FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore concluded that, as Glimepirida Parke-Davis 2, 3 and 4 mg strengths are bioequivalent to the reference medicine, marketing authorisation should be granted in the concerned Member States.
Estonian: Inimravimite komitee otsustas, et Glimepirida Parke-Davise 2, 3 ja 4 mg tugevused on bioekvivalentsed võrdlusravimi tugevustega, ja soovitas anda asjaomastes liikmesriikides ravimi müügiloa.
English: The grounds for the referral were concerns over the approach used to demonstrate that Glimepirida Parke-Davis 2, 3 and 4 mg are ‘bioequivalent' to Amaryl at the corresponding doses.
Estonian: Esildise aluseks olid probleemid meetodiga, mida kasutati näitamaks, et Glimepirida Parke-Davise 2, 3 ja 4 mg annused on bioekvivalentsed Amaryli vastavate annustega.
English: Although the Member States agreed that 1 mg Glimepirida Parke-Davis was bioequivalent to 1 mg Amaryl, concerns remained over whether a bioequivalence study should have been carried out with the highest strength, 4 mg, to show bioequivalence for Glimepirida Parke-Davis 2, 3 and 4 mg with Amaryl at the corresponding doses.
Estonian: Kuigi liikmesriigid nõustusid, et 1 mg Glimepirida Parke-Davis oli bioekvivalentne 1 mg Amaryliga, tõstatus
English: List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Estonian: Toote nimetuste, ravimvormide, tugevuste, manustamisviiside ja müügiloahoidjate nimekiri liikmesriikides
English: not less than 103.7 CCID50
Estonian: mitte vähem kui 103,7 CCID50
English: * Strength applicable for all countries After reconstitution, 1 dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain)
Estonian: * Annuse tugevus kehtib kõigile riikidele Pärast manustamiskõlblikkuks muutmist sisaldab 1 annus (0,5ml): Nõrgestatud leetrite viirust (Schwarzi tüvi)
English: GSK d.o.o., Ljubljana, Knezov štradon 90, 1000 Ljubljana
Estonian: GSK d.o.o., Ljubljana, Knezov štradon 90, 1000 Ljubljana Slovenia
English: not less than 103.0 CCID50
Estonian: mitte vähem kui 103,0 CCID50
English: United Kingdom SmithKline Beecham plc 980 Great West Road,
Estonian: Ühendkuningriik SmithKline Beecham plc 980 Great West Road,
English: Live attenuated rubella virus (Wistar RA 27/3 strain)
Estonian: Nõrgestatud punetiste viirust (Wistar RA 27/3 tüvi)
English: GlaxoSmithKline AB, Box 516, 169 29 Solna Sweden
Estonian: GlaxoSmithKline AB, Box 516, 169 29 Solna
English: Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain)
Estonian: Nõrgestatud mumpsiviirust (RIT 4385 tüvi, arendatud Jeryl Lynn'i tüvest)
English: Goštauto 40A LT-01112, Vilnius Lithuania
Estonian: LT-01112, Vilnius Lithuania
English: 9GS
Estonian: KG
English: Brentford, Middlesex TW8
Estonian: Brentford, Middlesex TW8 9GS United Kingdom
English: GlaxoSmithKline GmbH & Co. KG
Estonian: GlaxoSmithKline GmbH & Co.
English: Albert Schweitzer-Gasse 6 A-1140 Wien
Estonian: GlaxoSmithKline Pharma GmbH Albert Schweitzer-Gasse 6 A-1140 Wien
English: Czech Republic GlaxoSmithKline Biologicals s.a.
Estonian: Tšehhi Vabariik GlaxoSmithKline Biologicals s.a.
English: GlaxoSmithKline Pharma A/S
Estonian: GlaxoSmithKline Pharma A/S Nykær 68
English: UAB „GlaxoSmithKline Lietuva“
Estonian: UAB „GlaxoSmithKline Lietuva“ Goštauto 40A
English: Measles, mumps, and rubella vaccine (live)
Estonian: Priorix powder and solvent for solution for injection in a prefilled syringe Measles, mumps, and rubella vaccine (live)
English: Subcutaneous use
Estonian: Subkutaanne
English: This summary was last updated in 05-2011.
Estonian: Kokkuvõtte viimane uuendus: 05-2011
English: The full EPAR for Ovitrelle can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ovitrelle kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ovitrelle on 2 February 2001.
Estonian: Euroopa Komisjon andis Ovitrelle müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 2. veebruaril
English: The patient or their partner may carry out the injection if they have been trained and have access to expert advice.
Estonian: Patsient või tema partner võivad ravimit ise süstida, kui nad on saanud vastava väljaõppe ja kui neil on võimalik asjatundjalt nõu küsida.
English: Other information about Ovitrelle
Estonian: Muu teave Ovitrelle kohta
English: One study was also carried out in women who could not ovulate.
Estonian: Üks uuring tehti naistel, kellel ei esine ovulatsiooni.
English: Ovitrelle has mainly been studied in women undergoing fertility treatment (1,140 patients).
Estonian: Ovitrellet on peamiselt uuritud viljakusravi saavatel naistel (1140 patsienti).
English: The CHMP decided that Ovitrelle's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Ovitrelle kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: It must not be used when a response cannot be obtained (such as in ovarian failure).
Estonian: Seda ei tohi kasutada, kui ravivastust ei saavutata (nt munasarja puudulikkuse korral).
English: The most common side effects with Ovitrelle (seen in between 1 and 10 patients in 100) are reactions at the injection site, headache, tiredness, vomiting, nausea (feeling sick), abdominal pain (stomach ache) and ovarian hyperstimulation syndrome (such as feeling sick, weight gain and diarrhoea).
Estonian: Ovitrelle kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on reaktsioon süstekohas, peavalu, väsimus, oksendamine, iiveldus, kõhuvalu ja munasarjade hüperstimulatsiooni sündroom (st iiveldus, kaalutõus, kõhulahtisus).
English: Ovarian hyperstimulation syndrome occurs when the ovaries over respond to treatment, especially when medicines to trigger ovulation have been used.
Estonian: Munasarjade hüperstimulatsiooni sündroom tekib, kui munasarjad reageerivad ravile üliaktiivselt, eriti kui on kasutatud ovulatsiooni tekitavaid ravimeid.
English: Ovitrelle was as effective as urinary hCG in triggering ovulation, and the 250-microgram dose of Ovitrelle was as effective as the 500-microgram dose.
Estonian: Ovitrelle oli ovulatsiooni vallandamisel sama efektiivne kui uriinis esinev hCG ning 250 µg annus oli sama efektiivne kui 500 µg annus.
English: For more information about treatment with Ovitrelle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ovitrellega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Ovitrelle.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Ovitrelle is a medicine that contains the active substance choriogonadotropin alfa.
Estonian: Ovitrelle on ravim, mis sisaldab toimeainena alfakooriongonadotropiini.
English: What is Ovitrelle?
Estonian: Mis on Ovitrelle?
English: EPAR summary for the public choriogonadotropin alfa
Estonian: Kokkuvõte üldsusele alfakooriongonadotropiin
English: A dose of 250 micrograms is given 24 to 48 hours after the ovaries have produced follicles that are mature enough (eggs ready for ovulation).
Estonian: Üks annus Ovitrellet (250 µg) manustatakse 24-48 tundi pärast seda, kui munasarjas on moodustunud piisavalt küpsed folliikulid (ovulatsiooniks valmis munarakud).
English: This is a summary of the European public assessment report (EPAR) for Ovitrelle.
Estonian: Käesolev dokument on ravimi Ovitrelle Euroopa avaliku hindamisaruande kokkuvõte.
English: In anovulatory women, ovulation was seen in 92% of the women treated with Ovitrelle.
Estonian: Anovulatoorsetel naistel tekkis Ovitrelle ravi tagajärjel ovulatsioon 92% juhtudest.
English: Because of its similarity to luteinising hormone (LH), Ovitrelle is also used to trigger ovulation.
Estonian: Et Ovitrelle sarnaneb luteiniseerivale hormoonile (LH), kasutatakse ravimit ka ovulatsiooni vallandamiseks.
English: Why has Ovitrelle been approved?
Estonian: Miks Ovitrelle heaks kiideti?
English: In women undergoing fertility treatment, this is generally 24 to 48 hours after stopping treatment to stimulate the ovaries (such as a follicle stimulating hormone [FSH] or human menopausal gonadotrophin [hMG] preparation).
Estonian: Viljakusravi saavatel naistel toimub see tavaliselt 24-48 tundi pärast munasarjasid stimuleeriva ravi lõppu (nt ravi folliikuleid stimuleerivat hormooni (FSH) või inimese menopausaalset gonadotropiini (hMG) sisaldavate preparaatidega).
English: It can be used in women who are undergoing fertility treatment (such as in vitro fertilisation), and in women who are anovulatory (do not produce eggs) or oligo ovulatory (rarely produce eggs).
Estonian: Seda tohib kasutada naistel, kes saavad viljakusravi (assisteeriv reproduktiivtehnika, nt in vitro viljastamine), ning naistel, kellel ovulatsiooni ei esine (munarakke ei moodustu) või kes on oligoovulatoorsed (munarakud moodustuvad harva).
English: It must not be used in women with ovarian enlargement or cysts not due to polycystic ovarian disease, unexplained vaginal bleeding, or who have had an ectopic pregnancy (a pregnancy that develops outside the womb) in the previous three months.
Estonian: Ravimit ei tohi kasutada naistel, kellel on munasarjade laienemine või tsüstid, mis ei ole tingitud munasarja polütsüstilisest haigusest, seletamatu tupeverejooks või kellel on viimase kolme kuu jooksul olnud emakaväline rasedus.
English: It must not be used in patients with tumours of the hypothalamus, pituitary gland, ovary, womb or breast.
Estonian: Ovitrellet ei tohi kasutada patsiendid, kellel on hüpotalamuse-, hüpofüüsi (ajuripatsi-), munasarja-, emaka- või rinnanäärmekasvaja.
English: Ovitrelle is used in women who have received treatment to stimulate their ovaries, to trigger ovulation (the release of eggs by the ovaries) and the development of a special structure on the ovary (the corpus luteum) that helps pregnancy.
Estonian: Ovitrellet kasutatakse munasarju stimuleerivat ravi saanud naiste ravimiseks, et vallandada ovulatsiooni (munarakkude vabanemist munasarjast) ja tekitada teatav struktuur munasarjades (corpus luteum), mis aitab kaasa rasestumisele.
English: Ovitrelle should not be used in people who may be hypersensitive (allergic) to choriogonadotropin alfa or any of the other ingredients.
Estonian: Ovitrellet ei tohi kasutada patsiendid, kes võivad olla alfakooriongonadotropiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: What benefit has Ovitrelle shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ovitrelle kasulikkus?
English: Ovitrelle must also not be used in patients with active thromboembolic disorders (problems with blood clotting).
Estonian: Ovitrellet ei tohi kasutada tromboemboolia häiretega (verehüübehäired) patsientidel.
English: Treatment with Ovitrelle should be carried out under the supervision of a doctor who has experience in the treatment of fertility problems.
Estonian: Ravi Ovitrellega võib läbi viia üksnes viljatusravis kogenud arsti järelevalve all.
English: The choriogonadotropin alfa in Ovitrelle is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes cell able to produce it.
Estonian: Ovitrelles sisalduvat alfakooriongonadotropiini valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud alfakooriongonadotropiini tekkimist võimaldav geen (DNA).
English: What is the risk associated with Ovitrelle?
Estonian: Mis riskid Ovitrellega kaasnevad?
English: The active substance in Ovitrelle, choriogonadotropin alfa, is a copy of the natural hormone human chorionic gonadotropin (hCG), also known as the ‘pregnancy' hormone, which helps to maintain pregnancy.
Estonian: Ovitrelle toimeaine alfakooriongonadotropiin on identne inimese organismis leiduva kooriongonadotropiiniga (hCG) ehk nn rasedushormooniga, mis aitab säilitada rasedust.
English: It is available as a powder and solvent to be made up into a solution for injection and as a solution in a pre-filled syringe or pre-filled pen.
Estonian: Seda turustatakse süstelahuse pulbri ja lahustina, ja ühekordselt kasutatava süstelahusena eeltäidetud süstaldes või eeltäidetud pensüstaldes.
English: How does Ovitrelle work?
Estonian: Kuidas Ovitrelle toimib?
English: How is Ovitrelle used?
Estonian: Kuidas Ovitrellet kasutatakse?
English: What is Ovitrelle used for?
Estonian: Milleks Ovitrellet kasutatakse?
English: Ovitrelle (250 micrograms or 500 micrograms) was compared with the natural hCG hormone that had been extracted from urine.
Estonian: Ovitrellet (250 mg või 500 mg) võrreldi uriinist eraldatud inimese loomuliku hCG-ga. Ovitrelle efektiivsust mõõdeti selle põhjal, kui palju munarakke munasarjadest vabanes.
English: How has Ovitrelle been studied?
Estonian: Kuidas Ovitrellet uuriti?
English: Ovitrelle is given by injection under the skin.
Estonian: Ovitrellet manustatakse nahaaluse süstina.
English: Virulent means that the virus is capable of producing severe disease.
Estonian: Virulentne tähendab, et viirus võib põhjustada rasket haigust.
English: Further information on Gumbohatch can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/gumbohatch.
Estonian: Lisateave Gumbohatchi kohta on ameti veebilehel: ema.europa.eu/medicines/veterinary/EPAR/gumbohatch.
English: The European Medicines Agency decided that Gumbohatch's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Gumbohatchi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise saab Euroopa Liidus heaks kiita.
English: Gumbohatch was investigated in 5 laboratory and 3 field studies.
Estonian: Gumbohatchi uuriti 5 laboriuuringus ja 3 väliuuringus.
English: Hands and equipment should be washed and disinfected after use of the vaccine.
Estonian: Käed ja vaktsiini manustamise vahendid tuleb pärast vaktsineerimist pesta ja desinfitseerida.
English: Gumbohatch received a marketing authorisation valid throughout the EU on 12 November 2019.
Estonian: Gumbohatchi müügiluba, mis kehtib kogu Euroopa Liidus, anti 12/11/2019.
English: Studies have shown the start of protection to be from between 24 days of age and 28 days of age.
Estonian: Uuringutes on selgunud, et kaitse tekib 24.-28. elupäeval.
English: Protection against IBD starts from between 24 to 28 days of age and lasts up to 43 days of age.
Estonian: IBD-vastane kaitse tekib 24.28. elupäeval ja kestab 43. elupäevani.
English: It is also the time required after administration of a medicine before eggs may be used for human consumption.
Estonian: See on ka aeg, mis peab ravimi manustamisest mööduma, enne kui mune tohib inimtoiduks tarvitada.
English: After handling vaccinated birds or their litter, hands should be washed and disinfected because the virus is excreted by vaccinated birds for up to 3 weeks.
Estonian: Pärast vaktsineeritud lindude või nende allapanu käsitsemist tuleb käed pesta ja desinfitseerida, sest vaktsineeritud linnud võivad eritada viirust kuni 3 nädalat pärast vaktsineerimist.
English: Other information about Gumbohatch
Estonian: Muu teave Gumbohatchi kohta
English: Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a specific disease.
Estonian: Vaktsiinid valmistavad immuunsüsteemi (organismi looduslikud kaitsemehhanismid) ette kaitsma organismi konkreetse haiguse eest.
English: This overview was last updated in September 2019.
Estonian: Kokkuvõtte viimane uuendus: 09-2018.
English: The start of protection depends on the initial maternal antibody level of the batch of chickens and even then will be different for individual chickens.
Estonian: Kaitse teke sõltub kanade maternaalsete antikehade tasemest ja võib olla eri kanadel erinev.
English: What is Gumbohatch and what is it used for?
Estonian: Mis on Gumbohatch ja milleks seda kasutatakse?
English: Signs of chickens infected with Gumboro disease include trembling, ruffled feathers, poor appetite, dehydration, diarrhoea, huddling and depression.
Estonian: Gumboro haigusega nakatunud kanade sümptomid on muu hulgas värisemine, turris suled, isutus, dehüdratsioon, kõhulahtisus, kobarasse kogunemine ja depressioon.
English: This loss of lymphocytes does not cause immunosuppression in the chickens.
Estonian: Lümfotsüütide sisalduse vähenemine ei põhjusta kanadel immunosupressiooni.
English: When the chicken comes into contact with a similar IBD virus, these antibodies, together with other components of the chicken's immune system, will be able to fight the infection and help protect it against the disease.
Estonian: Kui kana puutub sarnase IBD-viirusega hiljem uuesti kokku, võitlevad antikehad ja immuunsüsteemi muud komponendid viiruse vastu ning aitavad kaitsta organismi haiguse eest.
English: For more information about using Gumbohatch, see the package leaflet or contact your veterinarian or pharmacist.
Estonian: Kui vajate Gumbohatchiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte või pöörduge oma veterinaararsti või apteekri poole.
English: The most common side effect with Gumbohatch (which may affect more than 1 in 10 animals) is a fall in the number of lymphocytes (a type of white blood cell which is part of the chicken's immune system) in the bursa of Fabricius, followed by an increase and recovery of the bursa of Fabricius.
Estonian: Gumbohatchi kõige sagedam kõrvalnäht (võib esineda enam kui 1 loomal 10st) on lümfotsüütide (teatud valgelibled, mis on kanade immuunsüsteemi osa) sisalduse vähenemine kloaagipaunas, millele järgneb sisalduse suurenemine ja kloaagipauna taastumine.
English: IBD, also known as Gumboro disease, is a highly contagious (spreads easily) viral infection of young chickens that reduces their immunity (body's ability to fight disease) and can lead to their death at 3 to 6 weeks of age.
Estonian: IBD ehk Gumboro haigus on noorkanade väga nakkav (kergesti leviv) viirusinfektsioon, mis nõrgestab nende immuunsüsteemi (organismi võimet haiguse vastu võidelda) ja võib põhjustada nende surma 36 nädala vanuses.
English: Gumbohatch contains a live strain of IBD virus (strain 1052) that has been weakened so that it does not cause the disease.
Estonian: Gumbohatch sisaldab IBD-viiruse elustüve (tüvi 1052), mis on nõrgestatud, nii et see ei põhjusta haigust.
English: The withdrawal period for meat and eggs from chickens treated with Gumbohatch is ‘zero' days, which means that there is no mandatory waiting time.
Estonian: Vaktsiiniga Gumbohatch ravitud kanade liha ja munade keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
English: Gumbohatch is a vaccine.
Estonian: Gumbohatch on vaktsiin.
English: Gumbohatch is a vaccine used to protect broiler chickens (reared for meat) against infectious bursal disease (IBD) virus infection caused by a very virulent IBD virus.
Estonian: Gumbohatch on vaktsiin, mida kasutatakse broilerite (lihakanade) kaitsmiseks lindude nakkava bursiidi (IBD) viirusinfektsiooni eest, mida põhjustab väga virulentne IBD-viirus.
English: The vaccine can be given to one-day-old chicks as a single injection under the skin or directly into 18day-old chicken eggs containing embryos (unhatched developing chicks).
Estonian: Vaktsiini tohib manustada ühepäevastele tibudele ühekordse subkutaanse süstena või otse 18päevastesse lootega kanamunadesse.
English: Gumbohatch contains small amounts of weakened IBD virus attached to antibodies.
Estonian: Gumbohatch sisaldab väikeses koguses nõrgestatud IBD-viirust, mis on seondunud antikehadega.
English: Gumbohatch (infectious bursal disease vaccine live attenuated)
Estonian: Gumbohatch (lindude nakkava bursiidi nõrgestatud elusvaktsiin)
English: An overview of Gumbohatch and why it is authorised in the EU
Estonian: Gumbohatchi ülevaade ja Euroopa Liidus heakskiitmise põhjused
English: How does Gumbohatch work?
Estonian: Kuidas Gumbohatch toimib?
English: What are the risks associated with Gumbohatch?
Estonian: Mis riskid Gumbohatchiga kaasnevad?
English: How is Gumbohatch used?
Estonian: Kuidas Gumbohatchi kasutatakse?
English: When a chick or chicken egg is given the vaccine, the immune system recognises the weakened virus in the vaccine as ‘foreign' and makes its own antibodies against the virus.
Estonian: Kui kanale või kanamunasse manustatakse vaktsiini, peab immuunsüsteem nõrgestatud viirust võõraks ja tekitab selle vastu antikehi.
English: The laboratory studies involved chicks with maternal antibodies against IBD virus.
Estonian: Laboriuuringutes uuriti IBD-viiruse vastaste maternaalsete antikehadega tibusid.
English: Gumbohatch must not be used in flocks without maternal antibodies against IBD virus.
Estonian: Gumbohatchi ei tohi kasutada linnukarjadel, kellel puuduvad IBD-viiruse vastased maternaalsed antikehad.
English: The studies showed Gumbohatch to reduce clinical signs and damage to the bursa of Fabricius caused by very virulent (powerful) IBD virus infection, following vaccination of eggs or chicks.
Estonian: Uuringutes selgus, et pärast munade või tibude vaktsineerimist vähendab Gumbohatch väga virulentse (tugevatoimelise) IBD-viirusinfektsiooni põhjustatavaid kliinilisi sümptomeid ja kloaagipauna kahjustusi.
English: The vaccine should be used only in flocks that are known to have maternal antibodies (transmitted from the mother) against IBD virus.
Estonian: Vaktsiini tuleb kasutada üksnes sellistel karjadel, millel on teadaolevalt olemas IBD-viiruse vastased maternaalsed antikehad.
English: The vaccine reduces signs of the disease and damage to the bursa of Fabricius, an organ only present in birds which is part of their immune system.
Estonian: Kloaagipaun on ainult lindudel esinev elund ja lindude immuunsüsteemi osa.
English: What benefits of Gumbohatch have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Gumbohatchi kasulikkus?
English: Gumbohatch is available as a freeze dried powder (lyophilisate) and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Estonian: Gumbohatchi turustatakse süstesuspensiooni lüofilisaadina (külmkuivatatud pulbrina) ja lahustina.
English: Why is Gumbohatch authorised in the EU?
Estonian: Gumbohatchi Euroopa Liidus heakskiitmise põhjused
English: On 28 January 2011, France triggered a referral under Article 31 of Directive 2001/83/EC, as amended.
Estonian: 18. jaanuaril 2011 algatas Prantsusmaa muudetud direktiivi 2001/83/EÜ artikli 31 kohaselt esildise.
English: Conclusion and recommendations
Estonian: Järeldused ja soovitused
English: The draft protocol of the study should be submitted to CHMP within 3 months of the Commission Decision.
Estonian: Uuringuprotokolli kava tuleb esitada inimravimite komiteele 3 kuu jooksul pärast Euroopa Komisjoni otsust.
English: Scientific discussion
Estonian: Teaduslik arutelu
English: 3 Johansson SGO et al. Pholcodine caused anaphylaxis in Sweden 30 years ago.
Estonian: Johansson SGO and al. Pholcodine caused anaphylaxis in Sweden 30 years ago.
English: The published data refers mainly to Norway and Sweden, where pholcodine is no longer marketed.
Estonian: Avaldatud andmed pärinevad eelkõige Norrast ja Rootsist, kus folkodiini enam ei turustata.
English: While the data from Sweden and Norway appear to be consistent, other factors can explain the observations.
Estonian: Ehkki Rootsi ja Norra andmed langevad kokku, võivad neid leide selgitada ka muud tegurid.