FrancophonIA/ELRC3.0 huggingface dataset:
English: Heavily contaminated clothes should be changed immediately and washed before re-use.
Estonian: Tugevalt saastunud riided tuleb esimesel võimalusel vahetada puhaste riiete vastu ning enne järgmist kasutuskorda puhtaks pesta.
English: Why is VarroMed approved?
Estonian: Miks VarroMed heaks kiideti?
English: VarroMed oxalic acid dihydrate / formic acid
Estonian: VarroMed oksaalhappe dihüdraat / sipelghape
English: VarroMed is intended to be used as part of an integrated varroa control programme, which includes other techniques.
Estonian: VarroMed on ette nähtud kasutamiseks ainult varroosi integreeritud tõrjeprogrammi raames, mis hõlmab ka teisi meetodeid.
English: The groups were treated during winter (in the absence of brood), spring and autumn (in the presence of brood) and included colonies of different sizes (5,000 to 30,000 bees) and different infestation levels.
Estonian: Uuringurühmi raviti talvel (ilma haudeta), kevadel ja sügisel (haudega) ja uuringusse olid kaasatud eri suurusega kolooniad (5000-30 000 mesilast), mille nakkusaste oli erinev.
English: In case of accidental spillage into the eye(s) flush the eye(s) immediately with clear running water for 10 minutes.
Estonian: Ravimi juhuslikul sattumisel silma loputage seda otsekohe puhta voolava veega 10 minuti vältel.
English: People should avoid contact with the skin, eyes and mucous membranes (moist body surfaces such as lining of mouth).
Estonian: Inimesed peavad vältima ravimi kokkupuudet naha, silmade ja limaskestaga (näiteks suu limaskest).
English: The most common side effect with VarroMed (which may affect more than 1 in 10 bee colonies) is an increased number of deaths of worker bees.
Estonian: VarroMedi kõige sagedasem kõrvalnäht (võib esineda enam kui 1 mesilaskoloonias 10st) on töömesilaste suremuse kasv.
English: It is not intended to provide practical advice on how to use VarroMed.
Estonian: Hindamisaruandes ei anta VarroMedi kasutamise praktilisi nõuandeid.
English: The withdrawal period for honey from honey bees treated with VarroMed for is ‘zero' days, which means there is no mandatory waiting time.
Estonian: VarroMediga ravitud mesilaste mee keeluaeg on 0 päeva, mis tähendab, et kohustuslikku keeluaega ei ole.
English: What are the risks associated with VarroMed?
Estonian: Mis riskid VarroMediga kaasnevad?
English: Children should be kept from contact with VarroMed.
Estonian: Vältida laste kokkupuutumist VarroMediga.
English: It can be used either as a single-dose treatment during the broodless period (winter treatment), or in the presence of brood (spring or autumn treatment) which will usually require repeated treatments.
Estonian: üheannuselise ravina või haude esinemisel (kevadine või sügisene ravi), mil tavaliselt on vaja korduvat ravi.
English: VarroMed must not be given during nectar flow, when honey is produced by bees, and should not be used when honey chambers are attached to the hive.
Estonian: VarroMedi ei tohi kasutada nektarierituse ajal, kui mesilased toodavad mett, ja seda ei tohi kasutada siis, kui meekambrid on tarusse kinnitatud.
English: For practical information about using VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad VarroMedi kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: How both oxalic acid and formic acid work is not well understood.
Estonian: Nii oksaalhappe kui ka sipelghappe toimemehhanism ei ole täpselt teada.
English: VarroMed contains the active substances oxalic acid dihydrate and formic acid.
Estonian: VarroMed sisaldab toimeainena oksaalhappe dihüdraati ja sipelghapet.
English: Varroosis is a disease of honey bees caused by infestation with a parasite called Varroa mite (Varroa destructor).
Estonian: Varroos on meemesilaste haigus, mida põhjustab nakatumine varroalestaks nimetatava parasiidiga (Varroa destructor).
English: The activity of oxalic acid on mites is thought to be due to the acidity of the medicine.
Estonian: Arvatakse, et oksaalhape toimib lestade puhul ravimi happelisuse tõttu.
English: In case of accidental spillage onto skin, the affected areas should be washed immediately with running water.
Estonian: Ravimi juhuslikul sattumisel nahale tuleb seda kohta otsekohe pesta voolava veega.
English: Formic acid is thought to kill Varroa mites by blocking the ability of their cells to generate energy; it may also act on mite nerve cells.
Estonian: Sipelghape tapab varroalestad arvatavasti lestarakkude energiatootmisvõime blokeerimise kaudu, kuid see võib mõjuda ka lestade närvirakkudele.
English: This is a summary of the European public assessment report (EPAR) for VarroMed.
Estonian: See on ravimi VarroMed Euroopa avaliku hindamisaruande kokkuvõte.
English: People who are hypersensitive (allergic) to formic acid or oxalic acid should give the medicine with caution.
Estonian: Inimesed, kes on sipelghappe või oksaalhappe suhtes ülitundlikud (allergilised), peavad käsitsema seda veterinaarravimit ettevaatusega.
English: How is VarroMed used?
Estonian: Kuidas VarroMedi kasutatakse?
English: The Varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in damage and / or death of bees; the mite can also help spread of viruses and bacteria.
Estonian: Varroalest toitub täiskasvanud mesilaste hemolümfist (verest) ja haudest (meemesilaste arengustaadiumid), põhjustades mesilastele kahju ja/või nende surma.
English: A significant mite infestation can lead to the collapse of a honey bee colony.
Estonian: Ulatuslik nakatumine lestaga võib lõppeda meemesilase koloonia hävinemisega.
English: The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
Estonian: Keeluaeg on alates ravimi manustamisest arvestatav aeg, mille jooksul ei tohi mett tarvitada inimtoiduks.
English: How does VarroMed work?
Estonian: Kuidas VarroMed toimib?
English: VarroMed is a medicine used to treat varroosis in honey bee colonies.
Estonian: VarroMed on meemesilaste kolooniate varroosi raviks kasutatav veterinaarravim.
English: VarroMed is available as a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Estonian: VarroMed on saadaval mesilastaru dispersioonina (mesilastarus kasutatava vedelikuna) ja see on käsimüügiravim.
English: What benefits of VarroMed have been shown in studies?
Estonian: Milles seisneb uuringute põhjal VarroMedi kasulikkus?
English: Protective clothing, acid-resistant gloves and glasses should be worn during treatment.
Estonian: Veterinaarravimi kasutamise ajal tuleb kasutada kaitserõivastust, happekindlaid kindaid ja kaitseprille.
English: VarroMed can be used on colonies with and without brood.
Estonian: VarroMedi võib kasutada haudega ja haudeta kolooniates.
English: VarroMed is trickled onto bees in the brood chamber of the hive.
Estonian: VarroMedi niristatakse mesilastele taru haudekambris.
English: Other information about VarroMed?
Estonian: Muu teave VarroMedi kohta
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vials (multipack)
Estonian: Pakendi suurus viaal (klaasist) 10 ml (3,5 mg/ml) 1 viaal viaal (klaasist) 10 ml (3,5 mg/ml) 2 viaali viaal (klaasist) 10 ml (3,5 mg/ml) 5 (5 x 1) viaali (multipakend)
English: 10 ml (3.5 mg/ml) 1 vial
Estonian: Pakendi sisu (kontsentratsioo n)
English: The referral procedure was initiated on 19 May 2011.
Estonian: Esildismenetlus algas 19. mail 2011.
English: PWS is a genetic disorder.
Estonian: PWS on geneetiline haigus.
English: Puberty development is also delayed and often incomplete.
Estonian: Ka puberteet on hiline ja sageli ebatäielik.
English: Most females with PWS suffer from amenorrhea.
Estonian: Enamikul PWS-iga naistest esineb amenorröa.
English: The latter two may lead to childhood obesity.
Estonian: Viimased kaks võivad viia rasvumise tekkele lapseeas.
English: Grounds for refusal Whereas
Estonian: Keeldumise alused
English: There were no deaths reported.
Estonian: Surmajuhtudest uuringus ei teatatud.
English: The safety profile of somatropin-containing products is well known.
Estonian: Somatropiini sisaldavate ravimite ohutusprofiil on hästi tuntud.
English: The diagnosis is based on a genetic test and on clinical findings.
Estonian: Diagnoos põhineb geneetilisel testimisel ja kliinilisel leiul.
English: Overall, the retrospective data collected were insufficient and of poor quality.
Estonian: Kokkuvõttes olid kogutud retrospektiivsed andmed ebapiisavad ja ebakvaliteetsed.
English: Benefit-Risk
Estonian: Kasulikkuse ja riski suhe
English: One center did not collect body composition data at all and from the other two centers data were only available in 11 children.
Estonian: Üks keskus ei kogunud andmeid kehaehituse kohta üldse ja ülejäänud kahes keskuses olid need andmed olemas üksnes 11 lapse kohta.
English: Another point of concern was the fact that based on the wording of the inclusion criteria it was doubtful whether all patients have been included in the study from the respective centres.
Estonian: Teiseks tekitas muret see, et uuringusse kaasamise kriteeriumi sõnastusest ei selgunud, kas kõik patsiendid kaasati uuringusse vastavatest keskustest.
English: Children with PWS often have concomitant growth hormone deficiency (GHD) (40 to 100%, depending on the provocation test used).
Estonian: PWS-iga lastel esineb sageli ka kasvuhormooni vaegus (40-100% sõltuvalt kasutatud provokatsioonitestist).
English: Scientific conclusions and grounds for refusal presented by the EMA
Estonian: II lisa Euroopa Ravimiameti esitatud teaduslikud järeldused ja keeldumise alused
English: Norditropin was approved in accordance with Article 8(3) of Directive 2001/83/EC.
Estonian: Norditropin on heaks kiidetud direktiivi 2001/83/EÜ artikli 8 lõike 3 alusel.
English: Data from 11 out of 41 children were too scarce to draw any conclusion on this endpoint.
Estonian: 11 lapse andmed 41-st uuringus osalenud lapsest on ilmselgelt liiga vähe, et kõnealuse tulemusnäitaja suhtes midagi järeldada.
English: In the GHLiquid-1961 study forty-one (41) children in Europe with genetically documented PWS were enrolled (19 girls and 22 boys).
Estonian: GHLiquid-1961 uuringus osales Euroopas kokku nelikümmend üks (41) geneetilise testiga tõestatud PWS-iga last (19 tüdrukut ja 22 poissi).
English: No additional information was given by the MAH on the other PWS children for which informed consent was not obtained.
Estonian: Müügiloa hoidja ei esitanud lisateavet teiste PWS-iga laste kohta, kelle puhul ei saadud informeeritud nõusolekut.
English: There was no restriction on the degree of short stature and the children had to be pre-pubertal at start of treatment.
Estonian: Kasvupeetuse astme osas ei olnud piiranguid ja lapsed pidid enne ravi algust olema puberteedieelses eas.
English: The incidence of PWS is 1 in about 10,000 to 29,000 live births.
Estonian: PWS-i esinemissagedus on umbes 1 juht 10 000-29 000 elussünni kohta.
English: • The Committee is of the opinion that the data submitted by the MAH in particular to support efficacy are considered limited since they are derived from a retrospective, observational, noncomparative study.
Estonian: • komitee on arvamusel, et müügiloa hoidja esitatud andmed eelkõige efektiivsuse kohta on piiratud, sest need pärinevad retrospektiivsest, vaatluslikust ja mittevõrdlevast uuringust.
English: Height velocity would also have been a valuable endpoint, however no data are available.
Estonian: Ka kasvu kiirus oleks olnud väärtuslik tulemusnäitaja, aga selle kohta puuduvad andmed.
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 20 April 2011, Denmark triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Estonian: Et viiteliikmesriik ja asjaomased liikmesriigid ei jõudnud muudatuse osas kokkuleppele, algatas Taani ravimiamet 20. aprillil 2011 Euroopa Komisjoni määruse (EÜ) 1234/2008 artikli 13 kohase esildismenetluse.
English: Norditropin contains somatropin which is a human growth hormone produced by recombinant DNA technology that has received marketing authorisation in the European Union through the Mutual Recognition Procedure (MRP).
Estonian: Norditropin sisaldab toimeainena somatropiini, mis on rekombinant-DNA-tehnika abil valmistatud inimese kasvuhormoon, millele on Euroopa Liidus antud müügiluba vastastikuse tunnustamise menetluse kaudu.
English: Safety was assessed by adverse events, HbA1c, IGF-I, haematology, TSH, total T3 and T4, free T3 and T4.
Estonian: Ohutust hinnati kõrvalnähtude, HbA1c sisalduse, IGF-1 sisalduse, hematoloogiliste näitajate, seerumi TSH, seerumi T3 ja T4 üldsisalduse ning seerumi vaba T3 ja T4 sisalduse alusel.
English: In conclusion, the data provided by the MAH in particular to support efficacy are insufficient to sustain the extension of indication in PWS.
Estonian: Kokkuvõttes olid müügiloa hoidja esitatud andmed eelkõige efektiivsuse osas ebapiisavad, et toetada näidustuse laiendamist PWS-i ravile.
English: • The Committee considered the notification of the referral triggered by Denmark under Article 13 of Commission Regulation (EC) No 1234/2008.
Estonian: • komitee arutas Taani ravimiameti algatatud esildismenetlust Euroopa Komisjoni määruse (EÜ) 1234/2008 artikli 13 alusel;
English: The efficacy of Norditropin on key secondary endpoints such as body composition and height velocity is unknown.
Estonian: Norditropini efektiivsus teiseste tulemusnäitajate osas, nagu kehaehitus ja kasvu kiirus, ei ole teada.
English: In order to demonstrate efficacy and safety in the applied indication, the application dossier was based on the study GHLiquid-1961.
Estonian: Taotlustoimikus sisalduvad efektiivsus- ja ohutusandmed pärinesid uuringust GHLiquid-1961.
English: Data on change in height velocity were not considered valid, as data on pre-trial height measurements were incomplete.
Estonian: Andmeid kasvukiiruse muutuse kohta ei peetud usaldusväärseks, sest andmed uuringueelse kasvu mõõtmiste kohta ei olnud täielikud.
English: Only 33 children were included in the primary efficacy analysis and selection bias cannot be excluded due to the design of the study.
Estonian: Esmase tulemusnäitaja analüüsi oli kaasatud üksnes 33 last ja uuringu ülesehitusest tulenevalt ei saa välistada patsientide ebakorrektset valimist uuringusse.
English: The most frequent adverse events were respiratory tract infections which are common in young children (14.6% of children) and scoliosis which is common in PWS (19.5% of children).
Estonian: Kõige sagedamini täheldatud kõrvalnähud olid hingamisteede infektsioonid, mis on väikestel lastel tavalised (14,6%-l lastest), ja skolioos, mis on PWS-i korral sage (19,5%-l lastest).
English: Thirty-three (33.26%) adverse events in 17 (41.5%) children were assessed as probably/possibly related to Norditropin treatment.
Estonian: 33 kõrvalnähu (33,26%) kohta 17 lapsel (41,5%) arvati, et need on tõenäoliselt seotud Norditropiniga.
English: Apart from the aforementioned general deficiency some other aspects of the GHLiquid-1961 study raised concerns to the CHMP namely the validity and the quality of the study results and are summarised below.
Estonian: Nimetatud üldise puuduse kõrval pidas inimravimite komitee probleemseks ka uuringu GHLiquid-1961 muid aspekte, nagu uuringutulemuste valiidsus ja kvaliteet, mida on täpsemalt käsitletud allpool.
English: The mean age at inclusion was 3.8 years (min 0.4 years; max 12.2 years).
Estonian: Laste keskmine vanus uuringusse kaasamise ajal oli 3,8 aastat (mitte alla 0,4 aasta ja mitte üle 12,2 aasta).
English: The data from the study that were submitted with the application of Novo Nordisk to support the proposed indication were not considered sufficient (open-label, non-controlled and retrospective study) and of good quality (wide range of doses used, height measurements incomplete) by the objecting Member States.
Estonian: Novo Nordiski taotletava näidustuse toetuseks esitatud andmeid pidasid muudatusele vastuseisvad liikmesriigid ebapiisavaks (avatud, kontrollita ja retrospektiivne uuring) ja ebakvaliteetseks (lai annuste vahemik, ebatäielikud pikkuse mõõtmised).
English: The number of children with an HSDS above -2 was 19 (46%) children at baseline, 27 (66%) children after 1 year of treatment and 35 (85%) children at last observation.
Estonian: 19 lapsel (46%) oli HSDS lähtetasemel suurem kui -2, pärast 1-aastast ravi oli selliseid lapsi 27 (66%) ja viimasel hindamisel 35 (85%).
English: The quality of the data was also considered questionable given the fact that basic information such as baseline height was missing in 10% of patients.
Estonian: Ka uuringu andmete kvaliteet oli küsitav, kui arvestada asjaolu, et 10% patsientide kohta puudus selline oluline teave nagu lähtekasv.
English: However, the practice of data collection on body composition differed across the three centers.
Estonian: Kehaehituse andmeid koguti aga kolmes uuringukeskuses erinevalt.
English: This was a retrospective, observational, open-label, multicentre, multinational study in children with PWS treated with Norditropin off-label for short stature.
Estonian: See retrospektiivne, vaatluslik, avatud, mitmekeskuseline ja rahvusvaheline uuring viidi läbi PWS-iga lastel, keda raviti kasvupeetuse tõttu ametliku näidustuse väliselt Norditropiniga.
English: All children were Caucasian.
Estonian: Kõik uuringus osalenud lapsed olid europiidsed.
English: The recommended dose is not the same as the one studied in the GHLiquid-1961 which was chosen at the discretion of the physician and was on average 0.03 mg/kg/day.
Estonian: Soovitatav annus ei ole sama, mida kasutati uuringus GHLiquid-1961, kus annus valiti arsti äranägemisel ja oli keskmiselt 0,03 mg/kg kehamassi kohta ööpäevas.
English: On 14 May 2010, the MAH submitted a type II variation via the MRP for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (DK/H/0001/005-007 and 011016/II/078), to request an extension of the indications.
Estonian: 14. mail 2010 esitas müügiloa hoidja Norditropin SimpleXxi, Norditropin Nordiflexi, Norditropin FlexPro ja sarnaste nimetuste vastastikuse tunnustamise menetluse kaudu II tüüpi muudatuse taotluse (DK/H/0001/005-007 ja 011-016/II/078), et laiendada ravimite näidustusi.
English: Hence, 35 of 41 (85%) children with PWS had a height within the reference range for normal children after Norditropin treatment.
Estonian: Seega oli 35-l PWS-iga lapsel 41-st (85%) pärast ravi Norditropiniga kasv normaalsete laste tavapärase kõikumise piires.
English: However, considering requests from some Concerned Member States (CMS) during the CMDh referral, the MAH agreed that the dose recommendation for PWS could be 0.035 mg/kg/day, the same as for the other two GH products approved in the same indication.
Estonian: Samas, võttes arvesse mõnede asjaomaste liikmesriikide tõstatatud küsimusi inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste töörühma (CMDh) esildismenetluse ajal, nõustus müügiloa hoidja, et PWS-i ravi soovitatav annus võiks olla 0,035 mg/kg kehamassi kohta ööpäevas sarnaselt kahele teisele samal näidustusel heakskiidetud kasvuhormooni preparaadile.
English: In addition, accepting the same recommended dose as for other GH products was not considered appropriate as Norditropin has not shown comparable efficacy and those two products have different dose recommendations for other indications, i.e. Turner syndrome and chronic renal disease.
Estonian: Lisaks peeti võrdlust kahe teise kasvuhormooni preparaadi soovitatava annusega kohatuks, sest Norditropini puhul ei ole tõendatud sarnane efektiivsus ning nimetatud ravimite annustamine on teistel näidustustel (näiteks Turneri sündroom ja krooniline neerupuudulikkus) Norditropinist erinev.
English: Sleep apnoea and sudden death have been reported in clinical practice after initiating therapy in patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Estonian: Ravi alustamise järel on kliinilises praktikas teatatud Praderi-Willi sündroomiga patsientide uneapnoest ja äkksurmast järgmiste riskitegurite esinemisel: tõsine rasvumine, ülemiste hingamisteede obstruktsioon või uneapnoe anamneesis või kindlakstegemata hingamisteede infektsioon.
English: In Europe, two recombinant GH products are approved for the treatment of children with PWS.
Estonian: Euroopas on PWS-iga laste raviks heaks kiidetud kaks rekombinantse kasvuhormooni preparaati.
English: IGF-1 SDS at baseline was only available for 28 patients.
Estonian: Lähtetaseme IGF-1 standardhälbe skoor (SDS) oli teada 28 patsiendil.
English: The secondary objectives were to evaluate in the same population the change in HSDS from start of treatment to last observation during Norditropin treatment (referenced to a PWS population), change in body composition (lean body mass and fat mass), height velocity (HV) and change in HV.
Estonian: Teine eesmärk oli hinnata samas patsientide populatsioonis HSDS-i muutust ravi algusest kuni viimase hindamiseni ravi ajal Norditropiniga (võrdluses PWS-i populatsiooniga), kehaehituse muutust (lihasmass ja rasvamass), kasvu kiirust ja kasvu kiiruse muutust.
English: Regarding efficacy on the basis of the available data the CHMP concluded that the demonstration of efficacy for Norditropin in PWS is based on limited and unreliable data of apparent poor quality.
Estonian: Esitatud efektiivsusandmete alusel otsustas inimravimite komitee, et andmed Norditropini efektiivsuse kohta PWS-i ravis on piiratud ja ebausaldusväärsed ning madala kvaliteediga.
English: Regarding safety, no new safety concern emerged from the submitted retrospective data.
Estonian: Ohutuse osas ei ilmnenud esitatud retrospektiivse uuringu andmetest uusi ohutusprobleeme.
English: A total of 128 adverse events were reported in 31 (75.6%) children with PWS during Norditropin exposure (mean exposure 4.1 years, range 0.3 to 9.5 years).
Estonian: 31 PWS-iga lapsel (75,6%) täheldati Norditropini kasutamise ajal (keskmine ekspositsiooniaeg 4,1 aastat, kõikumine 0,3-9,5 aastat) kokku 128 kõrvalnähtu.
English: • The Committee is also of the opinion that the particulars submitted in support of the application to extend the indications of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names do not comply with the requirements of a product authorised on the basis of Article 8(3) of Directive 2001/83/EC.
Estonian: • komitee on samuti arvamusel, et osa andmeid, mis esitati Norditropin SimpleXxi, Norditropin Nordiflexi, Norditropin FlexPro ja sarnaste nimetuste näidustuse laiendamise toetuseks, ei vasta kehtivatele nõuetele ravimite kohta, mis on saanud müügiloa direktiivi 2001/83/EÜ artikli 8 lõike 3 alusel;
English: Short stature, mental retardation, behavioural problems, hormonal dysfunctions, poor muscle tone and hyperphagia as well as hypoactivity are among its features.
Estonian: Antud sündroomile iseloomulikud nähud on kasvupeetus, vaimse arengu peetus, käitumisprobleemid, hormonaalsed häired, nõrk lihastoonus ja ülemäärane söögiisu (hüperfaagia) ning vähene aktiivsus (hüpoaktiivsus).
English: The actual lean body mass percentage was 61.8% at baseline, 71.9% at Year 1 and 72.9% at last observation.
Estonian: Keha lihasmassi protsent lähtetasemel oli 61,8%, pärast 1-aastast ravi 71,9% ja viimasel hindamisel 72,9%.
English: Taking into consideration the above mentioned data, the CHMP concluded that the provided study GHLiquid-1961 forming the basis for the application to extend the indication for Norditropin in children with PWS was uncontrolled, open-label and retrospective and not in accordance with the methodological standards for pivotal evidence.
Estonian: Ülaltoodud andmeid aluseks võttes järeldas inimravimite komitee, et Norditropini näidustuse laiendamise taotluse aluseks olev uuring GHLiquid-1961 PWS-iga lastel oli kontrollita, avatud ja retrospektiivne uuring, mis ei vasta otsustava tähtsusega tõendusmaterjali metodoloogilistele standarditele.