FrancophonIA/ELRC3.0 huggingface dataset:
English: Entire male pigs from 8 weeks of age onwards should be vaccinated with 2 doses of 2 ml at least 4 weeks apart, with the second dose normally given 4 to 6 weeks prior to slaughter.
Estonian: Kastreerimata kultidele alates 8 nädala vanusest tuleks vaktsiini manustada doosis 2 ml kaks korda vähemalt 4-nädalase vahega nii, et teine doos manustatakse tavaliselt 4 kuni 6 nädalat enne tapmist.
English: (a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid) Adjuvant:
Estonian: (difteeriatoksoidile konjugeeritud GnRF sünteetiline peptiidanaloog) Adjuvant:
English: The active ingredient in this immunological is a synthetically produced analogue of GnRF, which is conjugated with an immunogenic carrier protein.
Estonian: Selle immunoloogilise preparaadi toimeaine on GnRF-i sünteetiliselt toodetud analoog, mis on immunogeense kandurvalguga konjugeeritud.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Estonian: MANUSTAMISVIIS JA -TEE(D) Subkutaanne manustamine.
English: Clinically meaningful suppression of gonadal function should be managed with supportive endocrine replacement therapy until normal function returns.
Estonian: Gonaadfunktsiooni kliiniliselt olulist supressiooni peab ravima toetava endokriinasendusraviga normaalse funktsiooni taastumiseni.
English: The risk of a physiological effect is greater after a second or subsequent accidental injection than after a first injection.
Estonian: Füsioloogilise toime risk on suurem pärast teist või järgnevat juhuslikku süstimist kui pärast esimest.
English: Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular function.
Estonian: GnRF-vastaste antikehade indutseerimine, et esile kutsuda testikulaarfunktsiooni ajutine immunoloogiline supressioon.
English: Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based adjuvant
Estonian: Dietüülaminoetüül(DEAE)-dekstraan, mittemineraalne õlibaasiline vesiadjuvant
English: In very rare cases anaphylactoid type reactions (dyspnoea, collapse, cyanosis and hypersalivation associated with or without muscle twitching or emesis) have been observed within a few minutes after the first vaccination with a duration of up to 30 minutes.
Estonian: Väga harvadel juhtudel on mõni minut pärast vaktsineerimist täheldatud kuni 30 minutit kestvaid anafülaktoidset tüüpi reaktsioone (düspnoe, kollaps, lihasetõmblustega seonduv või mitteseonduv hüpersalivatsioon või emees).
English: Only healthy animals should be immunised.
Estonian: Vaktsineerida ainult terveid loomi.
English: The veterinary medicinal product must only be used with a safety vaccinator which has a dual safety system providing both a needle guard and a mechanism to prevent accidental operation of the trigger.
Estonian: Veterinaarravimit võib kasutada ainult turvalise vaktsineerimissüstlaga, mille on kahekordne ohutussüsteem nii nõelakaitsega kui mehhanismiga päästiku juhusliku vajutamise vältimiseks.
English: Special care should be taken to avoid accidental self-injection and needle stick injury when administering the veterinary medicinal product.
Estonian: Juhuslikku iseendale süstimist ja nõelatorkeid veterinaarravimi manustamisel tuleb väga hoolikalt vältida.
English: 1 x 250 ml
Estonian: 1 × 250 ml
English: Pharmacotherapeutic group: Gonadotropin releasing factor analogue, conjugated.
Estonian: Farmakoterapeutiline rühm: gonadotropiini vabastava faktori analoogvalgu konjugaat.
English: A transient increase in body temperature of 0.2 to 1.7°C was observed during the 24 hours after administration, returning to normal after two days.
Estonian: 24 tundi pärast manustamist täheldati kehatemperatuuri ajutist tõusu 0,2 kuni 1,7 ºC, mis normaliseerus kahe päeva pärast.
English: Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in palpable injection site reactions.
Estonian: 8 nädala vanustele põrsastele kahekordse Improvaci doosi (4 ml) manustamine tekitas tavaliselt süstekoha palpeeritava reaktsiooni.
English: When administered to older pigs (14-23 weeks of age) injection site swellings ranging from 2 cm to 5 cm in diameter are commonly observed, and injection site reactions at slaughter are commonly observed if the second vaccination is given only 4 weeks before slaughter.
Estonian: Manustamisel vanematele sigadele (14-23 nädala vanuselt), täheldatakse tavaliselt 2 cm kuni 5 cm diameetriga süstekoha reaktsioone, ja kui teine vaktsineerimine on tehtud ainult 4 nädalat enne tapmist, täheldatakse tapal sageli süstekoha reaktsioone.
English: Outer packaging:
Estonian: Välispakend:
English: EU/2/09/095/002 - 100 ml x 10 EU/2/09/095/003 - 250 ml x 4 EU/2/09/095/005 - 100 ml EU/2/09/095/006 - 250 ml
Estonian: EU/2/09/095/002 - 100 ml × 10 EU/2/09/095/003 - 250 ml × 4 EU/2/09/095/005 - 100 ml EU/2/09/095/006 - 250 ml
English: The risk of these effects occurring is greater after a second or subsequent accidental injection than after a first injection.
Estonian: Nende tagajärgede ilmnemise oht on suurem pärast teist või järgnevat juhuslikku süstimist kui pärast esimest.
English: STATEMENT OF ACTIVE SUBSTANCES GnRF analogue-protein conjugate min. 300 µg/2 ml
Estonian: TOIMEAINE(TE) SISALDUS GnRF analoogvalgu konjugaat min. 300 µg/2 ml
English: STATEMENT OF ACTIVE SUBSTANCES One dose (2 ml) contains:
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS Üks annus (2 ml) sisaldab:
English: When administered to pigs at the youngest recommended age (8 weeks), injection site swellings of up to 4 x 8 cm are very commonly observed.
Estonian: Noorimas soovitatavas kasutuseas (8-nädalastele) sigadele manustamisel täheldatakse väga sageli kuni 4x8 cm turset süstekohal.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Improvac solution for injection for pigs
Estonian: VETERINAARRAVIMI NIMETUS Improvac süstelahus sigadele
English: A transient increase in rectal temperature (post-vaccination hyperthermia) of around 0.5 °C is very commonly observed during the 24-hours period post vaccination.
Estonian: 24 tunni jooksul pärast vaktsineerimist võib täheldada rektaalse temperatuuri ajutist tõusu (vaktsineerimisjärgne hüpertermia) umbes 0,5 ºC võrra.
English: GnRF analogue-protein conjugate: Zoetis Belgium SA Rue Laid Burniat 1
Estonian: GnRF - DT - konjugaat Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIA
English: For use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty.
Estonian: Kasutamiseks alternatiivina kirurgilisele kastratsioonile peamise kuldi kõrvalmaitset tekitava ühendi androstenooni põhjustatud kõrvamaitse vähendamiseks kastreerimata kultidel pärast puberteedi algust.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/005 - 100 ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/09/095/005 - 100 ml
English: Read the package leaflet before use.
Estonian: Enne ravimi kasutamist lugeda pakendi infolehte.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/002 - 10 x 100 ml EU/2/09/095/003 - 4 x 250 ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/09/095/002 - 10 × 100 ml EU/2/09/095/003 - 4 × 250 ml
English: PACKAGE LEAFLET: Improvac, solution for injection for pigs
Estonian: PAKENDI INFOLEHT Improvac, süstelahus sigadele
English: Gonadotropin releasing factor (GnRF) analogue-protein conjugate min. 300 µg.
Estonian: Gonadotropiini vabastava faktori (GnRF) analoogvalgu konjugaat min 300 µg
English: Polyethylene bottle of 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Estonian: Kummisulguriga suletud ja alumiiniumkorgiga kinnitatud 100 ml (50 annust) või 250 ml (125 annust) polüetüleenpudel.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Improvac solution for injection
Estonian: VETERINAARRAVIMI NIMETUS Improvac süstelahus
English: PACKAGE SIZE 1 x 100 ml
Estonian: PAKENDI SUURUS(ED) 1 × 100 ml
English: WITHDRAWAL PERIOD (S) Withdrawal period(s): Zero days.
Estonian: KEELUAEG Keeluaeg: 0 päeva.
English: EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
Estonian: Pärast korgi läbistamist kasutada ära 28 päeva jooksul.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 10 x 100 ml and 4 x 250 ml HDPE bottles
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Pappkarp, 10 × 100 ml ja 4 × 250 ml HDPE pudelid
English: Polyethylene (HDPE) bottle of, 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Estonian: Kummisulguriga suletud ja alumiiniumkorgiga kinnitatud, 100 ml (50 annust) või 250 ml (125 annust) polüetüleenpudel (HDPE).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml and 250 ml HDPE bottles
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 100 ml ja 250 ml HDPE pudelid
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Estonian: − väga harv (vähem kui 1-l loomal 10,000-st ravitud loomast, kaasaarvatud üksikjuhud).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 1 x 100 ml and 1 x 250 ml HDPE bottles
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Pappkarp ühele pudelile, 1 × 100 ml ja 1 × 250 ml HDPE pudelid
English: Cardboard box with 4 bottles of 250 ml.
Estonian: Pappkarp 4 250 ml pudeliga.
English: EXPIRY DATE EXP {month/year} Once broached, use by ...
Estonian: Pärast korgi läbistamist kasutada kuni ...
English: Cardboard box with 1 bottle of 250 ml.
Estonian: Pappkarp 1 250 ml pudeliga.
English: 6.1 List of excipient(s)
Estonian: 6.1 Abiainete loetelu
English: Cardboard box with 10 bottles of 100 ml.
Estonian: Pappkarp 10 100 ml pudeliga.
English: CONTRAINDICATIONS Do not use in female pigs.
Estonian: VASTUNÄIDUSTUSED Mitte kasutada emistel.
English: Cardboard box with 1 bottle of 100 ml.
Estonian: Pappkarp 1 100 ml pudeliga.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Estonian: B. TARNIMIS - JA KASUTAMISTINGIMUSED VÕI PIIRANGUD Retseptiravim.
English: Another key contributor to boar taint, skatole, may also be reduced as an indirect effect.
Estonian: Kaudse toimena võib väheneda ka teise peamise kuldi kõrvalmaitse tekkes osaleva aine, skatooli, tase.
English: A reduction of typical male behaviour such as mounting and aggressiveness when mixed with non-penmates can be expected after the second vaccination.
Estonian: Pärast teist vaktsineerimist võib oodata, et väheneb isasloomale iseloomulik käitumise, nagu selgatõusmine ja agressiivsus.
English: − very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Estonian: − väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast)
English: Do not use in female pigs.
Estonian: Mitte kasutada aretuskultidel.
English: Do not use in female or male breeding pigs.
Estonian: Mitte kasutada suguemistel või -kultidel.
English: PACKAGE SIZE 10 x 100 ml 4 x 250 ml
Estonian: PAKENDI SUURUS(ED) 10 × 100 ml
English: − common (more than 1 but less than 10 animals in 100 animals treated)
Estonian: − sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast)
English: − common (more than 1 but less than 10 animals in 100 animals treated )
Estonian: − Sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast)
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Estonian: − Harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10000-st ravitud loomast)
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
Estonian: − harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10,000-st ravitud loomast)
English: International non-proprietary name (INN): human insulin
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): humaaninsuliin
English: The application was at day 120 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 120 päeva, kui ettevõte taotluse tagasi võttis.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Estonian: Pärast inimtervishoius kasutatavate ravimite komitee arvamust kulub Euroopa Komisjonil müügiloa väljastamiseks tavaliselt ligikaudu kaks kuud.
English: These medicines would have contained insulin in two different forms: a soluble form, which acts quickly (within 30 minutes of injection), and an ‘isophane' form, which is absorbed more slowly and gives a longer duration of action.
Estonian: Need ravimid oleksid sisaldanud insuliini kahel eri kujul: lahustuval kujul, mis toimib kiiresti (30 minuti jooksul süstimisest), ja isofaani vormis, mis imendub aeglasemalt ja on pikaajalisema toimega.
English: These three medicines are all solutions for injection that contain 100 International Units of insulin per millilitre.
Estonian: Kõik need kolm ravimit on süstelahused, mis sisaldavad 100 rahvusvahelist ühikut insuliini milliliitri kohta.
English: The three ‘Marvel insulins' were to contain one or both types of insulin:
Estonian: Kolm Marvel-insuliini pidid sisaldama üht või mõlemat järgmist tüüpi insuliini:
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Estonian: Diabeet on haigus, mille puhul organism ei tooda piisavalt insuliini veresuhkru taseme reguleerimiseks.
English: This means that they were to be similar to biological medicines that are already authorised in the European Union (EU) and contain the same active substances (also known as the ‘reference medicines').
Estonian: See tähendab, et need pidid sarnanema bioloogiliste ravimitega, millele on Euroopa Liidus müügiluba juba antud (ehk võrdlusravimitega) ja mis sisaldavad sama toimeainet.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte kiri, milles Euroopa Ravimiameti teavitati müügiloa taotluse tagasivõtmisest, on esitatud siin.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Estonian: Lisateavet bioekvivalentsete ravimite kohta leiate teabedokumendist siit.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Estonian: Pärast seda, kui ettevõte on esitatud küsimustele vastanud, vaatab inimtervishoius kasutatavate ravimite komitee need läbi ning võib enne oma arvamuse esitamist esitada ettevõttele täiendavaid küsimusi (180. päeval).
English: How are these medicines expected to work?
Estonian: Milline on nende ravimite eeldatav toime?
English: The active substance, insulin human, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin.
Estonian: Toimeainet humaaninsuliini toodetakse rekombinant-DNA-tehnika abil: seda toodab bakter, mis on saanud insuliini produtseerimist võimaldava geeni (DNA).
English: It also presented the results of one main study in 526 patients with diabetes, who received either the Marvel insulins or the Humulin insulins for up to 12 months.
Estonian: Ta esitas ka ühe 526 diabeedihaigega korraldatud põhiuuringu tulemused, milles patsiendid kasutasid kuni 12 kuu jooksul kas Marvel-insuliine või Humulin insuliine.
English: What were these medicines expected to be used for?
Estonian: Milleks kavatseti neid ravimeid kasutada?
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Estonian: Inimtervishoius kasutatavate ravimite komitee oli koostanud ettevõttele vastamiseks küsimuste loetelu ja ettevõte ei olnud neile vastanud.
English: The reference medicines for these insulins were to be Humulin S, Humulin I and Humulin M3.
Estonian: Nende insuliinide võrdlusravimid pidid olema Humulin S, Humulin I ja Humulin M3.
English: The medicines were expected to be used to treat patients with diabetes who need insulin to maintain their blood levels within normal levels, and to control diabetes in newly diagnosed patients and pregnant women.
Estonian: Ravimeid kavatseti kasutada diabeedihaigete raviks, kes vajavad insuliini vere normaalsete tasemete säilitamiseks, ning diabeedi kontrolli all hoidmiseks äsja diagnoositud patsientidel ja rasedatel.
English: London, 24 January 2008 Doc.
Estonian: London, 24. jaanuar 2008 Dokumendi nr EMEA/90165/2008
English: The studies in healthy volunteers did not show that the Marvel insulins had the same effect in lowering blood sugar levels as the Humulin insulins, and the main study showed a trend in favour of Humulin.
Estonian: Uuringud tervete vabatahtlikega ei näidanud, et Marvel-insuliinid oleksid avaldanud veresuhkru taseme alandamiseks sama toimet kui Humulin-insuliinid, ning põhiuuringus ilmnes suundumus Humulini eelistamisele.
English: • Insulin Human 30/70 Mix Marvel: 30% soluble insulin and 70% isophane insulin.
Estonian: • Insulin Human 30/70 Mix Marvel: 30% lahustuv insuliin ja 70% isofaan-insuliin.
English: The CHMP was also concerned that the company had not supplied enough information on how the active substance or the finished products are made, and that the processes used to make them had not been validated.
Estonian: Inimtervishoius kasutatavate ravimite komitee nägi põhjust ettevaatlikkuseks ka sellepärast, et ettevõte ei olnud esitanud piisavalt teavet toimeaine ega valmisravimi tootmise kohta ning et nende valmistamisprotsesse ei olnud valideeritud.
English: The company presented data from studies designed to show that the Marvel insulins were comparable with the reference medicines in experimental models and in humans.
Estonian: Ettevõte esitas uuringute andmed, mille eesmärk oli tõestada Marvel-insuliinide võrreldavust võrdlusravimitega inimuuringutes ja muude katsetega.
English: The company presented the results of studies carried out in 24 healthy volunteers looking at the effect of the Marvel insulins on blood sugar levels, compared with the Humulin insulins.
Estonian: Ettevõte esitas 24 terve vabatahtlikuga korraldatud uuringute tulemused, milles vaadeldi Marvel-insuliinide toimet veresuhkru tasemele, võrreldes Humulin-insuliinidega.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes currently with the Marvel insulins.
Estonian: Ettevõte teatas inimtervishoius kasutatavate ravimite komiteele, et Marvel-insuliinidega praegu kliinilisi uuringuid ega ravimi kasutamise programme ei toimu.
English: The main measure of effectiveness was the effect of the medicines on the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Estonian: Efektiivsust mõõdeti kõikides uuringutes põhiliselt ravimi toime järgi veresuhkru kontrollileallumist näitava aine (glükosüleeritud hemoglobiin, HbA1c) tasemetele veres.
English: They were to be available in vials or as cartridges to be used in injection pens.
Estonian: Neid kavatseti turustada viaalides või pensüstelites kasutamiseks mõeldud kolbampullides.
English: On 20 December 2007, Marvel LifeSciences Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel, for the treatment of diabetes mellitus.
Estonian: 20. detsembril 2007 teatas Marvel LifeSciences Ltd. ametlikult inimtervishoius kasutatavate ravimite komiteele oma otsusest võtta tagasi ravimite Insulin Human Rapid Marvel, Insulin Human Long Marvel ja Insulin Human 30/70 Mix Marvel müügiloa taotlus.
English: • Insulin Human Rapid Marvel: soluble insulin,
Estonian: • Insulin Human Rapid Marvel: lahustuv insuliin;
English: Therefore, at the time of the withdrawal, the CHMP's view was that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not be considered as biosimilar to the reference medicinal products Humulin S, Humulin I and Humulin M3.
Estonian: Seetõttu oli inimtervishoius kasutatavate ravimite komitee taotluse tagasivõtmise ajal arvamusel, et ravimeid Insulin Human Rapid Marvel, Insulin Human Long Marvel ja Insulin Human 30/70 Mix Marvel ei saa käsitada bioekvivalentsetena võrdlusravimitega Humulin S, Humulin I ja Humulin M3.
English: The main concerns of the CHMP were that the comparability of the Marvel insulins and the Humulin insulins had not been shown.
Estonian: Inimtervishoius kasutatavate ravimite komitee nägi põhjust ettevaatlikkuseks peamiselt sellepärast, et Marvel-insuliinide ja Humulin-insuliinide võrreldavust ei olnud tõestatud.
English: What are Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel?
Estonian: Mis on Insulin Human Rapid Marvel, Insulin Human Long Marvel ja Insulin Human 30/70 Mix Marvel?
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel are replacement insulins, which contain an active substance that is identical to the insulin made by the pancreas.
Estonian: Insulin Human Rapid Marvel, Insulin Human Long Marvel ja Insulin Human 30/70 Mix Marvel on insuliiniasendajad, milles sisalduv toimeaine on identne pankrease produtseeritava insuliiniga.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
Estonian: TEAVE MÜÜGILOA TAOTLUSE TAGASIVÕTMISE KOHTA INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
English: Based on the review of the data, the CHMP had some concerns and was of the provisional opinion that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not have been approved for the treatment of diabetes mellitus.
Estonian: Tuginedes esitatud andmete analüüsile, nägi inimtervishoius kasutatavate ravimite komitee põhjust ettevaatlikkuseks ning oli esialgsel seisukohal, et ravimite Insulin Human Rapid Marvel, Insulin Human Long Marvel ja Insulin Human 30/70 Mix Marvel kasutamist ei ole diabeedi raviks võimalik heaks kiita.
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel were to be ‘biosimilar' medicines.
Estonian: Ravimeid Insulin Human Rapid Marvel, Insulin Human Long Marvel ja Insulin Human 30/70 Mix Marvel kavatseti turustada bioekvivalentsete ravimitena.
English: • Insulin Human Long Marvel: isophane insulin,
Estonian: • Insulin Human Rapid Marvel: isofaan-insuliin;
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Insulin Human Rapid Marvel, Insulin Human Long Marvel or Insulin Human 30/70 Mix Marvel?
Estonian: Millised on taotluse tagasivõtmise tagajärjed praegu ravimite Insulin Human Rapid Marvel, Insulin Human Long Marvel ja Insulin Human 30/70 Mix Marvel kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele?
English: A procedure under Article 29(4) was therefore triggered in June 2012.
Estonian: Seetõttu algatati 2012. aasta juunis artikli 29 lõike 4 kohane menetlus.
English: Glimepiride has been authorised in the EU since 1996.
Estonian: Glimepiriidil on Euroopa Liidus müügiluba alates 1996. aastast.
English: This implies that the composition of the different strengths will have the same impact on the in vivo absorption.
Estonian: See tähendab, et eri tugevuste koostisel on in vivo absorbeerumisele sama mõju.
English: The Applicant therefore only performed the required bioequivalence studies.
Estonian: Seetõttu korraldas taotleja üksnes nõutud bioekvivalentsusuuringud.
English: Overall summary of the scientific evaluation of Glimepirida Parke-Davis and associated names (see Annex I)
Estonian: Glimepirida Parke-Davise ja sarnaste nimetuste (vt I lisa) teadusliku hindamise üldkokkuvõte
English: • the CHMP reviewed the available data and the justifications submitted by the Applicant,
Estonian: • inimravimite komitee vaatas üle taotleja esitatud olemasolevad andmed ja põhjendused;