natgillin/translations-raw huggingface dataset:
In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more. 
Lyrica vähendas epilepsiahoogude arvu: ligikaudu 45%-l patsientidest, kes said 600 mg, ja 35%-l patsientidest, kes said 300 mg Lyricat ööpäevas, vähenes epilepsiahoogude arv vähemalt 50%.
• for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles. 
• kümme neuropaatilise valu uuringut hõlmasid üle 3000 perifeerse neuropaatilise valuga patsiendi, kellest ligikaudu pooltel oli diabeetiline neuropaatia ja pooltel vöötohatise järgne valu.
Why has Lyrica been approved? 
Miks Lyrica heaks kiideti?
After three to seven days, the dose can be increased to 300 mg per day. 
Kolme kuni seitsme päeva möödudes võib ravimi ööpäevast annust suurendada 300 mg-ni. Annust võib suurendada kuni kaks korda kuni kõige efektiivsema annuse saavutamiseni.
What is the risk associated with Lyrica? 
Mis riskid Lyricaga kaasnevad?
In neuropathic pain, Lyrica was more effective than placebo in decreasing pain. 
Neuropaatilise valu vähendamisel oli Lyrica platseebost efektiivsem.
For the full list of all side effects reported with Lyrica, see the Package Leaflet. 
Lyrica kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
Lyrica is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment; 
• epilepsia; Lyricat võib kasutada lisaks olemasolevale ravile patsientidel, kelle partsiaalsed (aju teatud osas algavad) epilepsiahood ei ole allunud senisele ravile;
How does Lyrica work? 
Kuidas Lyrica toimib?
Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury; 
• neuropaatiline valu (närvikahjustusest põhjustatud valu); Lyricat võib kasutada perifeerse neuropaatilise valu korral, näiteks diabeediga patsientidel või pärast vöötohatist (herpes zoster),
The full EPAR for Lyrica can be found here. 
Euroopa avaliku hindamisaruande täistekst Lyrica kohta on siin.
What benefit has Lyrica shown during the studies? 
Milles seisneb uuringute põhjal Lyrica kasulikkus?
In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo. 
Generaliseerunud ärevushäire ravis oli Lyrica platseebost efektiivsem: nende patsientide osakaal, kellel toimus paranemine vähemalt 50%, oli Lyrica kasutamise korral 52% ja platseebo korral 38%.
How has Lyrica been studied? 
Kuidas Lyricat uuriti?
In central neuropathic pain, 22% of patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo. 
Tsentraalse neuropaatilise valu korral oli sama osakaal Lyricaga ravitud patsientidest 22% ja platseeboga ravitud patsientidest 8%.
What is Lyrica used for? 
Milleks Lyricat kasutatakse?
How is Lyrica used? 
Kuidas Lyricat kasutatakse?
Effectiveness was measured using a standard anxiety questionnaire after four to eight weeks. 
• kaheksa generaliseerunud ärevushäire uuringut hõlmasid üle 3000 patsiendi; efektiivsust mõõdeti standardse ärevusküsimustiku abil nelja kuni kaheksa nädala pärast.
In peripheral neuropathic pain, 35% of the patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo. 
Perifeerse neuropaatilise valu uuringus oli nende patsientide osakaal, kelle valuküsimustiku punktitulemus vähenes vähemalt 50% võrra, Lyricaga ravitud patsientidest 35% ja platseeboga ravitud patsientidest 18%.
The company presented results of five key studies from the published literature. 
Ettevõte esitas viie põhiuuringu tulemused avaldatud kirjandusest.
The European Commission granted a marketing authorisation valid throughout the European Union for Buccolam on 5 September 2011. 
Euroopa Komisjon andis Buccolami müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 5. septembril 2011.
Each syringe contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of midazolam. 
Iga süstal sisaldab 2,5 mg, 5 mg, 7,5 mg või 10 mg midasolaami.
The full EPAR for Buccolam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Euroopa avaliku hindamisaruande täistekst Buccolami kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
If necessary, the dose can be divided between both sides of the mouth. 
Vajaduse korral võib annuse jagada kahe suupoole vahel pooleks.
Other information about Buccolam 
Muu teave Buccolami kohta
The recommended dose ranges from 2.5.mg to 10 mg, depending on the child's age. 
Soovitatav annus on 2,5 mg kuni 10 mg sõltuvalt lapse vanusest.
EPAR summary for the public midazolam 
Kokkuvõte üldsusele midasolaam
If the seizure has not stopped within 10 minutes of giving Buccolam, they should seek medical help immediately. 
Kui krambihoog ei lõpe 10 minuti jooksul pärast Buccolami manustamist, tuleb kohe otsida arstiabi.
Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other. 
Neurotransmitter GABA on kemikaal, mis võimaldab närvirakkudel üksteisega suhelda.
The Committee therefore decided that Buccolam's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Seega otsustas komitee, et Buccolami kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
Buccolam has the advantage of being quicker and easier to administer than rectal or intravenous medicines. 
Buccolami eelis on see, et seda saab manustada kiiremini ja lihtsamini kui rektaalseid või intravenoosseid ravimeid.
In the four studies, oromucosal midazolam was effective in stopping a seizure within 10 minutes in 65 to 78% of children compared with 41 to 85% of children who received rectal diazepam. 
Neljas uuringus peatas oromukosaalne midasolaam krambihoo 10 minuti jooksul 6578%-l lastest, võrreldes 41-85%-ga rektaalset diasepaami saanud lastest.
This is a summary of the European public assessment report (EPAR) for Buccolam. 
See on ravimi Buccolam Euroopa avaliku hindamisaruande kokkuvõte.
With regard to side effects, the medicine may cause respiratory depression, as is the case with other comparable medicines, but is generally well tolerated. 
Kõrvalnähuna võib ravim sarnaselt teiste võrreldavate ravimitega põhjustada respiratoorset depressiooni, kuid üldiselt talutakse ravimit hästi.
The full amount of the appropriate prefilled syringe should be given slowly into the space between the gum and the cheek. 
Sobiva eeltäidetud süstla kogu sisu tuleb sisestada aeglaselt igeme ja põse vahelisse ruumi.
The most common side effects with Buccolam (seen in more than 1 patient in 10) are sedation, somnolence (sleepiness), depressed levels of consciousness, respiratory depression and nausea (feeling sick) and vomiting. 
Buccolami kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on sedatsioon, unisus, teadvuse nõrgenemine, respiratoorne depressioon ning iiveldus ja oksendamine.
In the brain, GABA is involved in reducing the electrical activity. 
GABA osaleb aju elektrilise aktiivsuse vähendamises.
Buccolam is used to stop prolonged, acute (sudden) convulsive seizures in children and adolescents (from 3 months to less than 18 years of age). 
Buccolami kasutatakse pikaajaliste ägedate krambihoogude raviks lastel ja noorukitel (vanuses 3 kuud kuni alla 18 eluaasta).
For more information about treatment with Buccolam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate Buccolamiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
When comparing buccal midazolam with intravenous diazepam, the results were also very similar. 
Suuõõnde manustatava midasolaami ja intravenoosse diasepaami võrdlemisel olid tulemused samuti väga sarnased.
Carers should only administer one dose. 
Hooldajad tohivad manustada ainult ühe annuse.
It must not be used in patients with myasthenia gravis (a disease causing muscle weakness), severe respiratory insufficiency (lung conditions that cause difficulty breathing), sleep apnoea syndrome (frequent interruption of breathing during sleep) or severe liver problems. 
Seda ei tohi kasutada patsiendid, kellel on raskekujuline müasteenia (lihasnõrkust põhjustav haigus), raskekujuline hingamispuudulikkus (kopsuhaigus, mis tekitab hingamisraskusi), uneapnoe sündroom (sagedad hingamiskatkestused magamise ajal) või rasked maksaprobleemid.
Reports from the published literature confirmed that oromucosal midazolam is effective in stopping seizures in children. 
Aruanded avaldatud kirjandusest kinnitasid, et oromukosaalne midasolaam on lastel krambihoogude peatamisel tõhus.
Buccolam is a medicine that contains the active substance midazolam. 
Buccolam on ravim, mis sisaldab toimeainena midasolaami.
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 Buccolam. 
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
Buccolam attaches to the receptors for the neurotransmitter GABA in the brain and activates them. 
Buccolam kinnitub ajus neurotransmitteri GABA retseptoritele ning aktiveerib need.
When given by carers or parents Buccolam should only be used when the child has already been diagnosed with epilepsy. 
Hooldajad või vanemad tohivad Buccolami kasutada ainult diagnoositud epilepsiaga lapsel.
Buccolam must not be used in people who may be hypersensitive (allergic) to midazolam, benzodiazepines or any of the other ingredients. 
Buccolami ei tohi kasutada patsiendid, kes võivad olla midasolaami, bensodiasepiinide või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
For the full list of all side effects reported with Buccolam, see the package leaflet. 
Buccolami kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
Although intravenous medicines may take less time to start working once injected, it takes time to gain access to the veins, especially in children. 
Kuigi intravenoossete ravimite toime võib süstituna olla kiirem, võtab veenitee rajamine aega, eriti laste puhul.
Based on the results of the studies presented, the CHMP concluded that Buccolam is at least as effective as existing treatments for stopping acute prolonged, convulsive seizures in children. 
Esitatud uuringute tulemuste alusel otsustas inimravimite komitee, et Buccolam on laste pikaajaliste ägedate krambihoogude peatamisel vähemalt sama tõhus kui juba kasutusel olevad ravimeetodid.
Buccolam is given in the side of the child's mouth. 
Buccolami manustatakse lapse suuõõnde.
Convulsions are caused by excessive electrical activity in the brain. 
Krampe põhjustab aju liigne elektriline aktiivsus.
By activating its receptors, Buccolam increases GABA's effects, which will stop a convulsion. 
Selle retseptorite aktiveerimisega suurendab Buccolam GABA toimet, mis peatab krambid.
What is Buccolam? 
Mis on Buccolam?
In infants from 3 months to less than 6 months Buccolam should only be used within a hospital and where equipment is available for resuscitation and monitoring of the patient due to an increased risk respiratory depression (inhibition of breathing). 
3-6 kuu vanuseid imikuid tohib Buccolamiga ravida ainult haiglas, kus on saadaval elustamisvahendid ning on võimalik patsienti jälgida, sest nende puhul on suurem risk hingamispuudulikkuse tekkeks.
What is the risk associated with Buccolam? 
Mis riskid Buccolamiga kaasnevad?
Why has Buccolam been approved? 
Miks Buccolam heaks kiideti?
These studies looked at children with acute convulsions and compared the effects of oromucosal midazolam with those of diazepam (another benzodiazepine) when given intravenously (into a vein) or rectally (into the rectum). 
Uuringud hõlmasid lapsi, kellel esinesid ägedad krambid, ning nendes võrreldi oromukosaalse midasolaami toimet intravenoosse (veeni süstitava) või rektaalse (pärasoolde manustatava) diasepaami (samuti bensodiasepiin) toimega.
The fifth study compared buccal midazolam with intravenous diazepam, where the measure of effectiveness was the treatment's ability to stop the seizure within 5 minutes. 
Viiendas uuringus võrreldi suuõõnde manustatavat midasolaami intravenoosse diasepaamiga ning efektiivsuse põhinäitaja oli see, kas ravi peatas krambihoo 5 minuti jooksul.
The active substance in Buccolam is midazolam, a benzodiazepine, which acts as an anti-convulsant medicine. 
Buccolami toimeaine midasolaam on bensodiasepiin, mis toimib krambivastase ravimina.
In four of these studies, oromucosal midazolam was compared with rectal diazepam and the measure of effectiveness was the treatment's ability to stop the seizure within 10 minutes. 
Neist uuringutest neljas võrreldi oromukosaalset midasolaami rektaalse diasepaamiga ning efektiivsuse põhinäitaja oli see, kas ravi peatas krambihoo 10 minuti jooksul.
It is available as ‘oromucosal solution' (a solution given in the side of the mouth, into the space between the gum and the cheek) in prefilled syringes. 
Seda turustatakse suuõõnelahusena (suuõõnde, igeme ja põse vahelisse ruumi manustatav lahus) eeltäidetud süstaldes.
What benefit has Buccolam shown during the studies? 
Milles seisneb uuringute põhjal Buccolami kasulikkus?
What is Buccolam used for? 
Milleks Buccolami kasutatakse?
How is Buccolam used? 
Kuidas Buccolami kasutatakse?
How has Buccolam been studied? 
Kuidas Buccolami uuriti?
How does Buccolam work? 
Kuidas Buccolam toimib?
Invented name 
Ravimi väljamõeld ud nimetus
Invented name 
Müügiloa nr Euroopa Liidus Ravimi väljamõeldud nimetus
What is Joicela? 
Mis on Joicela?
The studies looked at measurements of pain and disease activity after 13 weeks of treatment. 
Uuringutes vaadeldi valu ja haiguse aktiivsuse näitajaid pärast 13nädalast ravi.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'. 
Ettevõtte kiri, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, on avaldatud jaotises „All documents″.
The Committee was not convinced that screening patients for the DQA1*0102 gene variant sufficiently reduced this risk. 
Komitee ei olnud kindel, et patsientide kontrollimine geenivariandi DQA1*0102 suhtes vähendab seda riski piisavalt.
Withdrawal of the marketing authorisation application for Joicela (lumiracoxib) EMA/917506/2011 
Müügiloa taotluse tagasivõtmise teave: Joicela (lumirakoksiib) EMA/917513/2011
Two of the studies involved 3,235 patients with knee osteoarthritis while the third study involved 1,262 patients with hip osteoarthritis. 
Kahes uuringus osales 3235 põlve osteoartriidiga patsienti ning kolmandas uuringus 1262 puusa osteoartriidiga patsienti.
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process. 
See blokeerib COX-2 ensüümi, mille tulemusena väheneb põletikuprotsessis osalevate ainete prostaglandiinide teke.
It was to be available as filmcoated tablets. 
Seda kavatseti turustada õhukese polümeerikattega tablettidena.
Joicela is a medicine that contains the active substance lumiracoxib. 
Joicela on ravim, mis sisaldab toimeainena lumirakoksiibi.
The company informed the CHMP that no clinical trials or compassionate use programmes are currently on-going with Joicela. 
Ettevõte teatas inimravimite komiteele, et seoses ravimiga Joicela ei toimu praegu kliinilisi uuringuid või eriloaga kasutamise programme.
Withdrawal of the marketing authorisation application for Joicela (lumiracoxib) 
Müügiloa taotluse tagasivõtmise teave: Joicela (lumirakoksiib)
By reducing the production of prostaglandins, Joicela helps to reduce the symptoms of inflammation, such as pain, seen in osteoarthritis. 
Prostaglandiinide tekke vähendamisega aitab Joicela vähendada osteoartriidi puhul esinevaid põletiku sümptomeid, näiteks valu.
DQA1*0102 is thought to increase the risk of liver toxicity in patients taking Joicela. 
Arvatakse, et DQA1*0102 suurendab Joicelat võtvatel patsientidel maksatoksilisuse riski.
At the time of the withdrawal, the CHMP was of the view that the benefits of Joicela did not outweigh its risks, particularly its risk of liver toxicity. 
Inimravimite komitee oli müügiloa taotluse tagasivõtmise ajal arvamusel, et ravimi Joicela kasulikkus ei ole suurem kui sellega kaasnevad riskid, eriti maksatoksilisuse risk.
The effects of Joicela were first tested in experimental models before being studied in humans. 
Enne inimuuringuid kontrolliti Joicela toimet muude katsetega.
What was Joicela expected to be used for? 
Milleks kavatseti Joicelat kasutada?
Joicela was compared with celecoxib (another medicine used in osteoarthritis) and placebo (a dummy treatment) in three main studies. 
Kolmes põhiuuringus võrreldi Joicelat tselekoksiibi (samuti osteoartriidi puhul kasutatav ravim) ning platseeboga (näiv ravim).
Based on the review of the data and the company's response to the CHMP's lists of questions, the CHMP had some concerns and was of the provisional opinion that Joicela could not have been approved for the symptomatic treatment of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of DQA1*0102. 
Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Joicela kasutamist põlve ja puusa osteoartriidi sümptomaatiliseks raviks (liigeste tursed ja valu) patsientidel, kellel ei esine geenivarianti DQA1*0102, ei ole võimalik heaks kiita.
The active substance in Joicela, lumiracoxib, is a selective ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'. 
Joicela toimeaine lumirakoksiib on tsüklooksügenaas-2 (COX-2) inhibiitorite rühma kuuluv selektiivne mittesteroidne põletikuvastane ravim.
Joicela was expected to be used to relieve the symptoms of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of a gene variant called ‘DQA1*0102'. 
Joicelat kavatseti kasutada põlve ja puusa osteoartriidi sümptomite (liigeste tursed ja valu) leevendamiseks patsientidel, kellel ei esine geenivarianti DQA1*0102.
On 15 April 2011, Novartis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joicela for the symptomatic relief in the treatment of osteoarthritis of the knee and hip in patients who are not carriers of the DQA1*0102 allele. 
Novartis teatas 15. aprillil 2011 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Joicela müügiloa taotlus.
How is Joicela expected to work? 
Milline on Joicela eeldatav toime?
27 January 2010 
27. jaanuaril 2010
on 14 September 2009. 
14. septembril 2009.
Committee for Medicinal Products for Veterinary Use (CVMP) 
VETERINAARRAVIMITE KOMITEE (CVMP)
The final opinion was converted into a Decision by the European Commission on 27 January 2010. 
Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 27. jaanuaril 2010
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Slovakia and the Concerned Member States were Poland and Spain. 
Taotlus esitati muudetud direktiivi 2001/82/EÜ artikli 32 kohaselt; viiteliikmesriik oli Slovakkia ning asjaomased liikmesriigid Poola ja Hispaania.
The Mutual Recognition Procedure started on 3 April 2008. 
Vastastikuse tunnustamise menetlus algas 3. aprillil 2008.
Written explanations were provided by the Marketing Authorisation Holder on 14 January 2009 and supplementary information was submitted on 22 April 2009. 
Müügiloa hoidja esitas kirjalikud selgitused 14. jaanuaril 2009 ja lisateavet 22. aprillil 2009.
The Committee appointed Dr Anna-Maria Brady as rapporteur and Dr Frédéric Descamps as co-rapporteur. 
Komitee määras ettekandjaks dr Anna-Maria Brady ja kaasettekandjaks dr Frédéric Descampsi.
APPM Respipharm is a multi-component formaldehyde inactivated whole-cell bacterial vaccine containing three strains of Actinobacillus pleuropneumoniae (Serotypes 2, 9 and 11) and one strain of Pasteurella multocida (Serotype A). 
APPM Respipharm on formaldehüüdiga inaktiveeritud täisrakuline bakteriaalne mitmekomponentne vaktsiin, mis sisaldab kolme Actinobacillus pleuropneumoniae tüve (serotüübid 2, 9 ja 11) ning ühte Pasteurella multocida tüve (serotüüp A).
Due to concerns raised by Spain during the Mutual Recognition Procedure that APPM Respipharm may pose a potentially serious risk to human or animal health or to the environment with respect to quality and efficacy of the product, the Reference Member State, Slovakia, referred the matter to the Agency on 7 October 2008 under Article 33(4) of Directive 2001/82/EC. 
Kuna vastastikuse tunnustamise menetluse käigus tõstatas Hispaania küsimuse võimalikust riskist inimeste või loomade tervisele või keskkonnale vaktsiini APPM Respipharm kvaliteedi ja efektiivsuse tõttu, tegi viiteliikmesriik Slovakkia 7. oktoobril 2008 direktiivi 2001/82/EÜ artikli 33 lõike 4 alusel Euroopa Ravimiametile esildise.
On 28 July 2009, Pharmagal Bio s.r.o. 
28. juulil 2009 teatas Pharmagal Bio s.r.o.
The re-examination procedure started on 15 September 2009. 
Arvamuse läbivaatamist alustati 15. septembril 2009.
The product is indicated for use in pigs (sows and weaned piglets) from 6 weeks of age, intended to induce active immunisation of sows and piglets against pleuropneumonia caused by Actinobacillus pleuropneumoniae and against secondary infection by Pasteurella multocida. 
Vaktsiin on ette nähtud kasutamiseks sigadel (emistel ja võõrutatud põrsastel) alates kuuendast elunädalast aktiivseks immuniseerimiseks Actinobacillus pleuropneumoniae põhjustatud pleuropneumoonia ning Pasteurella multocida põhjustatud sekundaarse infektsiooni vastu.
The detailed grounds for the re-examination were submitted by Pharmagal Bio s.r.o. 
Üksikasjalikud põhjendused otsuse läbivaatamise toetuseks esitas Pharmagal Bio s.r.o.
Background information 
TAUSTTEAVE
Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that its opinion of 15 July 2009 should not be revised, and therefore adopted an opinion on 11 November 2009 recommending the suspension of the existing Marketing Authorisation and the refusal of the granting of the Marketing Authorisations for APPM Respipharm. 
Lähtudes ettekandja hinnangust kättesaadavate andmete kohta, leidis veterinaarravimite komitee, et tema 15. juuli 2009. aasta otsust ei ole vaja läbi vaadata, ning võttis seetõttu 11. novembril 2009 vastu arvamuse, milles soovitas tühistada vaktsiini APPM Respipharm kehtiva müügiloa ja keelduda andmast vaktsiinile uusi müügilube.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II. 
Teaduslikud järeldused on esitatud II lisas.
notified the Agency of its intention to request the reexamination of the CVMP opinion of 15 July 2009. 
Euroopa Ravimiametile, et soovib veterinaarravimite komitee 15. juuli 2009. aasta arvamuse läbivaatamist.
Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the application does not satisfy the criteria for authorisation in respect of efficacy. 
Lähtudes ettekandja hinnangust kättesaadavate andmete kohta, leidis veterinaarravimite komitee, et vaktsiini efektiivsuse poolest ei vasta taotlus müügiloa andmise kriteeriumitele.