FrancophonIA/ELRC3.0 huggingface dataset:
English: Eudorlin Ibuprofen 20 mg/ml Suspension zum Einnehmen
Estonian: Ibuprofeen RATIODOL 20 mg/ ml SUSPENSION
English: The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review.
Estonian: Uus uuringuplaan on nõuannete saamiseks esitatud Saksamaa pädevale asutusele (BfArM) ja seda vaadatakse praegu läbi.
English: Since testosterone levels measured were either below or close to limit of quantitation (0.1 ng/ml) and clearly below the castration level of 0.5 ng/ml clinical efficacy is ensured even if the analytical method is not sufficiently precise.
Estonian: Kuna mõõdetud testosteroonisisaldus oli kas alla määramispiiri (0,1 ng/ml) või selle lähedal ja selgelt alla kastratsiooni puhul saavutatava sisalduse (0,5 ng/ml), on kliiniline efektiivsus tagatud isegi siis, kui analüütiline meetod ei ole piisavalt täpne.
English: These included insufficient validation of the bioanalytical methods, deletion of raw data by re-injection of samples, inconsistent manual reintegration of chromatograms, lack of crucial acceptance criteria for analyses and an insufficient quality management by the sponsor.
Estonian: Nende rikkumiste hulka kuulusid bioanalüütiliste meetodite ebapiisav valideeritus, algandmete kustutamine proovide uuestisüstimise teel, kromatogrammide ebaühtlane manuaalne reintegreerimine, analüüside nõuetekohasuse oluliste näitajate puudumine ja sponsori puudulik kvaliteedijuhtimine.
English: In spite of the fact that patient safety and product efficacy was always ensured, the MAH decided to clinically reinvestigate the current goserelin 1-month product.
Estonian: Vaatamata sellele, et patsientide ohutus ja ravimi efektiivsus olid kogu aeg tagatud, otsustas müügiloa hoidja praegust gosereliini ühekuulist ravimit uuesti kliiniliselt uurida.
English: It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormonedepending prostate carcinoma.
Estonian: Tegemist on LHRH agonistiga (loodusliku luteiniseerivat hormooni vabastava hormooni analoog), mis langetab seerumi testosteroonisisalduse kastratsiooni korral saavutatavale tasemele, pärssides sel viisil hormoonsõltuva eesnäärmekartsinoomi kasvu.
English: Important aspects such as the difficulty of endogeneous testosterone levels in female blank plasma were only considered in the retrospective validation report with additional testing on either pre-treated or pre-selected matrix.
Estonian: Olulisi aspekte, näiteks probleemid endogeense testosteroonitaseme määramisel naiste plasma tühiproovis, kajastati ainult retrospektiivses valideerimisaruandes, kus esitati eeltöödeldud või eelvalitud maatriksi lisatestide tulemused.
English: Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I)
Estonian: Ravimi Novimp 3,6 mg Implantat ja sarnaste nimetuste (vt I lisa) teadusliku hindamise üldkokkuvõte
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Novimp 3,6 mg Implantat and associated names as listed in Annex I.
Estonian: • inimravimite komitee arutas direktiivi 2001/83/EÜ artikli 36 alusel tehtud esildist ravimi Novimp 3,6 mg Implantat ja sarnaste nimetuste (vt I lisa) kohta;
English: Analytical inadequacies would affect comparator and MAH's product in the same way: Since the clinical efficacy was based on a comparison between two products analytical errors would be expected to affect both products in the same way.
Estonian: Analüütilised puudused mõjutaks võrdlusravimi ja müügiloa hoidja ravimi kasutamisel saadud tulemusi samal moel − kuna kliiniline efektiivsus põhines kahe ravimi võrdlusel, mõjutavad analüütilised vead mõlema ravimi kasutamisel saadud tulemusi eeldatavalt samal moel.
English: Therefore, neither the comparative study design nor the cited results of the study can compensate for the breach of the legal requirements to provide GCP-compliant studies in support of a MAA.
Estonian: Seetõttu ei kompenseeri ei võrdlev uuringuplaan ega osutatud uuringutulemused õigusnõuete, mille kohaselt tuleb müügiloa taotluse toetuseks esitada hea kliinilise tava põhimõtteid järgivate uuringute tulemused, rikkumist.
English: Furthermore, the MAH has adapted the study design.
Estonian: Samuti kohandas müügiloa hoidja uuringuplaani.
English: Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
Estonian: Nii GOS/001 (ühekuuline depooravim) kui ka GOS/002 (ühe- ja kolmekuuline depooravim) uuringu vereproovide bioanalüütiliste analüüside teostamisel tehti kindlaks rahvusvahelise ühtlustamiskonverentsi hea kliinilise tava põhinormide ja rahvusvaheliselt tunnustatud laboristandardite olulisi rikkumisi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV <Esmase müügiloa väljastamise kuupäev:> <14/06/2018>
English: The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Estonian: Välistemperatuur peab Dany's BienenWohliga ravi ajal olema vähemalt 3 °C.
English: The active substance in Dany's BienenWohl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Estonian: Dany's BienenWohli toimeaine on komisjoni määruse (EL) nr 37/2010 lisa tabelis 1 kirjeldatud lubatud aine.
English: The use of Dany's BienenWohl with the above dosing scheme only applies to hives with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.
Estonian: Dany's BienenWohli eespool toodud annustamisskeem kehtib ainult ülalt ligipääsetavate vertikaalsete kärgedega tarude kohta, sest mesilaste ravi muud tüüpi tarudes ei ole uuritud.
English: PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Estonian: Perioodiliste ohutusaruannete esitamine peab toimuma sünkroonis ja sama sagedusega kui võrdlusravimi korral.
English: Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Estonian: Dany's BienenWohl ei tohi sattuda veekogudesse, sest võib olla ohtlik kaladele ja teistele veeorganismidele.
English: Citric acid monohydrate Glycerol (85%) Water, purified
Estonian: Sidrunhappe monohüdraat Glütserool (85%) Puhastatud vesi
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/18/225/001-002
English: EU/2/18/225/002 (750 g solution)
Estonian: EU/2/18/225/002 (750 g lahus)
English: Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Estonian: Dany's BienenWohlil on söövitav toime mesilaste pidamise varustuse korrosioonitundlikele osadele.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/18/225/001 (375 g lahus)
English: Advice on correct administration:
Estonian: SOOVITUSED ÕIGE MANUSTAMISE OSAS
English: Dany's BienenWohl should not be used when honey supers are present.
Estonian: Dany's BienenWohli ei tohi kasutada, kui tarus on meekärjed.
English: 1 ml of mixed bee-hive dispersion contains:
Estonian: 1 ml segatud mesitaru dispersiooni sisaldab Toimeaine
English: Dany's BienenWohl must only be applied only once in brood-free colonies.
Estonian: Dany's BienenWohli tohib haudeta peredes kasutada ainult üks kord.
English: Mix with Dany's BienenWohl solution before use.
Estonian: Enne kasutamist segage Dany's BienenWohli lahusega.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
Estonian: VETERINAARRAVIMI NIMETUS Dany's BienenWohl lahus mesitaru dispersiooni valmistamiseks Oksaalhappe dihüdraat
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Estonian: VETERINAARRAVIMI NIMETUS Dany's BienenWohl pulber mesitaru dispersiooni valmistamiseks sahharoos
English: AUTHORISATION
Estonian: Lahus
English: Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Estonian: Dany's BienenWohl 39,4 mg/ml mesitaru dispersiooni pulber ja lahus meemesilastele
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Estonian: VETERINAARRAVIMI NIMETUS Dany's BienenWohl 39,4 mg/ml mesitaru dispersiooni pulber ja lahus meemesilastele
English: Sucrose Anise oil Eucalyptus oil
Estonian: Sahharoos Aniisiõli Eukalüptiõli
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Estonian: Euroopa Komisjon andis Clopidogrel DURA müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Mylan dura GmbH 21. septembril 2009.
English: The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food.
Estonian: Clopidogrel DURA tavaannus on üks 75 mg tablett üks kord ööpäevas koos toiduga või ilma.
English: Clopidogrel DURA can be given to the following groups of patients:
Estonian: Clopidogrel DURAt võib kasutada järgmiste patsiendirühmade korral:
English: Clopidogrel DURA can be started between seven days and six months after the
Estonian: Clopidogrel DURA manustamist võib alustada seitsme päeva kuni kuue kuu jooksul pärast insulti;
English: The Committee recommended that Clopidogrel DURA be given marketing authorisation.
Estonian: Komitee soovitas anda Clopidogrel DURAle müügiloa.
English: The full EPAR for Clopidogrel DURA can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Clopidogrel DURA kohta leiate siit.
English: Clopidogrel DURA can be started between a few days and 35 days after the attack;
Estonian: Clopidogrel DURA manustamist võib alustada mõne kuni 35 päeva jooksul pärast infarkti;
English: Because Clopidogrel DURA is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Estonian: Et Clopidogrel DURA on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Clopidogrel DURA on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel DURA has been shown to have comparable quality and to be bioequivalent to Plavix.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel DURA võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Plavixi korral, ületab Clopidogrel DURA kasulikkus sellega kaasnevad riskid.
English: Clopidogrel DURA is a ‘generic medicine'.
Estonian: Clopidogrel DURA on geneeriline ravim.
English: Clopidogrel DURA is a medicine that contains the active substance clopidogrel.
Estonian: Clopidogrel DURA on ravim, mis sisaldab toimeainena klopidogreeli.
English: Why has Clopidogrel DURA been approved?
Estonian: Miks Clopidogrel DURA heaks kiideti?
English: Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Estonian: Clopidogrel DURAt kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
English: Because Clopidogrel DURA is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Estonian: Et Clopidogrel DURA on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Clopidogrel DURA bioekvivalentsust võrdlusravimiga Plavix.
English: What is Clopidogrel DURA?
Estonian: Mis on Clopidogrel DURA?
English: Other information about Clopidogrel DURA:
Estonian: Muu teave Clopidogrel DURA kohta
English: How has Clopidogrel DURA been studied?
Estonian: Kuidas Clopidogrel DURAt uuriti?
English: What are the benefit and risk of Clopidogrel DURA?
Estonian: Milles seisneb Clopidogrel DURA kasulikkus ja mis riskid ravimiga kaasnevad?
English: How is Clopidogrel DURA used?
Estonian: Kuidas Clopidogrel DURAt kasutatakse?
English: What is Clopidogrel DURA used for?
Estonian: Milleks Clopidogrel DURAt kasutatakse?
English: The active substance in Clopidogrel DURA, clopidogrel, is an inhibitor of platelet aggregation.
Estonian: Clopidogrel DURA toimeaine klopidogreel on trombotsüütide agregatsiooni (vereliistakute kokkukleepumise) inhibiitor, mis aitab ennetada organismis trombide tekkimist.
English: How does Clopidogrel DURA work?
Estonian: Kuidas Clopidogrel DURA toimib?
English: 40 mg/ml Oral solution bottle (glass)
Estonian: 40 mg/ml peroraalne lahus Suukaudne klaaspudel
English: Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus Pakendi sisu kontsentratsioon
English: The reasons being the following:
Estonian: Põhjused olid järgmised:
English: BACKGROUND INFORMATION (2)
Estonian: TAUSTTEAVE (2)
English: The final opinion was converted into a Decision by the European Commission on 5 September 2008.
Estonian: Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 5. septembril 2008.
English: The withdrawal period for milk was 2.5 days.
Estonian: Piima puhul on ravimi keeluaeg 2,5 päeva.
English: Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Estonian: Belgia, Saksamaa ja Ühendkuningriik ei nõustunud ravimi keeluaegadega ja taotlused võeti nendes riikides tagasi.
English: On 25 October 2006 the European Commission forwarded a draft decision to the Standing Committee on Veterinary Medicinal Products for adoption by written procedure.
Estonian: 25. oktoobril 2006 edastas Euroopa Komisjon otsuse eelnõu veterinaarravimite alalisele komiteele, et see võetaks vastu kirjaliku menetluse korras.
English: The procedure for evaluation of the new data started on 15 April 2008.
Estonian: Uute andmete hindamine algas 15. aprillil 2008.
English: The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
Estonian: Peatamise põhjused olid samad, mis nimetati veterinaarravimite komitee koosolekul 2006. aasta mais.
English: The arbitration procedure started on 8 September 2005 with the adoption of a list of questions.
Estonian: Vahekohtumenetlus algas 8. septembril 2005 küsimuste loetelu kinnitamisega.
English: The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain and the United Kingdom.
Estonian: 28. aprillil 2005 algas vastastikuse tunnustamise menetlus, milles viiteliikmesriik oli Prantsusmaa ning asjaomased liikmesriigid olid Belgia, Tšehhi Vabariik, Saksamaa, Itaalia, Hispaania ja Ühendkuningriik.
English: • the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard to the consumer.
Estonian: • hetkel kehtivad keeluajad ei kinnita piisavalt, et ravitud loomadest saadavad toiduained ei sisalda jääke, mis võivad olla ohtlikud tarbija tervisele.
English: During the written procedure a request was received from France for a scientific assessment of new studies made available by the Marketing Authorisation Holder.
Estonian: Kirjaliku menetluse ajal saadi Prantsusmaalt taotlus müügiloa hoidja poolt esitatud uute uuringute teaduslikuks hindamiseks.
English: The rapporteur was Mr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker.
Estonian: Ettekandja oli hr J. Schefferlie ja kaasettekandja prof R. Kroker.
English: The product was accepted by the Czech Republic, Italy and Spain.
Estonian: Ravim sai müügiloa Tšehhi Vabariigis, Itaalias ja Hispaanias.
English: The rapporteur was Mrs. R. Kearsley and the co-rapporteur was Prof. C. Friis.
Estonian: Ettekandja oli pr R. Kearsley ning kaasettekandja prof C. Friis.
English: The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Estonian: Ravimit kasutatakse veiste hingamisteede nakkuste raviks, mille on põhjustanud bakterid Pasteurella multocida ja Mannheimia haemolytica; ning sigade hingamisteede nakkuste raviks, mille on põhjustanud bakter Pasteurella multocida.
English: In both species the product is administered intramuscularly at a dose of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice with a 48 hour interval between doses.
Estonian: Mõlema liigi puhul manustatakse ravimit lihasesse annuses 15 mg amoksitsilliini kehakaalu kilogrammi kohta (vastab 1 milliliitrile Suramox 15% LA-le 10 kg kehakaalu kohta) kaks korda 48-tunnise intervalliga.
English: The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
Estonian: Palve üksikasjalikud põhjendused edastati Euroopa Ravimiametile 18. juulil 2006 ja 19. juulil 2006 algas ülevaatamise hindamismenetlus.
English: On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Estonian: 14. novembril 2006 peatas Euroopa Komisjon kirjaliku menetluse ja 16. novembril 2006 palus veterinaarravimite komiteel arvestada esildise hindamisel uute ravimijääkide uuringutega ning 13. septembril 2006 tehtud arvamus selle põhjal üle vaadata.
English: The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
Estonian: Esildise tegemise eesmärk oli jõuda selgusele, kas kehtestatud keeluajad (58 päeva veiste ja 35 päeva sigade puhul) on adekvaatsed.
English: FOLLOW-UP OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin
Estonian: JÄRELARVAMUS PÄRAST ARTIKLI 351 KOHAST ESILDIST, MIS KÄSITLES RAVIMIT Suramox 15% LA ja seotud nimetust Stabox 15% LA Rahvusvaheline mittekaubanduslik nimetus (INN): amoksitsilliin
English: The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007.
Estonian: 9. jaanuaril 2007 edastas müügiloa hoidja veterinaarravimite komiteele uued ravimijääkide uuringud ja andis komiteele suulisi selgitusi 13. märtsil 2007.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the SPC in Annex III.
Estonian: Asjaomaste ravimite nimekiri on esitatud I lisas, teaduslikud järeldused II lisas ning ravimi omaduste kokkuvõte III lisas.
English: • the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
Estonian: • kehtivad keeluajad veiste ja sigade puhul ei taga adekvaatselt, et loomaorganismi ravimijäägid ei ületa jääkide piirnorme;
English: During its June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Estonian: 2006. aasta juunis toimunud koosolekul määras veterinaarravimite komitee dr R. Breathnachi arvamuse ülevaatamise palve põhjendatuse hindamise ettekandjaks.
English: Therefore, the Committee adopted by consensus an opinion recommending the lifting of the suspension of the marketing authorisations for the above-mentioned product.
Estonian: Seega võttis komitee vastu konsensusliku arvamuse eelpool mainitud ravimi müügilubade peatamise lõpetamise kohta.
English: The Marketing Authorisation Holder (MAH) subsequently provided written explanations to the Committee on 16 January 2006.
Estonian: Seejärel (16. jaanuaril 2006) esitas müügiloa hoidja komiteele kirjalikud selgitused.
English: Furthermore, the Committee recommends varying the marketing authorisations of the veterinary medicinal products referred to in Annex I in accordance with the Summary of Product Characteristics (SPC) as set out in Annex III.
Estonian: Lisaks soovitas komitee viia I lisas nimetatud veterinaarravimite müügiload kooskõlla III lisas esitatud ravimi omaduste kokkuvõttega.
English: Belgium referred the issue to the EMEA on 28 July 2005.
Estonian: 28. juulil 2005 tegi Belgia esildise Euroopa Ravimiametile.
English: • it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
Estonian: • olemasolevate andmete põhjal ei ole võimalik veiste ja sigade puhul keeluaega kindlaks määrata;
English: On 13 September 2006 the CVMP considered the detailed grounds for the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Estonian: 13. septembril 2006 kaalus veterinaarravimite komitee arvamuse ülevaatamise üksikasjalikke põhjendusi ja kinnitas oma varasemat arvamust, mille kohaselt tuleb Suramox 15% LA müügiluba peatada.
English: On 1 June 2006, the MAH notified the EMEA of its intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Estonian: 1. juunil 2006 teatas müügiloa hoidja Euroopa Ravimiametile oma kavatsuse paluda veterinaarravimite komitee arvamuse uut läbivaatamist artikli 36 lõike 4 kohaselt2.
English: The Marketing Authorisation Holder submitted further new residue studies to the CVMP on 14 April 2008.
Estonian: 14. aprillil 2008 esitas müügiloa hoidja veterinaarravimite komiteele täiendavad ravimijääkide uuringud.
English: On 13 June 2007 the European Commission adopted a Commission Decision suspending the national marketing authorisations for Suramox 15% LA and Stabox 15% LA, but providing an opportunity for the decision to be reviewed further to a new opinion formulated by the CVMP on the basis of the assessment of new residue depletion studies.
Estonian: 13. juunil 2007 võttis Eurooa Komisjon vastu otsuse Suramox 15% LA ja Stabox 15% LA liikmesriikide müügilubade peatamiseks, jättes võimaluse pärast veterinaarravimite komitee täiendavate ravimijääkide vähenemise uuringute järgset arvamust otsus uuesti läbi vaadata.
English: Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic belonging to the penicillin group.
Estonian: Amoksitsilliin on penitsilliinide rühma kuuluv beetalaktaam-antibiootikum.
English: During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the marketing authorisations for Suramox 15% LA and the Stabox 15% LA, for cattle and pigs.
Estonian: 2006. aasta mais toimunud veterinaarravimite komitee koosolekul võeti edastatud andmetele ja komitees toimunud teaduslikule diskussioonile tuginedes vastu konsensuslik arvamus, millega soovitati peatada veiste ja sigade ravimi Suramox 15% LA ja seotud ravimi Stabox 15% LA müügiluba.