natgillin/translations-raw huggingface dataset:
This document is a summary of the European Public Assessment Report (EPAR) for DepoCyte. 
Käesolev dokument on ravimi DepoCyte Euroopa avaliku hindamisaruande kokkuvõte.
The Committee decided that DepoCyte's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Inimravimite komitee otsustas, et DepoCyte kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
DepoCyte helps to control the symptoms of the disease. 
DepoCyte aitab haigussümptomeid ohjeldada.
In the main study, 72% of the patients who received DepoCyte responded to treatment (13 out of 18), compared with 18% of those who received the standard formulation of cytarabine (3 out of 17). 
Põhiuuringus tekkis ravivastus 72%-l DepoCytet saanud patsiendist (13 patsienti 18st) ja 18%-l tsütarabiini standardset ravimvormi saanud patsiendist (3 patsiendist 17st).
This is then followed by maintenance doses of 50 mg every four weeks for a further four doses. 
Seejärel manustatakse veel neljal korral 50 mg säilitusannus iga nelja nädala järel.
Other information about DepoCyte: 
Muu teave DepoCyte kohta
These symptoms mainly affect the nerves, and include pain, fits, headache, problems walking, memory problems, incontinence and unusual sensations. 
Need sümptomid mõjutavad peamiselt närve, tekitavad valu, krampe, peavalu, raskusi kõndimisel, mäluhäireid, uriinipidamatust ja vääraistinguid.
For more information about treatment with DepoCyte, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate DepoCytega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
DepoCyte is first given as a 50-mg injection every two weeks for the first five doses, followed by a further 50 mg four weeks later. 
DepoCytet manustatakse kõigepealt esimese viie annuse korral 50 mg süstina iga kahe nädala järel ning pärast seda manustatakse neli nädalat hiljem veel 50 mg annus.
Cytarabine is an analogue of pyrimidine. 
Tsütarabiin on pürimidiini analoog.
The dose can be decreased to 25 mg if the patient shows signs of damage to the nerves (such as headache, abnormal vision, muscle weakness or pain). 
Annust võib vähendada kuni 25 mg-ni, kui patsiendil ilmnevad närvikahjustuse nähud (näiteks peavalu, nägemishäired, lihaste nõrkus või valu).
DepoCyte should not be given to people who may be hypersensitive (allergic) to cytarabine or any of the other ingredients. 
DepoCytet ei tohi kasutada patsiendid, kes võivad olla tsütarabiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
However, there was no difference between the two medicines in how long the patients lived without their nerve disease getting worse. 
Siiski ei täheldatud kahe ravimi erinevust närvihaiguse progresseerumiseni kulunud aja osas.
The active substance in DepoCyte, cytarabine (also known as ara-C), is an anticancer medicine that has been used since the 1970s. 
DepoCyte toimeaine tsütarabiin (teise nimetusega ara-C) on vähiravim, mida on kasutatud alates 1970. aastatest.
In the body, cytarabine takes the place of pyrimidine and interferes with the enzymes involved in the production of new DNA. 
Tsütarabiin asub organismis pürimidiini asemele ja häirib uue DNA moodustamises osalevate ensüümide toimet.
What is the risk associated with DepoCyte? 
Mis riskid DepoCytega kaasnevad?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for DepoCyte. 
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
It must not be used in patients who have an active infection in the meninges. 
Ravimit ei tohi kasutada ajukelmete aktiivse põletikuga patsiendid.
DepoCyte is a suspension for injection that contains 50 mg of the active substance, cytarabine. 
DepoCyte on süstesuspensioon, mis sisaldab toimeainena 50 mg tsütarabiini.
The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that it could improve patients' quality of life because fewer intrathecal injections are needed. 
Inimravimite komitee märkis, et DepoCyte on osutunud lümfomatoosse meningiidi ravis tsütarabiini standardsest ravimvormist efektiivsemaks ja et DepoCyte tõstab patsientide elukvaliteeti intratekaalsete süstide väiksema vajaduse tõttu.
DepoCyte should only be given by a doctor who has experience in the use of anticancer medicines. 
Ravi DepoCytega võib määrata üksnes vähiravimite kasutamise kogemusega arst.
For the full list of all side effects reported with DepoCyte, see the Package Leaflet. 
DepoCyte kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
A patient was classified as a ‘responder' if they had no cancer cells in the spinal fluid after treatment and if their symptoms had not got worse after four weeks. 
Ravivastus loeti tekkinuks, kui patsiendi seljaaju vedelikus puudusid vähirakud pärast ravi ja kui patsiendi haigus ei olnud pärast nelja nädalat progresseerunud.
What is DepoCyte? 
Mis on DepoCyte?
DepoCyte is a ‘depot' injection (a type of injection where the medicine is prepared so that it is absorbed by the body very slowly). 
DepoCytet süstitakse depoosüstina (süsti liik, mille korral ravim on valmistatud nii, et see imendub organismi väga aeglaselt).
In DepoCyte, cytarabine is contained in liposomes (small fatty particles), from which the medicine is released slowly. 
DepoCyte sisaldab tsütarabiini liposoomides (väikesed rasvaosakesed), millest ravim aeglaselt vabaneb.
Why has DepoCyte been approved? 
Miks DepoCyte heaks kiideti?
The study also looked at how long the patients lived without their nerve disease getting worse. 
Uuringus jälgiti patsientide elulemust närvihaiguse süvenemiseni.
The most common side effects with DepoCyte (seen in more than 1 treatment cycle in 10) are headache, arachnoiditis (inflammation of one of the membranes protecting the spine and the brain), confusion, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), weakness and thrombocytopenia (low blood platelet counts).To minimise the symptoms of arachnoiditis, patients should receive dexamethasone by mouth or by injection at the same time as DepoCyte and must be closely monitored. 
DepoCyte kõige sagedamad kõrvalnähud (esinenud enam kui 1 ravitsükli jooksul 10st) on peavalu, arahnoidiit (selja- ja peaaju teatud kelme ehk ämblikuvõrkkesta põletik), segasus, iiveldus, oksendamine, kõhulahtisus, palavik, nõrkus ja trombotsütopeenia (vereliistakute vähesus).
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the ‘anti-metabolite' group. 
See on antimetaboliitide rühma kuuluv tsütotoksiline aine (ravim, mis hävitab jagunevaid rakke, näiteks vähirakke).
The full EPAR for DepoCyte can be found here. 
Euroopa avaliku hindamisaruande täistekst DepoCyte kohta on siin.
What benefit has DepoCyte shown during the studies? 
Milles seisneb uuringute põhjal DepoCyte kasulikkus?
How has DepoCyte been studied? 
Kuidas DepoCytet uuriti?
The medicine must be injected ‘intrathecally' (directly into the spinal fluid in the space that surrounds the spinal cord and the brain). 
Ravimit peab süstima intratekaalselt (otse seljaaju vedelikku selja- ja peaaju ümbritsevate kelmete vahele).
The patient should also receive dexamethasone (a steroid) to help control some of the medicine's side effects. 
Ravimi mõningate kõrvalnähtude ärahoidmiseks peaks patsient saama ka deksametasooni (steroidi).
How is DepoCyte used? 
Kuidas DepoCytet kasutatakse?
What is DepoCyte used for? 
Milleks DepoCytet kasutatakse?
DepoCyte has been compared with a standard formulation of cytarabine in one main study involving 35 patients with lymphomatous meningitis. 
Põhiuuringus, milles osales 35 lümfomatoosse meningiidiga patsienti, võrreldi DepoCytet tsütarabiini standardse ravimvormi kasutamisega.
This is a condition in which cells from a lymphoma (a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes that surround the brain and spinal cord). 
DepoCytet kasutatakse lümfomatoosse meningiidi raviks: see on seisund, mille korral lümfoomirakud (lümfisüsteemi kasvaja) on tunginud seljaaju vedelikku ja ajukelmetesse (pea- ja seljaaju ümbritsevatesse kelmetesse).
28 x 1 tablets 
Blister (polüamiid/alumiinium/PVC) 28 x 1 tabletti
Dose adjustments might be necessary in these patients. 
Nendel patsientidel võib olla vajalik annust kohandada.
Gabapentin - Respiratory depression without concomitant opioid use (EPITT no 18814) 
Gabapentiin - respiratoorne depressioon ilma samaaegse opioidravita (EPITT nr 18 814)
Adopted at the 6-9 June 2017 PRAC 
Vastu võetud ravimiohutuse riskihindamise komitee 6.-9. juuni 2017 koosolekul
- if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen 
− kui teil on närvisüsteemi häired, hingamishäired või kui olete üle 65-aastane, võib arst teile määrata teistsuguse annustamisskeemi
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious: 
Pöörduge otsekohe oma arsti poole, kui teil esineb ravimi võtmise järel mis tahes järgmisi sümptomeid, sest need võivad olla rasked:
Special warnings and precautions for use Concomitant use with opioids 
Erihoiatused ja ettevaatusabinõud kasutamisel Kasutamine koos opioididega
In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems. 
Eriti teatage oma arstile (või apteekrile), kui te võtate või olete hiljuti võtnud mis tahes ravimeid krampide, unehäirete, depressiooni, ärevuse või muude neuroloogiliste või psühhiaatriliste probleemide vastu.
Gabapentin has been associated with severe respiratory depression. 
Gabapentiini on seostatud raske respiratoorse depressiooniga.
- breathing problems, which if severe you may need emergency and intensive care to continue breathing normally 
− hingamisprobleemid, mis raskel juhul võivad normaalse hingamise säilitamiseks vajada erakorralist abi või intensiivravi
Undesirable effects Respiratory, thoracic and mediastinal disorders Frequency ‘rare': Respiratory depression 
Respiratoorsed, rindkere ja mediastiinumi häired Esinemissagedus „harv“: Respiratoorne depressioon
What you need to know before you take <brand name> Warnings and precautions 
2. Mida on vaja teada enne <tootenimetuse> võtmist Hoiatused ja ettevaatusabinõud
Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction. 
Selle raske kõrvalnähu tekkerisk võib olla suurem patsiendil, kellel on hingamishäireted, hingamiselundite või neuroloogiline haigus, neerukahjustus või kes kasutab samaaegselt kesknärvisüsteemi depressante ja eakatel patsientidel.
Talk to your doctor or pharmacist before taking <brand name> 
Enne <kaubanduslik nimetus omastavas käändes> võtmist pidage nõu oma arsti või apteekriga,
Rare (may affect up to 1 in 1,000 people): 
Harv (võivad esineda kuni 1 inimesel 1000st): − Hingamisraskused, pindmine hingamine (respiratoorne depressioon)
Summary of product characteristics 4.4. 
Ravimi omaduste kokkuvõte
EU/1/18/1277/001 Mylotarg 
EU/1/18/1277/001
Intravenous use vial (glass) 
Viaal (klaas)
Pack size 
Intravenoosne
Treatment should be continued for as long as the patient benefits from it. 
Ravi tuleb jätkata, kuni sellest on patsiendile kasu.
The patches can be worn during bathing and hot weather. 
Plaastit tohib kanda ka vees ja kuuma ilmaga.
The patches should not be cut into pieces. 
Plaastrit ei tohi tükeldada.
The full EPAR and risk management plan summary for Rivastigmine 3M Health Care Ltd can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte ravimi Rivastigmine 3M Health Care Ltd kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Treatment should be started with the 4.6-mg-per-24-hours patch, with the dose increased to the higher strength 9.5 mg/24-h patch after at least four weeks if the lower dose is well tolerated. 
Ravi tuleb alustada 4,6 mg / 24 h plaastriga ja annust suurendatakse vähemalt nelja nädala pärast, võttes kasutusele suurema tugevusega 9,5 mg / 24 h plaastri, kui patsient talub väiksemat annust hästi.
The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours. 
Plaaster kinnitatakse seljale, õlavarrele või rindkerele puhtale kuivale karvadeta ja tervele nahale ning plaastrit vahetatakse iga 24 tunni järel.
In patients with Alzheimer's dementia, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). 
Alzheimeri dementsusega patsientidel hävivad ajus teatud närvirakud, mille tulemusena väheneb neurotransmitteri (keemiline aine, mis vahendab signaale närvirakkude vahel) atsetüülkoliini sisaldus.
Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects. 
Raviga tuleb jätkata, kuni ravimist kasu, kuid kõrvalnähtude tekkimisel tohib patsiendi annust vähendada või ravi katkestada.
Rivastigmine 3M Health Care Ltd is used to treat patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. 
Ravimit Rivastigmine 3M Health Care Ltd kasutatakse patsientide ravis, kellel on kerge kuni mõõdukalt raske Alzheimeri dementsus - see on progresseeruv ajuhäire, mis kahjustab järk-järgult mälu, vaimseid võimeid ja käitumist.
A risk management plan has been developed to ensure that Rivastigmine 3M Health Care Ltd is used as safely as possible. 
Töötati välja riskijuhtimiskava, et tagada ravimi Rivastigmine 3M Health Care Ltd võimalikult ohutu kasutamine.
This means that Rivastigmine 3M Health Care Ltd is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon. 
See tähendab, et Rivastigmine 3M Health Care Ltd on sarnane võrdlusravimiga Exelon, millel juba on Euroopa Liidus müügiluba.
Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Rivastigmine 3M Health Care Ltd by the patient. 
Ravi tohib alustada üksnes juhul, kui on olemas hooldaja, kes annab patsiendile regulaarselt ravimit Rivastigmine 3M Health Care Ltd ja jälgib, kuidas patsient seda kasutab.
Patients can be switched from rivastigmine capsules or oral solution to the patches. 
Patsiendid tohivad rivastigmiini kapslitelt või suukaudselt lahuselt üle minna plaastritele.
Rivastigmine 3M Health Care Ltd can only be obtained with a prescription and is available as transdermal patches, which release either 4.6 or 9.5 mg rivastigmine across the skin over 24 hours. 
Rivastigmine 3M Health Care Ltd on retseptiravim ja seda turustatakse transdermaalsete plaastritena, millest vabaneb ööpäeva jooksul naha kaudu 4,6 või 9,5 mg rivastigmiini.
The Committee recommended that Rivastigmine 3M Health Care Ltd be approved for use in the EU. 
Komitee soovitas Rivastigmine 3M Health Care Ltd kasutamise Euroopa Liidus heaks kiita.
By blocking these enzymes, Rivastigmine 3M Health Care Ltd allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia. 
Neid ensüüme blokeerides suurendab Rivastigmine 3M Health Care Ltd atsetüülkoliini sisaldust ajus, mis aitab vähendada Alzheimeri dementsuse sümptomeid.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine 3M Health Care Ltd has been shown to have comparable quality and to be bioequivalent to Exelon. 
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Rivastigmine 3M Health Care Ltd võrreldav kvaliteet ja bioekvivalentsus ravimiga Exelon.
Because Rivastigmine 3M Health Care Ltd is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Et Rivastigmine 3M Health Care Ltd on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
What measures are being taken to ensure the safe and effective use of Rivastigmine 3M Health Care Ltd? 
Mis meetmed võetakse, et tagada ravimi Rivastigmine 3M Health Care Ltd ohutu ja efektiivne kasutamine?
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 3M Health Care Ltd on 3 April 2014. 
Euroopa Komisjon andis ravimi Rivastigmine 3M Healt Care Ltd müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 03. aprillil 2014.
For practical information about using Rivastigmine 3M Health Care Ltd, patients should read the package leaflet or contact their doctor or pharmacist. 
Kui vajate ravimi Rivastigmine 3M Health Care Ltd kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
Rivastigmine 3M Health Care Ltd is a medicine that contains the active substance rivastigmine. 
Rivastigmine 3M Health Care Ltd on ravim, mis sisaldab toimeainena rivastigmiini.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rivastigmine 3M Health Care Ltd, including the appropriate precautions to be followed by healthcare professionals and patients. 
Selle alusel lisati ravimi Rivastigmine 3M Health Care Ltd omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
What is Rivastigmine 3M Health Care Ltd and what is it used for? 
Mis on Rivastigmine 3M Health Care Ltd ja milleks seda kasutatakse?
Other information about Rivastigmine 3M Health Care Ltd 
Muu teave ravimi Rivastigmine 3M Health Care Ltd kohta
For more information about treatment with Rivastigmine 3M Health Care Ltd, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate ravimiga Rivastigmine 3M Health Care Ltd toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
Rivastigmine 3M Health Care Ltd rivastigmine 
Rivastigmine 3M Health Care Ltd rivastigmiin
Treatment with Rivastigmine 3M Health Care Ltd should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's dementia. 
Ravi ravimiga Rivastigmine 3M Health Care Ltd tohib alustada üksnes Alzheimeri dementsuse diagnoosimise ja ravis kogenud arst ning see peab toimuma tema järelevalve all.
Rivastigmine 3M Health Care Ltd is a ‘generic medicine'. 
Rivastigmine 3M Health Care Ltd on geneeriline ravim.
This is a summary of the European public assessment report (EPAR) for Rivastigmine 3M Health Care Ltd. 
See on ravimi Rivastigmine 3M Health Care Ltd Euroopa avaliku hindamisaruande kokkuvõte.
It is not intended to provide practical advice on how to use Rivastigmine 3M Health Care Ltd. 
Hindamisaruandes ei anta ravimi Rivastigmine 3M Health Care Ltd kasutamise praktilisi nõuandeid.
Because Rivastigmine 3M Health Care Ltd is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon. 
Et Rivastigmine 3M Health Care Ltd on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi Rivastigmine 3M Health Care Ltd bioekvivalentsust võrdlusravimiga Exelon.
Why is Rivastigmine 3M Health Care Ltd approved? 
Miks Rivastigmine 3M Health Care Ltd heaks kiideti?
The active substance in Rivastigmine 3M Health Care Ltd, rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. 
Ravimi Rivastigmine 3M Health Care Ltd toimeaine rivastigmiin toime seisneb atsetüülkoliini lagundavate ensüümide atsetüülkoliinesteraasi ja butürüülkoliinesteraasi blokeerimises.
How does Rivastigmine 3M Health Care Ltd work? 
Kuidas Rivastigmine 3M Health Care Ltd toimib?
How has Rivastigmine 3M Health Care Ltd been studied? 
Kuidas ravimit Rivastigmine 3M Health Care Ltd uuriti?
Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk. 
Seetõttu on inimravimite komitee arvamusel, et nagu Exeloni korral, ületab ravimi Rivastigmine 3M Health Care Ltd kasulikkus sellega kaasnevad riskid.
How is Rivastigmine 3M Health Care Ltd used? 
Kuidas ravimit Rivastigmine 3M Health Care Ltd kasutatakse?
Article 35 of Directive 2001/82/EC, as amended. 
Muudetud direktiivi 2001/82/EÜ artikkel 35.
The CVMP was requested to give its opinion on the matter. 
Veterinaarravimite komiteel paluti esitada oma arvamus küsimuse kohta.
The final opinion was converted into a Decision by the European Commission on 1 October 2009. 
Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 1. oktoobril 2009.
International Non-Proprietary Name (INN): Ivermectin 
Rahvusvaheline mittekaubanduslik nimetus (INN): ivermektiin
The re-examination procedure started on 15 April 2009. 
Taasläbivaatamise menetlus algas 15. aprillil 2009.
On 9 December 2008 and 14 January 2009 two Marketing Authorisation Holders provided oral explanations at their request. 
9. detsembril 2008 ja 14. jaanuaril 2009 esitasid kaks müügiloa hoidjat oma taotluse põhjal suulised selgitused.
Oral explanations were given on 12 May 2009. 
Suulised selgitused anti 12. mail 2009.
On 4 June 2008 the National Competent Authorities of the Member States were requested to provide the missing information for the outstanding 120 Marketing Authorisations. 
4. juunil 2008 paluti liikmesriikide pädevatel asutustel esitada puuduv teave ülejäänud 120 müügiloa kohta.
On 21 May 2008 the EMEA received a total of 19 written explanations from the Marketing Authorisation Holders (either as a group of or individual Marketing Authorisation Holders). 
21. mail 2008 sai EMEA kokku 19 kirjalikku selgitust müügiloa hoidjatelt (nii rühmadena kui ka üksikute müügiloa hoidjatena).
The Committee appointed Dr G. J. Schefferlie as rapporteur and Dr J. G. Beechinor, Prof C. Friis, Prof R. Kroker and Dr B. Urbain as co-rapporteurs. 
Komitee määras ettekandjaks dr G. J. Schefferlie ning kaasettekandjaiks dr J. G. Beechinori, prof C. Friisi, prof R. Krokeri ja dr B. Urbaini.
National Marketing Authorisations for injectable products containing ivermectin for use in cattle have been granted in all the Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases. 
Kõigis Euroopa Liidu liikmesriikides on olemas kariloomadel kasutatavate ivermektiini sisaldavate süsteravimite riiklikud müügiload, mis on antud mitmesuguste heakskiidumenetluste teel (vastastikuse tunnustamise menetlused ja riiklikud menetlused) ning mitmesugustel juriidilistel alustel.
Ref. EMEA/471056/2009 
1. oktoober 2009 Viide: EMEA/471056/2009
The referral procedure started on 16 January 2008. 
Esildise menetlemine algas 16. jaanuaril 2008.
The submitted information concerned 173 of the 293 Marketing Authorisations involved in this referral procedure. 
Esitati teave 293 käesolevas esildismenetluses käsitletavast müügiloast 173 müügiloa kohta.
Written explanations were provided by the Marketing Authorisation Holders on 13 November 2008. 
Müügiloa hoidjad esitasid kirjalikud selgitused 13. novembril 2008.