FrancophonIA/ELRC3.0 huggingface dataset:
English: No effects on human fertility are anticipated, since the systemic exposure is negligible.
Estonian: Ei ole oodata toimet inimeste fertiilsusele, sest süsteemne ekspositsioon on tühine.
English: In the Grade 2a burn wound study an octenidine containing antiseptic wound gel and fatty gauze dressing were used as control.
Estonian: 2a astme põletuste uuringus kasutati kontrollravimina oktenidiini sisaldavat antiseptilist haavageeli ja kreemiga immutatud marlisidet.
English: Warnings and precautions Talk to your doctor or nurse before using Episalvan.
Estonian: Hoiatused ja ettevaatusabinõud Enne Episalvani kasutamist pidage nõu oma arsti või meditsiiniõega.
English: There is no clinical experience from use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers, venous leg ulcers or wounds in patients with epidermolysis bullosa.
Estonian: Puudub kliiniline kogemus Episalvani kasutamise kohta krooniliste haavade ravis, nt diabeetiliste jalahaavandite, venoossete jalahaavandite või bulloosepidermolüüsiga patsientide haavade ravis.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
Estonian: MANUSTAMISVIIS JA -TEE(D) Kutaanne.
English: Sunflower oil, refined.
Estonian: Rafineeritud päevalilleõli.
English: • Re-apply the gel each time the dressing is changed, until the wound is healed.
Estonian: • Kandke geeli haavale igal haavasideme vahetamise korral, kuni haav on paranenud.
English: In the Grade 2a burn wound study, the mean wound size treated with Episalvan was 108 cm² (range 23-395 cm²).
Estonian: IIa astme põletushaavade uuringus oli Episalvaniga ravitud haavade keskmine suurus 108 cm² (vahemik 23-395 cm²).
English: The 219 patients with split-thickness skin graft donor site wounds had a mean age of 53 years; their donor site mean wound size was 81.5 cm2.
Estonian: Osalise nahasiiriku doonori haavakohtadega 219 patsiendi keskmine vanus oli 53 aastat, nende nahasiirikute haavade keskmine suurus oli 81,5 cm2.
English: NAME OF THE MEDICINAL PRODUCT Episalvan gel
Estonian: RAVIMPREPARAADI NIMETUS Episalvan geel
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Estonian: Kui teil on lisaküsimusi selle ravimi kasutamise kohta, küsige nõu oma arstilt või meditsiiniõelt.
English: Do not stop using it without consulting your doctor or nurse.
Estonian: Ärge lõpetage Episalvani kasutamist arsti või meditsiiniõega nõu pidamata.
English: No data are available on possible interaction between Episalvan and other medicines applied to the skin.
Estonian: Episalvani ja teiste nahale kantavate ravimite vaheliste koostoimete kohta andmed puuduvad.
English: See section 4.4 and 5.1 with respect to type of wounds studied.
Estonian: Uuritud haavade tüüpe vt lõigud 4.4 ja 5.1.
English: The tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap.
Estonian: Tuubid on suletud läbitorgatava alumiiniummembraaniga ja valge polüpropüleenist keeratava korgiga.
English: There is no experience of the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg ulcers.
Estonian: Puuduvad kogemused Episalvani kasutamise kohta krooniliste haavade, nt diabeetiliste jalahaavandite või venoossete jalahaavandite raviks.
English: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Episalvan is negligible.
Estonian: Toimeid rinnapiima saavale vastsündinule/imikule ei ole oodata, sest imetava ema süsteemne ekspositsioon Episalvanile on tühine.
English: Other wound types
Estonian: Teised haavatüübid
English: Wound complication* * Wound complication comprises different kinds of local complications such as post-procedural complications, wound necrosis, wound secretion, impaired healing, or inflammation of wound.
Estonian: * Haavatüsistuste hulka kuuluvad erinevad paiksed tüsistused, nagu protseduurijärgsed tüsistused, haavanekroos, haavasekretsioon, hilinenud paranemine või haavapõletik.
English: No formal studies have been conducted with Episalvan in patients with renal or hepatic impairment.
Estonian: Vormikohaseid uuringuid Episalvaniga ei ole neeru- või maksakahjustusega patsientidel läbi viidud.
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment, see section 5.2.
Estonian: Neeru- või maksakahjustusega patsientidel ei ole annuste kohandamine ega erinõuded vajalikud (vt lõik 5.2).
English: It is not known whether Episalvan passes into human breast milk, but since the absorption of this medicine into the body is minimal, the risk to the baby is negligible.
Estonian: Ei ole teada, kas Episalvan eritub rinnapiima ja et seda ravimit imendub organismi väga vähe, on risk lapsele tühine.
English: (pooled)
Estonian: NN: {number}>
English: as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
Estonian: 'ilt ning mõlema liigi hübriididelt (ekvivalentne 0,5…1,0 g kasetohuga), mis vastab 72-88 mg betuliinile.
English: If your wound shows no signs of improvement over time, talk to your doctor or nurse.
Estonian: Kui teie haav ei näita paranemisnähte, rääkige sellest oma arsti või meditsiiniõega.
English: Interactions with topical products have not been investigated in clinical trials.
Estonian: Kliinilistes uuringutes ei ole koostoimeid paiksete ravimitega uuritud.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Episalvan in one or more subsets of the paediatric population for the treatment of skin injuries.
Estonian: Euroopa Ravimiamet on peatanud kohustuse esitada Episalvaniga läbi viidud uuringute tulemused laste ühe või mitme alarühma kohta nahavigastuste ravi korral (teave lastel kasutamise kohta: vt lõik 4.2).
English: See section 4.4 with respect to wound size and duration of treatment.
Estonian: Haava suuruse ja ravi kestuse kohta vt lõik 4.4.
English: Skin and subcutaneous tissue disorders
Estonian: Naha ja nahaaluskoe kahjustused Nahavalu
English: The gel should be applied to the wound surface at a thickness of approximately 1 mm and covered by sterile wound dressing.
Estonian: Geel tuleb kanda haava pinnale umbes 1 mm paksuselt ja katta steriilse haavasidemega.
English: The gel should be re-applied at each wound dressing change, until the wound is healed, for up to 4 weeks.
Estonian: Geeli tuleb kuni 4 nädala jooksul igal sideme vahetamisel uuesti haavale kanda, kuni haav paraneb.
English: Uncommon side effects (may affect up to 1 in 100 people): - wound infection - allergic reaction (hypersensitivity) - skin irritation (dermatitis) - itchy rash - purple coloured rash - pain
Estonian: Aeg-ajalt esinevad kõrvaltoimed (võivad tekkida kuni 1 inimesel 100-st): - haavainfektsioon, - allergiline reaktsioon (ülitundlikkus), - nahaärritus (dermatiit), - sügelev lööve, - lillavärviline lööve, - valu.
English: Episalvan gel is a herbal medicinal product which contains dry extract from birch bark.
Estonian: Episalvani geel on taimne ravim, mis sisaldab kasetohu kuivekstrakti.
English: How to use Episalvan
Estonian: Kuidas Episalvani kasutada
English: Adverse reactions were administration site reactions only.
Estonian: Kõrvaltoimed olid ainult manustamiskoha kõrvaltoimed.
English: ‘Less conservative calculation' differs from the ‘very conservative calculation' in one aspect: If wound closure was not observed in a wound half photo series, it was calculated to have occurred not one day, but approximately 3 days later (the mean time interval between wound dressing changes in the studies).
Estonian: Kui haavapoole fotoseerias ei täheldatud haava sulgumist, märgiti, et see toimus mitte 1, vaid ligikaudu 3 päeva hiljem (uuringutes keskmine periood haavasidemete vahetamise vahel).
English: 1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula, Betula pubescens as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
Estonian: 1 g geeli sisaldab: 100 mg kasetohuekstrakti (rafineeritud kuivekstraktina), mis pärineb Betula pendula'lt, Betula pubescens'ilt ning mõlema liigi hübriididelt (ekvivalentne 0,5…1,0 g kasetohuga), mis vastab 72-88 mg betuliinile.
English: Driving and using machines Your ability to drive and use machines will not be affected by this medicine.
Estonian: Autojuhtimine ja masinatega töötamine Episalvan ei mõjuta autojuhtimise ega masinate käsitsemise võimet.
English: The primary endpoint for the two split-thickness skin graft trials was the intra-individual difference in time to wound closure (at least 95% epithelialisation) based on blinded photo evaluations.
Estonian: Kahe osalise nahasiiriku haavade uuringu esmane tulemusnäitaja fotode pimemeetodil hindamiste alusel oli isikusisene erinevus haava sulgumise (epitelisatsioon vähemalt 95%) ajas.
English: Partial thickness burn wounds
Estonian: Pindmised põletushaavad
English: No studies have been done on the effects of Episalvan on pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the unborn baby is negligible.
Estonian: Uuringuid Episalvani toime kohta rasedatele ei ole läbi viidud ja et seda ravimit imendub organismi väga vähe, on risk lootele tühine.
English: Colourless to slightly yellowish, opalescent.
Estonian: Värvitu kuni kergelt kollakas, hägune.
English: How to store Episalvan
Estonian: Kuidas Episalvani säilitada
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax+49 (0) 7233 9749 - 210
Estonian: Tel +49 (0) 723 397 490
English: White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and with a sealing compound in the fold.
Estonian: Valge kokkusurutav alumiiniumtuub, sisekülg lakitud epoksüfenoolkattega ja tuubi otsa sulgemiseks on kasutatud tihendusainet.
English: Breast-feeding No data are available to evaluate whether Episalvan is excreted into human milk.
Estonian: Imetamine Puuduvad andmed Episalvani eritumise kohta inimese rinnapiima.
English: Birch pollen allergy
Estonian: Kaseõietolmu allergia
English: -1.0 days (CI: -1.4, -0.6) faster wound closure with Episalvan, p<0.0001a
Estonian: -1,0 päeva (usaldusvahemik: -1,4,0,6) kiirem haava sulgumine Episalvaniga, p < 0,0001a a Põhineb kahepoolsel paaris t-testil
English: Episalvan gel is administered topically to skin wounds and shows poor absorbtion.
Estonian: Episalvani geeli manustatakse paikselt nahahaavadele ja see imendub halvasti.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, local tolerance, and phototoxicity.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, paikse talutavuse ja fototoksilisuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1g gel contains: 100 mg birch bark extract (as dry extract, refined) from Betula pendula/Betula pubescens, corresponding to 72-88 mg betulin.
Estonian: 1 g geeli sisaldab: 100 mg kasetohuekstrakti (rafineeritud kuivekstraktina) Betula pendula'lt / Betula pubescens'ilt, vastab 72…88 mg betuliinile.
English: What Episalvan is and what it is used for 2.
Estonian: 1. Mis ravim on Episalvan ja milleks seda kasutatakse 2. Mida on vaja teada enne Episalvani kasutamist 3.
English: Episalvan plus wound dressing was applied to half of the wound area, and the same kind of non-adhesive wound dressing alone was applied to the other half as the control in the split-thickness skin graft donor site studies.
Estonian: Osalise nahasiiriku doonori haavakohtade uuringutes kasutati haava ühel poolel Episalvani koos haavasidemega ja teisel poolel üksnes sama liiki mittekleepuvat haavasidet.
English: No data have been generated to study the effect of accidental ingestion of Episalvan.
Estonian: Episalvani juhusliku allaneelamise uurimiseks ei ole andmeid genereeritud.
English: LIST OF EXCIPIENTS Excipient: Sunflower oil.
Estonian: ABIAINED Abiaine: rafineeritud päevalilleõli.
English: Episalvan gel Birch bark extract
Estonian: Episalvan geel Kasetohuekstrakt
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Estonian: B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD C. MÜÜGILOA MUUD TINGIMUSED JA NÕUDED D. RAVIMPREPARAADI OHUTU JA EFEKTIIVSE KASUTAMISE
English: No studies have been performed to establish whether Episalvan will interact with other medicines.
Estonian: Episalvani koostoimete kohta teiste ravimitega ei ole uuringuid läbi viidud.
English: The vaccine was generally well tolerated and shown to be safe.
Estonian: Loomad talusid vaktsiini üldiselt hästi ning tõestati, et see oli neile ohutu.
English: The vaccine is given just behind the ear.
Estonian: Vaktsiin süstitakse kõrva taha.
English: This summary was last updated in September 2011.
Estonian: Kokkuvõtte viimane uuendus: 09-2011.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption.
Estonian: Keeluaeg on aeg, mis peab mööduma, kuni looma võib tappa ja tema liha tarvitada inimtoiduks.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Estonian: Kui soovite ravitava looma haigusseisundi või vaktsineerimise kohta rohkem teavet, pöörduge oma loomaarsti poole.
English: The Package Leaflet should be taken to the doctor.
Estonian: Arsti juurde tuleb kaasa võtta pakendi infoleht.
English: This bacterium is often present with Pasteurella multocida and makes the disease worse.
Estonian: See bakter esineb sageli koos bakteriga Pasteurella multocida ja süvendab haigust.
English: The first dose is followed by a second injection 4 weeks later.
Estonian: Esimese annuse järel tehakse 4 nädalat hiljem teine süst.
English: In the study of the duration of effect, based on antibody levels, it was shown that revaccination with a single dose resulted in a clear booster response (that is, the resultant antibody levels were even higher than after the basic vaccination).
Estonian: Antikehade sisalduse järgi arvutatud toime kestuse uuring näitas, et ühekordse annusega revaktsineerimisel oli selge toimet tugevdav mõju (st tulemuseks oli antikehade suurem sisaldus kui pärast algset vaktsineerimist).
English: To maintain the immunity, a single injection of one dose should be carried out 2 - 4 weeks before each subsequent farrowing.
Estonian: Immuunsuse säilitamiseks tuleb süstida 2-4 nädalat enne iga järgmist poegimist ühekordne annus.
English: When exposed to any of these bacteria later in life, the pig will either not become infected or have a much less serious infection.
Estonian: Nende bakteritega hiljem elu jooksul kokku puutudes siga ei nakatu või on nakkus kergem.
English: Other side effects are reduced activity and lack of appetite in 10-20% of the pigs on the day of vaccination and/or a temporary swelling (maximum diameter: 10 cm) for up to two weeks at the injection site.
Estonian: Muud kõrvalnähud on loidus ja isutus vaktsineerimispäeval 10-20%-l sigadest ja/või kuni kaks nädalat püsiv süstekoha ajutine turse (läbimõõduga kuni 10 cm).
English: Porcilis AR-T DF can cause a temporary increase in body temperature of 1.5°C, and in some pigs of up to 3°C on the day of vaccination or the following day.
Estonian: Porcilis AR-T DF võib vaktsineerimise päeval või järgmisel päeval tekitada kehatemperatuuri ajutise tõusu 1,5 °C võrra ja osadel sigadel kuni 3 °C võrra.
English: Information on the prescription status of this product may be found on the outer package.
Estonian: Teave selle kohta, kas toode on retseptiravim, on välispakendil.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Estonian: Vaktsiini kasulikkuse ja riski suhe on käesoleva Euroopa avaliku hindamisaruande teadusliku arutelu kokkuvõttes.
English: The withdrawal period for Porcilis AR-T DF for pigs is zero days.
Estonian: Vaktsiini Porcilis AR-T DF keeluaeg sigadel on null päeva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis AR-T DF to Intervet International B.V. on 16 November 2000.
Estonian: Euroopa Komisjon andis vaktsiini Porcilis AR-T DF müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Intervet International B.V.
English: When the sow is injected, this small exposure helps the pig's immune system to recognise and attack the bacteria.
Estonian: Sea süstimisel satub sea organismi väike kogus bakterimaterjali, mis aitab immuunsüsteemil baktereid ära tunda ja rünnata.
English: The main measure of effectiveness was the amount of antibodies to Bordetella bronchiseptica and also to Pasteurella multocida toxin.
Estonian: Efektiivsuse põhinäitaja oli bakteri Bordetella bronchiseptica vastaste ja samuti bakteri Pasteurella multocida toksiini vastaste antikehade hulk.
English: Progressive atrophic rhinitis is caused by toxins from the bacteria Pasteurella multocida.
Estonian: Progresseeruvat atroofilist riniiti põhjustavad bakteri Pasteurella multocida toksiinid.
English: The first injection should be given 6 weeks before the expected date of farrowing (giving birth to the piglets).
Estonian: Esimene süst tuleb teha 6 nädalat enne eeldatavat poegimisaega.
English: If someone is accidentally injected with this product, they should seek immediate medical advice immediately.
Estonian: Vaktsiini juhuslikul enesele süstimisel tuleb pöörduda kohe arsti poole.
English: Porcilis AR-T DF is a vaccine for use in (female) pigs to reduce atrophic rhinitis in their piglets.
Estonian: Porcilis AR-T DF on sigadel (emistel) kasutatav vaktsiin, millega vähendatakse põrsaste atroofilist riniiti.
English: Why has Porcilis AR-T DF been approved?
Estonian: Miks Porcilis AR-T DF heaks kiideti?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis AR-T DF exceed the risks for the reduction of clinical signs of progressive atrophic rhinitis in piglets, by passive oral immunisation with colostrum from dams actively immunised with the vaccine, and recommended that Porcilis AR-T DF should be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et vaktsiini Porcilis AR-T DF kasulikkus kasutamisel põrsaste passiivseks suukaudseks immuniseerimiseks vaktsineeritud emistelt saadava ternespiimaga progresseeruva atroopilise riniidi kliiniliste nähtude vähendamiseks on suurem kui sellega kaasnevad riskid.
English: The trials showed good protection against the clinical signs of progressive atrophic rhinitis.
Estonian: Uuringud näitasid, et vaktsiin kaitseb hästi progresseeruva atroofilise riniidi kliiniliste nähtude eest.
English: In this study, blood was taken from piglets in each litter born from each sow, and tested for antibodies to Pasteurella multocida toxin and Bordetella bronchiseptica.
Estonian: Uuringus analüüsiti iga emise iga pesakonna põrsaste vereproove bakteri Pasteurella multocida toksiini ja bakteri Bordetella bronchiseptica suhtes.
English: Porcilis AR-T DF contains a non-toxic recombinant derivative (see later) of the Pasteurella multocida toxin and also inactivated Bordetella bronchiseptica bacterial cells.
Estonian: Porcilis AR-T DF sisaldab bakteri Pasteurella multocida toksiini mittetoksilist rekombineeritud derivaati (vt allpool) ja bakteri Bordetella bronchiseptica inaktiveeritud rakke.
English: How does Porcilis AR-T DF work?
Estonian: Kuidas Porcilis AR-T DF toimib?
English: Porcilis AR-T DF is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs of 18 weeks of age and older.
Estonian: Vaktsiini Porcilis AR-T DF manustatakse vähemalt 18-nädalastele emistele 2 ml annusena intramuskulaarse (lihasesse) süstina.
English: What is Porcilis AR-T DF?
Estonian: Mis on Porcilis AR-T DF?
English: Porcilis AR-T DF has been studied in sows, where it was compared with another vaccine for progressive atrophic rhinitis.
Estonian: Uuriti vaktsiini Porcilis AR-T DF toimet emistele, võrreldes seda progresseeruva atroofilise riniidi teise vaktsiiniga.
English: Other information about Porcilis AR-T DF:
Estonian: Muu teave Porcilis AR-T DF kohta
English: What is the risk associated with Porcilis AR-T DF?
Estonian: Mis riskid vaktsiiniga Porcilis AR-T DF kaasnevad?
English: The Pasteurella multocida toxin is made by a bacterium cell that has received a gene (DNA), which makes it able to produce Pasteurella multocida toxoid, a genetically modified form of toxin which has adequate immunogenic activity and which is free from the toxic properties.
Estonian: Toksoid on toksiini geneetiliselt muundatud vorm, millel on säilinud immunogeenne toime, kuid millel puuduvad toksilised omadused.
English: The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.
Estonian: Põrsaste progresseeruva atroofilise riniidi vastaste antikehade sisaldus oli võrreldav sisaldusega, mille tekitas teine müügiloaga vaktsiin.
English: Vaccine to reduce atrophic rhinitis in piglets
Estonian: Põrsaste atroofilise riniidi vähendamise vaktsiin
English: How has Porcilis AR-T DF been studied?
Estonian: Kuidas vaktsiini Porcilis AR-T DF uuriti?
English: This immunity is passed onto the sow's piglets through her colostrum.
Estonian: Immuunsus kandub emiselt ternespiimaga üle põrsastele.
English: Porcilis AR-T DF is used to reduce the clinical signs of progressive atrophic rhinitis (a disease where the nose tissues become infected and die) in piglets.
Estonian: Vaktsiini Porcilis AR-T DF kasutatakse põrsaste progresseeruva atroofilise riniidi (ninakudede infektsiooni ja kärbumise haigus) kliiniliste nähtude vähendamiseks.
English: The length of time that Porcilis AR-T DF is effective has also been studied.
Estonian: Samuti uuriti vaktsiini Porcilis AR-T DF mõju kestust.
English: The vaccine is given to sows (female pigs) only.
Estonian: Vaktsiini antakse ainult emistele.
English: Porcilis AR-T DF is a suspension for injection which contains a non-toxic recombinant derivative (see ‘How does Porcilis AR-T DF work?')
Estonian: Porcilis AR-T DF on süstesuspensioon, mis sisaldab bakteri Pasteurella multocida toksiini mittetoksilist rekombineeritud derivaati (vt punkt „Kuidas Porcilis AR-T DF toimib?”) ja bakteri Bordetella bronchiseptica inaktiveeritud rakke.
English: An active ingredient of Porcilis AR-T DF, Pasteurella multocida toxin, is produced by a method known as ‘recombinant technology'.
Estonian: Vaktsiini Porcilis AR-T DF toimeainet bakteri Pasteurella multocida toksiini valmistatakse rekombinantDNA-tehnika abil: seda toodab bakter, millele on lisatud bakteri Pasteurella multocida toksoidi teket võimaldav geen (DNA).
English: What is Porcilis AR-T DF used for?
Estonian: Milleks vaktsiini Porcilis AR-T DF kasutatakse?
English: The applicant had requested a re-examination of the opinion.
Estonian: Taotleja oli nõudnud arvamuse taasläbivaatamist.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Heparesc can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõtted Heparesci kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The Committee thus considered that the benefits of treatment had not been sufficiently demonstrated.
Estonian: Seega järeldas komitee, et ravi kasulikkust ei olnud piisavalt tõendatud.
English: The company that applied for authorisation is Cytonet GmbH & Ci KG.
Estonian: Müügiluba taotles Cytonet GmbH & Ci KG.
English: What is Heparesc?
Estonian: Mis on Heparesc?
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 22 October 2015.
Estonian: Pärast taotluse põhjenduste arutamist vaatas inimravimite komitee oma algse arvamuse uuesti läbi ja kinnitas müügiloa andmisest keeldumist 22. oktoobril 2015.