FrancophonIA/ELRC3.0 huggingface dataset:
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Estonian: Enne ravimi kasutamist lugege pakendi infolehte.
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, polycythaemia was reported in 1.5% of patients receiving axitinib.
Estonian: Neerurakk-kartsinoomiga patsientidel läbiviidud aksitiniibi kliiniliste uuringute (N = 672) koondandmete kohaselt esines polütsüteemiat 1,5%-l patsientidest, kes kasutasid aksitiniibi.
English: Dizziness
Estonian: Kaalulangus
English: Red triangular film-coated tablet debossed with “Pfizer” on one side and “5 XNB” on the other.
Estonian: Punane kolmnurkne õhukese polümeerikattega tablett, mille ühel küljel on pimetrükk „Pfizer“ ja teisel küljel „5 XNB“.
English: There was no effect on mating or fertility in male mice at exposure levels approximately 57-fold the expected human exposure.
Estonian: 57-kordse inimestel kasutatava annuse juures ei esinenud hiirtel toimet paaritumisele ega fertiilsusele.
English: EU/1/12/777/005 56 tablets
Estonian: EU/1/12/777/004 28 tabletti EU/1/12/777/005 56 tabletti
English: • Weight loss
Estonian: • kehakaalu vähenemine;
English: Stomatitis
Estonian: Asteenia
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A4/5 inhibition potential is recommended.
Estonian: Soovitatav on valida teine sarnase toimega ravim, millel puudub või on minimaalne CYP3A4/5 inhibeeriv toime.
English: NAME OF THE MEDICINAL PRODUCT Inlyta 7 mg film-coated tablets axitinib
Estonian: Inlyta 7 mg õhukese polümeerikattega tabletid aksitiniib
English: • Under-active thyroid gland (may show in your blood tests)
Estonian: • väheaktiivne kilpnääre (võib kajastuda teie vereanalüüsides);
English: NAME OF THE MEDICINAL PRODUCT Inlyta 1 mg film-coated tablets axitinib
Estonian: Inlyta 1 mg õhukese polümeerikattega tabletid aksitiniib
English: Amylase increased Aspartate aminotransferase increased
Estonian: Alaniini aminotransferaasi sisalduse suurenemine Amülaasisisalduse suurenemine Aspartaadiaminotransferaasi sisalduse suurenemine Aluselise fosfataasi sisalduse suurenemine Kreatiniinisisalduse suurenemine Kilpnääret stimuleeriva hormooni sisalduse suurenemine a
English: Inlyta 7 mg film-coated tablet
Estonian: Inlyta 7 mg õhukese polümeerikattega tablett
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was reported in 1.4% of patients receiving axitinib.
Estonian: Polütsüteemia (vt hemoglobiini- või hematokritisisalduse suurenemine lõigus 4.4) Kontrolliga kliinilises uuringus teatati 1,4%-l aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidest polütsüteemiast.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib.
Estonian: Inlyta 1 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 1 mg aksitiniibi.
English: Inlyta 5 mg film-coated tablet
Estonian: Inlyta 5 mg õhukese polümeerikattega tablett
English: Thyroid function should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Estonian: Kilpnäärme talitlust tuleb ravi ajal aksitiniibiga jälgida enne ravi algust ja hiljem perioodiliselt.
English: NAME OF THE MEDICINAL PRODUCT Inlyta 3 mg film-coated tablets axitinib
Estonian: Inlyta 3 mg õhukese polümeerikattega tabletid aksitiniib
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1.7% of patients receiving axitinib, including anal fistula (0.6%), fistula (0.3%) and gastrointestinal perforation (0.3%).In monotherapy studies with axitinib (N = 850), gastrointestinal perforation-type events were reported in 1.9% of patients and fatal gastrointestinal perforation was reported in one patient (0.1%).
Estonian: Seedetrakti perforatsioon ja fistuli moodustumine (vt lõik 4.4) Kontrolliga kliinilises uuringus täheldati 1,7% aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidest kõrvaltoimena seedetrakti perforatsiooni-tüüpi nähte, sealhulgas anaalfistul (0,6%), fistul (0,3%) ja seedetrakti perforatsioon (0,3%).
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in 20.9% of patients and hyperthyroidism was reported in 1.1% of patients.
Estonian: Kontrolliga kliinilises uuringus teatati aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidest hüpotüreoidismi 20,9%-l ja hüpertüreoidismi 1,1%-l. Kilpnääret stimuleeriva hormooni (Thyroid Stimulating Hormone, TSH) sisalduse suurenemist teatati kõrvaltoimena 5,3%-l aksitiniibravi saavatest patsientidest.
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Estonian: Soovitatav on valida selline ravim, millel puudub või on minimaalne CYP3A4/5 indutseeriv toime.
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A4/5 induction potential is recommended.
Estonian: Soovitatav on valida teine sarnase toimega ravim, millel puudub või on minimaalne CYP3A4/5 indutseeriv toime.
English: Creatinine increased Thyroid stimulating hormone increased a Adverse reactions are according to treatment-emergent, all causality frequency.
Estonian: Ravi ajal tekkinud kõrvaltoimed on esitatud esinemissageduse järgi kõikidel põhjustel.
English: NAME OF THE MEDICINAL PRODUCT Inlyta 5 mg film-coated tablets axitinib
Estonian: Inlyta 5 mg õhukese polümeerikattega tabletid aksitiniib
English: Gastrointestinal perforation and fistulac,k
Estonian: Seedetrakti perforatsioon ja fistul c,
English: Inlyta 3 mg film-coated tablet
Estonian: Inlyta 3 mg õhukese polümeerikattega tablett
English: Cardiac disorders Common
Estonian: Südamepuudulikkuse juhud
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 1 mg axitinib.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 1 mg aksitiniibi.
English: Mucosal inflammation 13.7
Estonian: 4.7 Toime reaktsioonikiirusele
English: Dyspepsia
Estonian: Imetamine
English: Dysphonia
Estonian: Neerupuudulikkus
English: The full EPAR and risk management plan summary for Cinacalcet Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Cinacalcet Mylani kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: ‘Primary' means that the hyperparathyroidism is not caused by any other condition.
Estonian: Primaarne tähendab, et hüperparatüreoidismi ei põhjusta ükski teine haigus.
English: A risk management plan has been developed to ensure that Cinacalcet Mylan is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Cinacalcet Mylani võimalikult ohutu kasutamine.
English: Cinacalcet Mylan is available as 30, 60 and 90 mg tablets.
Estonian: Cinacalcet Mylanit turustatakse 30, 60 ja 90 mg tablettidena.
English: Cinacalcet Mylan is taken with food or shortly after a meal.
Estonian: Cinacalcet Mylanit manustatakse söögi ajal või kohe pärast sööki.
English: • reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that their removal is not appropriate.
Estonian: • hüperkaltseemia (vere liigse kaltsiumisisalduse) vähendamine kõrvalkilpnäärme kartsinoomi (kõrvalkilpnäärme vähk) või primaarse hüperparatüreoidismiga patsientidel, kellel ei saa eemaldada kõrvalkilpnäärmeid või kui arst arvab, et nende eemaldamine ei ole kohane.
English: What measures are being taken to ensure the safe and effective use of Cinacalcet Mylan?
Estonian: Mis meetmed võetakse, et tagada Cinacalcet Mylani ohutu ja efektiivne kasutamine?
English: Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of calcium in the blood, bone and joint pain and deformities of the arms and legs.
Estonian: Hüperparatüreoidism (kõrvalkilpnäärme liigtalitlus) on haigusseisund, mille korral kaelal asuvad kõrvalkilpnäärmed eritavad liiga palju paratüreoidhormooni (PTH), mis võib põhjustada vere liigset kaltsiumisisaldust, luu- ja liigesevalu ning käte ja jalgade väärkujulisust.
English: • treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products.
Estonian: • sekundaarse hüperparatüreoidismi ravi raske neeruhaigusega patsientidel, kes vajavad dialüüsi, et puhastada verd jääkainetest.
English: The Committee recommended that Cinacalcet Mylan be approved for use in the EU.
Estonian: Komitee soovitas Cinacalcet Mylani kasutamise Euroopa Liidus heaks kiita.
English: This means that Cinacalcet Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU).
Estonian: See tähendab, et Cinacalcet Mylan on sarnane võrdlusravimiga, millel juba on Euroopa Liidus müügiluba.
English: The dose of Cinacalcet Mylan should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Estonian: Cinacalcet Mylani annust tuleb suurendada iga kahe kuni nelja nädala järel kuni annuseni 90 mg, mida manustatakse vastavalt vajadusele kolm või neli korda ööpäevas, et vähendada vere kaltsiumisisaldus normväärtuseni.
English: Cinacalcet Mylan is a medicine used in adults and older patients to:
Estonian: Cinacalcet Mylan on ravim, mida kasutatakse täiskasvanutel ja eakatel järgmistel näidustustel:
English: Cinacalcet Mylan can be used as part of treatment including phosphate binders or vitamin D;
Estonian: Cinacalcet Mylani võib kasutada fosfaate siduvaid preparaate või D-vitamiini sisaldava ravikava osana;
English: This is a summary of the European public assessment report (EPAR) for Cinacalcet Mylan.
Estonian: See on ravimi Cinacalcet Mylan Euroopa avaliku hindamisaruande kokkuvõte.
English: Because Cinacalcet Mylan 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.
Estonian: Et Cinacalcet Mylan on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Cinacalcet Mylan has been shown to have comparable quality and to be bioequivalent to Mimpara.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Cinacalcet Mylan võrreldav kvaliteet ja bioekvivalentsus ravimiga Mimpara.
English: What is Cinacalcet Mylan and what is it used for?
Estonian: Mis on Cinacalcet Mylan ja milleks seda kasutatakse?
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Cinacalcet Mylan for adults is 30 mg twice a day.
Estonian: Kõrvalkilpnäärme kartsinoomi ja primaarse hüperparatüreoidismi korral soovitatakse täiskasvanud patsientidel alustada Cinacalcet Mylani manustamist annuses 30 mg kaks korda ööpäevas.
English: In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day.
Estonian: Sekundaarse hüperparatüreoidismiga täiskasvanud patsientide soovituslik algannus on 30 mg üks kord ööpäevas.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cinacalcet Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Cinacalcet Mylani omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: For more information about treatment with Cinacalcet Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Cinacalcet Mylaniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For practical information about using Cinacalcet Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Cinacalcet Mylani kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
Estonian: Säilitusravi ajal tuleb kaltsiumisisaldust mõõta üks kord kuus ning PTH sisaldust tuleb mõõta üks kord 1-3 kuu jooksul.
English: The dose is adjusted every two to four weeks, according to the patient's PTH levels, up to a maximum of 180 mg once a day.
Estonian: Annust kohandatakse vastavalt patsiendi paratüreoidhormooni (PTH) sisaldusele iga kahe kuni nelja nädala järel kuni maksimaalse annuseni 180 mg üks kord ööpäevas.
English: Cinacalcet Mylan cinacalcet
Estonian: Cinacalcet Mylan tsinakaltseet
English: PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Cinacalcet Mylan.
Estonian: PTH sisaldust tuleb mõõta vähemalt 12 tundi pärast Cinacalcet Mylani annuse kindlaksmääramist ning ühe kuni nelja nädala järel pärast annuse kohandamist.
English: Why is Cinacalcet Mylan approved?
Estonian: Miks Cinacalcet Mylan heaks kiideti?
English: The active substance in Cinacalcet Mylan, cinacalcet, works by increasing the sensitivity of the calciumsensing receptors on the parathyroid glands that regulate PTH secretion.
Estonian: Cinacalcet Mylani toimeaine tsinakaltseet suurendab kõrvalkilpnäärmete pinnal olevate ja PTH eritumist reguleerivate kaltsiumitundlike retseptorite tundlikkust.
English: It is not intended to provide practical advice on how to use Cinacalcet Mylan.
Estonian: Hindamisaruandes ei anta Cinacalcet Mylani kasutamise praktilisi nõuandeid.
English: Other information about Cinacalcet Mylan
Estonian: Muu teave Cinacalcet Mylani kohta
English: Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Cinacalcet Mylan.
Estonian: Vere kaltsiumisisaldust tuleb mõõta sageli ja vähemalt ühe nädala jooksul pärast ravimi annuse kohandamist.
English: Cinacalcet Mylan contains the active substance cinacalcet and is a ‘generic medicine'.
Estonian: Cinacalcet Mylan sisaldab toimeainena tsinakaltseeti ja on geneeriline ravim.
English: The reference medicine for Cinacalcet Mylan is Mimpara.
Estonian: Cinacalcet Mylani võrdlusravim on Mimpara.
English: Therefore, the CHMP's view was that, as for Mimpara, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Mimpara korral, ületab ravimi Cinacalcet Mylan kasulikkus sellega kaasnevad riskid.
English: Because Cinacalcet Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Mimpara.
Estonian: Et Cinacalcet Mylan on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati Cinacalcet Mylani bioekvivalentsust võrdlusravimiga Mimpara.
English: The reduction in PTH levels leads to a decrease in blood calcium levels.
Estonian: Selle tulemusena eritavad kõrvalkilpnäärmed vähem PTH-d. PTH sisalduse vähenemine vähendab seejärel kaltsiumisisaldust veres.
English: ‘Secondary' means that it is caused by another condition.
Estonian: Sekundaarne tähendab, et hüperparatüreoidismi põhjustab muu haigus.
English: How has Cinacalcet Mylan been studied?
Estonian: Kuidas Cinacalcet Mylanit uuriti?
English: How is Cinacalcet Mylan used?
Estonian: Kuidas Cinacalcet Mylanit kasutatakse?
English: How does Cinacalcet Mylan work?
Estonian: Kuidas Cinacalcet Mylan toimib?
English: What are the benefits and risks of Cinacalcet Mylan?
Estonian: Milles seisneb Cinacalcet Mylani kasulikkus ja mis riskid ravimiga kaasnevad?
English: The following deficiencies were identified:
Estonian: Tuvastati järgmised puudused:
English: In addition, any significant safety events may only develop after a long period of time.
Estonian: Peale selle võivad mis tahes olulised ohutusjuhtumid kujuneda alles pika aja jooksul.
English: The consistent and continuous lack of adequate quality assurance since before 2015 is therefore of serious concern.
Estonian: Küllaldase kvaliteedikontrolli püsiv ja kestev puudumine enne 2015. aastat on seega oluline probleem.
English: The reliability of the safety database to detect such an effect is very low.
Estonian: Ohutusandmebaasi usaldusväärsus seda liiki toimete tuvastamisel on väga väike.
English: Nevertheless, the quality system at the manufacturing site is still significantly lacking in terms of change control and quality oversight.
Estonian: Siiski esinevad tootmiskoha kvaliteedisüsteemis jätkuvalt olulised puudused seoses tootmisprotsessi muutmise kontrolliga ja kvaliteedijärelevalvega.
English: Ammonaps is available as white oval tablets (500 mg) and as granules (940 mg/g).
Estonian: Ammonapsi turustatakse valgete ovaalsete tablettidena (500 mg) ja graanulitena (940 mg/g).
English: This is a severe condition and a significant number of patients are treated with Ammonaps in the EU.
Estonian: See on raske seisund ja ELis kasutab Ammonapsi arvukalt patsiente.
English: The CHMP was requested to issue an opinion as to whether marketing authorisations of the medicinal products that include the above mentioned site should be maintained, varied, suspended, or revoked.
Estonian: Inimravimite komiteel paluti esitada arvamus, kas eespool nimetatud tootmiskohas toodetud ravimite müügiload tuleb säilitada, muuta, peatada või tühistada.
English: SoliCol D3 20,000 IU tablets and SoliCol D3 50,000 IU tablets are medicinal products containing 20,000 or 50000 IU colecalciferol (vitamin D3 analogue) as active substance.
Estonian: SoliCol D3 20 000 IU tabletid ja SoliCol D3 50 000 IU tabletid on ravimid, mis sisaldavad toimeainena 20 000 või 50 000 IU kolekaltsiferooli (D3-vitamiini analoogi).
English: SoliCol D3 was approved in the UK through a national procedure on 18 December 2015.
Estonian: Ravimile SoliCol D3 anti riikliku menetluse kaudu Ühendkuningriigis müügiluba 18. detsembril 2015.
English: The DHPCs should be sent in accordance with the agreed communication plan.
Estonian: Tervishoiutöötajate teatised tuleb saata kokku lepitud teavituskava alusel.
English: In addition, Ammonaps should not be used if an alternative treatment option is available and appropriate for the patient.
Estonian: Ammonapsi ei tohi kasutada, kui patsiendi jaoks on olemas sobiv alternatiivne ravivõimalus.
English: A detailed assessment of all product complaint reports over the past 5 years provided by the MAH did not reveal any product complaint that could be associated to potential cross contamination.
Estonian: Müügiloa hoidja esitatud üksikasjalik aruanne kõigi ravimiga seotud kaebuste kohta viimase 5 aasta jooksul ei sisaldanud ühtegi sellist kaebust, mida saaks seostada võimaliku ristsaastumisega.
English: • Critical deficiencies relating to the failure of organisational and technical measures to minimise the risk of cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment, as well as failures of the quality unit to ensure the effective operation of the quality system;
Estonian: • kriitilised puudused, mis olid seotud samades tootmisüksustes ühiste seadmetega toodetavate ohtlike ja mitteohtlike toodete risksaastumise riski minimeerimise organisatsiooniliste ja tehniliste meetmete ebapiisavusega ning kvaliteediüksuse puudustega kvaliteedisüsteemi efektiivse toimimise tagamisel;
English: It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life).
Estonian: Ravim on näidustatud kõigile vastsündinueas alanud haigusega patsientidele (ensüümide täielik vaegus, avaldub esimese 28 elupäeva jooksul).
English: It is acknowledged that the shift of manufacturing of Ammonaps to a dedicated area using dedicated equipment provides some reassurance and the risk of cross-contamination following this change is considered low.
Estonian: On teada, et Ammonapsi tootmise üleviimine eraldatud alasse ja omaette seadmete kasutamine pakub teatud kindlustunnet, ning tootmisprotsessi muutmise järgset ristsaastumise riski peetakse väikeseks.
English: This product was approved in the EU via a decentralised procedure including all 28 Member States, with Sweden acting as reference Member State.
Estonian: Ravim kiideti ELis heaks kõiki 28 liikmesriiki hõlmava detsentraliseeritud menetluse kaudu, mille viiteliikmesriik oli Rootsi.
English: • Major deficiencies relating to organisational data governance failures, sterilisation and depyrogenation processes, and insufficient control of aseptic operations to provide the required level of sterility assurance.
Estonian: • olulised puudused, mis olid seotud ebapiisava ettevõttesisese andmehaldusega, steriliseerimise ja depürogeenimise protsessidega ning nõutava steriilsuse taseme tagamiseks vajalike aseptiliste toimingute ebapiisava kontrolliga.
English: Dutasteride Actavis (and associated names)
Estonian: Dutasteride Actavis (ja sarnased nimetused)
English: Further, patients need life-long treatment and other available treatment options appear limited, because of concerns over the supply of alternatives and the fact that some of these cannot be administered via naso-gastric/gastrostomy tubes, which is often needed in these patients.
Estonian: Lisaks sellele vajavad patsiendid elukestvat ravi ja muud olemasolevad ravivõimalused on piiratud, sest alternatiivina kasutatavate ravimite tarne ei ole kindel ning mõnda nendest ravimitest ei ole võimalik manustada nasogastraalsondi/gastrostoomiasondi kaudu, mis nende patsientide puhul on sageli vajalik.
English: Dutasteride Actavis is indicated for the treatment of the benign prostatic hyperplasia and was first approved in the EU on 3 June 2015 via a decentralised procedure, with Denmark acting as Reference Member State.
Estonian: Dutasteride Actavis on näidustatud eesnäärme healoomulise hüperplaasia raviks ja sellele anti ELis esmakordselt müügiluba 3. juunil 2015 detsentraliseeritud menetluse kaudu, mille viiteliikmesriik oli Taani.
English: A medicinal product may be considered critical based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective Member State(s) and, as appropriate, the nature of the disease to be treated.
Estonian: Ravimit võidakse pidada kriitilise tähtsusega ravimiks võimaliku rahuldamata ravivajaduse hindamise alusel, arvestades sobiva alternatiivse ravimi kättesaadavust asjaomases liikmesriigis (asjaomastes liikmesriikides) ja vajaduse korral ravitava haiguse iseloomu.
English: A detailed assessment of cumulative safety data on Lutinus up to 31 May 2016 was also performed which did not raise any significant safety concerns related to GMP non-compliance.
Estonian: Lutinuse kohta tehti ka kumulatiivsete ohutusandmete üksikasjalik hindamine kuni 31. maini 2016, milles ei tuvastatud ühtegi heale tootmistavale mittevastavusega seotud ohutusprobleemi.
English: On 17 June 2016, the European Commission (EC) initiated a referral procedure under Article 31 of Directive 2001/83/EC, and requested the Agency to assess the potential impact of the deficiencies on the quality, safety and the benefit risk balance of the medicinal products which have been authorised by the European Commission and the Member States.
Estonian: 17. juunil 2016 algatas Euroopa Komisjon direktiivi 2001/83/EÜ artikli 31 kohase esildismenetluse ja taotles ametilt kvaliteedi ja ohutuse puuduste võimaliku mõju hindamist ning Euroopa Komisjoni ja liikmesriikide heakskiidetud ravimite kasulikkuse ja riski suhte hindamist.