FrancophonIA/ELRC3.0 huggingface dataset:
English: CARTON OF UNIT PACK - pre-filled syringe
Slovenian: ŠKATLA POSAMIČNEGA PAKIRANJA- napolnjena injekcijska brizga
English: Aimovig 140 mg solution for injection in pre-filled syringe erenumab
Slovenian: Aimovig 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku erenumab
English: The entire contents of the Aimovig pre-filled pen should be injected.
Slovenian: Injicirati je treba celotno vsebino napolnjenega injekcijskega peresnika z zdravilom Aimovig.
English: Aimovig 70 mg injection erenumab
Slovenian: Aimovig 70 mg injekcija erenumab s.c.
English: - Aimovig 70 mg solution for injection in pre-filled pen contains 70 mg erenumab.
Slovenian: - Aimovig 70 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku vsebuje 70 mg erenumaba.
English: MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENA ZA PROMET Z ZDRAVILOM
English: - Aimovig 140 mg solution for injection in pre-filled pen contains 140 mg erenumab.
Slovenian: - Aimovig 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku vsebuje 140 mg erenumaba.
English: In patients failing two or more prophylactic pharmacotherapies the treatment difference was -4.3 days (95% CI: -5.8; -2.8) between 140 mg and placebo and -2.7 days (95% CI: -4.2, -1.2) between 70 mg and placebo.
Slovenian: Pri bolnikih z neuspehom dveh ali več profilaktičnih farmakoterapij je znašala razlika zaradi zdravljenja z erenumabom 140 mg v primerjavi z uporabo placeba -4,3 dneva (95-odstotni IZ: -5,8; -2,8) razlika zaradi zdravljenja z erenumabom 70 mg v primerjavi z uporabo placeba pa -2,7 dneva (95-odstotni IZ: -4,2 -1,2).
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).
Slovenian: Pri bolnikih z neuspehom ene ali več profilaktičnih farmakoterapij je razlika zaradi zdravljenja z erenumabom 140 mg v primerjavi z uporabo placeba za zmanjševanje števila migrenskih dni na mesec (MDM) znašala -3,3 dneva (95-odstotni IZ: -4,6; -2,1), razlika zaradi zdravljenja z erenumabom 70 mg v primerjavi z uporabo placeba pa -2,5 dneva (95-odstotni IZ: -3,8;-1,2).
English: One pre-filled syringe contains 70 mg erenumab.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 70 mg erenumaba.
English: Aimovig 70 mg solution for injection in pre-filled syringe
Slovenian: Aimovig 70 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: MIDAS (modified) total Mean changec (95% CI)
Slovenian: MIDAS (modificirana) skupna ocena povprečna spremembac
English: CARTON OF UNIT PACK - pre-filled pen
Slovenian: ŠKATLA POSAMIČNEGA PAKIRANJA - napolnjen injekcijski peresnik
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Slovenian: Napolnjene injekcijske peresnike shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
English: Pack containing 1 pre-filled pen
Slovenian: Pakiranje vsebuje 1 napolnjen injekcijski peresnik.
English: Label and expiry date
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Aimovig 140 mg solution for injection in pre-filled syringe
Slovenian: Aimovig 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Do not use the pen if the cap is missing or is not securely attached.
Slovenian: injekcijskega peresnika ne smete uporabiti, če je brez pokrovčka ali ta ni varno nameščen.
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).
Slovenian: Pri bolnikih z neuspehom ene ali več profilaktičnih farmakoterapij je razlika zaradi zdravljenja z erenumabom 140 mg v primerjavi z uporabo placeba za zmanjševanje števila MDM znašala -2,5 dneva (95-odstotni IZ: -3,4; -1,7), razlika zaradi zdravljenja z erenumabom 70 mg v primerjavi z uporabo placeba pa -2,0 dneva (95-odstotni IZ: -2,8;-1,2).
English: Do not use this medicine if you notice that the solution contains particles, is cloudy or is distinctly yellow.
Slovenian: Če opazite, da raztopina vsebuje delce, je motna ali izrazito rumene barve, zdravila ne smete uporabiti.
English: Each pre-filled syringe contains 70 mg erenumab.
Slovenian: Ena napolnjen injekcijski peresnik vsebuje 70 mg erenumaba.
English: MIDAS total Mean changec (95% CI)
Slovenian: MIDAS skupna ocena povprečna spremembac (95-odstotni IZ)
English: Cotton balls or gauze pads Adhesive plasters Sharps disposal container
Slovenian: rumen varnostni ščitnik oranžen pokrovček je odstranjen sivi sprožilni gumb
English: To avoid discomfort at the site of injection, leave the syringe(s) at room temperature for at least 30 minutes before injecting.
Slovenian: Da ne bi prišlo do neprijetnega občutka na mestu injiciranja, je treba eno oziroma dve injekcijski brizgi pred injiciranjem pustiti na sobni temperaturi najmanj 30 minut.
English: Hypersensitivity reactions including rash, swelling/oedema and urticaria
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije, vključno z izpuščajem, otekanjem/edemi in urtikarijo pogosti
English: Posology
Slovenian: Splošni napotki
English: Sodium hydroxide (for pH adjustment) Glacial acetic acid
Slovenian: 6.1 Seznam pomožnih snovi saharoza polisorbat 80 natrijev hidroksid (za uravnavanje pH) ocetna kislina, koncentrirana voda za injekcije
English: Each pre-filled syringe contains 140 mg erenumab.
Slovenian: En napolnjen injekcijski peresnik vsebuje 140 mg erenumaba.
English: Pull the cap straight off, only when you are ready to inject.
Slovenian: Ko ste povsem pripravljeni na injiciranje, potegnite pokrovček naravnost z injekcijskega peresnika.
English: Do not leave the cap off for more than 5 minutes.
Slovenian: Opozorilo: injekcijskega peresnika ne puščajte brez pokrovčka več kot 5 minut, da se zdravilo ne bi posušilo.
English: Aimovig 140 mg solution for injection in pre-filled pen
Slovenian: Aimovig 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: SYRINGE LABEL
Slovenian: NALEPKA NA INJEKCIJSKI BRIZGI
English: OTHER
Slovenian: d
English: Package size blister (PVC/Aclar/PVC-alu) 1 tablet
Slovenian: EU/1/10/642/001 Ibandronska kislina Teva 50 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/Aclar/PVC-alu) 28 tablet EU/1/10/642/002 Ibandronska kislina Teva 50 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/Aclar/PVC-alu) 84 tablet EU/1/10/642/003 Ibandronska kislina Teva 150 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/Aclar/PVC-alu) 1 tableta EU/1/10/642/004 Ibandronska kislina Teva 150 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/Aclar/PVC-alu) 3 tablete
English: Strength Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika pot uporabe ovojnina
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoRapid on 7 September 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom NovoRapid, veljavno po vsej Evropski uniji, izdala 7. septembra 1999.
English: This allows it to start acting faster than human insulin.
Slovenian: To mu omogoča, da lahko začne hitreje učinkovati kot humani insulin.
English: The usual dose is between 0.5 and 1.0 units per kilogram body weight per day.
Slovenian: Običajni odmerek je med 0,5 in 1,0 enote na kilogram telesne mase na dan.
English: What measures are being taken to ensure the safe and effective use of NovoRapid?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila NovoRapid?
English: The injection site should be changed for each injection.
Slovenian: Mesto injiciranja je treba pri vsakem injiciranju injekciji menjati.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NovoRapid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is NovoRapid and what is it used for?
Slovenian: Kaj je zdravilo NovoRapid in za kaj se uporablja?
English: Other information about NovoRapid
Slovenian: Druge informacije o zdravilu NovoRapid
English: NovoRapid is used to treat adults, adolescents and children over one year old who have diabetes.
Slovenian: Zdravilo NovoRapid se uporablja za zdravljenje odraslih, mladostnikov in otrok, starejših od enega leta, ki imajo sladkorno bolezen.
English: NovoRapid can be used in pregnant women.
Slovenian: Zdravilo NovoRapid lahko uporabljajo nosečnice.
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila NovoRapid večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: NovoRapid reduced HbA1c levels by 0.12% and by 0.15% more than human insulin did after six months.
Slovenian: Zdravilo NovoRapid je po šestih mesecih znižalo ravni HbA1c za 0,12 % in 0,15 % bolj kot humani insulin.
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.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila NovoRapid, so bili vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This is a summary of the European public assessment report (EPAR) for NovoRapid.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NovoRapid.
English: It is not intended to provide practical advice on how to use NovoRapid.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Patients can inject themselves under the skin with NovoRapid if they have been trained appropriately.
Slovenian: Bolniki si lahko zdravilo NovoRapid v podkožje injicirajo sami, če so bili za to ustrezno usposobljeni.
English: NovoRapid is usually given immediately before a meal, although it may be given after a meal if necessary.
Slovenian: Zdravilo NovoRapid se običajno daje neposredno pred obrokom, po potrebi pa tudi po obroku.
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.
Slovenian: Kadar se uporablja s hrano, lahko zdravilo NovoRapid zadovolji 50-70 % potrebe po insulinu, preostanek pa srednjedolgodelujoči ali dolgodelujoči insulin.
English: Why is NovoRapid approved?
Slovenian: Zakaj je bilo zdravilo NovoRapid odobreno?
English: What are the risks associated with NovoRapid?
Slovenian: Kakšna tveganja so povezana z zdravilom NovoRapid?
English: What benefits of NovoRapid have been shown in studies?
Slovenian: Kakšne koristi je zdravilo NovoRapid izkazalo med študijami?
English: The most common side effect with NovoRapid (seen in between 1 and 10 patients in 100) is hypoglycaemia (low blood glucose levels).
Slovenian: Najpogostejši neželeni učinek zdravila NovoRapid (opažen pri 1 do 10 bolnikih od 100) je hipoglikemija (nizka koncentracija glukoze v krvi).
English: NovoRapid is normally used in combination with an intermediate- or long-acting insulin given at least once a day.
Slovenian: Običajno se uporablja v kombinaciji s srednjedolgodelujočim ali dolgodelujočim insulinom in se daje vsaj enkrat na dan.
English: For more information about treatment with NovoRapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom NovoRapid preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: NovoRapid insulin aspart
Slovenian: Povzetek EPAR za javnost insulin aspart
English: It contains the active substance insulin aspart, a rapid-acting insulin.
Slovenian: Vsebuje zdravilno učinkovino insulin aspart, ki je hitro delujoči insulin.
English: It is given by injection under the skin in the abdominal (belly) wall, the thigh, the upper arm, the shoulder or the buttock.
Slovenian: Injicira se v podkožje trebušne stene (trebuha), stegna, nadlakti, ramena ali zadnjice.
English: NovoRapid is a replacement insulin that is very similar to the insulin made by the body but is absorbed faster by the body.
Slovenian: Zdravilo NovoRapid je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja telo vendar ga za razliko od humanega insulina telo hitreje absorbira.
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.
Slovenian: Poleg tega se lahko uporablja v sistemih s črpalko za kontinuirano infundiranje insulina pod kožo ali pa se vbrizga v veno, vendar ga tako smeta dati samo zdravnik ali medicinska sestra.
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.
Slovenian: V študijah so primerjali zdravilo NovoRapid s humanim insulinom z merjenjem koncentracije snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi uravnana.
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).
Slovenian: Rezultati za zdravilo NovoRapid so bili skoraj popolnoma enaki kot za humani insulin v dveh študijah, v katerih so zdravilo proučevali pri 1 954 bolnikih s sladkorno boleznijo tipa 1 (pri kateri trebušna slinavka ne more tvoriti insulina) in pri 182 bolnikih s sladkorno boleznijo tipa 2 (pri kateri telo ne more učinkovito izrabiti insulina).
English: The replacement insulin works in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Slovenian: Nadomestni insulin deluje enako kot naravno proizvedeni insulin in omogoča, da lahko glukoza iz krvi preide v celice.
English: For practical information about using NovoRapid, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila NovoRapid naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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.
Slovenian: Zdravilo NovoRapid je raztopina za injiciranje, ki je na voljo v vialah, injekcijskih vložkih (PenFill in PumpCart) in napolnjenih injekcijskih peresnikih (FlexPen, FlexTouch in InnoLet).
English: For the full list of all side effects and restrictions with NovoRapid, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila NovoRapid, glejte navodilo za uporabo.
English: NovoRapid has also given comparable results when studied in children from one year of age.
Slovenian: Primerljive rezultate je pokazalo tudi pri proučevanju zdravila pri otrocih, starejših od enega leta.
English: How is NovoRapid used?
Slovenian: Kako se zdravilo NovoRapid uporablja?
English: How does NovoRapid work?
Slovenian: Kako zdravilo NovoRapid deluje?
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).
Slovenian: V dveh študijah, v kateri je bilo vključenih 349 nosečnic s sladkorno boleznijo tipa 1 ali nosečnostno sladkorno boleznijo (sladkorno boleznijo, ki se pojavi zaradi nosečnosti) so dokazali, da je njegova varnost enaka kot pri humanem insulinu.
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.
Slovenian: Vloga je bila predložena Irski kot referenčni državi članici ter Belgiji, Danski, Franciji, Nemčiji, Grčiji, Italiji, Luksemburgu, Nizozemski, Portugalski, Španiji in Združenemu kraljestvu kot zadevnim državam članicam.
English: The final opinion was converted into a Decision by the European Commission on 17 September 2012.
Slovenian: Končno mnenje je bilo 17. septembra 2012 spremenjeno v odločbo Evropske komisije.
English: The Committee appointed Prof Christian Friis as rapporteur and Dr David Murphy as co-rapporteur.
Slovenian: Odbor je imenoval prof. Christiana Friisa za poročevalca in dr. Davida Murphyja za soporočevalca.
English: Article 33(4) of Directive 2001/82/EC
Slovenian: Člen 33(4) Direktive 2001/82/ES.
English: The decentralised procedure (IE/V/0269/001/DC) started on 13 August 2010.
Slovenian: Decentralizirani postopek (IE/V/0269/001/DC) se je začel 13. avgusta 2010.
English: This application was an extension (Article 19 of Regulation 1234/2008/EC) to add sheep as new target species.
Slovenian: Pri tej vlogi je šlo za razširitev (člen 19 Uredbe 1234/2008/ES), s katero bi se ovce dodale kot nova ciljna vrsta.
English: During the procedure the applicant provided additional data and the issues raised by France regarding the proposed indications were resolved.
Slovenian: Med tem postopkom je predlagatelj predložil dodatne podatke in pomisleki, ki jih je izpostavila Francija o predlaganih indikacijah, so bili odpravljeni.
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.
Slovenian: Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetka glavnih značilnosti zdravila in navodila za uporabo v Prilogi III.
English: Written explanations were provided by the applicant on 9 January 2012 and 23 April 2012.
Slovenian: Predlagatelj je 9. januarja in 23. aprila 2012 predložil pisna pojasnila ter 15. maja 2012 še ustna pojasnila.
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.
Slovenian: Zdravilno učinkovino vsebujejo zdravila za uporabo v veterinarski medicini, ki so trenutno odobrena v več državah članicah Evropske unije za zdravljenje bolezni dihal pri govedu in prašičih.
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.
Slovenian: Šestdeseti dan postopka CMD(v) je bil 20. september 2011, in ker zadevne države članice niso uspele doseči soglasja v zvezi z zdravilom, je bil postopek napoten na odbor CVMP.
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.
Slovenian: Med decentraliziranim postopkom sta dve zadevni državi članici opredelili možna resna tveganja v zvezi s predlaganimi indikacijami (Francija) in učinkovitostjo zdravila (Danska).
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.
Slovenian: Ker ti pomisleki na 210. dan še vedno niso bili rešeni, je bila zadeva 22. julija 2011 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
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.
Slovenian: Na podlagi ocene poročevalcev o trenutno razpoložljivih podatkih je odbor CVMP menil, da je razmerje med koristmi in tveganji za zdravilo Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce pozitivno pod pogojem, da se informacije o zdravilu dopolnijo s pojasnilom, da priporočeni terapevtski odmerek in interval odmerjanja temeljita na času, dokler se povprečne koncentracije florfenikola ohranjajo nad MIK90.
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.
Slovenian: Dne 21. septembra 2011 je referenčna država članica, Irska, obvestila Evropsko agencijo za zdravila, da Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v veterinarski medicini (CMD(v)) ni dosegla soglasja glede zdravila, in zadevo napotila na odbor CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
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.
Slovenian: Odbor je zato 12. junija 2012 sprejel pozitivno mnenje, v katerem priporoča odobritev dovoljenja za promet z zdravilom Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce.
English: Nuflor 300 mg/ml solution for injection for cattle and sheep contains 300 mg florfenicol per ml.
Slovenian: Zdravilo Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce vsebuje 300 mg florfenikola na mililiter.
English: Opinion following an Article 33(4) referral for Nuflor 300 mg/ml solution for injection for cattle and sheep
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4) za zdravilo Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce
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.
Slovenian: Predlagatelj, družba Intervet International BV, je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce po decentraliziranem postopku.
English: referral for Nuflor 300 mg/ml solution for injection for cattle and sheep
Slovenian: za zdravilo Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce
English: Date of first authorisation: 10 April 2014 Date of last renewal: 12 December 2018
Slovenian: Datum prve odobritve: 10. april 2014 Datum zadnjega podaljšanja: 12. december 2018
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU(seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.