FrancophonIA/ELRC3.0 huggingface dataset:
English: Coglapix is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Estonian: Coglapix on ette nähtud sigade aktiivseks immuniseerimiseks A. pleuropneumoniae serotüüpide 1 ja 2 põhjustatud pleuropneumoonia vastu.
English: In particular, the MAH was requested to provide evidence that the reduction of lung lesions and clinical signs would result in reduced weight losses in vaccinated animals as compared to controls.
Estonian: Nimelt nõuti, et müügiloa hoidja esitaks tõendeid, et võrreldes kontrollrühma loomadega vähendab kopsukahjustuste ja kliiniliste nähtude vähenemine vaktsineeritud loomade kaalulangust.
English: The concern related to the overall efficacy of the vaccine have been assessed and it is concluded that Coglapix is expected to be efficacious in immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Estonian: Vaktsiini üldise efektiivsusega seotud probleeme on hinnatud ja järeldatakse, et eeldatavasti on Coglapix sigade immuniseerimisel efektiivne abivahend A. pleuropneumoniae serotüüpide 1 ja 2 põhjustatud pleuropneumoonia kontrolli all hoidmiseks, vähendades haigusega seotud kliinilisi nähte ja kopsukahjustusi.
English: Str. Chindiei nr. 5
Estonian: Ceva Santé Animale Romania Str. Chindiei nr. 5 Sector 4
English: The vaccine contains five, formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae.
Estonian: Vaktsiin sisaldab formaldehüüdiga inaktiveeritud Actinobacillus pleuropneumoniae viit tüve.
English: Route of administration
Estonian: Road
English: 1130 Brussel
Estonian: Metrologielaan 6 1130 Brussel Belgia
English: A sentence is included in section 5 Immunological properties of the Summary of Product Characteristics to reflect the lack of data from field trials.
Estonian: Väliuuringute andmete puudumise kajastamiseks lisatakse ravimi omaduste kokkuvõtte lõiku 5 „Immunoloogilised omadused” järgmine lause: „Efektiivsus tõendatud laboritingimustes, kuid mitte välitingimustes”.
English: Conclusion on the benefit-risk balance
Estonian: Järeldus kasulikkuse ja riski suhte kohta
English: Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae.
Estonian: Vaktsineeritud sigadel tekib immuunsus Actinobacillus pleuropneumoniae serotüüpide 1 ja 2 vastu.
English: Coglapix is intended for active immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, and reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory studies.
Estonian: Coglapix on ette nähtud sigade aktiivseks immuniseerimiseks, et hoida kontrolli all A. pleuropneumoniae serotüüpide 1 ja 2 põhjustatud pleuropneumooniat, ning laboriuuringutes on tõendatud haigusega seotud kliiniliste nähtude ja kopsukahjustuste vähenemine.
English: For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Estonian: Sigade aktiivseks immuniseerimiseks Actinobacillus pleuropneumoniae serotüüpide 1 ja 2 põhjustatud pleuropneumoonia vastu, et vähendada haigusega seotud kliinilisi nähte ja kopsukahjustusi.
English: Libourne
Estonian: II lisa
English: Ballastière, 33500
Estonian: 10, av. de La Ballastière, 33500 Libourne
English: Pharmaceutical form
Estonian: Ravimvorm Loomaliik Manustamistee
English: It is given once every three weeks as an infusion lasting 10 minutes.
Estonian: Ravimit manustatakse iga kolme nädala järel 10-minutilise infusioonina.
English: The recommended dose is calculated using the patient's height and weight.
Estonian: Soovitatav annus arvutatakse patsiendi pikkuse ja kehakaalu järgi.
English: The full EPAR for Pemetrexed Hospira UK Limited can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Pemetrexed Hospira UK Limited kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Estonian: Ravimit tohib kasutada ka säilitusraviks patsientidel, kes on saanud plaatinapõhist keemiaravi.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Hospira UK Limited.
Estonian: Kõrvalnähtude vähendamiseks tuleb patsiendil võtta kortikosteroide (põletikuvastane ravim) ja foolhapet (teatud vitamiin) ning talle tuleb ravimiga Pemetrexed Hospira UK Limited toimuva ravi ajal süstida B12-vitamiini.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Hospira UK Limited.
Estonian: Võrdlusravimiga Alimta on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Pemetrexed Hospira UK Limited korrata.
English: This means that Pemetrexed Hospira UK Limited contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Estonian: See tähendab, et Pemetrexed Hospira UK Limited sisaldab sama toimeainet ja toimib samal viisil kui võrdlusravim Alimta, millel juba on Euroopa Liidus müügiluba.
English: As for every medicine, the company provided studies on the quality of Pemetrexed Hospira UK Limited.
Estonian: Nagu iga ravimi korral, esitas ettevõte uuringud ravimi Pemetrexed Hospira UK Limited kvaliteedi kohta.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira UK Limited?
Estonian: Mis meetmed võetakse, et tagada ravimi Pemetrexed Hospira UK Limited ohutu ja efektiivne kasutamine?
English: When Pemetrexed Hospira UK Limited is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Estonian: Kui ravimit Pemetrexed Hospira UK Limited kasutatakse koos tsisplatiiniga, tuleb enne või pärast tsisplatiini annuse manustamist anda antiemeetikumi (oksendamise ennetamiseks) ja vedelikke (dehüdratsiooni ennetamiseks).
English: Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Pemetrexed Hospira UK Limited on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The Committee recommended that Pemetrexed Hospira UK Limited be approved for use in the EU.
Estonian: Komitee soovitas ravimi Pemetrexed Hospira UK Limited kasutamise Euroopa Liidus heaks kiita.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Hospira UK Limited have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Pemetrexed Hospira UK Limited ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:
Estonian: Pemetrexed Hospira UK Limited on vähiravim, mida kasutatakse kaht tüüpi kopsuvähi raviks:
English: For practical information about using Pemetrexed Hospira UK Limited, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate ravimi Pemetrexed Hospira UK Limited kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Hospira UK Limited has been shown to be comparable to Alimta.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Pemetrexed Hospira UK Limited sarnane toime ravimiga Alimta.
English: For more information about treatment with Pemetrexed Hospira UK Limited, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Pemetrexed Hospira UK Limited toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Hospira UK Limited is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Estonian: Samas ei uuritud ravimi bioekvivalentsust, st kas ravim Pemetrexed Hospira UK Limited imendub organismis samamoodi kui võrdlusravim, et saavutada toimeaine sarnane sisaldus veres.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira UK Limited.
Estonian: See on ravimi Pemetrexed Hospira UK Limited Euroopa avaliku hindamisaruande kokkuvõte.
English: The active substance in Pemetrexed Hospira UK Limited is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Estonian: Ravimi Pemetrexed Hospira UK Limited toimeaine pemetrekseed on antimetaboliitide rühma kuuluv tsütotoksiline ravim (ravim, mis hävitab poolduvaid rakke, näiteks vähirakke).
English: What is Pemetrexed Hospira UK Limited and what is it used for?
Estonian: Mis on Pemetrexed Hospira UK Limited ja milleks seda kasutatakse?
English: Pemetrexed Hospira UK Limited pemetrexed
Estonian: Pemetrexed Hospira UK Limited pemetrekseed
English: It is not intended to provide practical advice on how to use Pemetrexed Hospira UK Limited.
Estonian: Hindamisaruandes ei anta ravimi Pemetrexed Hospira UK Limited kasutamise praktilisi nõuandeid.
English: Why is Pemetrexed Hospira UK Limited approved?
Estonian: Miks Pemetrexed Hospira UK Limited heaks kiideti?
English: Other information about Pemetrexed Hospira UK Limited
Estonian: Muu teave ravimi Pemetrexed Hospira UK Limited kohta
English: Pemetrexed Hospira UK Limited contains the active substance pemetrexed.
Estonian: Pemetrexed Hospira UK Limited sisaldab toimeainena pemetrekseedi.
English: This is because Pemetrexed Hospira UK Limited is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Estonian: Seda ei olnud vaja, sest ravimit Pemetrexed Hospira UK Limited manustatakse veeniinfusioonina, mille abil satub toimeaine otse vereringesse.
English: How has Pemetrexed Hospira UK Limited been studied?
Estonian: Kuidas ravimit Pemetrexed Hospira UK Limited uuriti?
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Estonian: Pemetrexed Hospira UK Limited on retseptiravim ja seda tohib manustada üksnes keemiaravi kasutamises kogenud arsti järelevalve all.
English: Pemetrexed Hospira UK Limited is available as a powder that is made up into a solution for infusion (drip) into a vein.
Estonian: Ravimit Pemetrexed Hospira UK Limited turustatakse infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu Alimta korral, ületab ka ravimi Pemetrexed Hospira UK Limited kasulikkus sellega kaasnevad riskid.
English: How is Pemetrexed Hospira UK Limited used?
Estonian: Kuidas ravimit Pemetrexed Hospira UK Limited kasutatakse?
English: How does Pemetrexed Hospira UK Limited work?
Estonian: Kuidas Pemetrexed Hospira UK Limited toimib?
English: Invented name
Estonian: Müügiloa nr Euroopa Liidus Ravimi väljamõeldud nimetus Tugevus
English: Zerbaxa received a marketing authorisation valid throughout the EU on 18 September 2015.
Estonian: Zerbaxa on saanud müügiloa, mis kehtib kogu ELis, 18. septembril 2015.
English: Further information on Zerbaxa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zerbaxa.
Estonian: Lisateave Zerbaxa kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/zerbaxa.
English: It is given over 1 hour, every 8 hours.
Estonian: Zerbaxat manustatakse 1 tunni jooksul, iga 8 tunni järel.
English: What measures are being taken to ensure the safe and effective use of Zerbaxa?
Estonian: Mis meetmed võetakse, et tagada Zerbaxa ohutu ja efektiivne kasutamine?
English: The European Medicines Agency decided that Zerbaxa's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Zerbaxa kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: Other information about Zerbaxa
Estonian: Muu teave Zerbaxa kohta
English: As for all medicines, data on the use of Zerbaxa are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Zerbaxa kasutamise kohta pidevat järelevalvet.
English: The dose and duration of treatment depends on the infection being treated and how the infection responds to the medicine.
Estonian: Annus ja ravi kestus sõltuvad ravitavast infektsioonist ja sellest, kuidas infektsioon ravile allub.
English: The most common side effects with Zerbaxa (which may affect up to 1 in 10 people) are nausea (feeling sick), headache, constipation, diarrhoea and fever.
Estonian: Zerbaxa kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on iiveldus, peavalu, kõhukinnisus, kõhulahtisus ja palavik.
English: Regarding safety, side effects were considered to be typical and expected for an antibiotic of this kind.
Estonian: Ohutusega seoses peeti kõrvalnähte seda liiki antibiootikumi korral tüüpiliseks ja ootuspäraseks.
English: Side effects reported with Zerbaxa are carefully evaluated and any necessary action taken to protect patients.
Estonian: Zerbaxa kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: • hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).
Estonian: • haiglatekkene pneumoonia ehk kopsupõletik (kopsuinfektsioon, mis tekkis haiglas), sealhulgas hingamisaparaadi kasutamisest tingitud pneumoonia (pneumoonia patsientidel, kes kasutavad kopsude kunstliku ventileerimise seadet, mis aitab patsiendil hingata).
English: The third study involved 726 patients who were using a ventilator and who had either hospitalacquired pneumonia or ventilator-associated pneumonia.
Estonian: Kolmandas uuringus osales 726 patsienti, kes kasutasid hingamisaparaati ja kellel oli kas haiglatekkene pneumoonia või hingamisaparaadi kasutamisest tekkinud pneumoonia.
English: Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Estonian: Zerbaxat ei tohi kasutada patsiendid, kes on Zerbaxa või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised), ega inimesed, kes on ülitundlikud muude tsefalosporiinantibiootikumide suhtes või kellel on kunagi tekkinud raske allergiline reaktsioon mõne muu beetalaktaamantibiootikumi suhtes.
English: For more information about using Zerbaxa, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Zerbaxa kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zerbaxa have been included in the summary of product characteristics and the package leaflet.
Estonian: Zerbaxa ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What is Zerbaxa and what is it used for?
Estonian: Mis on Zerbaxa ja milleks seda kasutatakse?
English: One study involved 1,083 patients who mostly had kidney infection or in some cases a complicated urinary-tract infection.
Estonian: Ühes uuringus osales 1083 patsienti, kellest enamikul oli neeruinfektsioon või mõnel juhul kuseteede tüsistunud infektsioon.
English: Why is Zerbaxa authorised in the EU?
Estonian: Miks Zerbaxa ELis heaks kiideti?
English: The Agency considered that Zerbaxa was effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
Estonian: Amet leidis, et Zerbaxa osutus uuringutes osalenud patsientide infektsioonide ravimisel efektiivseks, kuid märkis, et uuringutes osales vähe kuseteede tüsistunud infektsioonidega patsiente.
English: The second study involved 993 patients with complicated intra-abdominal infections.
Estonian: Teises uuringus osales 993 kõhuõõne tüsistunud infektsiooniga patsienti.
English: The Agency also noted that tazobactam is not active against some classes of beta-lactamase that can cause problems of resistance.
Estonian: Samuti märkis amet, et tasobaktaam ei toimi teatud beetalaktamaasirühmadele, mis võib põhjustada resistentsusprobleeme.
English: Zerbaxa (ceftolozane / tazobactam)
Estonian: Zerbaxa (tseftolosaan/tasobaktaam)
English: These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making the bacteria resistant to the antibiotic's action.
Estonian: Need ensüümid võimaldavad bakteritel lagundada beetalaktaamantibiootikume, näiteks tseftolosaani, muutes bakterid antibiootikumi toimele resistentseks.
English: Both medicines cured 94% of patients (353 out of 375 given Zerbaxa and 375 out of 399 given meropenem).
Estonian: Mõlema ravimiga paranes ligikaudu 94% patsientidest (Zerbaxaga 353 patsienti 375st ja meropeneemiga 375 patsienti 399st).
English: Zerbaxa is an antibiotic used to treat adults with:
Estonian: Zerbaxa on ravim, mida kasutatakse täiskasvanutel järgmiste haigusseisundite raviks:
English: • serious kidney infection (acute pyelonephritis);
Estonian: • rasked neeruinfektsioonid (äge püelonefriit);
English: It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem.
Estonian: Uuring tõendas, et Zerbaxa oli vähemalt sama efektiivne kui meropeneem: infektsioon paranes 54%-l patsientidest (197 patsienti 362st) pärast 7-14 päevast ravi Zerbaxaga ning 53%-l (194 patsienti 362st) meropeneemi saanud patsientidest.
English: What are the risks associated with Zerbaxa?
Estonian: Mis riskid Zerbaxaga kaasnevad?
English: By blocking the action of these enzymes, tazobactam allows ceftolozane to act against bacteria that would otherwise be resistant to ceftolozone.
Estonian: Neid ensüüme blokeerides võimaldab tasobaktaam tseftolosaanil toimida bakterite vastu, mis muidu oleksid tseftolosaanile resistentsed.
English: How is Zerbaxa used?
Estonian: Kuidas Zerbaxat kasutatakse?
English: Zerbaxa successfully treated the infection in about 85% of the cases where it was given (288 of 340), compared with 75% (266 of 353) of those given another antibiotic called levofloxacin.
Estonian: Zerbaxa ravis edukalt 85% infektsioonijuhtudest (288 juhtu 340st) ning levofloksatsiin (samuti antibiootikum) 75% infektsioonijuhtudest (266 juhtu 353st).
English: How does Zerbaxa work?
Estonian: Kuidas Zerbaxa toimib?
English: It works by interfering with the production of molecules that bacteria need to build their protective cell walls.
Estonian: Tseftolosaan häirib nende molekulide teket, mida bakterid vajavad neid kaitsva rakuseina moodustamiseks.
English: Zerbaxa has been shown to be at least as effective as other antibiotics in curing infections in three main studies.
Estonian: Kolmes põhiuuringus osutus Zerbaxa infektsioonide ravis vähemalt sama efektiivseks kui muud antibiootikumid.
English: Zerbaxa was compared with another antibiotic, meropenem.
Estonian: Zerbaxat võrreldi meropeneemiga (samuti antibiootikum).
English: Zerbaxa contains the active substances ceftolozane and tazobactam.
Estonian: Zerbaxa sisaldab toimeainetena tseftolosaani ja tasobaktaami.
English: Ceftolozane is a type of antibiotic called a cephalosporin, which belongs to the wider group of antibiotics called betalactams.
Estonian: Tseftolosaan on tsefalosporiinantibiootikum, mis kuulub suuremasse betalaktaamantibiootikumide rühma.
English: For the full list of side effects of Zerbaxa, see the package leaflet.
Estonian: Zerbaxa kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: • complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections);
Estonian: • tüsistunud (raskelt ravitavad) kõhuõõne kudede ja elundite infektsioonid (kõhuõõneinfektsioonid);
English: An overview of Zerbaxa and why it is authorised in the EU
Estonian: Ülevaade ravimist Zerbaxa ja ELis müügiloa väljastamise põhjendus
English: This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Estonian: See nõrgendab bakterite rakuseina, mistõttu rakk langeb kokku ja hävib.
English: What benefits of Zerbaxa have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Zerbaxa kasulikkus?
English: The active substances in Zerbaxa, ceftolozane and tazobactam, work in different ways.
Estonian: Zerbaxa toimeainetel tseftolosaanil ja tasobaktaamil on eri toimemehhanismid.
English: • complicated infections of the urinary tract (structures that carry urine, such as the bladder);
Estonian: • kuseteede infektsioonid (nt kusepõieinfektsioon);
English: The European Commission issued a decision on 10 January 2010.
Estonian: Euroopa Komisjon võttis otsuse vastu 10. jaanuaril 2010.
English: What is Extraneal?
Estonian: Mis on Extraneal?
English: Dr Ian Hudson (United Kingdom)
Estonian: Dr Ian Hudson (Ühendkuningriik)
English: This variation was to be recognised in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden (the concerned Member States).
Estonian: Muudatuse pidid heaks kiitma Austria, Belgia, Hispaania, Iirimaa, Itaalia, Kreeka, Luksemburg, Madalmaad, Portugal, Prantsusmaa, Rootsi, Saksamaa, Soome ja Taani (asjaomased liikmesriigid).
English: Ref.: EMEA/CHMP/683039/2009 EMEA/H/A-6(12)/1203
Estonian: London, 22. oktoober 2009 Viide: EMEA/CHMP/683039/2009 EMEA/H/A-6(12)/1203
English: Dr Barbara van Zwieten Boot (Netherlands)
Estonian: Dr Barbara van Zwieten Boot (Madalmaad)
English: 23 July 2009
Estonian: 23. juuli 2009
English: Because these Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 9 July 2009.
Estonian: Kuna need liikmesriigid ei jõudnud kokkuleppele, andis Madalmaade ravimiamet 9. juulil 2009 asja üle inimravimite komiteele vahekohtumenetluseks.
English: Article 6(12) of Regulation (EC) 1084/2003 as amended, referral on a variation to a marketing authorisation
Estonian: Muudetud määruse (EÜ) nr 1084/2003 artikli 6 lõige 12, esildise tegemine müügiloa muutmiseks.
English: The review was carried out under an ‘Article 6(12)' referral1.
Estonian: Läbivaatamine toimus artikli 6 lõike 12 kohase esildismenetluse1 korras.
English: Extraneal is authorised in the European Union under a mutual recognition procedure on the basis of the initial authorisation granted by the United Kingdom in 1997.
Estonian: Extranealile anti Euroopa Liidus vastastikuse tunnustamise menetluse korras müügiluba Ühendkuningriigis 1997. aastal antud algse müügiloa alusel.