FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains the active substance doxorubicin (2 mg/ml).
Estonian: See sisaldab toimeainena doksorubitsiini (2 mg/ml).
English: ‘Metastatic' means the cancer has spread to other parts of the body.
Estonian: Metastaatiline tähendab, et vähk on levinud organismis ka mujale.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Estonian: Ettevõtte kiri, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, on avaldatud jaotises „All documents“.
English: The application was withdrawn after ‘day 181'.
Estonian: Taotluse menetlemine oli kestnud 181 päeva, kui ettevõte võttis taotluse tagasi.
English: It also reduces its effects on non-cancer tissues and cells, so it is less likely to cause some side effects.
Estonian: See vähendab ka toimet vähita kudedele ja muudele kui vähirakkudele, mistõttu kõrvalnähtude tekkimise tõenäosus on väiksem.
English: What is Doxorubicin SUN?
Estonian: Mis on Doxorubicin SUN?
English: The active substance has an effect in the body when it is released (freed) from the liposome.
Estonian: Toimeaine mõjutab organismi, kui ta vabaneb liposoomist.
English: • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already undergone or are unsuitable for a bone marrow transplant.
Estonian: • hulgimüeloom (luuüdi rakkude teatav vähk) patsientidel, kes on varem saanud vähemalt ühte muud liiki ravi ja kellele on luuüdi juba siiratud või kellele seda ei saa siirata.
English: Because Doxorubicin SUN was assessed as a hybrid generic medicine, the company presented the results of studies carried out to investigate whether it is similar to the reference medicine.
Estonian: Et Doxorubicin SUN on hübriidne geneeriline ravim, esitas ettevõte nende uuringute tulemused, milles uuriti ravimi sarnasust võrdlusravimiga.
English: Doxorubicin SUN was originally also expected to be used to treat AIDS-related Kaposi's sarcoma (a cancer of the blood vessels) but this indication was withdrawn during the evaluation process.
Estonian: Doxorubicin SUNi kavatseti algselt kasutada ka omandatud immuunpuudulikkuse sündroomiga seotud Kaposi sarkoomi (veresoonte teatud vähk) raviks, kuid see näidustus võeti hindamisprotsessi käigus tagasi.
English: • advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working;
Estonian: • kaugelearenenud munasarjavähk naistel, kellele varasem ravi plaatinat sisaldava vähiravimiga enam ei toimi;
English: 18 August 2011
Estonian: Lk 2/2
English: Based on the data submitted, the CHMP was of the opinion that the studies did not provide enough evidence to show that Doxorubicin SUN was similar to the reference medicine.
Estonian: Tuginedes esitatud andmetele, oli inimravimite komitee arvamusel, et uuringud ei tõestanud piisavalt Doxorubicin SUNi sarnasust võrdlusravimiga.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Doxorubicin SUN.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ettevõte ei ole esitanud piisavalt andmeid ravimi Doxorubicin SUN taotluse toetuseks.
English: It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Estonian: Selle toime seisneb rakkudes sisalduva DNA pärssimises, mis takistab rakke DNAd paljundamast ja valke tootmast.
English: These included studies in patients with ovarian cancer and multiple myeloma to investigate the concentrations of doxorubicin in the blood produced by Doxorubicin SUN compared with Caelyx.
Estonian: Need hõlmasid munasarjavähiga ja hulgimüeloomiga patsientide uuringuid, milles võrreldi doksorubitsiini kontsentratsiooni veres, kui patsientidele manustati vastavalt Doxorubicin SUNi või Caelyxit.
English: Doxorubicin SUN was expected to work in the same way as the reference medicine, Caelyx.
Estonian: Eeldati, et Doxorubicin SUN toimib samal viisil kui võrdlusravim Caelyx.
English: Doxorubicin SUN was expected to be used to treat the following types of cancer in adults:
Estonian: Doxorubicin SUNi kavatseti kasutada täiskasvanutel järgmiste vähivormide raviks:
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Doxorubicin SUN could not have been approved.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimit Doxorubicin SUN ei ole võimalik heaks kiita.
English: Doxorubicin SUN was assessed as a ‘hybrid generic medicine'.
Estonian: Doxorubicin SUN on hübriidne geneeriline ravim.
English: This included the total amount of doxorubicin and the amounts of liposome-encapsulated doxorubicin, free doxorubicin and doxorubicinol (the main metabolite of doxorubicin).
Estonian: Võrreldi doksorubitsiini üldkogust ning liposoomides sisalduva doksorubitsiini, vaba doksorubitsiini ja doksorubitsinooli (doksorubitsiini peamine metaboliit) koguseid.
English: On 20 Jul 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Doxorubicin SUN, intended for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma.
Estonian: teatas 20. juulil 2011 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Doxorubicin SUN müügiloa taotlus.
English: Doxorubicin SUN was expected to be used on its own for this disease;
Estonian: Doxorubicin SUNi oleks kasutatud selle haiguse ravimisel ainsa ravimina;
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union containing the same active substance, called Caelyx.
Estonian: See tähendab, et Doxorubicin SUN on sarnane sama toimeainet sisaldava võrdlusravimiga Caelyx, millel juba on Euroopa Liidus müügiluba.
English: Doxorubicin accumulates in areas of the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated.
Estonian: Doksorubitsiin koguneb organismis ebatavalise kujuga veresoontega piirkonda, näiteks kasvajatesse, kuhu ravimi toime koondub.
English: Doxorubicin SUN was to be used in combination with bortezomib (another anticancer medicine).
Estonian: Doxorubicin SUNi oleks kasutatud koos bortesomiibiga (samuti vähiravim).
English: Doxorubicin SUN is concentrate to be made up into a solution for infusion (drip into a vein).
Estonian: Doxorubicin SUN on kontsentraat, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: The active substance in Doxorubicin SUN and Caelyx, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Estonian: Doxorubicin SUNi ja Caelyxi toimeaine doksorubitsiin on antratsükliinide rühma kuuluv tsütotoksiline ravim.
English: How was Doxorubicin SUN expected to work?
Estonian: Milline on Doxorubicin SUNi eeldatav toime?
English: In Caelyx and Doxorubicin SUN, doxorubicin is contained (encapsulated) in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Estonian: Caelyxis ja Doxorubicin SUNis sisaldub doksorubitsiin pegüleeritud liposoomides (keemilise aine polüetüleenglükooliga ümbritsetud tillukesed rasvakuulid), see aeglustab toimeaine lagunemist ja toimeaine püsib kauem vereringes.
English: What was Doxorubicin SUN expected to be used for?
Estonian: Milleks kavatseti Doxorubicin SUNi kasutada?
English: Pazenir received a marketing authorisation valid throughout the EU on 6 May 2019.
Estonian: Pazenir on saanud müügiloa, mis kehtib kogu ELis, 6. mail 2019.
English: Further information on Pazenir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pazenir.
Estonian: Lisateave Pazeniri kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/pazenir.
English: What measures are being taken to ensure the safe and effective use of Pazenir?
Estonian: Mis meetmed võetakse, et tagada Pazeniri ohutu ja efektiivne kasutamine?
English: The medicine is given once a day on days 1, 8 and 15 of each cycle.
Estonian: Ravimit manustatakse üks kord ööpäevas iga ravitsükli 1., 8. ja 15. päeval.
English: Pazenir (paclitaxel)
Estonian: Pazenir (paklitakseel)
English: What is Pazenir and what is it used for?
Estonian: Mis on Pazenir ja milleks seda kasutatakse?
English: Information on the reference medicine can also be found on the Agency's website.
Estonian: Teave võrdlusravimi kohta on samuti Euroopa Ravimiameti veebilehel.
English: Other information about Pazenir
Estonian: Muu teave Pazeniri kohta
English: Why is Pazenir authorised in the EU?
Estonian: Miks Pazenir ELis heaks kiideti?
English: By keeping this structure intact, the cells cannot divide and they eventually die.
Estonian: Kui tsütoskelett püsib muutumatuna, ei saa rakk poolduda ning lõpuks hävib.
English: This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Estonian: Tänu sellele on lihtne valmistada paklitakseeli suspensiooni, mida saab manustada veeniinfusiooniga.
English: Side effects reported with Pazenir are carefully evaluated and any necessary action taken to protect patients.
Estonian: Pazeniri kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: As for every medicine, the company provided studies on the quality of Pazenir.
Estonian: Nagu iga ravimi korral, esitas ettevõte Pazeniri kvaliteedi uuringud.
English: For more information about using Pazenir, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Pazeniri kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Pazenir has been shown to be comparable to Abraxane.
Estonian: Euroopa Ravimiamet otsustas, et vastavalt ELi nõuetele on tõendatud Pazeniri võrreldav toime ravimi Abraxane toimega.
English: As for all medicines, data on the use of Pazenir are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Pazeniri kasutamise kohta pidevat järelevalvet.
English: The recommended dose depends on the patient's height and weight.
Estonian: Soovitatav algannus sõltub patsiendi pikkusest ja kehamassist.
English: Paclitaxel has been available as a cancer medicine since 1993.
Estonian: Paklitakseeli on turustatud vähiravimina alates 1993. aastast.
English: Pazenir also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Estonian: Pazenir toimib ka muudele rakkudele peale vähirakkude, näiteks vere- ja närvirakkudele, mis võib põhjustada kõrvalnähte.
English: It should not be interchanged with other medicines containing paclitaxel.
Estonian: Pazeniri ei tohi asendada muude paklitakseeli sisaldavate ravimitega.
English: ‘Metastatic' means that the cancer has spread to other parts of the body;
Estonian: Metastaatiline (siiretega) tähendab, et vähk on levinud organismis ka mujale.
English: • non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
Estonian: • Mitteväikerakk-kopsuvähk, esmaravina koos vähiravimi karboplatiiniga, kui patsienti ei saa ravida kirurgiliselt või kiiritusraviga.
English: Immediately after giving Pazenir, gemcitabine should be given.
Estonian: Vahetult pärast Pazeniri tuleb manustada gemtsitabiini.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pazenir have been included in the summary of product characteristics and the package leaflet.
Estonian: Pazeniri ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: For more information on generic medicines, see the question-and-answer document here.
Estonian: Lisateave geneeriliste ravimite kohta on teabedokumendis siin.
English: Because Pazenir 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 Pazenir on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: In non-small cell lung cancer, treatment is carried out in 3-week cycles with Pazenir given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Pazenir.
Estonian: Mitteväikerakk-kopsuvähi korral manustatakse Pazeniri 3-nädalaste ravitsüklitena: Pazeniri manustatakse tsükli 1., 8. ja 15. päeval; 1. päeval manustatakse vahetult pärast Pazeniri ka karboplatiini.
English: Therefore, the Agency's view was that, as for Abraxane, the benefits of Pazenir outweigh the identified risks and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Abraxane korral, ületab Pazeniri kasulikkus sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: This means that Pazenir contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Abraxane.
Estonian: See tähendab, et Pazenir sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Abraxane, millel juba on ELis müügiluba.
English: Pazenir is used to treat the following cancers in adults:
Estonian: Pazeniri kasutatakse täiskasvanutel järgmiste vähiliikide raviks.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Abraxane, and do not need to be repeated for Pazenir.
Estonian: Võrdlusravimiga Abraxane on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja Pazeniriga korrata.
English: Pazenir should only be given under the supervision of a cancer doctor in clinics that are specialised in giving ‘cytotoxic' (cell-killing) medicines.
Estonian: Pazeniri tohib kasutada ainult onkoloogi järelevalve all tsütotoksiliste (rakke hävitavate) ravimite manustamisele spetsialiseerunud kliinikutes.
English: Pazenir is given as an infusion into a vein over a period of 30 minutes.
Estonian: Pazeniri manustatakse 30 minutit kestva veeniinfusioonina.
English: How is Pazenir used?
Estonian: Kuidas Pazeniri kasutatakse?
English: In metastatic breast cancer, Pazenir is given on its own every three weeks.
Estonian: Metastaatilise rinnavähi korral manustatakse Pazeniri ainuravimina iga 3 nädala järel.
English: How has Pazenir been studied?
Estonian: Kuidas Pazeniri uuriti?
English: • metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline (another type of cancer medicine) is not suitable.
Estonian: • Metastaatiline rinnavähk, kui esmaravi enam ei toimi ja standardravi antratsükliiniga (samuti vähiravim) ei sobi.
English: Paclitaxel blocks a stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Estonian: Paklitakseel blokeerib rakkude jagunemise etapi, kus tsütoskelett (rakuskelett, raku toes) raku jagunemiseks ümber korraldub.
English: What are the benefits and risks of Pazenir?
Estonian: Milles seisneb Pazeniri kasulikkus ja mis riskid ravimiga kaasnevad?
English: In metastatic adenocarcinoma of the pancreas, Pazenir is given in 4-week treatment cycles.
Estonian: Pankrease metastaatilise adenokartsinoomi korral manustatakse Pazeniri 4-nädalaste ravitsüklitena.
English: In Pazenir, as in its reference medicine Abraxane, paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles'.
Estonian: Nagu võrdlusravimis Abraxanes, on ka Pazeniris paklitakseel seondunud inimvalgu albumiiniga väikeste nanoosakestena.
English: An overview of Pazenir and why it is authorised in the EU
Estonian: Ülevaade ravimist Pazenir ja ELis müügiloa väljastamise põhjendus
English: The active substance in Pazenir, paclitaxel, belongs to the group of cancer medicines known as the ‘taxanes'.
Estonian: Pazeniri toimeaine paklitakseel kuulub vähiravimite taksaanide rühma.
English: Pazenir contains the active substance paclitaxel attached to a human protein called albumin and is a ‘generic medicine'.
Estonian: Pazenir sisaldab toimeainena paklitakseeli, mis on seondunud inimvalgu albumiiniga.
English: There was no need for ‘bioequivalence' studies to investigate whether Pazenir is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Estonian: Bioekvivalentsust (kas Pazenir imendub organismis samamoodi kui võrdlusravim, et saavutada toimeaine sarnane sisaldus veres) ei olnud vaja uurida.
English: • metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine;
Estonian: • Pankrease (kõhunäärme) metastaatilise adenokartsinoom, esmaravina koos gemtsitabiiniga (samuti vähiravim).
English: This is because Pazenir is given by infusion into a vein and the nanoparticles it contains rapidly separate into its constituent parts in the same way as Abraxane's.
Estonian: Seda ei olnud vaja, sest Pazeniri manustatakse veeniinfusioonina ning samuti nagu ravimi Abraxane korral, eralduvad nanoosakestest, mida ravim sisaldab, kiiresti selle koostisosad.
English: How does Pazenir work?
Estonian: Kuidas Pazenir toimib?
English: The medicine can only be obtained with a prescription.
Estonian: Pazenir on retseptiravim.
English: The Physician Leaflet should contain the following key elements:
Estonian: Arsti infolehes peavad sisalduma järgmised võtmeelemendid:
English: Pictures of rash according to different grades
Estonian: Löövete pildid vastavalt raskusastmetele
English: Rash and Severe Cutaneous Adverse Reactions safety data from Phases 2 and 3 Incidence of rash and severe cutaneous reactions Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other
Estonian: Lööbe ja raskete nahareaktsioonide ohutusandmed 2. ja 3. faasi uuringutes Lööbe ja raskete nahareaktsioonide esinemissagedus Lööbe ja raskete nahareaktsioonide liigitus ja ravi, eeskätt ravi jätkamise või lõpetamise suhtes telapreviiri ja teiste ravikomponentidega.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Estonian: Liikmesriik peab tagama, et rakendatakse kõiki alljärgnevalt kirjeldatud ravimi ohutu ja efektiivse kasutamise tingimusi või piiranguid:
English: The Member States shall ensure that the MAH provides to all physicians who are expected to prescribe or use INCIVO a healthcare professional educational pack containing the following:
Estonian: Liikmesriigid peavad tagama, et müügiloa hoidja varustaks kõik arstid, kes hakkavad INCIVO't välja kirjutama või kasutama, tervishoiutöötaja infomaterjalide komplektiga, milles sisalduvad:
English: The Member States shall agree to the final healthcare educational pack with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Estonian: Enne ravimi turustamist oma territooriumil peab liikmesriik müügiloa hoidjaga kooskõlastama lõpliku tervishoiupersonali infomaterjalide komplekti.
English: 250 µg Solution for injection
Estonian: 250 µg Süstelahus
English: 5 capsules
Estonian: 5 kapslid
English: Invented name
Estonian: Ravimi väljamõeldud nimetus
English: Intravenous use vial (glass) 5 ml
Estonian: Intravenoosne Viaal (klass)
English: Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus
English: Packaging Content (concentration) Package size
Estonian: Pakendi suurus
English: Prohippur was not studied directly in patients with these conditions.
Estonian: Prohippurit ei olnud nende seisunditega patsientidel otseselt uuritud.
English: The conditions are caused by a lack of enzymes needed to remove them.
Estonian: Seisundite põhjuseks on nende ainete eemaldamiseks vajalike ensüümide puudumine.
English: What was the recommendation of the CHMP at that time?
Estonian: Mis oli sel ajal inimravimite komitee soovitus?
English: What is Prohippur?
Estonian: Mis on Prohippur?
English: If you are in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete eriloaga kasutamise programmis ja vajate ravi kohta lisateavet, pöörduge palun arsti poole, kes teile ravi määras.
English: The company had not responded to the last round of questions at the time of the withdrawal.
Estonian: Ettevõte ei olnud taotluse tagasivõtmise ajaks viimastele küsimustele veel vastanud.
English: Both glycine and ammonia are harmful in high amounts and can cause severe brain damage.
Estonian: Nii glütsiin kui ka ammoonium on suurtes kogustes kahjulikud ja võivad põhjustada rasket ajukahjustust.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Estonian: Kuidas mõjutab tagasivõtmine praegu kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it needed more time to prepare adequate answers to questions raised by the CHMP.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et vajab inimravimite komitee poolt taotlusega seoses tõstatatud küsimustele adekvaatsete vastuste ettevalmistamiseks rohkem aega.
English: Withdrawal of the marketing authorisation application for Prohippur (sodium benzoate) EMA/258015/2018
Estonian: Müügiloa taotluse tagasivõtmise teave: Prohippur (naatriumbensoaat) EMA/258015/2018
English: Prohippur was designated an ‘orphan medicine' (a medicine to be used in rare diseases) for non-ketotic hyperglycinaemia on 11 September 2002 and for urea cycle disorders on 14 July 2016, 29 August 2016 and 18 November 2016.
Estonian: Prohippur nimetati 11. septembril 2002 mitteketootilise hüperglütsineemia harvikravimiks (ravim, mida kasutatakse harvaesinevate haiguste korral) ja 14. juulil 2016, 29. augustil 2016 ja 18. novembril 2016 uureatsükli häirete harvikravimiks.
English: Furthermore, as Prohippur was not used in clinical trials, the company should have provided data to show that Prohippur granules worked in the same way as the sodium benzoate used in the published studies.
Estonian: Kuna kliinilistes uuringutes ei olnud kasutatud Prohippurit, oleks ettevõte pidanud esitama andmed, mis oleksid pidanud tõendama, et Prohippuri graanulid toimivad samamoodi nagu avaldatud uuringutes kasutatud naatriumbensoaat.
English: Withdrawal of the marketing authorisation application for Prohippur (sodium benzoate)
Estonian: Müügiloa taotluse tagasivõtmise teave: Prohippur (naatriumbensoaat)
English: Prohippur was expected to be used to treat the following inherited disorders:
Estonian: Prohippurit kavatseti kasutada järgmiste pärilike häirete raviks:
English: Prohippur also helps remove excess nitrogen from the body, thereby lowering levels of ammonia.
Estonian: Prohippur aitab organismist eemaldada ka liigset lämmastikku, vähendades seeläbi ammooniumisisaldust.
English: The CHMP noted that the published studies submitted by the company did not provide enough evidence of the effectiveness and safety of sodium benzoate in the various disorders.
Estonian: Inimravimite komitee märkis, et ettevõtte esitatud avaldatud uuringutest ei saadud piisavat tõendusmaterjali naatriumbensoaadi efektiivsuse ja ohutuse kohta mitmesuguste häirete korral.