FrancophonIA/ELRC3.0 huggingface dataset:
English: A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab.
Estonian: Teises uuringus osales 840 melanoomiga patsienti, kellele manustati kas Keytrudat või teist ravimit, ipilimumaabi.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a protein that has been designed to recognise and block a receptor (‘target') called PD-1.
Estonian: Keytruda toimeaine pembrolisumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära ja blokeerib organismis leiduva retseptori PD‑1 (sihtmärk).
English: Keytruda is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments.
Estonian: Keytrudat kasutatakse peamiselt kaugelearenenud, organismi muudesse osadesse levinud (metastaatilise) või muule ravile mittereageeriva vähi korral.
English: In a further study of 559 patients with ‘squamous' NSCLC that had spread, patients given Keytruda with carboplatin and paclitaxel or nab-paclitaxel lived on average for 15.9 months compared with 11.3 months for patients given placebo with carboplatin and paclitaxel or nab-paclitaxel.
Estonian: Veel ühes uuringus, milles osales 559 metastaseerunud lamerakulise mitteväikerakk-kopsuvähiga patsienti, elasid Keytrudat koos karboplatiini ja paklitakseeliga või nab-paklitakseeliga (paklitakseel albumiiniga seotud nanoosakestena) saanud patsiendid keskmiselt 15,9 kuud ning platseebot koos paklitakseeli või nab-paklitakseeliga saanud patsiendid 11,3 kuud.
English: Head and neck cancer
Estonian: Pea- ja kaelapiirkonna vähk
English: Another study in 882 patients with HNSCC showed that Keytruda alone or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy is effective at prolonging patients' lives when HNSCC tests positive for a certain level of PD-L1.
Estonian: Veel üks uuring 882 pea- ja kaelapiirkonna lamerakk-kartsinoomiga patsiendil tõendas, et Keytruda ainuravimina ja koos plaatina ja 5-fluorouratsiili (5-FU) põhise keemiaraviga on efektiivne nende patsientide elumuse pikendamisel, kelle pea- ja kaelapiirkonna lamerakk-kartsinoom toodab teatud koguses valku PD-L1.
English: For renal cell carcinoma, Keytruda is used in combination with other cancer medicines.
Estonian: Neerurakk-kartsinoomi ravis kasutatakse Keytrudat koos muude vähiravimitega.
English: In a study of 495 patients, patients treated with Keytruda who had high levels of PD-L1 lived on average for 11.6 months while those taking standard cancer treatments lived for 6.6 months.
Estonian: Suure PD-L1 sisaldusega kasvajaga 495 patsiendi uuringus elasid Keytrudaga ravitud patsiendid keskmiselt 11,6 kuud ning standardset vähiravi saanud patsiendid 6,6 kuud.
English: The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Estonian: Ravi tohib alustada vähiravimite kasutamises kogenud arst ning see peab toimuma tema järelevalve all.
English: Keytruda is effective at improving survival or delaying the worsening of disease in patients with advanced cancers or cancers that have spread or come back.
Estonian: Keytruda on efektiivne elumuse pikendamisel ja haiguse süvenemise edasilükkamisel kaugelearenenud vähiga või metastaatilise või taastekkinud vähiga patsientidel.
English: In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 30 (8%) of them, meaning they no longer had any signs of cancer.
Estonian: Teises uuringus, milles osales 370 patsienti, keda ei saanud ravida tsisplatiini sisaldavate ravimitega, saavutasid Keytrudaga vähi täieliku või osalise remissiooni (taandumise) 108 patsienti (29%).
English: The doctor may delay doses if certain side effects occur or stop treatment altogether if side effects are severe.
Estonian: Teatud kõrvalnähtude ilmnemisel võib arst ravimi manustamist edasi lükata ja raskete kõrvalnähtude korral ravi lõpetada.
English: In a main study of 210 patients, Keytruda produced a complete or partial remission (clearing) of the cancer in 145 patients (69%); a complete remission occurred in 47 (22%) of them, meaning they no longer had any signs of cancer.
Estonian: 210 patsiendiga põhiuuringus saavutasid Keytrudaga täieliku või osalise remissiooni (vähi taandumine) 145 patsienti (69%).
English: Keytruda is also effective in combination treatment of a type of NSCLC known as ‘non-squamous' cancer, based on the type of cancer cells involved.
Estonian: Keytruda on samuti efektiivne mitteväikerakk-kopsuvähi ühe vormi - mittelamerakulise vähi (nimetus tuleneb vähirakkude tüübist) kombinatsioonravis.
English: In a study looking at around 1,000 previously treated patients, patients lived longer with Keytruda given alone (around 11 months) than with another cancer medicine called docetaxel (around 8 months) and the period during which the disease did not get worse was around 4 months with both treatments.
Estonian: Ligikaudu 1000 varem ravitud patsiendi uuringus oli Keytrudat ainuravimina kasutanud patsientide elumus (ligikaudu 11 kuud) pikem kui vähiravimi dotsetakseeli kasutamisel (ligikaudu 8 kuud) ning progresseerumiseta elumus oli mõlemas ravirühmas ligikaudu 4 kuud.
English: • a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC),
Estonian: • pea- ja kaelapiirkonnas esinev vähk, mida nimetatakse pea- ja kaelapiirkonna lamerakk kartsinoomiks;
English: In a study of 616 patients with non-squamous NSCLC that had spread, 69% of patients taking Keytruda with pemetrexed and platinum chemotherapy were alive at 11 months, compared with less than half of patients who had only pemetrexed and platinum chemotherapy.
Estonian: 616 metastaatilise mittelamerakulise mitteväikerakkkopsuvähiga patsiendi uuringus oli 11 kuu pärast elus 69% Keytrudat koos pemetrekseedi ja plaatinapõhise keemiaraviga kasutanud patsientidest, samas kui ainult pemetrekseedi ja plaatinapõhist keemiaravi saanud patsientidest olid elus vähem kui pooled.
English: After one and a half years of treatment, 72% of patients on Keytruda were still disease-free compared with 54% of patients on placebo.
Estonian: Pärast poolteiseaastast ravi oli Keytrudat saanud patsientidest endiselt haiguseta 72% ning platseebot (näiv ravim) saanutest 54%.
English: Keytruda is a cancer medicine used to treat:
Estonian: Keytruda on vähiravim, mida kasutatakse järgmiste kasvajate raviks:
English: Patients in the Keytruda group lived on average for around 6 months without their disease getting worse compared with 4.8 months for patients in the placebo group.
Estonian: Keytruda rühmas elasid patsiendid keskmiselt ligikaudu 6 kuud ilma progresseerumiseta ning platseeborühmas 4,8 kuud.
English: Also, up to 74% of patients treated with Keytruda lived for at least 12 months after the start of their treatment compared with 59% of patients on ipilimumab.
Estonian: Vähemalt 12 kuud pärast ravi algust oli elus kuni 74% Keytrudaga ning 59% ipilimumaabiga ravitud patsientidest.
English: Keytruda improves survival of patients with urothelial cancer.
Estonian: Keytruda suurendab uroteeliaalse kartsinoomiga patsientide elumust.
English: In this study, disease did not get worse for 5.1 months on average in patients taking Keytruda combination, 3.2 months in patients taking Keytruda alone and 5.0 months in patients taking other standard treatments.
Estonian: Selles uuringus oli progresseerumiseta elumus Keytruda kombinatsiooni kasutanud patsientidel keskmiselt 5,1 kuud, Keytrudat ainuravimina kasutanud patsientidel 3,2 kuud ja muud standardravi saanud patsientidel 5,0 kuud.
English: Keytruda is also effective in preventing melanoma from coming back in patients who have had surgery.
Estonian: Keytruda ennetab efektiivselt ka melanoomi taasteket opereeritud patsientidel.
English: In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.
Estonian: Mõne vähiliigi ravis manustatakse seda ainult patsientidele, kelle kasvaja toodab suures koguses valku PD‑L1 (programmeeritud rakusurmligand 1).
English: Patients treated with Keytruda lived for up to 5.6 months without their disease getting worse compared with 2.8 months with ipilimumab.
Estonian: Keytrudaga ravitud patsiendid elasid ilma haiguse progresseerumiseta kuni 5,6 kuud ning ipilimumaabi saanud 2,8 kuud.
English: Patients treated with Keytruda lived on average around 10 months compared with around 7 months with the other cancer medicines.
Estonian: Keytrudaga ravitud patsiendid elasid keskmiselt ligikaudu 10 kuud ning muid vähiravimeid saanud patsiendid ligikaudu 7 kuud.
English: Patients taking the Keytruda combination lived on average for 13.6 months compared with 10.4 months for patients taking other standard treatments.
Estonian: Keytruda kombinatsiooni kasutanud patsiendid elasid keskmiselt 13,6 kuud ning muud standardravi saanud patsiendid 10,4 kuud.
English: An overview of Keytruda and why it is authorised in the EU
Estonian: Ülevaade ravimist Keytruda ja ELis müügiloa väljastamise põhjendus
English: Before starting treatment, patients with NSCLC, previously untreated urothelial cancer or HNSCC should have tests to check their levels of PD-L1.
Estonian: Mitteväikerakk-kopsuvähi, varem ravimata uroteeliaalse kartsinoomi või pea- ja kaelapiirkonna lamerakk-kartsinoomiga patsientidel tuleb enne ravi algust kontrollida PD‑L1 sisaldust.
English: It can be used on its own or in combination with other cancer medicines for NSCLC and HNSCC.
Estonian: Seda tohib kasutada ainuravimina või koos muude mitteväikerakk-kopsuvähi ja pea- ja kaelapiirkonna lamerakkkartsinoomi ravimitega.
English: In addition, patients who had Keytruda treatment lived on average for 8.8 months without the disease getting worse compared with 4.9 months for patients who were not given Keytruda.
Estonian: Keytrudaga ravitud patsientide progresseerumiseta elumus oli keskmiselt 8,8 kuud ja Keytrudat mitte kasutanud patsientidel 4,9 kuud.
English: In a study of 861 patients with renal cell carcinoma, patients given Keytruda in combination with an already authorised medicine for renal cell carcinoma, axitinib, lived for around 15 months without their disease getting worse, compared with 11 months for patients who received treatment with another renal cell carcinoma medicine, sunitinib, which was used as a control treatment.
Estonian: 861 neerurakk-kartsinoomiga patsiendi uuringus oli progresseerumiseta elumus Keytrudat koos neerurakk-kartsinoomi heakskiidetud ravimi aksitiniibiga kasutanud patsientidel ligikaudu 15 kuud ja sunitiniibiga (samuti neerurakk-kartsinoomi ravim, mida kasutati kontrollravimina) ravitud patsientidel 11 kuud.
English: • non-small cell lung cancer (NSCLC), a type of lung cancer,
Estonian: • mitteväikerakk-kopsuvähk (kopsuvähi liik);
English: In a second lung cancer study of 305 patients whose tumours tested strongly for PD-L1 who had not been treated before, patients on Keytruda lived for around 10 months without their disease getting worse compared with 6 months in patients receiving platinum-based chemotherapy.
Estonian: Teises kopsuvähi uuringus, milles osales 305 varem ravimata patsienti, kellel laboriuuringute põhjal esines valgu PD-L1 suhtes tugevalt positiivne kasvaja, oli progresseerumiseta elumus Keytruda kasutamisel ligikaudu 10 kuud ja plaatinapõhise keemiaravi kasutamisel ligikaudu 6 kuud.
English: Keytruda is also effective in improving survival of patients with head and neck squamous cell carcinoma (HNSCC) that had spread or come back.
Estonian: Keytruda oli efektiivne elumuse parandamisel pea- ja kaelapiirkonna lamerakk-kartsinoomiga patsientidel, kellel kasvaja oli levinud organismis mujale või taastekkinud.
English: Keytruda is given as an infusion (drip) into a vein.
Estonian: Keytrudat manustatakse veenisisese infusioonina.
English: For the other cancers, Keytruda is only used on its own.
Estonian: Teiste vähiliikide ravis kasutatakse Keytrudat ainuravimina.
English: Urothelial cancer
Estonian: Uroteliaalne kartsinoom
English: Kidney cancer
Estonian: Nahavähk
English: In addition, patients taking Keytruda alone lived on average 12.3 months compared with 10.3 months for patients taking other standard treatments.
Estonian: Keytrudat ainuravimina kasutanud patsiendid elasid keskmiselt 12,3 kuud ning muud standardravi saanud patsiendid 10,3 kuud.
English: Keytruda contains the active substance pembrolizumab.
Estonian: Keytruda toimeaine on pembrolisumaab.
English: • urothelial cancer, a cancer of the bladder and urinary tract,
Estonian: • uroteeliaalne kartsinoom (põie ja kuseteede vähk);
English: Keytruda is also effective in improving survival of patients with renal cell cancer.
Estonian: Keytruda on efektiivne ka neerurakk-kartsinoomiga patsientide elumuse pikendamisel.
English: • melanoma, a skin cancer,
Estonian: • melanoom (nahavähi liik);
English: Keytruda was more effective in patients who tested strongly for PD-L1, with these patients living for 15 months on average, 5 months of which without their disease worsening.
Estonian: Keytruda oli efektiivsem patsientidel, kellel oli suur valgu PD-L1 sisaldus.
English: Skin cancer
Estonian: Neeruvähk
English: --1 1 dose (0.5 ml) contains:
Estonian: --1 Üks annus (0,5 ml) sisaldab:
English: Recombinant lipidated fHbp (factor H binding protein) Produced in Escherichia coli cells by recombinant DNA technology Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)
Estonian: rekombinantne lipiiditud fHbp (faktor H‑d siduv valk) toodetud Escherichia coli rakkudes rekombinantse DNA tehnoloogia abil adsorbeeritud alumiiniumfosfaadile (0,25 milligrammi alumiiniumi annuse kohta)
English: Neisseria meningitidis serogroup B fHbp subfamily B
Estonian: B-serogrupi Neisseria meningitidis'e fHbp-valgu alamtüüp B
English: Neisseria meningitidis serogroup B fHbp subfamily A
Estonian: B-serogrupi Neisseria meningitidis'e fHbp-valgu alamtüüp A
English: 1 pre-filled syringe with needle
Estonian: 1 nõelaga süstel
English: The recommended dose is 0.14 mg per kilogram body weight, once a day for five days.
Estonian: Soovituslik annus on 0,14 mg kehamassi kilogrammi kohta üks kord päevas viie päeva jooksul.
English: The marketing authorisation was renewed on 14 April 2009.
Estonian: Müügiluba pikendati 14. aprillil 2009.
English: The most common side effects with Litak (seen in more than 1 patient in 10) are infections, pancytopenia or myelosuppression (low blood cell counts), purpura (bruising), immunosuppression (a weakened immune system), decreased appetite, headache, dizziness, abnormal breath and chest sounds, cough, nausea (feeling sick), vomiting, constipation, diarrhoea, rash, localised exanthema (skin eruptions), diaphoresis (excessive sweating), injection site reactions (pain and inflammation at the site of injection), fever, fatigue (tiredness), chills and asthenia (weakness).
Estonian: Litaki kõige sagedamad kõrvalnähud (esinenud enam kui ühel patsiendil kümnest) on nakkused, pantsütopeenia või müelosupressioon (vererakkude vähesus), purpur (verevalumid), immuunsupressioon (immuunsüsteemi nõrgenemine), isutus, peavalu, peapööritus, ebanormaalsed helid hingamisel ja rinnus, köha, iiveldus, oksendamine, kõhukinnisus, kõhulahtisus, lööve, paikne eksanteem (punetavad laigud nahal), diaforees (liigne higistamine), süstekoha reaktsioonid (süstekoha valu ja põletik), palavik, väsimus, külmavärinad ja asteenia (nõrkus).
English: Because cladribine has been used for a number of years, the company presented data from the published literature.
Estonian: Et kladribiini on kasutatud juba aastaid, esitas ettevõte avaldatud kirjandusest pärinevaid andmeid.
English: The European Commission granted a marketing authorisation valid throughout the EU for Litak to Lipomed GmbH on 14 April 2004.
Estonian: Euroopa Komisjon andis Litaki müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Lipomed GmbH 14. aprillil 2004.
English: In the main study, 97% of the patients had either complete or partial remission (60 out of 62), and 76% had complete remission (47 out of 62).
Estonian: Põhiuuringus toimus täielik remissioon 97%-l patsientidest (60 patsiendil 62-st) ja osaline remissioon 76%-l (47 patsiendil 62-st).
English: Other information about Litak:
Estonian: Muu teave Litaki kohta
English: The Committee recommended that Litak be given marketing authorisation.
Estonian: Komitee soovitas anda Litakile müügiloa.
English: These results were similar to those seen in other published studies using intravenous cladribine and were better than results seen with alternative treatments such as interferon alfa and pentostatin.
Estonian: Need tulemused sarnanesid muude avaldatud uuringute tulemustega, milles kasutati intravenoosset kladribiini, ning olid paremad muude sarnaste raviviisidega, näiteks alfainterferooni või pentostatiiniga saavutatud tulemustest.
English: CdATP can also affect other cells, particularly other types of blood cell, which can cause side effects.
Estonian: CdATP võib mõjutada ka muid rakke, eelkõige muud liiki vererakke, mis võib põhjustada kõrvaltoimeid.
English: This prevents the cells from dividing, slowing down the progression of leukaemia.
Estonian: See takistab rakkude jagunemist, aeglustades leukeemia süvenemist.
English: Cladribine has been in use in anticancer medicines since the 1980s and it has been available as an intravenous infusion (drip into a vein) in some European Union (EU) Member States since 1993.
Estonian: Kladribiini on kasutatud vähiravimites alates 1980. aastatest ning seda on turustatud Euroopa Liidu teatud liikmesriikides intravenoosse infusioonina (veeni tilgutatava ravimina) alates 1993. aastast.
English: What is Litak?
Estonian: Mis on Litak?
English: Litak was not compared with any other treatments in this study.
Estonian: Litakit selles uuringus teiste ravimitega ei võrreldud.
English: Why has Litak been approved?
Estonian: Miks Litak heaks kiideti?
English: It should be used with caution in patients over 65 years of age, with frequent monitoring of blood counts, the liver and the kidneys.
Estonian: Üle 65-aastased patsiendid peavad ravimit kasutama ettevaatlikult, jälgides sageli verenäite, maksa- ja neerutalitlust.
English: The main measures of effectiveness were the numbers of patients who had complete and partial remission following treatment.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel toimus ravi järel täielik või osaline remissioon (haigusnähtude leevendumine).
English: What is the risk associated with Litak?
Estonian: Mis riskid Litakiga kaasnevad?
English: Complete remission is the disappearance of all evidence of disease, whereas partial remission is improved blood counts and the reduction in the number of cancerous cells.
Estonian: Täielikuks remissiooniks loeti kõikide haigusnähtude kadumist ning osaliseks leevendumiseks verenäitude paranemist ja vähirakkude arvu vähenemist.
English: Litak has been examined in one main study involving 63 adults with hairy cell leukaemia.
Estonian: Litakit on uuritud ühes põhiuuringus, milles osales 63 karvrakkleukeemiaga patsienti.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LITAK EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE LITAK Kokkuvõte üldsusele
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Litak's benefits are greater than its risks for the treatment of hairy cell leukaemia.
Estonian: Inimravimite komitee otsustas, et Litaki kasulikkus karvrakkleukeemia ravis on suurem kui sellega kaasnevad riskid.
English: Because the number of patients with hairy cell leukaemia is low, the disease is considered ‘rare', and Litak was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 September 2001.
Estonian: Et karvrakkleukeemiaga patsiente on vähe ja see haigus esineb harva, nimetati Litak 18. septembril 2001 harvikravimiks.
English: Litak treatment should be started by a doctor who has experience in the use of cancer treatments.
Estonian: Ravi Litakiga peab alustama vähiravis kogenud arst.
English: Litak must not be used during pregnancy or breast-feeding, in patients less than 18 years of age, in patients with moderate to severe kidney or liver disease or in combination with other medicines that reduce the production of blood cells.
Estonian: Litakit ei tohi kasutada raseduse ega imetamise ajal, alla 18-aastastel patsientidel, mõõduka või raske neeru- või maksahaigusega patsientidel ega koos muude vererakkude teket pärssivate ravimitega.
English: It belongs to the group of anticancer medicines called ‘antimetabolites'.
Estonian: Kladribiin kuulub antimetaboliitideks nimetatavate vähiravimite rühma.
English: Litak should not be used in people who may be hypersensitive (allergic) to cladribine or any of the other ingredients.
Estonian: Litakit ei tohi kasutada patsiendid, kes võivad olla kladribriini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The active substance in Litak, cladribine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Estonian: Litaki toimeaine kladribiin on tsütotoksiline aine, mis hävitab jagunevaid rakke, näiteks vähirakke.
English: Patients can inject themselves once they have been trained appropriately.
Estonian: Kui patsient on saanud asjakohase väljaõppe, võib ta ravimit süstida endale ise.
English: What benefit has Litak shown during the studies?
Estonian: Milles seisneb uuringute põhjal Litaki kasulikkus?
English: How has Litak been studied?
Estonian: Kuidas Litakit uuriti?
English: For the full list of all side effects reported with Litak, see the Package Leaflet.
Estonian: Litaki kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: What is Litak used for?
Estonian: Milleks Litakit kasutatakse?
English: Litak must not be given to patients with moderate to severe liver or kidney disease.
Estonian: Litakit ei tohi manustada raske maksa- või neeruhaigusega patsientidele.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Litak is available here.
Estonian: Harvikravimite komitee arvamuse kokkuvõtte Litaki kohta leiate siit.
English: How is Litak used?
Estonian: Kuidas Litakit kasutatakse?
English: The term ‘hairy cell' refers to the hair-like projections that can be seen on the surface of the lymphocytes when they are examined under a microscope.
Estonian: Nimetus „karvrakk“ viitab lümfotsüütide pinnal olevatele mikroskoopilistele nääpsudele.
English: The full EPAR for Litak can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Litaki kohta leiate siit.
English: Cladribine is an ‘analogue' of purine (a substance that has a similar chemical structure to purine).
Estonian: Kladribiin on puriini, DNA ühe põhilise koostisaine analoog (aine, mis on keemilise struktuuri poolest puriiniga sarnane).
English: How does Litak work?
Estonian: Kuidas Litak toimib?
English: Litak is used to treat adults with hairy cell leukaemia, a cancer of blood in which too many B-lymphocytes (a type of white blood cell) are produced.
Estonian: See haigus on verevähk, mille korral tekib liiga palju Blümfotsüüte (valgeliblede liik).
English: Litak is a solution for injection that contains the active substance cladribine.
Estonian: Litak on süstelahus, mis sisaldab toimeainena kladribiini.
English: In the body, cladribine is converted within lymphocytes into a chemical called CdATP, which interferes with the production of new DNA.
Estonian: Organismis muundub kladribiin aineks CdATP, mis pärsib uue DNA moodustamist.
English: Litak is given as an injection under the skin.
Estonian: Litakit manustatakse nahaaluse süstena.
English: The procedure started on 29 March 2007.
Estonian: Menetlus algas 29. märtsil 2007. aastal.
English: The Marketing Authorisation Holder provided supplementary information on 16 October 2007.
Estonian: Müügiloa hoidja esitas täiendava teabe 16. oktoobril 2007.
English: A Decision was issued by the European Commission on 23 July 2008.
Estonian: Euroopa Komisjon tegi otsuse 23. juulil 2008.
English: With respect to quality aspects,
Estonian: Kvaliteediaspektidega seoses võeti arvesse järgmist: