FrancophonIA/ELRC3.0 huggingface dataset:
English: Using these data PNECs were derived using the appropriate assessment factors.
Estonian: Kasutades neid andmeid, saadi nõuetekohaseid hindamistegureid kasutades PNECväärtused.
English: Data from an acceptable study gave a bioconcentration factor of 510 l/kg which is below the value of 2000 l/kg which would indicate a potential to bioaccumulate.
Estonian: Aktsepteeritavast uuringust saadud andmed andsid bioakumulatsiooni teguriks 510 l/kg, mis jääb allapoole väärtust 2000 l/kg, mis osutaks bioakumulatsiooni potentsiaalile.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Estonian: Kehtiv ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht on lõplikud versioonid, milleni jõuti koordinatsioonirühma protseduuril, järgnevate muudatustega:
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Estonian: Veterinaarravimi nimetuste, ravimvormide, tugevuste, loomaliikide, manustamisviiside ja müügiloahoidjate loetelu liikmesriikides
English: As the PECgroundwater was below 0.1 µg/l no further assessment for the water compartment was required.
Estonian: Kuna prognoositav sisaldus põhjavees (PECgroundwater) oli väiksem kui 0,1 µg/l, ei olnud edasine hindamine veekeskkonna suhtes nõutav.
English: Scientific justifications were provided for the cases of deviations from guidelines and a number of peer reviewed publications were submitted.
Estonian: Suunistest kõrvalekallete kohta esitati teaduslikud põhjendused ja esitati mitu retsenseeritud publikatsiooni.
English: New acute OECD studies were carried out on aquatic organisms followed by an OECD chronic study with daphnia.
Estonian: Tehti uued OECD akuutsuse uuringud veeorganismidel, millele järgnes OECD kroonilisuse uuring vesikirpudel.
English: It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of the products.
Estonian: Selles esitati kogu teave, mis on vajalik ravimite kasutamisest tekkiva keskkonnaohu kohta järelduse tegemiseks.
English: Direct therapeutic benefit
Estonian: Otsene ravist saadav kasu
English: Add, where applicable, “Deltamethrin is toxic to aquatic organisms and honey bees and may accumulate in sediment.”
Estonian: Lisada asjakohasele lõigule, „Deltametriin on toksiline veeorganismidele ja mesilastele ning võib akumuleeruda settes.”
English: The RQ values for surface water were <1 for all target animal types.
Estonian: Pinnavee riskikoefitsiendi väärtused olid kõikide sihtloomaliikide korral <1.
English: The efficacy of Deltanil has been demonstrated according to current rules during the decentralised procedure.
Estonian: Detsentraliseeritud menetluse käigus näidati Deltanili efektiivsust praegu kehtivate eeskirjade kohaselt.
English: No degradation rate for deltamethrin in sediment was required in order to complete the ERA, but some information in the published literature suggests that in some sediments degradation occurs with a half-life in soil of about 10 days (Åkerblom et al. 2008)4.
Estonian: Keskkonnaohu hindamise läbiviimiseks ei nõutud deltametriini degradatsioonimäära kindlakstegemist, kuid avaldatud kirjandusest saadud mõningane teave osutab, et teatud setetes toimub degradeerumine, mille puhul poolestusaeg pinnases on umbes 10 päeva (Åkerblom et al. 2008)4.
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands who considered no acceptable data in the environmental risk assessment has been provided on: n-octanol:water partition coefficient (KOW); soil adsorption coefficient (KOC); soil degradation; bioaccumulation (BCF); toxicity to dung insects, and therefore the environmental risk assessment cannot be finalised.
Estonian: Saksamaa ja Madalmaad tuvastasid detsentraliseeritud menetluse käigus võimalikke raskeid riske ja leidsid, et keskkonnaohu hindamises ei esitatud vastuvõetavaid andmeid järgmise kohta: n-oktanool-vesi jaotuskoefitsient (KOW); mulla adsorbtsioonitegur (KOC); mulla degradeerumine; bioakumulatsioon; sõnnikuputukatele mõjuv toksilisus, ja seetõttu ei saa keskkonnaohu hindamist lõpetada.
English: The applications in question, submitted via the decentralised procedure, are generic applications according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose authorised in the United Kingdom.
Estonian: Kõnealused taotlused, mis esitati detsentraliseeritud menetluse kaudu, on muudetud direktiivi 2001/82/EÜ artikli 13 lõike 3 kohased geneeriliste ravimite taotlused, viidates võrdlusravimitele Pfizer Pour On Insecticide 1% w/v Cutaneous Solution ja Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose, millel on müügiluba Ühendkuningriigis.
English: The amended Summaries of Product Characteristics and package leaflets of the reference Member State are set out in Annex III.
Estonian: Viiteliikmesriigi muudetud ravimiomaduste kokkuvõtted ja pakendi infolehed on sätestatud III lisas.
English: As the active substance is an ectoparasiticide a Phase II ERA was presented.
Estonian: Kuna toimeaine on ektoparasititsiid, esitati faasi II keskkonnaohu hindamine.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the products.
Estonian: Kõnealune direktiivi 2001/82/EÜ artikli 33 lõike 4 kohane esildis tehti mure tõttu, et taotleja ei olnud rahuldavalt tõendanud ravimi Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning ravimi Deltanil 100 mg täpilahus veistele keskkonnaohutust, sest puuduvad kesksed andmed, milleta ei ole võimalik otsustada nende ravimite keskkonnaohutuse üle.
English: Risk Assessment
Estonian: Riskihindamine
English: Acceptable data on the acute toxicity of deltamethrin to dung fly larvae and adult beetles were provided which indicated that RQ values for dung insects were in the order of 90 - 10 000.
Estonian: Esitati vastuvõetavad andmed deltametriini ägeda mürgisuse kohta sõnnikukärbse vastetele ja täiskasvanud põrnikatele, mis osutasid, et sõnnikuputukatega seotud riskikoefitsiendi väärtused jäid vahemikku 90-10 000.
English: The reference member state (RMS) is the United Kingdom for both products.
Estonian: Mõlema ravimi viiteliikmesriik on Ühendkuningriik.
English: Published data from a field study using a pour-on deltamethrin product indicated that the effects of deltamethrin can persist for a number of weeks and have the potential to affect dung insect populations in some circumstances.
Estonian: Kriipsmanustatava deltametriini sisaldava ravimiga tehtud väliuuringust saadud andmed osutasid, et deltametriini toime võib püsida mitu nädalat ja sellel on teatud tingimuste korral potentsiaalne toime sõnnikuputukate populatsioonidele.
English: Furthermore, appropriate risk mitigation measures (RMMs) were considered missing in the product information as a consequence of the identified unacceptable risk to aquatic organisms.
Estonian: Lisaks leiti, et ravimiinfos puuduvad asjakohased riskivähendusmeetmed veeorganismide suhtes tuvastatud vastuvõetamatu riski kohta.
English: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines
Estonian: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Deltanil Pour-On and Spot-on products shows that the products are not expected to pose a risk for the environment when used as recommended in the product information including the recommended RMMs.
Estonian: Olles kaalunud kõiki kirjalikult esitatud üldandmeid, järeldas veterinaarravimite komitee, et Deltanili kriipsmanustatavate ja täppmanustatavate ravimite keskkonnaohu hindamine näitab, et ravimid ei ole eeldatavasti keskkonnale ohtlikud, kui neid kasutatakse nii, nagu ravimiinfos soovitatakse, sealhulgas arvestades soovitatud riskivähendusmeetmeid.
English: A new study was carried out on earthworms according to the recommended OECD guideline and a predicted no effect concentration (PNEC) was derived using the accepted assessment factor (10).
Estonian: Uus katse vihmaussidel viidi läbi OECD soovitatud suunise kohaselt ja tulemuseks saadi arvutuslik mittetoimiv sisaldus (PNEC), kasutades heakskiidetud hindamistegurit (10).
English: Deltamethrin residues will be introduced into the environment following direct excretion onto pasture.
Estonian: Deltrametriini jäägid satuvad keskkonda pärast otsest eritamist karjamaale.
English: 5 Environmental properties
Estonian: 5 Keskkonnaomadused
English: The high soil adsorption coefficient (KOC, expressed as logKOC) of >4.2 suggests that any deltamethrin which enters the aquatic environment will move to the sediment.
Estonian: Mulla kõrge adsorbtsioonitegur >4,2 (KOC, väljendatuna logKOC) osutab, et veekeskkonda sattuv deltametriin liigub setetesse.
English: Evaluation of secondary poisoning showed the risk quotient (RQ) values for terrestrial and aquatic predators were <1 and further assessment was not required.
Estonian: Teisese mürgisuse hindamine näitas, et riskikoefitsiendi (RQ) väärtused maismaa- ja veeröövloomade suhtes olid <1 ja edasine hindamine ei olnud nõutav.
English: As a result of this referral it was considered that due to the high adsorption coefficient (KOC) of deltamethrin the following environmental information should also be added to the previously agreed warning sentence in the SPC (section 5 Environmental Properties) and the package leaflet (section 15 Environmental Properties) "...and may accumulate in sediment".
Estonian: Kõnealuse esildise tulemusena leiti, et deltametriini kõrge adsorptsiooniteguri (KOC) tõttu tuleks ravimi omaduste kokkuvõtte varem heaks kiidetud hoiatuslausesse (lõik 5, „Keskkonnaomadused”) ja pakendi infolehele (lõik 15) lisada ka järgmine keskkonnaalane teave „...ja võib setetes akumuleeruda”.
English: No further assessment of risks to surface water and sediment was necessary and no RMMs were needed.
Estonian: Edasine riskide hindamine pinnavee ja sette suhtes ei olnud vajalik ja riskivähendusmeetmeid ei olnud vaja.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as CMS.
Estonian: Täppmanustatava ravimi asjaomased liikmesriigid on Belgia, Madalmaad, Prantsusmaa ja Saksamaa.
English: However, it was considered that information on the possible accumulation of deltamethrin in sediments should be communicated to the user in the product information.
Estonian: Siiski leiti, et kasutajat tuleks ravimiinfos teavitada deltametriini võimaliku akumuleerumise kohta setetes.
English: GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf
Estonian: guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf
English: The RMMs and warnings in the Summary of Product Characteristics (SPC) and package leaflet address the risk to dung insects by advising on the frequency of re-treatments and the duration of deltamethrin excretion.
Estonian: Riskivähendusmeetmed ja hoiatused ravimi omaduste kokkuvõttes ja pakendi infolehel käsitlevad sõnnikuputukaid ohustavat riski, andes nõu järelravi sageduse kohta ja deltametriini eritumise kestuse kohta.
English: In order to address the concerns raised by the referral, the applicant provided an environmental risk assessment (ERA) in accordance with VICH guidelines GL61 and GL382 and in accordance with the CVMP guideline in support of VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)3.
Estonian: Esildises tõstatatud probleemide hindamiseks esitas taotleja keskkonnaohu hindamise kooskõlas veterinaarravimite tehniliste registreerimisnõuete rahvusvahelise ühtlustamiskonverentsi suunistega GL61 ja GL382 ning kooskõlas veterinaarravimite komitee suunisega veterinaarravimite tehniliste registreerimisnõuete rahvusvahelise ühtlustamiskonverentsi suuniste GL6 ja GL38 toetuseks (EMEA/CVMP/ERA/418282/2005)3.
English: Based on acceptable published data for sediment species the RQ for sediment was <1.
Estonian: Setteliikide kohta avaldatud vastuvõetavate andmete alusel oli setete riskikoefitsient <1.
English: The benefit of the products is that treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs can be carried out using the products.
Estonian: Kõnealuste ravimite kasulikkus seisneb veiste täi- ja kärbseinfestatsioonide ravis ja tõrjes; neid ravimeid kasutades saab teha lammastel puugi-, täi- põdrakärbeste ja porikärbeste nakkuse ravi ning talledel täi- ja puugitõrjet.
English: An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Estonian: Kooskõlas veterinaarravimite tehniliste registreerimisnõuete rahvusvahelise ühtlustamiskonverentsi ja veterinaarravimite komitee suunistega esitati keskkonnaohu hindamine, mis hõlmas avaldatud ja taotlejalt tellitud uuringuid ning käsitles kõiki keskkonnaohu aspekte.
English: As deltamethrin has a n-octanol/water partition coefficient (KOW, expressed as logKOW) of >5.1, its bioaccumulation potential, potential for being considered a persistent, bioaccumulative and toxic (PBT) compound and secondary poisoning were addressed as required by the VICH and CVMP guidelines.
Estonian: Kuna deltametriini n-oktanooli-vee jaotuskoefitsient (KOW, väljendatuna logKOW) on >5,1, käsitleti selle bioakumulatsiooni potentsiaali, võimalust liigitada aine püsivaks, bioakumuleeruvaks ja toksiliseks (PBT) ja teisest mürgisust, nagu nõutakse veterinaarravimite tehniliste registreerimisnõuete rahvusvahelise ühtlustamiskonverentsi ja veterinaarravimite komitee suunistes.
English: Deltamethrin is used topically (dip, spray or pouron) for the control of ectoparasites in cattle and sheep.
Estonian: Deltametriini kasutatakse paikselt (tilgutamine, pihustamine või pealevalamine) ektoparasiitide tõrjeks veistel ja lammastel.
English: Comparison of the predicted environmental concentration (PEC) value for soil with the PNEC showed that the RQ for the soil compartment was <1 and no further assessment was required.
Estonian: Võrreldes mulla PECväärtust (prognoositav sisaldus keskkonnas) PNEC-väärtusega, nähtus, et mullakeskkonna riskikoefitsient oli <1 ja edasine hindamine ei olnud nõutav.
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Estonian: Keskkonnaohu hindamise põhjal taotleja muid riskivähendusmeetmeid ei esitanud.
English: Therefore, the CVMP recommended the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle with amendment to the Summaries of Product Characteristics and package leaflets of the reference Member State.
Estonian: Seetõttu soovitas veterinaarravimite komitee anda müügiload ravimitele Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning Deltanil 100 mg täpilahus veistele ning muuta sellega seoses viiteliikmesriigi ravimi omaduste kokkuvõtteid ja pakendi infolehti.
English: Add the following text in the relevant sections of the product information:
Estonian: Lisada järgnev tekst ravimiinfo asjakohastele lõikudele: Ravimi omaduste kokkuvõte
English: Amendments in the relevant sections of the Summaries of Product Characteristics and package leaflets
Estonian: Ravimi omaduste kokkuvõtte ja pakendi infolehe asjakohaste lõikude muudatused
English: Consequently in order to mitigate the risk for dung insects RMMs were included in the SPC in sections 4.5.iii and 5 (Environmental properties).
Estonian: Seetõttu lisati ravimi omaduste kokkuvõtte lõikudesse 4.5.iii ja 5 („Keskkonnaomadused”) meetmed sõnnikuputukaid ohustavate riskide vähendamiseks.
English: ENVIRONMENTAL PROPERTIES
Estonian: KESKKONNAOMADUSED
English: Overall deltamethrin was not considered to be a PBT compound.
Estonian: Kokkuvõttes ei peetud deltametriini püsivaks, bioakumuleeruvaks ja toksiliseks aineks.
English: Additionally, RMMs have been considered and proposed for the risk identified for dung insects.
Estonian: Lisaks kaaluti riskivähendusmeetmeid ja tehti ettepanekuid sõnnikuputukaid ohustavate riskide kohta.
English: These PNECs were compared with the PEC values (calculated using agreed methods) for surface water exposed via drainage through soil, via direct excretion by cattle and via loss from the fleece of sheep.
Estonian: kasutades) seoses pinnavee kokkupuutega pinnase drenaaži kaudu, otsese eritamise kaudu veistelt ja lammaste villast eritumise teel.
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin, a synthetic pyrethroid.
Estonian: Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning Deltanil 100 mg täpilahus veistele sisaldab sünteetilist püretroidi deltametriini.
English: A screening for PBT properties as required by the CVMP guidelines indicated that deltamethrin did not fulfil the criteria for either 'P' or 'B' although it is considered to be 'T'.
Estonian: Veterinaarravimite komitee suunistes nõutud püsivate, bioakumuleeruvate ja toksiliste omaduste kontroll osutas, et deltametriin ei täida ei püsiva ega bioakumuleeruva aine kriteeriume, kuigi seda peetakse toksiliseks.
English: A risk for dung insects was identified by the ERA and RMMs were proposed to address the risk.
Estonian: Keskkonnaohu hindamises tuvastati sõnnikuputukaid ohustav risk ja tehti ettepanek riskivähendusmeetmete kohta.
English: The adsorption/desorption of deltamethrin was determined by the HPLC method which showed that deltamethrin was expected to be non-mobile in soil.
Estonian: Deltametriini adsorptsioon/desorptsioon määrati kõrgefektiivse vedelikkromatograafia (HPLC) meetodil.
English: Deltamethrin was shown to have a half-life in soil of 72 days based on acceptable published data.
Estonian: Vastuvõetavate avaldatud andmete põhjal näidati, et deltametriini poolestusaeg mullas on 72 päeva.
English: An ERA was provided for the Deltanil products, which was in accordance with VICH and CVMP guidelines.
Estonian: Deltanili ravimite kohta esitati keskkonnaohu hindamine, mis oli kooskõlas veterinaarravimite tehniliste registreerimisnõuete rahvusvahelise ühtlustamiskonverentsi ja veterinaarravimite komitee suunistega.
English: Environmental risk
Estonian: Keskkonnaohud
English: Strength Pharmaceutical form
Estonian: Tugevus Ravimvorm Loomaliik Manustamisvii s
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Estonian: Teaduslikud järeldused ja ravimile Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning ravimile Deltanil 100 mg täpilahus veistele müügiloa andmise alused
English: The benefit-risk balance is considered positive for both Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Estonian: Nii ravimi Deltanil 10 mg/ml kriipsulahus veistele ja lammastele kui ka ravimi Deltanil 100 mg täpilahus veistele kasulikkuse ja riski tasakaalu peeti positiivseks.
English: Name
Estonian: Ravimi nimetus
English: Grounds for the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Estonian: Ravimile Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning ravimile Deltanil 100 mg täpilahus veistele müügilubade andmise alused
English: Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Estonian: Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX PRANTSUSMAA
English: Overall summary of the scientific evaluation of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Estonian: Ravimi Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning ravimi Deltanil 100 mg täpilahus veistele teadusliku hindamise üldkokkuvõte
English: United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Estonian: United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX PRANTSUSMAA
English: Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Estonian: Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX PRANTSUSMAA
English: Luxembourg Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Estonian: Luxembourg Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX PRANTSUSMAA
English: Applicant
Estonian: Täpilahus
English: Halaven eribulin
Estonian: Halaven eribuliin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.
Estonian: Euroopa Komisjon andis Halaveni müügiloa, mis kehtib kogu Euroopa Liidus, 17. märtsil 2011.
English: The full EPAR for Halaven can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Halaveni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Halaven is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Halaveni võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Halaven?
Estonian: Mis meetmed võetakse, et tagada Halaveni ohutu ja efektiivne kasutamine?
English: Other information about Halaven
Estonian: Muu teave Halaveni kohta
English: The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle.
Estonian: Arvutatud annus süstitakse veeni 2-5 minuti jooksul iga tsükli 1. ja 8. päeval.
English: The main measure of effectiveness was overall survival (how long the patients lived).
Estonian: Efektiivsuse põhinäitaja oli üldine elumus (kui kaua patsiendid elasid).
English: Safety in this patient population was considered acceptable and similar to that in patients with breast cancer.
Estonian: Ohutust selles patsiendirühmas peeti vastuvõetavaks ja sarnaseks ohutusega rinnavähi ravis.
English: The active substance in Halaven, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai.
Estonian: Halaveni toimeaine eribuliin sarnaneb vähivastase ainega halihondriin B, mida leidub merikäsnas Halichondria okadai.
English: The CHMP decided that Halaven's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Halaveni kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: The dose to be given is calculated using the patient's height and weight.
Estonian: Annus arvutatakse patsiendi pikkuse ja kehamassi järgi.