FrancophonIA/ELRC3.0 huggingface dataset:
English: EXPIRY DATE EXP {month/year} Once opened use within 10 days.
Estonian: Pärast pakendi avamist kasutada kuni 10 päeva.
English: Shake the bottle thoroughly before first administration and prime the pump by pressing it. Introduce the atraumatic canula in the ear canal.
Estonian: Enne esimest tarvitamist loksutada hoolikalt pudelit ja vajutage pumba eeltäitmiseks nii kaua pumbale, kuni sellest väljub ravim.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Estonian: TOIMEAINE(TE) SISALDUS Hüdrokortisoonatseponaat
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Estonian: VETERINAARRAVIMI NIMETUS Easotic
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast) - aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast)
English: 76505 Saue/Harjumaa, ESTONIA
Estonian: 76505 Saue/Harjumaa,ESTONIA Tel: + 372 6 709 006
English: PHARMACEUTICAL FORM Ear drops suspension.
Estonian: RAVIMVORM Kõrvatilkade suspensioon
English: Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Estonian: Süsteemsel manustamisel ja terapeutilisest annusest suuremates doosides kasutamisel seostatakse gentamütsiini ototoksilisusega.
English: Magyarország VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Estonian: Magyarország VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros FRANCE
English: 2 pre-filled pens + 2 alcohol wipes
Estonian: 2 pen-süstlit + 2 alkoholiga immutatud lappi
English: Pre-filled syringe (glass) with needle guard
Estonian: Subkutaanne Süstel (klaas) nõelakaitsega
English: 2 dose-dispenser cartridges + 2 alcohol wipes
Estonian: 2 annuseid doseerivat kolbampulli + 2 alkoholiga immutatud lappi
English: The company that applied for authorisation is Wyeth Europa Ltd.
Estonian: Müügiluba taotles Wyeth Europa Ltd.
English: What is Mylotarg?
Estonian: Mis on Mylotarg?
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 24 January 2008.
Estonian: Pärast taotluse põhjenduste kaalumist vaatas komitee algse arvamuse uuesti läbi ja kinnitas 24. jaanuaril 2008 soovitust müügiloa andmisest keelduda.
English: International non-proprietary name (INN): gemtuzumab ozogamicin
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): gemtusumabosogamitsiin
English: Ref. EMEA/37537/2008
Estonian: London, 24. jaanuar 2008 Dokumendi nr EMEA/186672/2008
English: These included severe and long-lasting bone marrow suppression causing low levels of white blood cells and platelets, liver problems, and side effects related to the infusion, such as chills, fever and low blood pressure.
Estonian: Nende hulka kuulusid raske pikaajaline luuüdi supressioon, mis põhjustab valgeliblede ja trombotsüütide sisalduse vähenemist, maksahäired ja infusiooniga seotud kõrvalnähud, näiteks külmavärinad, palavik ja madal vererõhk.
English: On 20 September 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mylotarg 5 mg powder for solution for infusion, intended for the treatment of acute myeloid leukaemia.
Estonian: 20. septembril 2007 võttis inimravimikomitee vastu negatiivse otsuse, soovitades ägeda müeloidleukeemia raviks kasutatava ravimi Mylotarg 5 mg infusioonilahuse pulbri müügiloa andmisest keelduda.
English: The effects of Mylotarg were studied in three main studies involving a total of 277 patients with CD33-positive acute myeloid leukaemia, whose disease had come back after one previous course of treatment.
Estonian: Mylotargi toimet uuriti kolmes põhiuuringus, milles osalenud kokku 277 patsiendil oli CD33positiivne äge müeloidleukeemia ja kelle haigus oli pärast üht varasemat ravikuuri taastunud.
English: A small proportion of the patients whose disease had come back after one previous course of treatment achieved complete remission.
Estonian: Täielik remissioon esines väikesel osal patsientidest, kelle haigus oli pärast üht varasemat ravikuuri taastunud.
English: Mylotarg was to be used to treat patients whose disease had come back after one previous course of treatment, and who were not suitable for other types of intensive chemotherapy such as highdose cytarabine (another anticancer medicine).
Estonian: Mylotargi kavatseti kasutada patsientide ravimiseks, kelle haigus oli pärast üht varasemat ravikuuri taastunud ja kellel ei saanud kasutada muud tüüpi intensiivset keemiaravi, näiteks suurtes annustes tsütarabiini (samuti vähiravim).
English: At that point in time, the CHMP was of the opinion that there was insufficient evidence to establish the effectiveness of Mylotarg in the treatment of acute myeloid leukaemia, and therefore that the medicine's benefits did not outweigh its risks.
Estonian: Sel ajal arvas inimravimikomitee, et Mylotargi efektiivsuse kindlaksmääramiseks ägeda müeloidleukeemia ravis ei ole piisavalt tõendeid, mistõttu ravimi kasulikkus ei olnud suurem kui sellega seotud riskid.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mylotarg?
Estonian: Kuidas mõjutab keeldumine praegu Mylotargi kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: The company also stated that it will continue to supply Mylotarg for use in existing, ongoing clinical trials.
Estonian: Ettevõtte märkis ka, et ta jätkab käimasolevate kliiniliste uuringute varustamist Mylotargiga.
English: Mylotarg was not compared to any other treatment in any of the studies.
Estonian: Mylotargi neis uuringuis teiste ravimitega ei võrreldud.
English: Mylotarg is a powder that is made up into a solution for infusion (drip into a vein).
Estonian: Mylotarg on pulber, millest valmistatakse infusioonilahus (tilgutamiseks veeni).
English: However, it was difficult to compare the effectiveness of Mylotarg and other treatments used for this disease, in terms of how long remission would last, how long it would take until the disease got worse, or what the medicines' effects would be on survival.
Estonian: kasutatud ravimite efektiivsust remissiooni püsimise, haiguse süvenemiseni kulunud aja ning elulemusele avaldatava mõju osas oli siiski raske võrrelda.
English: The company informed the CHMP that patients currently included in compassionate use programmes will continue to receive Mylotarg until they have finished their course of treatment.
Estonian: Ettevõte teatas inimravimikomiteele, et praegu Mylotargi kliinilistes uuringutes või eriloaga kasutamise programmides osalevad patsiendid jätkavad ravimi kasutamist kuni ravikuuri lõpuni.
English: Hence, the CHMP recommended that Mylotarg be refused marketing authorisation.
Estonian: Inimravimikomitee soovitas seepärast Mylotargile müügiloa andmisest keelduda.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for MYLOTARG
Estonian: TEAVE SOOVITUSE KOHTA KEELDUDA ANDMAST MÜÜGILUBA ravimile MYLOTARG
English: The Committee noted that there were side effects associated with Mylotarg.
Estonian: Komitee märkis, et Mylotargi kasutamisega kaasnesid kõrvalnähud.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Estonian: Monoklonaalne antikeha on selline antikeha (teatud valk), mille eesmärgiks on ära tunda organismi teatavates rakkudes leiduv spetsiifiline struktuur (antigeen) ja sellega seonduda.
English: Mylotarg was designated as an orphan medicinal product on 18 October 2000 for acute myeloid leukaemia.
Estonian: 18. oktoobril 2000 nimetati Mylotarg harvikravimiks, millega ravitakse ägedat müeloidleukeemiat.
English: The monoclonal antibody part of the active substance (gemtuzumab) has been designed to bind to CD33, an antigen which is found on the surface of acute myeloid leukaemia cells in about 80% of patients.
Estonian: Toimeaine monoklonaalse antikeha osa (gemtusumab) eesmärk on seonduda CD33-ga ehk antigeeniga, mida leidub ligikaudu 80% patsientidel ägeda müeloidleukeemia rakkude pinnal.
English: How is Mylotarg expected to work?
Estonian: Milline on Mylotargi eeldatav toime?
English: When the antibody attaches to CD33, the cells absorb the antibody, as well as the cytotoxic substance that it is attached to.
Estonian: Kui antikeha on seondunud CD33-ga, imendub antikeha rakkudesse koos antikehale kinnitunud tsütotoksilise ainega.
English: It contains the active substance gemtuzumab ozogamicin.
Estonian: See sisaldab toimeainena gemtusumabosogamitsiini.
English: The active substance in Mylotarg, gemtuzumab ozogamicin, is a cytotoxic (cell-killing) substance that is linked to a monoclonal antibody.
Estonian: Mylotargis toimeainena sisalduv gemtusumabosogamitsiin on tsütotoksiline (rakke hävitav) aine, mis on seotud monoklonaalse antikehaga.
English: The effects of Mylotarg were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Mylotargi toimet muude katsetega.
English: The CHMP was concerned that the studies of Mylotarg had not shown a benefit of the medicine, because of the way they were designed.
Estonian: Inimravimikomitee nägi põhjust ettevaatlikkuseks, sest Mylotargi uuringute ülesehituse tõttu ei olnud nendega ravimi kasulikkust tõestatud.
English: The calicheamicin then breaks up the leukaemia cells' DNA, eventually killing the cells.
Estonian: Tsütotoksiline aine kalihheamütsiin vabaneb rakkude sisemuses ja lagundab leukeemiarakkude DNA, mille tulemusel leukeemiarakud hävivad.
English: What was Mylotarg expected to be used for?
Estonian: Milleks kavatseti Mylotargi kasutada?
English: Mylotarg was expected to be used to treat acute myeloid leukaemia, a type of cancer of the white blood cells.
Estonian: Mylotargi kavatseti kasutada ägeda müeloidleukeemia (valgeliblede vähi vorm) raviks.
English: In all three studies, the main measure of effectiveness was the proportion of patients who achieved ‘complete remission' after a seven-month course of treatment.
Estonian: Kõigis kolmes uuringus mõõdeti efektiivsust põhiliselt nende patsientide osakaalu järgi, kellel oli toimunud pärast seitse kuud kestnud ravikuuri täielik remissioon (leukeemiarakud ei ole veres enam avastatavad ning sisaldus luuüdis on väga väike).
English: It was to be used in patients who were ‘CD33-positive', meaning that their cancerous white blood cells had a protein called CD33 on their surface.
Estonian: Mylotargi kavatseti kasutada CD33-positiivsetel patsientidel (patsientidel, kelle vähist haaratud valgeliblede pinnal leidub valku CD33).
English: The study was then extended to four years.
Estonian: Seejärel pikendati uuringut nelja aastani.
English: All patients should be assessed at least once every two years.
Estonian: Kõiki patsiente tuleb hinnata vähemalt kord kahe aasta jooksul.
English: Other information about Rebif
Estonian: Muu teave Rebifi kohta
English: What measures are being taken to ensure the safe and effective use of Rebif?
Estonian: Mis meetmed võetakse, et tagada Rebifi ohutu ja efektiivne kasutamine?
English: Further information on Rebif can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rebif.
Estonian: Lisateave Rebifi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/rebif.
English: Rebif received a marketing authorisation valid throughout the EU on 4 May 1998.
Estonian: Rebif on saanud müügiloa, mis kehtib kogu ELis, 4. mail 1998.
English: The European Medicines Agency decided that Rebif's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Rebifi kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: As for all medicines, data on the use of Rebif are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Rebifi kasutamise kohta pidevat järelevalvet.
English: The patients had experienced at least two relapses in the previous two years.
Estonian: Patsientidel oli esinenud viimase kahe aasta jooksul vähemalt kaks relapsi.
English: What is Rebif and what is it used for?
Estonian: Mis on Rebif ja milleks seda kasutatakse?
English: Side effects reported with Rebif are carefully evaluated and any necessary action taken to protect patients.
Estonian: Rebifi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Rebif (interferon beta-1a)
Estonian: Rebif (beeta-1a-interferoon)
English: Some effect on progression of disability could be seen, but only in the patients who had relapses in the two years before the start of the study.
Estonian: Teatud mõju puude progresseerumisele täheldati üksnes patsientidel, kellel oli esinenud kahe aasta jooksul enne uuringu algust relapse.
English: The probability of developing MS over 24 months was 62.5% for patients given Rebif three times a week and 75.5% for patients given Rebif once a week compared with 85.8% for patients given placebo.
Estonian: Hulgiskleroosi tekke tõenäosus 24 kuu jooksul oli kolm korda nädalas Rebifit saanud patsientidel 62,5%, üks kord nädalas Rebifit saanud patsientidel 75,5% ja platseebot saanud patsientidel 85,8%.
English: Why is Rebif authorised in the EU?
Estonian: Miks Rebif ELis heaks kiideti?
English: A 22-microgram dose is recommended for patients who cannot tolerate the higher dose.
Estonian: 22 µg annus on soovitatav patsientidele, kes ei talu suuremat annust.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rebif have been included in the summary of product characteristics and the package leaflet.
Estonian: Rebifi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: When first starting treatment with Rebif, the dose should be slowly increased from a starting dose of 8.8 micrograms three times a week to avoid side effects.
Estonian: Rebif-ravi esmakordsel alustamisel tuleb kolm korda nädalas manustatavat 8,8 µg algannust aeglaselt suurendada, et vältida kõrvalnähte.
English: Rebif (44 micrograms given once or three times a week) has also been compared with placebo in 515 patients who had experienced a single attack of demyelination.
Estonian: Rebifit (44 µg 1 või 3 korda nädalas) võrreldi platseeboga ka 515 patsiendil, kellel oli esinenud üksainus demüelinisatsiooniepisood.
English: For more information about using Rebif, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Rebifi kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: What are the risks associated with Rebif?
Estonian: Mis riskid Rebifiga kaasnevad?
English: The most common side effects with Rebif (which may affect more than 1 in 10 people) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
Estonian: Rebifi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on gripilaadsed sümptomid, neutropeenia, lümfopeenia ja leukopeenia (vere valgeliblede vähesus), trombotsütopeenia (trombotsüütide vähesus), aneemia (vere punaliblede vähesus), peavalu, põletik ja muud süstekoha reaktsioonid ning maksaensüümide transaminaaside arvu suurenemine.
English: Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
Estonian: Patsiendid said kaks aastat Rebifit (22 või 44 µg) või platseebot (näiv ravim).
English: How is Rebif used?
Estonian: Kuidas Rebifit kasutatakse?
English: The doctor may advise the patient to take a fever-reducing painkiller before each injection and for 24 hours after injection to reduce the influenza (flu)-like symptoms that may occur as a side effect of treatment.
Estonian: Arst võib soovitada patsiendil võtta enne ja 24 tunni jooksul pärast süstimist palavikku vähendavat valuvaigistit, et vähendada gripilaadseid sümptomeid, mis võivad tekkida ravi kõrvalnähuna.
English: Rebif was more effective than placebo in reducing the number of relapses in relapsing MS. Relapses were reduced by about 30% over two years for both Rebif 22 and 44 micrograms compared with placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
Estonian: Relapside arv vähenes kahe aasta jooksul Rebifi 22 ja 44 µg annusega ligikaudu 30% võrreldes platseeboga ning nelja aasta jooksul ligikaudu 22% (Rebif 22 µg) ja 29% (Rebif 44 µg).
English: The exact way that Rebif works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Estonian: Rebifi täpne toimemehhanism hulgiskleroosi korral ei ole veel teada, kuid selle toimeaine beeta-1a-interferoon näib vähendavat immuunsüsteemi aktiivsust ja ennetab hulgiskleroosi relapside teket.
English: Rebif can also be used in patients who have had a single attack of demyelination accompanied by inflammation.
Estonian: Rebifit tohib kasutada ka patsientidel, kellel on olnud üksainus demüelinisatsiooniepisood koos põletikuga.
English: Rebif contains the active substance interferon beta-1a.
Estonian: Rebif sisaldab toimeainena beeta-1a-interferooni.
English: The recommended dose of Rebif is 44 micrograms given three times a week by injection under the skin.
Estonian: Rebifi soovitatav annus on 44 µg, mis manustatakse kolm korda nädalas nahaaluse süstina.
English: For the full list of side effects and restrictions with Rebif, see the package leaflet.
Estonian: Rebifi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Rebif must not be used in patients who have severe depression or have thoughts of suicide.
Estonian: Rebifit ei tohi kasutada raske depressiooni või suitsiidimõtetega patsiendid.
English: The active substance in Rebif is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Estonian: Rebifi toimeaine on looduslike interferoonide rühma kuuluv valk beeta-1a-interferoon, mis tekib organismis, et aidata sel võidelda viiruste ja muude haigusetekitajatega.
English: How does Rebif work?
Estonian: Kuidas Rebif toimib?
English: Rebif is available as a solution for injection in prefilled syringes, prefilled pens and cartridges for use in an electronic injection device.
Estonian: Rebifit turustatakse süstelahusena eeltäidetud süstaldes, eeltäidetud pensüstaldes ja elektroonilistes süsteseadmetes kasutatavates kassettides.
English: Rebif has been studied in 560 patients with relapsing MS.
Estonian: Rebifi uuriti 560 relapseeruva hulgiskleroosiga patsiendil.
English: The patients can inject Rebif themselves once they have been trained.
Estonian: Pärast asjakohase väljaõppe saamist tohivad patsiendid süstida endale Rebifit ise.
English: Rebif can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Estonian: Rebif on retseptiravim ja ravi peab alustama hulgiskleroosi ravis kogenud arst.
English: It is used when the patient is considered to be at high risk of developing MS. Before using Rebif, doctors need to exclude other causes for the symptoms.
Estonian: Enne Rebifi kasutamist peab arst välistama muud sümptomite põhjused.
English: An overview of Rebif and why it is authorised in the EU
Estonian: Ülevaade ravimist Rebif ja ELis müügiloa väljastamise põhjendus
English: What benefits of Rebif have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Rebifi kasulikkus?
English: Rebif has also been studied in patients with secondary progressive MS. Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
Estonian: Rebif ei mõjutanud oluliselt puude progresseerumist, kuid relapside arv vähenes ligikaudu 30%.
English: Rebif's effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS) that is not relapsing.
Estonian: Rebifi efektiivsust ei ole tõendatud patsientidel, kellel on sekundaarne progresseeruv relapsideta hulgiskleroos.
English: Rebif is a medicine used to treat patients with relapsing multiple sclerosis (MS).
Estonian: Rebifit kasutatakse relapseeruva hulgiskleroosiga täiskasvanute raviks.
English: Relapsing MS is the type of MS where the patient has attacks (relapses) between periods with no symptoms.
Estonian: Relapseeruva hulgiskleroosi korral järgnevad relapsidele ehk haiguse ägenemistele sümptomiteta perioodid.
English: 3 x 30 tablets (multipack)
Estonian: 3 x 30 tabletti (multipakend)
English: 15 December 2017 EMA/821654/2017 EMEA/H/C/004153
Estonian: 15. detsember 2017 EMA/821654/2017 EMEA/H/C/004153
English: Progressive means that symptoms get steadily worse over time.
Estonian: „Progresseeruv“ tähendab, et sümptomid aja jooksul süvenevad.
English: The main measure of effectiveness was improvement in vision.
Estonian: Efektiivsuse põhinäitaja oli nägemise paranemine.
English: Symptoms include weakness, difficulty walking and problems with vision.
Estonian: Sümptomid on näiteks nõrkus ning kõndimis- ja nägemisprobleemid.
English: What is Qizenday?
Estonian: Mis on Qizenday?
English: measure of effectiveness was the number of patients whose overall disability decreased and whose ability to walk improved.
Estonian: Efektiivsuse põhinäitaja oli patsientide arv, kelle üldine funktsioonide häiritus vähenes ja kelle kõndimisvõime paranes.
English: In addition, the Committee was of the opinion that more information was needed about how the medicine is absorbed, modified and removed from the body.
Estonian: Peale selle oli inimravimite komitee arvamusel, et vaja on veel teavet ravimi organismis omastamise ja muundumise ning organismist eemaldumise kohta.
English: Qizenday is a medicine that contains the active substance biotin.
Estonian: Qizenday on ravim, mis sisaldab toimeainena biotiini.
English: The first study involved 154 patients with spinal progressive multiple sclerosis.
Estonian: Esimeses uuringus osales 154 seljaaju progresseeruva hulgiskleroosiga patsienti.
English: How does Qizenday work?
Estonian: Kuidas Qizenday toimib?
English: Withdrawal of the marketing authorisation application for Qizenday (biotin) EMA/821654/2017
Estonian: Müügiloa taotluse tagasivõtmise teave: Qizenday (biotiin) EMA/821654/2017
English: The company presented data from two main studies comparing Qizenday with placebo (a dummy treatment).
Estonian: Ettevõte esitas andmed kahest põhiuuringust, milles Qizendayd võrreldi platseeboga (näiva ravimiga).
English: Three of these enzymes are involved in energy production, while a fourth is believed to be involved in the production of sheaths around the nerve cells.
Estonian: Kolm nendest ensüümidest osalevad energia tootmisel ja neljas arvatakse osalevat närvirakke ümbritseva kaitsekihi tekkes.
English: The second study involved 93 patients with multiple sclerosis who had visual loss due to inflammation of the optic nerve.
Estonian: Teises uuringus osales 93 hulgiskleroosiga patsienti, kellel oli nägemisnärvi põletiku tagajärjel tekkinud nägemiskaotus.
English: Withdrawal of the marketing authorisation application for Qizenday (biotin)
Estonian: Müügiloa taotluse tagasivõtmise teave: Qizenday (biotiin)