FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally]
Estonian: RAVIMPREPARAADI NIMETUS Daivobet ja sarnased nimetused (vt lisa I) 50 mikrogrammi / 0,5 mg/g geel [Vt lisa I - täidetakse riiklikult]
English: No major updates to the Daivobet gel SPC according to the adoption of Daivobet ointment SPC (MRP) were required.
Estonian: Daivobeti geeli ravimi omaduste kokkuvõttes ei ole vaja Daivobeti salvi ravimi omaduste kokkuvõtte (vastastikuse tunnustamise menetlus) heakskiitmise menetluse põhjal suuri muudatusi teha.
English: NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally]
Estonian: RAVIMPREPARAADI NIMETUS Daivobet ja sarnased nimetused (vt lisa I) 50 mikrogrammi / 0,5 mg/g salv [Vt lisa I - täidetakse riiklikult]
English: Caution should be exercised when prescribing Daivobet ointment to women who breast feed.
Estonian: Daivobeti salvi ordineerimisel rinnaga toitvale naisele tuleb olla ettevaatlik.
English: Section 4.3- Contraindications
Estonian: 4.3 - Vastunäidustused
English: The side effects include the following: - Your adrenal glands may stop working properly.
Estonian: - Teie neerupealised ei pruugi korralikult töötada.
English: One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Estonian: Ühes grammis geelis on 50 mikrogrammi kaltsipotriooli (monohüdraadina) ja 0,5 mg beetametasooni (dipropionaadina).
English: Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally] calcipotriol/betamethasone
Estonian: Daivobet ja sarnased nimetused (vt lisa I) 50 mikrogrammi / 0,5 mg/g geel [Vt lisa I - täidetakse riiklikult] kaltsipotriool/beetametasoon
English: Acne
Estonian: Geel
English: High-density polyethylene bottles with low-density polyethylene nozzle and a high-density polyethylene screw cap.
Estonian: Suure tihedusega polüetüleenist pudelid väikese tihedusega polüetüleenist valmistatud otsikuga ja suure tihedusega polüetüleenist korgiga.
English: Adverse reactions to excipients
Estonian: Abiainetest tingitud kõrvaltoimed
English: Exacerbation of psoriasis Skin pain or irritation Dermatitis
Estonian: Aeg-ajalt psoriaasi ägenemine valu nahal või nahaärritus dermatiit erüteem follikuliit manustamiskoha pigmendimuutused
English: The wording in the national SPC of a number of MSs largely reflected the wording used in MRP SPC.
Estonian: Mitme liikmesriigi riikliku ravimi omaduste kokkuvõtte sõnastus oli suures osas kooskõlas vastastikuse tunnustamise menetluse teel heaks kiidetud ravimi omaduste kokkuvõtte sõnastusega.
English: Luxembourg LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Estonian: Luksemburg LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)
English: The text “impact on the metabolic control of diabetes mellitus” has been added to the undesirable effects of betamethasone dipropionate as already stated in section 4.4 of the DCP SPC.
Estonian: Beetametasoondipropionaadi kõrvalnähtudele on lisatud detsentraliseeritud menetluse käigus heaks kiidetud ravimi omaduste kokkuvõtte lõigus 4.4 esitatud tekst „mõju suhkurtõve metaboolsele regulatsioonile”.
English: Czech Republic LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Estonian: Tšehhi Vabariik LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)
English: If you have an allergic reaction, stop taking Daivobet, tell your doctor immediately or go to the casualty department at your nearest hospital - Treatment with this ointment may cause the level of calcium in your blood or urine to increase (usually when too much ointment has been used).
Estonian: Kui teil tekib allergiline reaktsioon, lõpetage Daivobeti kasutamine, pöörduge viivitamatult arsti poole või lähima haigla vastuvõtuosakonda.
English: The wording in the national SPC of a number of MSs largely reflected the wording used in MRP.
Estonian: Paljude liikmesriikide riikliku menetluse teel heaks kiidetud ravimi omaduste kokkuvõtte sõnastus oli suures osas kooskõlas vastastikuse tunnustamise menetluse teel heaks kiidetud ravimi omaduste kokkuvõtte sõnastusega.
English: Paediatric population
Estonian: Kasutamine peanahal
English: If you have an allergic reaction, stop taking Daivobet, tell your doctor immediately or go to the casualty department at your nearest hospital - Treatment with this gel may cause the level of calcium in your blood or urine to increase (usually when too much gel has been used).
Estonian: - Ravi selle geeliga võib põhjustada kaltsiumitaseme tõusu teie veres või uriinis (tavaliselt siis, kui kasutatud on liiga palju geeli).
English: However, in a number of member states alternative text has been included following the outcome of National Procedures.
Estonian: Müügiloa hoidja väljapakutud ühtlustatud tekst oli kooskõlas vastastikuse tunnustamise menetluse teel heaks kiidetud ravimi omaduste kokkuvõtte sõnastusega, kuid mitmes liikmesriigis on riiklike menetluste tulemusena lisatud ravimi omaduste kokkuvõttesse teistsugune tekst.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
Estonian: Euroopa Komisjon andis Dacogeni müügiloa, mis kehtib kogu Euroopa Liidus, 20. septembril 2012.
English: Dacogen decitabine
Estonian: Dacogen detsitabiin
English: What measures are being taken to ensure the safe and effective use of Dacogen?
Estonian: Mis meetmed võetakse, et tagada Dacogeni ohutu ja efektiivne kasutamine?
English: In a 4-week treatment cycle, Dacogen is given daily for the first 5 days.
Estonian: 4-nädalase ravitsükli jooksul manustatakse Dacogeni esimese viie päeva jooksul iga päev.
English: Other information about Dacogen
Estonian: Muu teave Dacogeni kohta
English: Treatment was given for as long as patients benefited from it.
Estonian: Patsient sai ravi nii kaua, kuni see oli talle kasulik.
English: These enzymes promote the development and progression of cancer.
Estonian: Need ensüümid aitavad kaasa vähi kasvule ja levikule.
English: The dose is calculated using the patient's height and weight.
Estonian: Annus arvutatakse patsiendi pikkuse ja kehamassi järgi.
English: If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
Estonian: Kui patsiendil tekivad rasked kõrvalnähud, võib arst otsustada ravi Dacogeniga edasi lükata või lõpetada.
English: Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
Estonian: Dacogeni saanud patsiendid elasid keskmiselt 7,7 kuud, toetavat ravi või tsütarabiini saanud patsiendid elasid keskmiselt 5,0 kuud.
English: This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells.
Estonian: See tähendab, et ta on sarnane tsütidiindeoksünukleosiidiga, mis on rakkude DNA (geneetilise materjali) oluline komponent.
English: The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Dacogeni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: This is a summary of the European public assessment report (EPAR) for Dacogen.
Estonian: See on ravimi Dacogen Euroopa avaliku hindamisaruande kokkuvõte.
English: The main measure of effectiveness was how long the patients lived.
Estonian: Efektiivsuse põhinäitaja oli patsiendi elumus.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Dacogeni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It contains the active substance decitabine.
Estonian: See sisaldab toimeainena detsitabiini.
English: The full EPAR for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Dacogeni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs).
Estonian: Organismis muudetakse detsitabiin detsitabiintrifosfaadiks, mis kaasatakse seejärel DNA-sse, kus see blokeerib ensüüme DNA metüültransferaase (DNMTd).
English: For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.
Estonian: Dacogeni kohta teatatud piirangute ja kõrvalnähtude täielik loetelu on pakendi infolehel.
English: For more information about treatment with Dacogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Dacogeniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue.
Estonian: Dacogeni toimeaine detsitabiin on tsütidiindeoksünukleosiidi analoog.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dacogen.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.
Estonian: DNMTde blokeerimisega takistab detsitabiin kasvajarakkude jagunemist ja aitab neid hävitada.
English: As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.
Estonian: Kuna ei ole teada, kas toimeaine eritub rinnapiima, peab Dacogeni vajav patsient, kes toidab last rinnaga, imetamise lõpetama.
English: There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen.
Estonian: Lisaks ei esinenud Dacogeniga suuri ohutusprobleeme ja ravimi üldine ohutusprofiil on sarnane väikeses annuses manustatud tsütarabiini ohutusprofiiliga, v.a mõned kõrvalnähud, nagu infektsioonid ja neutropeenia, mis on Dacogeni kasutamisel enam levinud.
English: It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
Estonian: Dacogeni kasutatakse patsientidel, kes ei saa kasutada standardset kemoteraapia induktsioonravi (esialgne ravi vähiravimitega).
English: At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control.
Estonian: Soovitav on teha vähemalt neli ravitsüklit, kuid ravi võib jätkata seni, kuni äge müeloidne leukeemia ravile allub.
English: Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy.
Estonian: Dacogeni uuriti ühes põhiuuringus, kus osales 485 äsja diagnoositud ägeda müeloidse leukeemiaga täiskasvanut, kellel ei olnud võimalik kasutada standardset kemoteraapia induktsioonravi.
English: Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine).
Estonian: Dacogeni võrreldi kas toetava raviga (iga ravim või raviviis, mis aitab patsienti, kuid ei ole vähiravi või operatsioon) või väikeses annuses tsütarabiiniga (samuti vähiravim).
English: Because the number of patients with AML is low, the disease is considered ‘rare', and Dacogen was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2006.
Estonian: Et ägeda müeloidse leukeemiaga patsientide arv on väike ja see haigus esineb harva, nimetati Dacogen 8. juunil 2006 harvikravimiks.
English: Why has Dacogen been approved?
Estonian: Miks Dacogen heaks kiideti?
English: Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Estonian: Dacogeni kasutatakse täiskasvanud patsientide raviks, kellel on äsja diagnoositud äge müeloidne leukeemia (AML), vere teatud valgeliblede vähi liik.
English: What is Dacogen?
Estonian: Mis on Dacogen?
English: The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy.
Estonian: Inimravimite komitee märkis, et kuigi Dacogeniga ravitud ägeda müeloidse leukeemiaga patsientide elumus on tagasihoidlik, on see asjakohane, sest patsientidel, kes ei saa kasutada standardset kemoteraapia induktsioonravi, on piiratud ravivõimalused.
English: The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Estonian: Dacogeni kõige sagedamad rasked kõrvalnähud (esinenud enam kui 20%-l patsientidest) on kopsupõletik, trombotsütopeenia, neutropeenia (valgeliblede neutrofiilide vähesus), febriilne neutropeenia (valgeliblede vähesus koos palavikuga) ja aneemia.
English: Dacogen is given as an infusion into a vein over one hour.
Estonian: Dacogeni manustatakse üks tund kestva veeniinfusioonina.
English: The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count).
Estonian: Dacogeni kõige sagedamad kõrvalnähud (esinenud enam kui 35%-l patsientidest) on palavik, aneemia (vere punaliblede vähesus) ja trombotsütopeenia (trombotsüütide vähesus).
English: What is the risk associated with Dacogen?
Estonian: Mis riskid Dacogeniga kaasnevad?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.
Estonian: Dacogeni omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Dacogen is a powder that is made up into a solution for infusion (drip) into a vein.
Estonian: Dacogen on infusioonilahuse (veeni tilgutatava lahuse) pulber.
English: Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.
Estonian: Ravi Dacogeniga tohib alustada üksnes kemoteraapias kogenud arsti järelevalve all.
English: Dacogen must not be used in people who are breastfeeding.
Estonian: Dacogeni ei tohi kasutada imetavad naised.
English: How is Dacogen used?
Estonian: Kuidas Dacogeni kasutatakse?
English: Dacogen can only be obtained with a prescription.
Estonian: Dacogen on retseptiravim.
English: What benefit has Dacogen shown during the studies?
Estonian: Milles seisneb uuringute põhjal Dacogeni kasulikkus?
English: How does Dacogen work?
Estonian: Kuidas Dacogen toimib?
English: What is Dacogen used for?
Estonian: Milleks Dacogeni kasutatakse?
English: How has Dacogen been studied?
Estonian: Kuidas Dacogeni uuriti?
English: Previously known as Zenas.
Estonian: Varasem nimetus Zenas.
English: The name of the medicine was changed to Firdapse on 28 January 2010.
Estonian: Ravimi nimetus muudeti Firdapseks 28. jaanuaril 2010.
English: It is available as tablets (10 mg).
Estonian: Seda turustatakse tablettidena (10 mg).
English: A risk management plan has been developed to ensure that Firdapse is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Firdapse võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zenas on 23 December 2009.
Estonian: Euroopa Komisjon andis Zenase müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. detsembril 2009.
English: What measures are being taken to ensure the safe and effective use of Firdapse?
Estonian: Mis meetmed võetakse, et tagada Firdapse ohutu ja efektiivne kasutamine?
English: This means that because the disease is rare, it has not been possible to obtain complete information about Firdapse.
Estonian: Et see haigus esineb harva, ei ole olnud võimalik saada Firdapse kohta täielikku teavet.
English: Other information about Firdapse
Estonian: Muu teave Firdapse kohta
English: Firdapse is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Firdapse should be taken with food.
Estonian: Firdapset tuleb manustada ühesuurusteks annusteks jaotatuna kolm või neli korda ööpäevas ning üksikannus ei tohi ületada 20 mg. Firdapset tuleb võtta koos toiduga.
English: Firdapse amifampridine
Estonian: amifampridiin
English: The recommended starting dose of Firdapse is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day.
Estonian: Firdapse soovitatav algannus on 15 mg ööpäevas, mida võib suurendada iga 4-5 päeva järel 5 mg kaupa suurima annuseni 60 mg ööpäevas.
English: Because amifampridine-containing medicines have been used in the European Union (EU) for over 20 years, the company presented the results of studies from the scientific literature on amifampridine to support the use of Firdapse.
Estonian: Et amifampridiini sisaldavaid ravimeid on Euroopa Liidus kasutatud üle 20 aasta, esitas ettevõte Firdapse kasutamise toetuseks uuringute tulemused teaduskirjandusest.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Firdapse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Firdapse kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Another study combined data from the two published studies and looked at compound muscle action potential (CMAP).
Estonian: Ühes teises uuringus ühendati kahe avaldatud uuringu andmed ja analüüsiti lihasetalitluse koondpotentsiaali (CMAP).
English: What is Firdapse?
Estonian: Mis on Firdapse?
English: Firdapse is a medicine that contains the active substance amifampridine.
Estonian: Firdapse on ravim, mis sisaldab toimeainena amifampridiini.
English: The company will ensure that all healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Estonian: Tootja peab lisaks tagama, et kõik ravimit tõenäoliselt kasutavad meditsiinitöötajad saavad teabe, kuidas patsiente registrisse kanda.
English: The CHMP decided that Firdapse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Firdapse kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: What information is still awaited for Firdapse?
Estonian: Milliseid andmeid Firdapse kohta veel oodatakse?
English: The full EPAR for Firdapse can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Firdapse kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In two published studies involving a total of 38 adults with LEMS, amifampridine was compared with placebo (a dummy treatment).
Estonian: Kahes avaldatud uuringus, kus osales kokku 38 LEMSiga täiskasvanut, võrreldi amifampridiini platseeboga (näiv ravim).
English: The main measures of effectiveness were based on the rating of how well the muscles worked using a scoring system, either the neurological disability score (NDS) or the quantitative myasthenia gravis (QMG) score.
Estonian: Efektiivsuse põhinäitajana hinnati lihasetalitlust, kasutades punktisüsteemi, milleks oli kas neuroloogilise häire punktisumma (NDS) või kvantitatiivne myasthenia gravis'e (QMG) punktisumma.
English: Because the number of patients with LEMS is low, the disease is considered ‘rare', and Firdapse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Estonian: Et LEMSiga patsientide arv on väike ja see haigus esineb harva, nimetati Firdapse 18. detsembril 2002 harvikravimiks.
English: What is the risk associated with Firdapse?
Estonian: Mis riskid Firdapsega kaasnevad?
English: Why has Firdapse been approved?
Estonian: Miks Firdapse heaks kiideti?
English: Firdapse is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Estonian: Firdapset kasutatakse Lamberti-Eatoni müasteenilise sündroomi (LEMS) sümptomaatiliseks raviks täiskasvanutel.
English: CMAP is a measure of electrical activity in muscles.
Estonian: CMAP on lihaste elektrilise talitluse näitaja.
English: For more information about treatment with Firdapse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Firdapsega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects and restrictions with Firdapse, see the package leaflet.
Estonian: Firdapse kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Firdapse, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Firdapse ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The most common side effects reported with Firdapse are paraesthesia (unusual sensations like pins and needles) and gastro-intestinal disorders such as epigastralgia (pain around the upper part of the stomach), diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Estonian: Firdapse kohta teatatud kõige sagedamad kõrvalnähud on paresteesia (vääraistingud, nt torkiv valu) ja seedetrakti häired, nt epigastraalne (ülakõhu) valu, kõhulahtisus, iiveldus ja kõhuvalu.
English: Additionally, the effect of Firdapse on the QT interval (the electrical activity of the heart) was investigated.
Estonian: Lisaks uuriti Firdapse mõju QT-intervallile (südame elektrilisele talitlusele).
English: It must not be used with sultopride (an antipsychotic medicine), or medicines known to cause QTc prolongation (an alteration of the electrical activity of the heart).
Estonian: Ravimit ei tohi kasutada koos sultopriidi (psühhoosivastane ravim) ega ravimitega, mis pikendavad QTc-intervalli (muudavad südame elektrilist talitlust).
English: It must also not be used with medicines that have a narrow therapeutic window.
Estonian: Firdapset ei tohi kasutada ka koos ravimitega, mille terapeutiline vahemik on väike.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Firdapse.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.