (%) [95% CI]1 pCR määrade erinevus [95% CI]3
English: There is no relevant use of Perjeta in the paediatric population in the indication of breast cancer.
Estonian: Rinnanäärmevähi ravi näidustusel ei ole Perjeta kasutamine lastel asjakohane.
English: In the neoadjuvant trial NEOSPHERE, in which patients received 4 cycles of Perjeta as neoadjuvant treatment, the incidence of LVD (during the overall treatment period) was higher in the Perjeta,
Estonian: Neoadjuvantravi uuringus NEOSPHERE, kus patsiendid said neoadjuvantravina 4 tsüklit Perjeta't, oli LVD esinemissagedus (kogu raviperioodi jooksul) suurem Perjeta't, trastuzumabi ja dotsetakseeli saanud rühmas (7,5%) kui trastuzumabi ja dotsetakseeliga ravitud rühmas (1,9%).
English: How you are given Perjeta
Estonian: Kuidas Perjeta't manustatakse
English: Nausea
Estonian: Tursed
English: 18.1% of patients in the Perjeta arm vs. 9.2% of patients in the placebo arm in the post-chemotherapy targeted therapy period.
Estonian: Pärast kemoteraapia lõpetamist oli kõhulahtisuse esinemissagedus palju väiksem, seda esines kemoteraapia järgsel suunatud ravi perioodil 18,1%-l Perjeta ravirühma patsientidest vs. 9,2%-l platseeborühma patsientidest.
English: Hot flush
Estonian: • Kuumahood
English: Cough
Estonian: • Köha
English: Perjeta 420 mg concentrate for solution for infusion pertuzumab
Estonian: Perjeta 420 mg infusioonilahuse kontsentraat pertuzumab
English: Glacial acetic acid L-Histidine Sucrose
Estonian: Jää-äädikhape Histidiin Sahharoos Polüsorbaat 20 Süstevesi
English: The active substance is pertuzumab.
Estonian: • Toimeaine on pertuzumab.
English: The dose of docetaxel could be escalated to 100 mg/m2 at the investigator's discretion if the initial dose was well tolerated.
Estonian: Kui algannus oli hästi talutav, võidi dotsetakseeli annust uurija äranägemisel suurendada 100 mg/m2-ni.
English: Clear to slightly opalescent, colourless to pale yellow, liquid.
Estonian: Läbipaistev või kergelt opalestseeruv, värvitu või kahvatukollane vedelik.
English: (vs. Trastuzumab +Docetaxel)
Estonian: (vs. trastuzumab dotsetakseel)
English: No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Estonian: Makaakidega läbi viidud korduvtoksilisuse uuringu põhjal ei saa teha lõplikku järeldust kahjulike toimete kohta isasloomade reproduktiivorganitele.
English: On 8 March 2010, Mylan S.A.S.
Estonian: 8. märtsil 2010 teatas Mylan S.A.S.
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Estonian: See tähendab, et inimravimite komitee oli ettevõtte esialgselt esitatud dokumentidega tutvunud ja koostanud küsimuste loetelu.
English: This means that Docetaxel Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
Estonian: See tähendab, et Docetaxel Mylan pidi olema sarnane võrdlusravimiga Taxotere, millel juba on Euroopa Liidus müügiluba.
English: Because of this and the complex nature of micelles themselves, the Committee had concluded that additional studies on Docetaxel Mylan were necessary, including studies on how the medicine would be treated by the body and its safety.
Estonian: Seetõttu ning ka mitsellide keerukuse tõttu leidis komitee, et ravimi Docetaxel Mylan lisauuringud on vajalikud, sealhulgas peab uurima, kuidas organism ravimit töötleb ning ka ravimi ohutust.
English: Withdrawal of the marketing authorisation application for Docetaxel Mylan (docetaxel) EMA/166011/2010
Estonian: Müügiloa taotluse tagasivõtmise teave Docetaxel Mylan (dotsetakseel) EMA/352872/2010
English: Because Docetaxel Mylan contains the same active substance as Taxotere and was to be given directly into a vein, the company did not consider additional studies on the Docetaxel Mylan to be necessary according to EU rules.
Estonian: Et Docetaxel Mylan sisaldab sama toimeainet kui Taxotere ning et seda manustatakse veeni, leidis ettevõte, et Docetaxel Mylani lisauuringud ei ole Euroopa Liidu nõuete kohaselt vajalikud.
English: What is Docetaxel Mylan?
Estonian: Mis on Docetaxel Mylan?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Mylan.
Estonian: Seetõttu oli inimravimite komitee müügiloa tagasivõtmise ajal arvamusel, et ettevõte ei ole esitanud piisavalt andmeid ravimi Docetaxel Mylan taotluse toetuseks.
English: It was to be available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Estonian: Seda kavatseti turustada pulbri ja lahustina, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: The application was withdrawn at ‘day 120'.
Estonian: Taotluse menetlemine oli kestnud 120 päeva, kui ettevõte võttis taotluse tagasi.
English: Withdrawal of the marketing authorisation application for Docetaxel Mylan (docetaxel)
Estonian: Müügiloa taotluse tagasivõtmise teave Docetaxel Mylan (dotsetakseel)
English: The company provided data on docetaxel from the published literature.
Estonian: Ettevõte esitas doksetakseeli kohta teaduslikus kirjanduses avaldatud andmed.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Estonian: Dotsetakseel mõjutab ka muid rakke peale vähirakkude, näiteks vererakke, mis võib põhjustada kõrvaltoimeid.
English: Docetaxel Mylan is a medicine that contains the active substance docetaxel.
Estonian: Docetaxel Mylan on ravim, mis sisaldab toimeainena dotsetakseeli.
English: Docetaxel Mylan was developed as a ‘generic medicine'.
Estonian: Docetaxel Mylan töötati välja geneerilise ravimina.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Estonian: ametlikult inimravimite komiteele oma soovist tagasi võtta rinnavähi, mitteväikerakk-kopsuvähi, eesnäärmevähi, mao adenokartsinoomi ning pea- ja kaelapiirkonna vähi raviks kasutada kavatsetud ravimi Docetaxel Mylan müügiloa taotlus.
English: Other substances are added to docetaxel to help it form small spherical structures called ‘micelles' that are suitable for injection.
Estonian: Dotsetakseelile lisatakse abiaineid, mille abil moodustuvad väikesed kerakujulised osakesed, mitsellid, mis sobivad süstimiseks.
English: Docetaxel Mylan was expected to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and head and neck cancer.
Estonian: Docetaxel Mylanit kavatseti kasutada rinnavähi, mitteväikerakk-kopsuvähi, eesnäärmevähi, mao adenokartsinoomi (maovähi liik) ning pea- ja kaelapiirkonna vähi raviks Seda kavatseti kasutada kas ainsa ravimina või koos teiste vähiravimitega.
English: However, the substances added in Docetaxel Mylan and Taxotere to form the micelles are not the same.
Estonian: Siiski ei ole ravimitele Docetaxel Mylan ja Taxotere lisatavad ning mitselle moodustavad aineid samad.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Mylan could not have been approved.
Estonian: Tuginedes esitatud andmete analüüsile nägi inimravimite komitee müügiloa tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel arvamusel, et ravimile Docetaxel Mylan ei või anda müügiluba.
English: The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Estonian: Docetaxel Mylani toimeaine dotsetakseel kuulub vähiravimite taksaanide rühma.
English: How is Docetaxel Mylan expected to work?
Estonian: Milline on Docetaxel Mylani eeldatav toime?
English: What was Docetaxel Mylan expected to be used for?
Estonian: Milleks kavatseti Docetaxel Mylanit kasutada?
English: What is Javlor?
Estonian: Mis on Javlor?
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Estonian: Ettevõte võib taotleda arvamuse taasläbivaatamist 15 päeva jooksul pärast negatiivse arvamuse teate saamist.
English: The full European Public Assessment Report for Javlor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Javlori kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 September 2014
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26.
English: Javlor is a cancer medicine that has been authorised in the EU since September 2009.
Estonian: Javlor on vähiravim, millel on Euroopa Liidus müügiluba alates septembrist 2009.
English: Although there was an improvement in progression-free survival, this was considered to be small.
Estonian: Kuigi progresseerumiseta elulemus suurenes, peeti seda väheseks.
English: In addition, there was no benefit in terms of other important measures of effectiveness, including overall survival (how long patients lived).
Estonian: Kasulikkus puudus ka muude tähtsate efektiivsusnäitajate suhtes, sealhulgas üldise elulemuse suhtes (aeg, kui kaua patsiendid elasid).
English: The change concerned an extension of indication to add treatment of breast cancer.
Estonian: Muudatus käsitles näidustuse laiendamist, et lisada rinnavähi ravi.
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Estonian: Metastaatiline (siiretega) tähendab, et vähk on levinud organismis ka mujale.
English: The company that applied for the change to the authorisation is Pierre Fabre Médicament.
Estonian: Müügiloa muutmist taotles ettevõte Pierre Fabre Médicament.
English: Refusal of a change to the marketing authorisation for Javlor (vinflunine) EMA/587197/2014
Estonian: Javlori (vinfluniin) müügiloa muutmisest keeldumine EMA/587197/2014
English: Compared with patients given capecitabine alone, more patients receiving Javlor plus capecitabine experienced side effects including neutropenia (abnormally low blood levels of white blood cells), gastrointestinal events such as constipation, nausea and vomiting and stomach ache, fatigue and nervous system disorders such as damage to the nerves in the extremities.
Estonian: Võrreldes ainult kapetsitabiini kasutanud patsientidega oli Javlori ja kapetsitabiini kombinatsiooni kasutanute seas rohkem neid, kellel esines kõrvalnähte, sealhulgas neutropeeniat (neutrofiilide (teatud valgeliblede) vähesus), seedetrakti häired, näiteks kõhukinnisus, iiveldus, oksendamine ja kõhuvalu, ning väsimus ja närvisüsteemi häired, näiteks perifeerne neuropaatia (jäsemete närvikahjustus).
English: On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Javlor.
Estonian: 25. septembril 2014 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades ravimi Javlor müügiloa muutmisest keelduda.
English: By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.
Estonian: Vähirakkudes sisalduva tubuliiniga seondudes takistab vinfluniin rakutoese moodustumist ning takistab vähirakkude jagunemist ja levikut.
English: Therefore, at that point in time, the CHMP was of the opinion that the modest effect of Javlor in the treatment of breast cancer did not outweigh the additional risks observed.
Estonian: Inimravimite komitee oli sel ajal seepärast arvamusel, et Javlori tagasihoidlik toime rinnavähi ravis ei ületa täheldatud lisariske.
English: The main measure of effectiveness was progression-free survival (how long patients lived without their disease getting worse).
Estonian: Efektiivsuse põhinäitaja oli progresseerumiseta elulemus (aeg haiguse süvenemiseni).
English: The company presented the results of a main study involving 770 patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.
Estonian: Ettevõte esitas põhiuuringu tulemused, milles osales 770 varem antratsükliiniga ravitud või selle suhtes resistentse ja taksaani suhtes resistentse kaugelearenenud rinnavähiga patsienti.
English: Refusal of a change to the marketing authorisation for Javlor (vinflunine)
Estonian: Javlori (vinfluniin) müügiloa muutmisest keeldumine
English: The active substance in Javlor, vinflunine, belongs to the group of cancer medicines known as ‘vinca alkaloids'.
Estonian: Javlori toimeaine vinfluniin kuulub vähiravimite vinka-alkaloidide rühma.
English: The CHMP noted that the effectiveness of Javlor in combination with capecitabine had not been sufficiently demonstrated.
Estonian: Inimravimite komitee märkis, et Javlori ja kapetsitabiini kombinatsiooni efektiivsus ei ole piisavalt tõestatud.
English: There are no consequences on the use of Javlor in its authorised indication.
Estonian: Keeldumine ei mõjuta Javlori kasutamist heakskiidetud näidustusel.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Javlor.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Javlori kliinilistes uuringutes osalevatele patsientidele keeldumine mõju ei avalda.
English: Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Estonian: Inimravimite komitee soovitas seepärast müügiloa muutmisest keelduda.
English: Javlor was also expected to be used in combination with the cancer medicine capecitabine for the treatment of adult patients with locally advanced or metastatic breast cancer.
Estonian: Javlori kavatseti kasutada ka kombinatsioonis vähiravimi kapetsitabiiniga lokaalselt kaugelearenenud või metastaatilise rinnavähiga täiskasvanud patsientide raviks.
English: What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisation?
Estonian: Mis olid peamised probleemid, mille tõttu soovitas inimravimite komitee müügiloa muutmisest keelduda?
English: It was to be used in patients previously treated with, or resistant to, another type of cancer medicine called an anthracycline and who are also resistant to a third type of cancer medicines called taxanes.
Estonian: Seda kavatseti kasutada patsientidel, keda oli varem ravitud teist liiki vähiravimi antratsükliiniga või kelle haigus on selle suhtes resistentne ning kelle haigus on resistentne ka kolmandat liiki vähiravimite taksaanide suhtes.
English: What is happening with Javlor for the treatment of transitional-cell carcinoma of the urothelial tract?
Estonian: Kuidas mõjutab keeldumine Javlori kasutamist uroteeli transitoorrakulise kartsinoomi ravis?
English: In the study, Javlor given together with capecitabine was compared with capecitabine alone.
Estonian: Uuringus võrreldi kapetsitabiini ja Javlori kombinatsiooni toimet ainult kapetsitabiini toimega.
English: It attaches to a cell protein called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to allow them to divide.
Estonian: See seondub rakkudes sisalduva valgu tubuliiniga, mis on oluline rakkude jagunemiseks vajaliku raku sisetoese
English: It is already used to treat adults with advanced or metastatic ‘transitional-cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Estonian: Praegu kasutatakse seda täiskasvanutel uroteeli (kusepõie ja kuseteede limaskesta) kaugelearenenud või metastaatilise transitoorrakulise kartsinoomi (teatud vähiliigi) raviks.
English: What was Javlor expected to be used for?
Estonian: Milleks kavatseti Javlori kasutada?
English: How is Javlor expected to work?
Estonian: Milline on Javlori eeldatav toime?
English: Javlor contains the active substance vinflunine and is available as a concentrate for solution for infusion (drip) into a vein.
Estonian: Seda turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina.
English: 1 Previously known as DuoCover.
Estonian: 1 anteriormente conocido como DuoCover.
English: EPAR summary for the public
Estonian: Resumen del EPAR para el público general
English: The medicine can only be obtained with a prescription.
Estonian: Este medicamento solo se podrá dispensar con receta médica.
English: The European Commission granted a marketing authorisation valid throughout the EU for DuoCover on 15 March 2010.
Estonian: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento DuoCover el 15 de marzo de 2010.
English: Both active substances have been available in the European Union (EU) for a number of years.
Estonian: Ambos principios activos se comercializan en la Unión Europea (UE) desde hace varios años.
English: This summary was last updated in 03-2016.
Estonian: Fecha de la última actualización del presente resumen: 03-2016.
English: It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.
Estonian: También presentó los resultados de 3 estudios previos en los que participaron más de 61.000 pacientes con angina inestable o que habían sufrido un ataque cardíaco.
English: It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Estonian: Puede usarse en los siguientes grupos de pacientes que presenten un trastorno denominado «síndrome coronario agudo»:
English: The full EPAR for Clopidogrel/Acetylsalicylic acid Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: El EPAR completo de Clopidogrel/Ácido acetilsalicílico Zentiva puede consultarse en el sitio web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee therefore decided that Clopidogrel/Acetylsalicylic acid Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Por tanto, el Comité decidió que los beneficios de Clopidogrel/Ácido acetilsalicílico Zentiva son mayores que sus riesgos y recomendó autorizar su comercialización.
English: It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Estonian: Se presenta en comprimidos que contienen 75 mg de clopidogrel, y 75 mg o 100 mg de ácido acetilsalicílico.