FrancophonIA/ELRC3.0 huggingface dataset:
English: • Detailed instructions on the dose, number and localization of the injections
Estonian: • üksikasjalik annuse, süstide arvu ja süstekoha valiku juhend;
English: A transient reduction of triglycerides for up to 12 weeks in some individual patients has been observed.
Estonian: Mõnel üksikul juhul täheldati mööduvat triglütseriidide sisalduse vähenemist kuni 12 nädalaks.
English: There is very limited information about the safety of Glybera in pregnant women.
Estonian: Teated Glybera kasutamise ohutusest rasedatel on piiratud.
English: Re-evaluation of immune responses from all patients enrolled in study CT-AMT-011-01 by using a validated assay method should also be provided.
Estonian: Esitada tuleb ka valideeritud analüüsimeetodit kasutades immuunvastuse ümberhindamise tulemused kõikidelt patsientidelt, kes olid kaasatud uuringusse CT-AMT-011-01.
English: Immunosuppressants (see section 5.2) Immediately prior to initiation of the immunosuppressant regimen and prior to Glybera injection the patient must be checked for symptoms of active infectious disease of any nature, and in case of such infection the start of treatment must be postponed until after the patient has recovered.
Estonian: Vahetult enne immunosupressantravi alustamist ja enne Glybera süste tuleb patsiente kontrollida mis tahes aktiivse nakkushaiguse sümptomite esinemise suhtes.
English: There is limited experience in the use of Glybera in elderly subjects.
Estonian: Glybera kasutamise kohta eakatel on kogemused piiratud.
English: In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered.
Estonian: Lisaks tuleb pool tundi enne Glybera süsti manustada intravenoosse boolusena 1 mg/kg metüülprednisolooni.
English: Dizziness was commonly observed after Glybera administration.
Estonian: Glybera manustamise järel täheldati sageli pearinglust.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL
Estonian: ERIKOHUSTUSED ERANDLIKEL ASJAOLUDEL VÄLJAANTUD MÜÜGILOA JÄRGSETE MEETMETE TÄITMISEKS
English: • The necessity to carry the patient alert card, that is included in each pack, with them at all
Estonian: • vajadus kanda endaga alati kaasas igas pakendis sisalduvat patsiendikaarti.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL VIAALI ETIKETT
English: Vials must be stored and transported frozen at -25ºC to -15ºC.
Estonian: Viaale tuleb hoida ja transportida sügavkülmas (-25 °C…-15 °C).
English: • The need to provide the educational material to patients and request their informed consent to be enrolled into the registry prior to treatment o the need and duration of barrier contraception o not to donate organs nor blood nor cells o on the need to continue on a low-fat diet and avoid drinking alcohol o the necessity to carry the patient alert card, that is included in each pack, with them at o that enrolment is mandatory for patients treated with Glybera o that patients treated with Glybera in a clinical trial should be enrolled in the registry at o that, where possible, patients with familial LPLD who are not treated with Glybera o the need to obtain the patient's informed consent prior to treatment o how to enter patients in it - including those not treated with Glybera
Estonian: • haiguse registri juhised: o Glyberaga ravitud patsientide kaasamine on kohustuslik; o kõik kliinilistes uuringutes Glyberaga ravitud patsiendid tuleb uuringu lõpus registrisse kanda; o kui võimalik, kaasata ka neid perekondliku LPLD-ga patsiente, keda ei ole Glyberaga ravitud; o enne ravi on vaja saada patsiendi informeeritud nõusolek; o kuidas patsiente sisestada, sh neid, keda ei ole Glyberaga ravitud.
English: After the amount of Glybera to be administered has been calculated (see section posology) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Estonian: Pärast manustatava Glybera koguse arvutamist (vt lõik: „Annustamine“) võtke enne süstalde täitmist vajalik arv ühekordseks kasutamiseks mõeldud viaale sügavkülmast umbes 30…45 minutiks toatemperatuurile (15
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISE TEE(D)
English: Manufacturer uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Estonian: Tootja: uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Holland.
English: It is not known whether Glybera is excreted in human milk.
Estonian: Imetamine Ei ole teada, kas Glybera eritub inimese rinnapiima.
English: In mice local cellular infiltrates and signs of degeneration and regeneration without necrosis, were seen at the clinical dose in the injected muscle upon histopathological examination.
Estonian: Hiirtel täheldati histopatoloogilisel uuringul kliinilise annuse lihasesse süstimise järel paikseid rakulisi infiltraate ja degeneratsiooni ning regeneratsiooni ilma nekroosita.
English: To calculate the number of injection sites and the number of syringes, the patient's weight is determined to the nearest whole kg.
Estonian: Süstekohtade ja süstalde hulga arvutamiseks tuleb määrata patsiendi kehakaal lähima täisarvu kilogrammini.
English: PSUR/ annual reassessment
Estonian: Perioodiline ohutusaruanne / iga-aastane läbivaatus
English: Clinical pharmacokinetics and shedding
Estonian: Kliiniline farmakokineetika ja levik
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Estonian: E. ERIKOHUSTUSED ERANDLIKEL ASJAOLUDEL VÄLJAANTUD MÜÜGILOA JÄRGSETE MEETMETE TÄITMISEKS
English: To calculate the number of vials, the patient's weight is determined to the nearest whole kg.
Estonian: Viaalide hulga arvutamiseks tuleb määrata patsiendi kehakaal lähima täisarvu kilogrammini.
English: Marketing Authorisation Holder uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Estonian: Müügiloa hoidja uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Holland.
English: Glybera has minor influence on the ability to drive and use machines¸ dizziness was commonly observed after Glybera administration (see section 4.8).
Estonian: Glybera manustamise järel täheldati sageli pearinglust (vt lõik 4.8).
English: • You should continue to follow a fat-restricted, alcohol-free diet. People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should restrict their intake of ‘normal diet fats' and should not drink
Estonian: Inimestel, kelle on diagnoositud lipoproteiinlipaasi puudus, soovitatakse nii enne kui ka pärast ravi Glyberaga hoolikalt oma dieeti järgida; nad peavad piirama normaalsete toidurasvade sisaldust ega tohi tarvitada alkoholi.
English: Serum creatine kinase
Estonian: Seerumi kreatiinkinaas
English: Patient-specific pack containing sufficient amount of vials to dose each patient Liquid absorbing sheet is also contained.
Estonian: Patsiendispetsiifiline pakend, mis sisaldab piisavas koguses viaale, et manustada igale patsiendile sobiv annus.
English: This is the number of injection sites and the total number of syringes (each filled with 0.5ml) needed to administer a volume of 0.5ml per injection site for the patient's treatment.
Estonian: See on süstekohtade arv ja patsiendi raviks vajaminevate süstalde (igas süstlas 0,5 ml) koguarv manustamiseks 0,5 ml süstekohta.
English: After you have been given Glybera, you may notice that your legs have a yellow colour; this might occur in case iodine was used to clean (sterilise) your legs before you received the medicine.
Estonian: Pärast seda, kui teile on Glyberat manustatud, võite märgata, et teie jalad on kollast värvi.
English: Potassium dihydrogen phosphate Sodium chloride
Estonian: Kaaliumdivesinikfosfaat Naatriumkloriid
English: No clinical data on the effect of Glybera on fertility are available.
Estonian: Glybera toime kohta fertiilsusele ei ole kliinilisi andmeid.
English: This medicine has been authorised under "exceptional circumstances”.
Estonian: Ravimpreparaat on saanud müügiloa erandlikel asjaoludel.
English: Cell and tissue donation
Estonian: Kudede ja rakkude annetamine
English: • muscle pain and joint aches, pains and stiffness
Estonian: • lihasvalu ja liigesevalud ja -jäikus
English: Non-clinical biodistribution
Estonian: Mittekliiniline biojaotuvus
English: The indication is restricted to patients with detectable levels of LPL protein (see section 4.4).
Estonian: Glybera on näidustatud ainult nendele patsientidele, kellel esineb tuvastatav LPL-valk (vt lõik 4.4).
English: • If you do become pregnant during treatment with Glybera, tell your doctor.
Estonian: Rääkige oma arstile, kui te jääte ravi ajal Glyberaga rasedaks.
English: Glybera therapy will be overseen by a doctor who is specialised in the treatment of patients affected by your condition and will be administered to you by an appropriately qualified and trained doctor or nurse.
Estonian: Glyberat manustab teile vastava kvalifikatsiooni ja väljaõppega arst või meditsiiniõde.
English: Please ask your doctor for more information about the exact immunosuppressant medicine you will be taking.
Estonian: Lisateabe saamiseks teile manustatavate immunosupressantide kohta pidage nõu oma arstiga.
English: Burning sensation, Dizziness, Formication, Presyncope
Estonian: Põletustunne, pearinglus, „sipelgad“, presünkoop
English: Glybera 3 × 1012 genome copies/ml solution for injection
Estonian: Glybera 3 × 1012 genoomi koopiat/ml süstelahus
English: • tiredness (fatigue)
Estonian: Kehakaal (kg)
English: Each vial contains 1 extractable ml of solution containing 3 × 1012 genome copies (gc) of alipogene tiparvovec.
Estonian: Üks viaal sisaldab 1 ml väljavõetavat lahust, milles on 3 × 1012 alipogeentiparvoveki genoomikoopiat (gk).
English: Number of injection sites
Estonian: Süstekohtade arv
English: This is the number of injection sites and the total number of syringes (each filled with 0.5ml) required for the patient's treatment.
Estonian: See on süstekohtade ja patsiendi raviks vajaminevate süstalde (igas süstlas 0,5 ml) koguarv.
English: Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
Estonian: Glybera 3 × 1012 genoomi koopiat/ml süstelahus Alipogeentiparvovek
English: • injection site discomfort, swelling, rash and pain
Estonian: • ebamugavustunne, turse, lööve ja valu süstekohal.
English: Clinical trial CT-AMT-010-01
Estonian: Kliiniline uuring CT-AMT-010-01
English: Breast-feeding is not recommended during treatment with Glybera.
Estonian: Ravi ajal Glyberaga ei ole imetamine soovitatav.
English: B. PACKAGE LEAFLET
Estonian: Kõrvaltoimete tabel
English: The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Estonian: Müügiloa hoidja peab tagama patsiendikaardi olemasolu igas ravimipakendis.
English: Clinical trial CT-AMT-11-05
Estonian: Kliiniline uuring CT-AMT-11-05
English: Clinical trial CT-AMT-11-03
Estonian: Kliiniline uuring CT-AMT-11-03
English: • Guidance on the prevention of risks associated with Glybera intramuscular injections,
Estonian: • juhis Glybera intramuskulaarsete süstidega seotud ohtude ennetamiseks, sealhulgas vajadus teha süstid ultraheli või elektrofüsioloogia juhtimisel;
English: uniQure biopharma B.V. Meibergdreef 61
Estonian: uniQure biopharma B.V.
English: Each vial of alipogene tiparvovec contains 1 extractable ml of solution, containing 3 x 1012 genome copies (gc).
Estonian: Üks alipogeentiparvoveki viaal sisaldab 1 ml ekstraheeritavat lahust, milles on 3 × 1012 genoomikoopiat (gk).
English: T-cell responses against AAV were detected in approximately half of the subjects post therapy only.
Estonian: Ainult ravi järel tuvastati umbes pooltel isikutel AAV vastane T-rakuline vastus.
English: SPECIAL STORAGE CONDITIONS Store and transport vial frozen at -25°C to -15°C.
Estonian: Hoida ja transportida sügavkülmas (-25 °C…-15 °C).
English: Chiesi Pharmaceuticals B.V. Tel: +31 0 70 413 20 80
Estonian: Tel: +31 0 70 413 20 80
English: Clinical trial CT-AMT-011-01
Estonian: Kliiniline uuring CT-AMT-011-01
English: Chills, Injection site pain, Oedema peripheral, Pyrexia
Estonian: Külmavärinad, valu süstekohas, perifeerne turse, palavik
English: Each vial of alipogene tiparvovec contains 1 ml of solution, containing 3 x 1012 genome copies (gc).
Estonian: Üks alipogeentiparvoveki viaal sisaldab 1 ml lahust, milles on 3 × 1012 genoomikoopiat (gk).
English: 1) Educational material for Pharmacists including the following key safety elements: • Detailed guidelines for product receipt and storage, procedure for the preparation, handling
Estonian: Tervishoiutöötajate koolitus tuleb kooskõlastada riikliku pädeva asutusega enne tarnimist ja peab sisaldama järgmisi komponente: - ravimiteave (ravimi omaduste kokkuvõte, pakendi infoleht ja patsiendikaart); - õppematerjalid tervishoiutöötajatele; - õppematerjalid patsiendile; - patsiendi sündmuste päevik.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER uniQure biopharma B.V.
Estonian: Ravimpartii kasutamiseks vabastamise eest vastutava tootja nimi ja aadress uniQure biopharma B.V.
English: Examples of these immunosuppressants are ciclosporin, mycophenolate mofetil.
Estonian: Immunosupressandid on näiteks tsüklosporiin ja mükofenolaatmofetiil.
English: The active substance is alipogene tiparvovec.
Estonian: Toimeaine on alipogeentiparvovek.
English: A single intravenous bolus of methylprednisolone (1 mg/kg bodyweight) was given 30 minutes prior to alipogene tiparvovec administration.
Estonian: 30 minutit enne alipogeentiparvovekki manustati patsientidele üks metüülprednisolooni (1 mg/kg kehakaalu kohta) intravenoosne boolus.
English: Diabetic patients
Estonian: Diabeet
English: Dyspnoea exertional, Pulmonary embolism
Estonian: Pingutusdüspnoe, kopsuembol
English: Limited data are available in diabetic patients.
Estonian: Glybera kasutamise kohta diabeetikutel on vaid piiratud andmeid.
English: INSTRUCTIONS ON USE
Estonian: Teave tagaküljel
English: Glybera should not be administered to women who are breast-feeding as long as breastfeeding is ongoing.
Estonian: Glyberat ei tohi imetavatele naistele manustada.
English: ▼ This medicinal product is subject to additional monitoring.
Estonian: Alipogeentiparvovek Käesoleva ravimi suhtes kohaldatakse täiendavat järelevalvet, mis võimaldab kiiresti tuvastada uut ohutusteavet.
English: Abdominal pain.Nausea, Constipation
Estonian: Kõhuvalu, iiveldus, kõhukinnisus
English: Chiesi Farmaceutici S.p.A. Tηλ: + 39 0521 2791
Estonian: Tηλ: + 39 0521 2791
English: • Hypersensitivity to the active substance or any of the excipients of Glybera listed in section
Estonian: • Ülitundlikkus toimeaine(te) või lõigus 6.1 loetletud mis tahes abiaine(te) suhtes.
English: Sodium content and potassium content
Estonian: RAVIMVORM JA PAKENDI SUURUS
English: EU/1/13/869/001 Lemtrada
Estonian: EU/1/13/869/001
English: 1.2 ml (10 mg/ml) 1 vial
Estonian: Intravenoosne viaal (klaas) 1,2 ml (10 mg/ml)
English: 12 mg Concentrate for solution for infusion
Estonian: 12 mg Infusioonilahuse kontsentraat
English: Pack size
Estonian: Lemtrada
English: Official languages:
Estonian: Ametlikud keeled:
English: The European Union - key facts
Estonian: Euroopa Liit - peamised faktid
English: Guidelines and scientific advice
Estonian: Suunised ja teaduslikud nõuanded
English: This process allows Member States to rely on each other's scientific assessments.
Estonian: See protsess võimaldab liikmesriikidel tugineda üksteise teaduslikele hinnangutele.
English: Pricing and reimbursement
Estonian: Hinnakujundus ja hüvitamine
English: Supporting regulatory science outside the EU - the Article 58 procedure
Estonian: Reguleerimisalase teadustegevuse toetamine väljaspool ELi - artikli 58 kohane menetlus
English: The European Commission can also take action concerning other aspects of medicine regulation:
Estonian: Euroopa Komisjon võib võtta ka muude ravimiregulatsiooni aspektidega seotud meetmeid:
English: International cooperation
Estonian: Rahvusvaheline koostöö
English: This network is what makes the EU regulatory system unique.
Estonian: Just see võrgustik muudab ELi reguleerimissüsteemi ainulaadseks.
English: The role of the European Commission
Estonian: Euroopa Komisjoni roll
English: The EMA has seven scientific committees that carry out its scientific assessments:
Estonian: EMA-l on seitse teaduskomiteed, mis viivad läbi teaduslikke hindamisi:
English: GDP: € 12.9tn
Estonian: SKP: 12,9 triljonit eurot
English: Population: >500m
Estonian: Rahvaarv: üle 500 miljoni
English: The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.
Estonian: Iga liikmesriigi reguleerivad asutused vastutavad selliste tegevuslubade andmise eest oma territooriumil.
English: These guidelines reflect the latest thinking on developments in biomedical science.
Estonian: Suunised kajastavad biomeditsiini uusimaid suundumusi.
English: When a company wants to authorise a medicine in several Member States, it can use one of the following procedures:
Estonian: Kui äriühing soovib saada ravimi müügiluba mitmes liikmesriigis, võib ta kasutada üht järgmistest menetlustest:
English: Public hearings
Estonian: Avalikud ärakuulamised
English: By working closely together, Member States reduce duplication, share the workload and ensure the efficient and effective regulation of medicines across the EU.
Estonian: Tihedalt koostööd tehes vähendavad liikmesriigid dubleerimist, jagavad töökoormust ning tagavad ravimite tõhusa ja tulemusliku reguleerimise kogu ELis.
English: • Global outreach - it ensures appropriate collaboration with relevant international partners and promotes the EU regulatory system globally.
Estonian: • üleilmne haare - komisjon tagab sobiva koostöö asjakohaste rahvusvaheliste partneritega ja edendab ELi reguleerimissüsteemi kogu maailmas.
English: Increasingly, patients and healthcare professionals are involved in the work of the Agency including in the evaluation of medicines.
Estonian: Ka patsiendid ja tervishoiutöötajad osalevad üha enam ameti töös, sealhulgas ravimite hindamisel.
English: • Right of initiative - it can propose new or amended legislation for the pharmaceutical sector;
Estonian: • algatusõigus - komisjon võib teha ravimisektoris uute õigusaktide või õigusaktide muudatuste ettepanekuid;
English: EU Member States: 28
Estonian: Euroopa Liit= 28 liikmesriiki
English: National Competent Authorities
Estonian: Riikide pädevad asutused
English: These data are continuously monitored by EMA and the Member States in order to identify any new safety information.
Estonian: EMA ja liikmesriigid jälgivad neid andmeid pidevalt uue ohutusteabe tuvastamiseks.
English: The European Commission plays an important role in the regulation of medicines in the EU.
Estonian: Euroopa Komisjonil on ELis ravimite reguleerimisel oluline roll.
English: EMA's scientific committees
Estonian: EMA teaduskomiteed
English: Regulatory cooperation and exchange of information with international regulators is also assured through the International Pharmaceutical Regulators' Forum (IPRF).
Estonian: Reguleerimisalane koostöö ja teabevahetus rahvusvaheliste reguleerivate asutustega tagatakse ka ravimeid reguleerivate asutuste rahvusvahelise foorumi (IPRF) kaudu.
English: There are also a number of bilateral cooperation agreements in place that facilitate the exchange of important information on medicines between regulators inside and outside the EU.
Estonian: Sõlmitud on ka hulk kahepoolseid koostöölepinguid, mis hõlbustavad olulise ravimiteabe vahetamist reguleerivate asutuste vahel ELis ja väljaspool.
English: The role of EMA
Estonian: EMA roll
English: • Implementation - it can adopt implementing measures as well as oversee the correct application of EU law on pharmaceuticals;
Estonian: • rakendamine - komisjon võib võtta rakendusmeetmeid ning teha ELi ravimiõiguse nõuetekohase rakendamise üle järelevalvet;
English: Accession to the EU means a commitment to apply the “acquis communautaire” (the body of EU legislation and guidance) to ensure that all EU Member States operate to the same standards.
Estonian: ELiga ühinemine tähendab kohustust kohaldada ühenduse õigustikku (ELi õigusaktide ja suuniste kogumit), et tagada samade standardite järgimine kõikides ELi liikmesriikides.
English: Inspection outcomes can be accessed by all Member States and are made publicly available across the EU through EudraGMDP.
Estonian: Inspekteerimise tulemusi saavad hinnata kõik liikmesriigid ja need tehakse EudraGMDP kaudu kogu ELis avalikult kättesaadavaks.
English: EMA prepares scientific guidelines in cooperation with experts from its scientific committees and working groups.
Estonian: EMA koostab koostöös oma teaduskomiteede ja töörühmade ekspertidega teaduslikke suuniseid.
English: Authorisation and supervision of manufacturers
Estonian: Tootjatele tegevuslubade andmine ja nende järelevalve
English: EMA also gives product-specific scientific advice to companies for the development of medicines.
Estonian: EMA annab äriühingutele ravimite arendamiseks ka tootepõhiseid teaduslikke nõuandeid.
English: Experts participate in the work of EMA as members of its scientific committees, working parties, scientific advisory groups and other ad hoc advisory groups, or as members of the national assessment teams that evaluate medicines.
Estonian: Eksperdid osalevad EMA töös teaduskomiteede, töörühmade, teadusnõuanderühmade ja muude ad hoc nõuanderühmade liikmetena või ravimeid hindavate riiklike hindamisrühmade liikmetena.
English: A strategic forum at the level of global agencies has recently been established - the International Coalition of Medicines Regulatory Authorities (ICMRA).
Estonian: Hiljuti loodi kogu maailma asutusi hõlmav strateegiline foorum - ravimeid reguleerivate asutuste rahvusvaheline koalitsioon (ICMRA).
English: The regulation of medical devices does not fall within the scope of the European regulatory system for medicines.
Estonian: Meditsiiniseadmete reguleerimine ei kuulu Euroopa ravimite reguleerimissüsteemi kohaldamisalasse.
English: This includes vaccines used in the WHO Expanded Programme on Immunization, or for protection against a public health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria or tuberculosis.
Estonian: Nende hulka kuuluvad WHO laiendatud immuniseerimisprogrammis kasutatavad või rahvatervist ohustavate prioriteetsete haiguste eest kaitsvad vaktsiinid ning WHO sihthaiguste, nagu HIV/AIDSi, malaaria ja tuberkuloosi ravimid.
English: Medicines eligible for this procedure, which is derived from Article 58 of the regulation founding the Agency, are used to prevent or treat diseases that impact global public health.
Estonian: Ravimeid, millele kohaldatakse ameti asutamismääruse artiklist 58 tulenevat menetlust, kasutatakse üleilmselt rahvatervist mõjutavate haiguste ennetamiseks või raviks.
English: These activities aim to foster the timely exchange of regulatory and scientific expertise and the development of best practices in the regulatory field across the world.
Estonian: Selle tegevuse eesmärk on edendada reguleerimisalaste ja teaduslike eriteadmiste õigeaegset vahetamist ning reguleerimisvaldkonna parimate tavade väljatöötamist kogu maailmas.
English: To protect public health and ensure the availability of high quality, safe and effective medicines for European citizens, all medicines must be authorised before they can be placed on the market in the EU.
Estonian: Rahvatervise kaitsmiseks ja Euroopa kodanikele kvaliteetsete, ohutute ja tõhusate ravimite kättesaadavuse tagamiseks peavad kõik ravimid saama enne ELi turule laskmist müügiloa.
English: Pharmaceutical companies submit a single authorisation application to EMA.
Estonian: Farmaatsiaettevõtted esitavad EMA-le ühtse müügiloa taotluse.