FrancophonIA/ELRC3.0 huggingface dataset:
English: - Aimovig 140 mg solution for injection in pre-filled syringe contains 140 mg erenumab.
Estonian: - Aimovig 140 mg süstelahuse süstel sisaldab 140 mg erenumabi.
English: There was also a higher proportion of subjects treated with erenumab who achieved at least 50% reduction of MMD compared to placebo (39.7% for 140 mg and 38.6% for 70 mg, with an odds ratio of 3.1 [95% CI: 1.7, 5.5] and 2.9 [95% CI: 1.6, 5.3], respectively).
Estonian: erenumab-ravi saanute seas oli suurem ka uuritavate osakaal, kes saavutasid MMD vähemalt 50% vähenemise võrreldes platseeboga (39,7% 140 mg korral ja 38,6% 70 mg korral; šansside suhe oli vastavalt 3,1 [95% CI: 1,7; 5,5] ja 2,9 [95% CI: 1,6; 5,3]).
English: - Aimovig 70 mg solution for injection in pre-filled syringe contains 70 mg erenumab.
Estonian: - Aimovig 70 mg süstelahuse süstel sisaldab 70 mg erenumabi.
English: Used barrel
Estonian: Kasutatud nõel
English: Do not choose an area where the skin is tender, bruised, red, or hard.
Estonian: Märkus: enne süstimist ärge puudutage puhastatud piirkonda; ärge valige piirkonda, kus nahk on õrn, verevalumiga, punetav või kõva.
English: Pack containing 1 pre-filled pen
Estonian: 1 pen-süstlit sisaldav pakend
English: Cutaneous reactions
Estonian: Nahareaktsioonid
English: To avoid discomfort at the site of injection, the pre-filled pen(s) should be left to stand at room temperature (up to 25°C) for at least 30 minutes before injecting.
Estonian: Vältimaks ebamugavustunnet süstekohas, tuleb pen-süstel (pen-süstlid) jätta enne süstimist vähemalt 30 minutiks toatemperatuurile (kuni 25 °C) soojenema.
English: To avoid discomfort at the site of injection, the pre-filled syringe(s) should be left to stand at room temperature (up to 25°C) for at least 30 minutes before injecting.
Estonian: Vältimaks ebamugavustunnet süstekohas, tuleb süstel (süstlid) jätta enne süstimist vähemalt 30 minutiks toatemperatuurile (kuni 25 °C) soojenema.
English: White cap on
Estonian: Valge kork on peal
English: Treatment difference (95% CI)
Estonian: Ravierinevus (95% CI)
English: There was a higher proportion of patients in the erenumab group who achieved at least a 50% reduction of MMD compared to placebo (34.6% for 140 mg, 36.4% for 70 mg versus 17.7% for placebo), with an odds ratio of 2.5 (95% CI: 1.3, 4.9) and 2.7 (95% CI: 1.4, 5.2), respectively.
Estonian: Erenumabi rühmas oli suurem patsientide osakaal, kes saavutasid MMD vähemalt 50% vähenemise võrreldes platseeboga (34,6% 140 mg, 36,4% 70 mg versus 17,7% platseebo korral); šansside suhe oli vastavalt 2,5 (95% CI: 1,3; 4,9) ja 2,7 (95% CI: 1,4; 5,2).
English: CARTON OF UNIT PACK - pre-filled pen
Estonian: ÜKSIKPAKENDI KARP - pen-süstel
English: Aimovig 140 mg injection erenumab
Estonian: Aimovig 140 mg süstevedelik erenumabum s.c.
English: It is unknown whether erenumab is excreted in human milk.
Estonian: Pole teada, kas erenumab eritub inimese rinnapiima.
English: For the 140 mg dose you must inject the contents of either one 140 mg single-use syringe or two 70 mg single-use syringes, one after the other.
Estonian: 140 mg annuse puhul peate süstima kas ühe 140 mg ühekordselt kasutatava süstli sisu või üksteise järel kahe 70 mg ühekordselt kasutatava süstli sisu.
English: Remove Aimovig pre-filled syringe(s) from the carton by holding it/them at the barrel.
Estonian: Võtke Aimovigi süstel (süstlid) karbist välja, hoides silindrist kinni.
English: In patients failing one or more prophylactic pharmacotherapies the treatment difference for the reduction of monthly migraine days (MMD) observed between erenumab 140 mg and placebo was -3.3 days (95% CI: -4.6, -2.1) and between erenumab 70 mg and placebo -2.5 days (95% CI: -3.8, -1.2).
Estonian: Patsientidel, kellel ebaõnnestus üks või enam profülaktilist farmakoteraapiat, täheldati ravierinevust igakuiste migreenipäevade (MMD) arvu vähenemises erenumab 140 mg ja platseebo vahel -3,3 päeva (95%CI: -4,6; -2,1) ning erenumab 70 mg ja platseebo vahel -2,5 päeva (95% CI: -3,8; -1,2).
English: Pack containing 1 pre-filled syringe
Estonian: 1 süstlit sisaldav pakend
English: Aimovig 70 mg injection erenumab
Estonian: Aimovig 70 mg süstevedelik erenumabum s.c.
English: To avoid discomfort at the site of injection, leave the syringe(s) at room temperature for at least 30 minutes before injecting.
Estonian: Vältimaks ebamugavust süstekohas, laske süstlil (süstlitel) vähemalt 30 minuti jooksul enne süstimist toatemperatuurini soojeneda.
English: Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe erenumab
Estonian: Aimovig 70 mg süstelahus süstlis Aimovig 140 mg süstelahus süstlis erenumab (erenumabum)
English: One pre-filled syringe contains 140 mg erenumab.
Estonian: Üks süstel sisaldab 140 mg erenumabi.
English: Muscle spasms
Estonian: Episoodiline migreen
English: One pre-filled pen contains 140 mg erenumab.
Estonian: Üks pen-süstel sisaldab 140 mg erenumabi.
English: Patients with hepatic impairment
Estonian: Naha ja nahaaluskoe kahjustused
English: Do not use the syringe if the needle cap is missing or is not securely attached.
Estonian: Märkus: ärge kasutage süstlit, mille mõni osa tundub olevat mõranenud või katki; ärge kasutage süstlit, mis on maha kukkunud; ärge kasutage süstlit, mille nõelakate on puudu või ei ole turvaliselt kinnitatud.
English: Label and expiry date
Estonian: Etikett ja kõlblikkusaeg
English: Chronic migraine
Estonian: Lihasspasmid
English: - Aimovig 140 mg solution for injection in pre-filled pen contains 140 mg erenumab.
Estonian: - Aimovig 140 mg süstelahuse pen-süstel sisaldab 140 mg erenumabi.
English: Step 2: Get ready
Estonian: Samm 2: Süstimiseks valmistumine
English: Keep the syringe(s) in the outer carton in order to protect from light.
Estonian: Hoida süstel (süstlid) välispakendis valguse eest kaitstult.
English: Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
Estonian: Lükake kolb aeglaselt ja ühtlase kiirusega lõpuni alla.
English: Instructions for use of Aimovig pre-filled syringe
Estonian: Aimovigi süstli kasutusjuhend
English: One pre-filled syringe contains 70 mg erenumab.
Estonian: Üks pen-süstel sisaldab 70 mg erenumabi.
English: - Aimovig 70 mg solution for injection in pre-filled pen contains 70 mg erenumab.
Estonian: - Aimovig 70 mg süstelahuse pen-süstel sisaldab 70 mg erenumabi.
English: To avoid discomfort at the site of injection, leave the pen(s) at room temperature for at least 30 minutes before injecting.
Estonian: Vältimaks ebamugavust süstekohas, laske pen-süstlil (pen-süstlitel) vähemalt 30 minuti jooksul enne süstimist toatemperatuurini soojeneda.
English: In patients failing one or more prophylactic pharmacotherapies the treatment difference for the reduction of MMD observed between erenumab 140 mg and placebo was -2.5 (95% CI: -3.4, -1.7) and between erenumab 70 mg and placebo -2.0 (95% CI: -2.8, -1.2).
Estonian: Patsientidel, kellel ebaõnnestus üks või enam profülaktilist farmakoteraapiat, täheldati ravierinevust igakuiste migreenipäevade (MMD) arvu vähenemises erenumab 140 mg ja platseebo vahel -2,5 päeva (95% CI: -3,4; -1,7) ning erenumab 70 mg ja platseebo vahel -2,0 päeva (95% CI: -2,8; -1,2).
English: Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen erenumab
Estonian: Aimovig 70 mg süstelahus pen-süstlis Aimovig 140 mg süstelahus pen-süstlis erenumab (erenumabum)
English: How to store Aimovig
Estonian: Muud ravimid ja Aimovig
English: Keep the pre-filled pens in the outer carton in order to protect from light.
Estonian: Hoida pen-süstlid välispakendis valguse eest kaitstult.
English: Instructions for use of Aimovig pre-filled pens
Estonian: Aimovigi pen-süstli(te) kasutusjuhendid
English: Each pre-filled pen contains 140 mg erenumab.
Estonian: Üks pen-süstel sisaldab 140 mg erenumabi (erenumabum).
English: Each pre-filled pen contains 70 mg erenumab.
Estonian: Üks pen-süstel sisaldab 70 mg erenumabi (erenumabum).
English: responders
Estonian: Annustamine
English: Upper arm
Estonian: SÜSTLI SILT
English: Do not rub the injection site.
Estonian: Süstekohta ei tohi hõõruda.
English: Alcohol wipes
Estonian: Keskmine muutusc
English: Aimovig 140 mg solution for injection in pre-filled syringe erenumab
Estonian: Aimovig 140 mg süstelahus pen-süstlis erenumabum
English: Note: Keep skin pinched while injecting.
Estonian: Märkus: süstimise ajal hoidke nahavolt sõrmede vahel.
English: Keep the pen(s) in the outer carton in order to protect from light.
Estonian: Hoida pen-süstel (pen-süstlid) välispakendis valguse eest kaitstult.
English: Barrel
Estonian: Silinder
English: Discard the used syringe and the grey needle cap.
Estonian: Visake ära kasutatud süstel ja hall nõelakate.
English: Each pre-filled syringe contains 140 mg erenumab.
Estonian: Üks süstel sisaldab 140 mg erenumabi (erenumabum).
English: Aimovig 70 mg solution for injection in pre-filled pen erenumab
Estonian: Aimovig 70 mg süstelahus pen-süstlis erenumabum
English: Package size blister (PVC/Aclar/PVC-alu) 1 tablet
Estonian: Pakendi suurus blister (PVC/Aclar/PVC-alu) 1 tablett
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoRapid on 7 September 1999.
Estonian: Euroopa Komisjon andis NovoRapidi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 7. septembril 1999.
English: Other information about NovoRapid
Estonian: Muu teave NovoRapidi kohta
English: What measures are being taken to ensure the safe and effective use of NovoRapid?
Estonian: Mis meetmed võetakse, et tagada NovoRapidi ohutu ja efektiivne kasutamine?
English: The full EPAR for NovoRapid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst NovoRapidi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The usual dose is between 0.5 and 1.0 units per kilogram body weight per day.
Estonian: Tavaline annus on 0,5-1,0 ühikut kehakaalu kilogrammi kohta ööpäevas.
English: NovoRapid is usually given immediately before a meal, although it may be given after a meal if necessary.
Estonian: Ravimit manustatakse tavaliselt vahetult enne sööki, kuid vajaduse korral võib seda manustada ka pärast sööki.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that NovoRapid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et NovoRapidi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: This summary was last updated in 09-2016.
Estonian: Kokkuvõtte viimane uuendus: 11-2013.
English: When it is used with meals, 50 to 70% of the insulin requirement may be provided by NovoRapid and the remainder by an intermediate or long-acting insulin.
Estonian: Ravimit koos söögiga tarvitades võib 50-70% insuliinivajadusest katta NovoRapidiga ning ülejäänud osa keskmise või pika toimeajaga insuliiniga.
English: NovoRapid can be used in pregnant women.
Estonian: NovoRapidit tohivad kasutada rasedad.
English: The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Estonian: Patsiendi vere glükoosisisaldust tuleb regulaarselt kontrollida, et leida väikseim efektiivne annus.
English: NovoRapid reduced HbA1c levels by 0.12% and by 0.15% more than human insulin did after six months.
Estonian: Mõlemas I tüüpi diabeedi uuringus vähendas NovoRapid kuue kuu möödudes HbA1c sisaldust 0,12% ja 0,15% võrra rohkem kui iniminsuliin.
English: The most common side effect with NovoRapid (seen in between 1 and 10 patients in 100) is hypoglycaemia (low blood glucose levels).
Estonian: NovoRapidi kõige sagedam kõrvalnäht (esinenud 1-10 patsiendil 100st) on hüpoglükeemia (vere vähene glükoosisisaldus).
English: NovoRapid is used to treat adults, adolescents and children over one year old who have diabetes.
Estonian: NovoRapidit kasutatakse diabeedi raviks täiskasvanutel, noorukitel ja üle 2-aastastel lastel.
English: NovoRapid is normally used in combination with an intermediate- or long-acting insulin given at least once a day.
Estonian: Tavaliselt kasutatakse NovoRapidit koos keskmise või pika toimeajaga insuliiniga, mida manustatakse vähemalt kord ööpäevas.
English: Why is NovoRapid approved?
Estonian: Miks NovoRapid heaks kiideti?
English: NovoRapid gave almost identical results to human insulin in two studies involving 1,954 patients with type 1 diabetes (when the pancreas cannot produce insulin) and in one study involving 182 patients with type 2 diabetes (when the body is unable to use insulin effectively).
Estonian: NovoRapidit uuriti kahes uuringus, milles osales 1954 täiskasvanud patsienti, kellel oli I tüüpi diabeet (kõhunäärmes ei teki insuliini), ja ühes uuringus, milles osales 182 täiskasvanud patsienti, kellel oli II tüüpi diabeet (organism ei suuda insuliini efektiivselt kasutada).
English: This is a summary of the European public assessment report (EPAR) for NovoRapid.
Estonian: See on ravimi NovoRapid Euroopa avaliku hindamisaruande kokkuvõte.
English: What are the risks associated with NovoRapid?
Estonian: Mis riskid NovoRapidiga kaasnevad?
English: NovoRapid can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be given into a vein but only by a doctor or a nurse.
Estonian: NovoRapidit tohib kasutada ka nahaaluse pidevinfusiooni insuliinipumbasüsteemis; veeni tohib ravimit manustada üksnes arst või meditsiiniõde.
English: The safety has been found to be the same as human insulin when compared in two studies involving 349 pregnancies in women with type 1 or gestational diabetes (diabetes caused by pregnancy).
Estonian: NovoRapidi ohutust võrreldi samuti iniminsuliini ohutusega kahes uuringus, milles osales 349 rasedat, kellel oli I tüüpi või rasedusaegne diabeet.
English: For more information about treatment with NovoRapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate NovoRapidiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The replacement insulin works in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Estonian: Asendusinsuliin toimib samal viisil kui organismis looduslikult tekkiv insuliin, aidates glükoosil siseneda verest rakkudesse.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The studies compared NovoRapid with human insulin by measuring the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Estonian: Uuringutes võrreldi NovoRapidit iniminsuliiniga, mõõtes vere glükoosisisalduse tasakaalu näitava aine, glükoseerunud hemoglobiini (HbA1c) sisaldust veres.
English: How is NovoRapid used?
Estonian: Kuidas NovoRapidit kasutatakse?
English: It is given by injection under the skin in the abdominal (belly) wall, the thigh, the upper arm, the shoulder or the buttock.
Estonian: NovoRapidit süstitakse naha alla kõhuseina, reide, õlavarde, õlga või tuharasse.
English: EPAR summary for the public
Estonian: Kokkuvõte üldsusele aspartinsuliin
English: What benefits of NovoRapid have been shown in studies?
Estonian: Milles seisneb uuringute põhjal NovoRapidi kasulikkus?
English: NovoRapid is a solution for injection available in vials, cartridges (PenFill and PumpCart) and pre-filled pens (FlexPen, FlexTouch and InnoLet) and can only be obtained with a prescription.
Estonian: Seda turustatakse viaalides, kolbampullides (PenFill) ja eeltäidetud pensüstaldes (FlexPen, FlexTouch ja InnoLet).
English: For the full list of all side effects and restrictions with NovoRapid, see the package leaflet.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
English: NovoRapid is a replacement insulin that is very similar to the insulin made by the body but is absorbed faster by the body.
Estonian: NovoRapid on asendusinsuliin, mis on väga sarnane organismis tekkiva insuliiniga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoRapid have been included in the summary of product characteristics and the package leaflet.
Estonian: Selle alusel lisati NovoRapidi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: How does NovoRapid work?
Estonian: Kuidas NovoRapid toimib?
English: NovoRapid has also given comparable results when studied in children from one year of age.
Estonian: NovoRapidiga saavutatud tulemused olid peaaegu samalaadsed iniminsuliini tulemustega.
English: It contains the active substance insulin aspart, a rapid-acting insulin.
Estonian: NovoRapid on süstelahus, mis sisaldab toimeainena aspartinsuliini.
English: NovoRapid insulin aspart
Estonian: NovoRapid on kiire toimega insuliin.
English: What is NovoRapid and what is it used for?
Estonian: Milleks NovoRapidit kasutatakse?
English: It is not intended to provide practical advice on how to use NovoRapid.
Estonian: Töötati välja riskijuhtimiskava, et tagada NovoRapidi võimalikult ohutu kasutamine.
English: The application was submitted to Ireland as reference Member State and Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and the United Kingdom as concerned Member States.
Estonian: Viiteliikmesriik oli Iirimaa ning asjaomased liikmesriigid Belgia, Hispaania, Itaalia, Kreeka, Luksemburg, Madalmaad, Portugal, Prantsusmaa, Saksamaa, Taani ja Ühendkuningriik.
English: The final opinion was converted into a Decision by the European Commission on 17 September 2012.
Estonian: Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 17. septembril 2012.
English: The decentralised procedure (IE/V/0269/001/DC) started on 13 August 2010.
Estonian: Detsentraliseeritud menetlus (IE/V/0269/001/DC) algas 13. augustil 2010.
English: Written explanations were provided by the applicant on 9 January 2012 and 23 April 2012.
Estonian: Taotleja esitas kirjalikud selgitused 9. jaanuaril 2012 ja 23. aprillil 2012.
English: Article 33(4) of Directive 2001/82/EC
Estonian: Direktiivi 2001/82/EÜ artikli 33 lõige 4
English: Oral explanations were given on 15 May 2012.
Estonian: Suulised selgitused esitati 15. mail 2012.
English: During the procedure the applicant provided additional data and the issues raised by France regarding the proposed indications were resolved.
Estonian: Menetluse ajal esitas taotleja lisaandmeid ja Prantsusmaa tõstatatud küsimus seoses kavandatavate näidustustega lahenesid.
English: The Committee appointed Prof Christian Friis as rapporteur and Dr David Murphy as co-rapporteur.
Estonian: Veterinaarravimite komitee määras hindajaks prof Christian Friisi ja kaashindajaks dr David Murphy.
English: This application was an extension (Article 19 of Regulation 1234/2008/EC) to add sheep as new target species.
Estonian: Taotlus käsitles müügiloa laiendamist (määruse (EÜ) nr 1234/2008 artikli 19 kohaselt) lammaste lisamiseks uue sihtliigina.
English: The active substance is included in veterinary medicinal products currently authorised in several Member States in the European Union for use in cattle and pigs for the treatment of respiratory diseases.
Estonian: Toimeaine sisaldub veterinaarravimites, millel on praegu müügiluba mitmes Euroopa Liidu riigis kasutamiseks veiste ja sigade respiratoorhaiguste ravis.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States, by France regarding the proposed indications and by Denmark regarding the efficacy of the product.
Estonian: Kaks asjaomast liikmesriiki tõstatasid detsentraliseeritud menetluses võimaliku suure riski küsimuse: Prantsusmaa seoses kavandatavate näidustuste ja Taani seoses ravimi efektiivsusega.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the Summary of Product Characteristics and package leaflet in the Annex III.
Estonian: Asjaomased raviminimetused on esitatud I lisas, teaduslikud järeldused II lisas ning ravimi omaduste kokkuvõtte ja pakendi infolehe muudatused III lisas.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 22 July 2011.
Estonian: Menetluse 210. päeval olid need küsimused lahendamata ning seetõttu tehti 22. juulil 2011 veterinaarravimite vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühmale direktiivi 2001/82/EÜ artikli 33 lõike 1 kohane esildis.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit-risk profile of Nuflor 300 mg/ml solution for injection for cattle and sheep is positive subject to changes in the product information in order to clarify that the recommended treatment dose and treatment interval for sheep is based on the time mean florfenicol concentrations are maintained above MIC90.
Estonian: Tuginedes hindaja hinnangule olemasolevate andmete kohta, leidis veterinaarravimite komitee, et Nuflor 300 mg/ml veiste ja lammaste süstelahuse kasulikkuse ja riski profiil on positiivne, kui muudetakse ravimiteavet selgitades, et soovitatav raviannus ja raviintervall lammastel põhineb ajal, kui kaua florfenikooli keskmine kontsentratsioon püsib üle MIC90 väärtuse.
English: Day 60 of the CMD(v) procedure was on 20 September 2011, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Estonian: Koordineerimisrühma menetluse 60. päev oli 20. septembril 2011 ja et asjaomased liikmesriigid ei saavutanud ravimi osas kokkulepet, tehti esildis veterinaarravimite komiteele.
English: Therefore, the Committee adopted a positive opinion on 12 June 2012 recommending the granting of a marketing authorisation for Nuflor 300 mg/ml solution for injection for cattle and sheep.
Estonian: Seetõttu võttis veterinaarravimite komitee 12. juunil 2012 vastu positiivse arvamuse, soovitades anda veterinaarravimi Nuflor 300 mg/ml veiste ja lammaste süstelahusele müügiloa.
English: The applicant, Intervet International BV, submitted an application for a decentralised procedure for Nuflor 300 mg/ml solution for injection for cattle and sheep.
Estonian: Taotleja Intervet International BV esitas Nuflor 300 mg/ml veiste ja lammaste süstelahuse detsentraliseeritud menetluse taotluse.
English: Nuflor 300 mg/ml solution for injection for cattle and sheep contains 300 mg florfenicol per ml.
Estonian: Nuflor 300 mg/ml veiste ja lammaste süstelahus sisaldab toimeainena 300 mg florfenikooli milliliitri kohta.
English: referral for Nuflor 300 mg/ml solution for injection for cattle and sheep
Estonian: kohast esildist Nuflor 300 mg/ml veiste ja lammaste süstelahus
English: On 21 September 2011, the reference Member State, Ireland, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Estonian: 21. septembril 2011 teatas viiteliikmesriik Iirimaa Euroopa Ravimiametile, et veterinaarravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm ei saavutanud ravimi
English: Opinion following an Article 33(4) referral for Nuflor 300 mg/ml solution for injection for cattle and sheep
Estonian: Arvamus pärast artikli 33 lõike 4 kohast esildist Nuflor 300 mg/ml veiste ja lammaste süstelahus EMA/657650/2012