FrancophonIA/ELRC3.0 huggingface dataset:
English: Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment.
Estonian: Ravile reageeris ligi 33% metastaatilise haigusega patsientidest (11 patsienti 33st) ja 48% lokaalselt kaugelearenenud haigusega patsientidest (30 patsienti 63st).
English: The company will report any pregnancies that occur during treatment with Erivedge and will monitor their outcome.
Estonian: Ettevõte teatab igast rasedusest, mis ilmneb Erivedgega ravimise ajal, ja jälgib nende tagajärgi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Erivedge kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: It also considered that the side effects were manageable.
Estonian: Lisaks leidis komitee, et kõrvalnähud on ohjatavad.
English: The most common side effects with Erivedge (seen in more than 3 in 10 people) are muscle spasms, hair loss, taste disturbances, weight loss, tiredness, nausea (feeling sick) and diarrhoea.
Estonian: Erivedge kõige sagedamad kõrvalnähud (täheldatud enam kui 3 patsiendil 10st) on lihasekrambid, juuste väljalangemine, maitsetundlikkuse häired, kehakaalu vähenemine, väsimus, iiveldus ja kõhulahtisus.
English: It is not intended to provide practical advice on how to use Erivedge.
Estonian: Hindamisaruandes ei anta Erivedge kasutamise praktilisi nõuandeid.
English: The main measure of effectiveness was the response to treatment, based on reduction by at least 30% in tumour size or disappearance of all signs of cancer (the objective response rate).
Estonian: Efektiivsuse põhinäitaja oli ravivastus, mis põhines kasvaja vähemalt 30% vähenemisel või kõigi vähinähtude kadumisel (objektiivne ravivastuse määr).
English: Erivedge was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Estonian: Erivedge kiideti esialgu heaks tingimuslikult, sest ravimi kohta oodati veel andmeid.
English: The Committee considered that the benefits of Erivedge had been shown for patients with locally advanced and metastatic disease.
Estonian: Komitee leidis, et Erivedge kasulikkus lokaalselt kaugelearenenud ja metastaatilise haigusega patsientidel on kinnitust leidnud.
English: The company will implement a pregnancy prevention programme, by providing educational materials on the risks to the unborn baby, including a reminder card, to patients and healthcare professionals who prescribe and dispense Erivedge.
Estonian: Ettevõte rakendab raseduse ennetusprogrammi, jagades teabematerjale lootele avalduvate riskide kohta, sealhulgas meeldetuletuskaardi patsientidele ja tervishoiutöötajatele, kes Erivedget määravad ja väljastavad.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erivedge have also been included in the summary of product characteristics and the package leaflet.
Estonian: Erivedge ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Erivedge is a cancer medicine that contains the active substance vismodegib.
Estonian: Erivedge on vähiravim, mis sisaldab toimeainena vismodegiibi.
English: Since Erivedge disrupts the mechanism involved in the early development stages of unborn babies, the CHMP concluded that appropriate measures were needed for both men and women treated with Erivedge to prevent pregnancy during and after stopping treatment.
Estonian: Et Erivedge häirib loote varastes arengustaadiumides osaleva mehhanismi toimimist, järeldas inimravimite komitee, et asjakohased meetmed tuleb võtta nii Erivedgega ravitavate meeste kui ka naiste suhtes, et ennetada rasedust ravi ajal ja pärast selle lõppu.
English: It is used to treat adults with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages: when the cancer is metastatic (has spread to other parts of the body) and is causing symptoms, or when it is locally advanced (has started to spread to nearby areas) and is not suitable for surgery or radiotherapy (treatment with radiation).
Estonian: Seda kasutatakse täiskasvanutel kaugelearenenud basaalrakulise kartsinoomi (nahavähi teatud aeglaselt arenev vorm) raviks: kui kasvaja on metastaatiline (on levinud organismis ka mujale) ja põhjustab sümptomeid või kui haigus on lokaalselt kaugelearenenud (on hakanud levima kõrval olevatele aladele) ja kui ei saa kasutada operatsiooni või kiiritusravi.
English: In basal cell carcinoma, the Hedgehog signalling pathway becomes abnormally active and leads to the growth and spread of the cancerous cells.
Estonian: Basaalrakulise kartsinoomi korral muutub Hedgehogi signaali ülekanderada ebanormaalselt aktiivseks ja põhjustab vähirakkude kasvu ja levimist.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Estonian: Et ettevõte esitas lisateabe, muudeti müügiluba tingimuslikust müügiloast tavaliseks müügiloaks.
English: Erivedge must not be used in women who are pregnant or breast-feeding, or who could potentially have children and do not comply with the special pregnancy prevention programme for Erivedge.
Estonian: Erivedget ei tohi kasutada rasedad või imetavad naised või fertiilses eas naised, kes ei järgi Erivedgega seotud raseduse ennetamise eriprogrammi.
English: What are the risks associated with Erivedge?
Estonian: Mis riskid Erivedgega kaasnevad?
English: By attaching to SMO, vismodegib blocks this pathway, thereby slowing down the growth and spread of the cancer cells in basal cell carcinoma.
Estonian: Valgule SMO kinnitudes blokeerib vismodegiib selle raja, aeglustades seega vähirakkude kasvu ja levimist basaalrakulise kartsinoomi korral.
English: The active substance in Erivedge, vismodegib, disrupts the so-called ‘Hedgehog signalling pathway', which is normally involved in regulating the early stages of cell development in unborn babies and certain cell processes in adults.
Estonian: Erivedge toimeaine vismodegiib häirib nn Hedgehogi signaali ülekanderada, mis osaleb tavaliselt loote rakkude arengu varastes staadiumides ja teatud rakuprotsessides täiskasvanutel.
English: This is a summary of the European public assessment report (EPAR) for Erivedge.
Estonian: See on ravimi Erivedge Euroopa avaliku hindamisaruande kokkuvõte.
English: For practical information about using Erivedge, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Erivedge kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: It must not be used together with St John's wort (a herbal medicine used to treat depression).
Estonian: Ravimit ei tohi kasutada koos naistepunaga (teatud taimne depressiooniravim).
English: How is Erivedge used?
Estonian: Kuidas Erivedget kasutatakse?
English: For more information about treatment with Erivedge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Erivedgega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What benefits of Erivedge have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Erivedge kasulikkus?
English: For the full list of all side effects reported with Erivedge, see the package leaflet.
Estonian: Erivedge kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: It should only be prescribed by or under the supervision of a specialist doctor experienced in managing basal cell carcinoma.
Estonian: Seda tohib määrata ainult basaalrakulise kartsinoomi ravis kogenud eriarst või tema järelevalve all olev arst.
English: How does Erivedge work?
Estonian: Kuidas Erivedge toimib?
English: Vismodegib attaches to a protein called ‘SMO', which is involved in activating the Hedgehog signalling pathway.
Estonian: Vismodegiib seondub valguga SMO, mis osaleb Hedgehogi signaali ülekanderaja aktiveerimises.
English: Erivedge can only be obtained with a prescription.
Estonian: Erivedge on retseptiravim.
English: Milk: 7 days.
Estonian: Piim: 7 päeva.
English: The mean half-life calculated is 20.41 days.
Estonian: Keskmine arvutuslik poolväärtusaeg on 20,41 päeva.
English: It is normally used as the sulfate salt.
Estonian: Tavaliselt kasutatakse seda sulfaatsoolana.
English: The study design is in accordance with current standards.
Estonian: Uuringu ülesehitus oli kooskõlas kehtivate standarditega.
English: No stability data were presented.
Estonian: Stabiilsusandmeid ei esitatud.
English: In that case an extrapolated withdrawal period of 228 days is recommended.
Estonian: Sellisel juhul soovitatakse kasutada ekstrapoleeritud keeluaega 228 päeva.
English: 1, it was not possible for Belgium to confirm that the withdrawal periods of 95 days for cattle and 60 days for pigs are safe.
Estonian: 1, ei olnud Belgial võimalik kinnitada, et veiste 95-päevane ja sigade 60-päevane keeluaeg on ohutud.
English: It should be emphasised that the extrapolation method used is a pragmatic approach aimed at preserving product availability while in the same time ensuring consumer safety.
Estonian: Tuleb rõhutada, et kasutatud ekstrapoleerimismeetod on pragmaatiline lähenemine, mille eesmärk on säilitada ravimi kättesaadavus turul ja ühtlasi tagada tarbijaohutus.
English: Applicant/Marketing Authorisation Holder
Estonian: Müügiloa taotleja/hoidja Nimetus
English: Meat and offal: as recommended in the relevant sections of Annex III above.
Estonian: Liha ja söödavad koed: nagu on soovitatud eespool III lisa asjakohastes punktides.
English: PROPHARMA VET d.o.o.
Estonian: Horvaatia PROPHARMA VET d.o.o.
English: Poligono Industrial Vallecas 28031 Madrid Spain
Estonian: Poligono Industrial Vallecas 28031 Madrid
English: CEVA SANTE ANIMALE 10 Avenue de la Ballastiere 33500 Libourne France
Estonian: Prantsusmaa CEVA SANTE ANIMALE 10 Avenue de la Ballastiere 33500 Libourne
English: For the target species pigs, three studies were identified from which a sufficiently reliable withdrawal period could be drawn.
Estonian: Sigade kui sihtliigi kohta leiti kolm uuringut, mille põhjal on võimalik tuletada piisavalt usaldusväärne keeluaeg.
English: The withdrawal periods are, respectively, 44, 66 and 146 days.
Estonian: Keeluajad on vastavalt 44, 66 ja 146 päeva.
English: Milk samples were collected up to 90 hours after the last administration.
Estonian: Piimaproovid võeti kuni 90 tundi pärast viimast manustamiskorda.
English: Krka - Farma d.o.o.
Estonian: Horvaatia Krka - Farma d.o.o.
English: PASTEUR - Filiala Filipesti SRL
Estonian: Rumeenia PASTEUR - Filiala Filipesti SRL
English: The approved withdrawal period of 146 days was derived using the alternative method with a safety span of 30%, and can be considered as safe for the consumer.
Estonian: Heaks kiidetud keeluaeg 146 päeva tuletati alternatiivmeetodiga, kasutades 30% ohutusvaru, ning seda peetakse tarbijale ohutuks.
English: 1ere Avenue 2065 MLID 06516 Carros Cedex France
Estonian: Prantsusmaa VIRBAC 1ere Avenue 2065 MLID 06516 Carros Cedex France
English: LABIANA LIFE SCIENCES, S.A.
Estonian: Hispaania LABIANA LIFE SCIENCES, S.A.
English: Only two animals per slaughter time were involved (14 hours, 7 days, 14 days, 28 days).
Estonian: Korraga tapeti ainult 2 looma (ajapunktides 14 tundi, 7 päeva, 14 päeva ja 28 päeva).
English: The microbiological assay was adequately validated.
Estonian: Mikrobioloogiline analüüsimeetod oli adekvaatselt valideeritud.
English: 19 300 Aspropyrgos mailbox 26
Estonian: Rumeenia Alapis SA 19 300 Aspropyrgos mailbox 26
English: Only two animals per slaughter point were involved.
Estonian: Korraga tapeti ainult 2 looma.
English: In both studies, calves of maximum 1.5 months, presumably nonruminating, were involved.
Estonian: Mõlemad uuringud toimusid kuni 1,5-kuustel eeldatavalt mittemäletsevatel vasikatel.
English: This is not a standard approach and is not referred to in CVMP guidance.
Estonian: See ei ole tavapärane lähenemine ja veterinaarravimite komitee suunises seda võimalust ei ole.
English: The study is not provided as a full report but rather as a summary.
Estonian: Uuringust ei ole esitatud täielikku aruannet, vaid kokkuvõte.
English: WPnew = WPold + {log2(Dnew/Dold) x T1/2(final phase)}
Estonian: KAuus = KAvana + {log2(Duus / Dvana) × T1/2(lõppfaas)}
English: A validated HPLC-MS/MS analytical method was used.
Estonian: Kasutati valideeritud HPLC-MS/MS-analüüsimeetodit.
English: However, in the context of this referral procedure, where products are already authorised and where limited residue depletion data are available, use of this pragmatic approach was considered to be an acceptable way to maintain the availability of medicinal products while ensuring consumer safety.
Estonian: Käesoleva esildismenetluse kontekstis, kus ravimitel juba on müügiluba, aga jääkide kadumise kohta on vähe andmeid, peeti sellist pragmaatilist lähenemist vastuvõetavaks viisiks, kuidas säilitada ravimite kättesaadavus ja ühtlasi tagada tarbijaohutus.
English: Therefore, on 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs.
Estonian: Sel põhjusel algatas Belgia 8. jaanuaril 2016 direktiivi 2001/82/EÜ artikli 35 kohase menetluse gentamütsiini sisaldavate veterinaarravimite kohta, mida manustatakse veistele ja sigadele süstelahusena.
English: The 192 days withdrawal period was established in ruminating animals; however the Committee considers that it is applicable also to non-ruminating calves.
Estonian: Mäletsevatele loomadele määrati keeluaeg 192 päeva, kuid komitee on arvamusel, et seda saab kasutada ka mittemäletsevate vasikate jaoks.
English: Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
Estonian: Bulgaaria Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
English: Calves (up to 13 weeks of age)
Estonian: vasikad (kuni 13nädalased)
English: For that reason it is not possible to use the study to demonstrate a safe withdrawal period, despite the fact that no residues above the sensitivity limit of 100 µg/kg were detected.
Estonian: Sel põhjusel ei ole võimalik seda uuringut kasutada ohutu keeluaja määramiseks, ehkki selles ei leitud ühtki tundlikkuspiiri 100 µg/kg ületavat jäägi väärtust.
English: Vetoquinol SA Magny-Vernois 70200 Lure France
Estonian: Prantsusmaa Vetoquinol SA Magny-Vernois 70200 Lure
English: No complete validation data are available.
Estonian: Täielikud valideerimisandmed ei ole kättesaadavad.
English: No full study report and analytical method validation report are available.
Estonian: Uuringu täielik aruanne ja analüüsimeetodi valideerimise aruanne ei ole kättesaadavad.
English: H. For products listed in Annex I for which lactating cows have already been approved as target species
Estonian: H. I lisas loetletud ravimid, mille puhul lakteerivad lehmad on sihtliigina heaks kiidetud
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Estonian: Gentamütsiin on aminoglükosiidantibiootikum, mis on näidustatud mitmesuguste bakteriaalsete infektsioonide raviks.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Estonian: Veterinaarravimite nimetuste, ravimvormide, tugevuste, loomaliikide, manustamisviiside ja müügiloa taotlejate/hoidjate loetelu liikmesriikides
English: Moreover the residue depletion period is long for gentamicin, and will in most cases cover a period where animals will at least partly, be ruminating.
Estonian: Gentamütsiini jääkide kadumise aeg on pikk ja enamasti hõlmab see ajavahemikku, mille jooksul loomad vähemalt osaliselt mäletsevad.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics
Estonian: Teaduslikud järeldused ja ravimi omaduste kokkuvõtte muutmise alused
English: Overall the data from this study were not considered adequate for the purpose of deriving a milk withdrawal period.
Estonian: Üldiselt ei peetud selle uuringu andmeid piima keeluaja tuletamiseks adekvaatseks.
English: Taking a pragmatic approach intended to preserve product availability in lactating cows while ensuring consumer safety, it is considered appropriate to apply to the maximum milk withdrawal period currently authorised, i.e., 7 days, to all products that have lactating cows as an indicated species.
Estonian: Pragmaatilise lähenemise alusel, mille eesmärk on säilitada ravimi kättesaadavus lakteerivatel lehmadel kasutamiseks ja ühtlasi tagada tarbijaohutus, peetakse praegu asjakohaseks kasutada piima korral pikimat praegu lubatud keeluaega (7 päeva) kõigi ravimite jaoks, mille sihtliik on lakteerivad lehmad.
English: The study meets current standards, although the analytical method was microbiological and no control surrounding injection site sample was collected (on the other hand, two injection sites per animal, one on each side, were analysed).
Estonian: Uuring vastab kehtivatele standarditele, kuigi analüüsimeetod oli mikrobioloogiline ja süstekoha ümbruse kontrollproovi ei võetud (samas analüüsiti igal loomal kaht süstekohta, üht kummalgi küljel).
English: The statistical method could not be applied as, for all edible tissues, an insufficient number of data points were available.
Estonian: Statistilist meetodit ei olnud võimalik kasutada, sest kõigi söödavate kudede kohta ei olnud piisavalt andmepunkte.
English: It is the responsibility of each National Competent Authority to apply the recommendations of this opinion based on the recommended maximum dose as per the approved SPC, and to take action in case the recommendations in the product information cannot be properly interpreted.
Estonian: Kõik riiklikud pädevad asutused vastutavad käesolevas arvamuses olevate soovituste kohaldamise eest, lähtudes heaks kiidetud ravimi omaduste kokkuvõttes soovitatud suurimast annusest, ja peavad võtma meetmeid, kui ravimiteabes olevaid soovitusi ei ole võimalik õigesti tõlgendada.
English: Lithuania Interchemie werken "de Adelaar" B.V.
Estonian: Bulgaaria Interchemie werken "de Adelaar" B.V.
English: Intramuscular or intravenous use:
Estonian: Intramuskulaarne või intravenoosne manustamine:
English: The study is considered by the MAH as a pilot study and involves only 8 animals.
Estonian: Müügiloa hoidja pidas seda uuringut katseuuringuks ja see toimus ainult 8 loomal.
English: 08017 Barcelona Spain
Estonian: 08017 Barcelona
English: No antimicrobial active residues could be detected in any milk sample collected, which is indicative of an overall very rapid depletion.
Estonian: Üheski võetud piimaproovis ei tuvastatud antimikroobse toimega jääke, mis viitab jääkide üldisele väga kiirele kadumisele.
English: Belgium also noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pigs meat and offal from 28 days to 150 days.
Estonian: Belgia märkis ka, et gentamütsiini sisaldavatele veterinaarravimitele, mida manustatakse süstelahusena veistele ja sigadele, on Euroopa Liidus kehtestatud eri keeluajad: näiteks veiselihale ja söödavatele kudedele 28-210 päeva; lehmapiimale 2-7 päeva, mõne ravimi korral märkega „Mitte kasutada toidupiimalehmadel“; ning sealihale ja söödavatele kudedele 28-150 päeva.
English: Germany Eurovet Animal Health B.V. Handelsweg 25
Estonian: Saksamaa Eurovet Animal Health B.V.
English: It is noted that the dose used in the relevant study (50 mg gentamicin base per kg bw) appears to cover all of the currently recommended dosing regimens.
Estonian: Tuleb märkida, et asjakohases uuringus kasutatud annus (50 mg gentamütsiini alusena kehamassi kg kohta) näib hõlmavat kõiki praegu soovitatavaid annustamisskeeme.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to review all available residue depletion data and recommend withdrawal periods for cattle (meat and milk) and pigs.
Estonian: Veterinaarravimite komiteel paluti läbi vaadata kõik olemasolevad jääkide kadumise andmed ning soovitada veiste (liha ja piima) ja sigade keeluajad.
English: Residue concentrations in milk were determined 12, 24, 36, 48, 60, 72, 84 and 96 hours after the last administration.
Estonian: Jääkide kontsentratsioon piimas määrati 12, 24, 36, 48, 60, 72, 84 ja 96 tundi pärast viimast manustamiskorda.
English: General considerations
Estonian: Üldjäreldused
English: No full report is available for the study with Genta-kel 5%, while the study with Gentaveto-5 was provided as a full report.
Estonian: Ravimi Genta-kel 5% uuringu täielik aruanne ei ole kättesaadav, kuid Gentaveto-5 kohta on esitatud täielik aruanne.
English: However, in view of the residues above the MRL in liver at day 89, and given that no full study report is available and no analytical method validation report is available, it is not possible to derive a withdrawal period from the study.
Estonian: Arvestades, et 89. päeval olid ravimijäägid maksas üle piirnormi ning et uuringu täielik aruanne ja analüüsimeetodi valideerimisaruanne ei ole kättesaadavad, ei ole selle uuringu põhjal võimalik tuletada keeluaega.
English: The intention is to address those products concerned by this procedure for which the maximum recommended dose is high and for which no withdrawal period can be set in a conventional manner based on residue data.
Estonian: Kavas on käsitleda käesoleva menetlusega hõlmatud ravimeid, mille suurim soovitatav annus on suur ja mille kohta ei ole jääkide andmete põhjal tavapärasel viisil võimalik määrata keeluaega.
English: KRKA, d.d.
Estonian: Sloveenia KRKA, d.d.
English: Furthermore, data available in Belgium for comparable products clearly indicate that residue levels can be above the maximum residue limits (MRLs) at the proposed withdrawal periods.
Estonian: Lisaks tõendavad Belgias kättesaadavad võrreldavate ravimite andmed selgesti, et ravimijääkide sisaldus võib kavandatud keeluaegade jooksul ületada piirnorme.
English: The withdrawal period derived from those data, based on the alternative method with a 10% safety span, and relating to a single dose of 5 mg/animal, is 44 days for piglets.
Estonian: Nende andmete alusel tuletatud keeluaeg, mille arvutamiseks kasutati 10% ohutusvaru ja alternatiivmeetodit ning mis kehtib 5 mg üksikannuse korral looma kohta, on põrsaste jaoks 44 päeva.
English: It can be considered that this withdrawal period is sufficient to cover differences in product composition that could have an impact on the residue depletion pattern.
Estonian: Võib oletada, et see keeluaeg on piisav, et korvata ravimi koostise erinevused, mis võiksid mõjutada jääkide kadumise kulgu.
English: The low number of animals and data points did not allow analysis of the results using the TTSC (time to safe concentration) or SCLR (safe concentrations, based on linear regression, and allowing for measurements below the limit of quantification) statistical methods, as per CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)
Estonian: Loomade ja andmepunktide väike arv ei võimalda tulemusi analüüsida statistikameetoditega TTSC (aeg ohutu kontsentratsioonini) ega SCLR (lineaarregressioonil põhinev ohutu kontsentratsioon, mis võimaldab kasutada kvantifitseerimispiirist väiksemaid mõõtmistulemusi), nagu sätestatakse veterinaarravimite komitee suunises piima keeluaegade määramise kohta (EMEA/CVMP/473/98)
English: VetProm JSC 26, Otets Paisii Str 2400 Radomir Bulgaria
Estonian: Bulgaaria VetProm JSC 26, Otets Paisii Str 2400 Radomir