FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spherox have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Spherox.
English: Spherox has been shown to improve patients' symptoms and knee function in two studies in adults between 18 and 50 years of age.
Danish: I to undersøgelser hos voksne i alderen 18-50 år blev det påvist, at Spherox forbedrer patienternes symptomer og knæfunktion.
English: It was to be available as tablets (5, 10, 25 and 50 mg).
Danish: Det skulle have været leveret som tabletter (5, 10, 25 og 50 mg).
English: Withdrawal of the marketing authorisation application for Elmisol (levamisole)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Elmisol (levamisol)
English: The company provided the results of studies on the quality, safety and effectiveness of the medicine, including information from the literature.
Danish: Virksomheden fremlagde resultaterne af undersøgelser af lægemidlets kvalitet, sikkerhed og virkning, herunder information fra litteraturen.
English: The study looked at the ability of the medicine to prevent the disease coming back.
Danish: I undersøgelsen så man nærmere på lægemidlets evne til at forhindre sygdommen i at vende tilbage.
English: What was Elmisol expected to be used for?
Danish: Hvad forventedes Elmisol anvendt til?
English: Levamisole has been used for many years to treat a variety of conditions, including worm infections and cancers.
Danish: Levamisol er i mange år blevet anvendt til at behandle forskellige tilstande, herunder ormeinfektioner og kræft.
English: Other concerns included the possibility of dosing errors because the different strengths of tablet might get confused, the way the stability of the active substance in the tablets had been tested, and inadequate information on the medicine's actions, distribution in the body and risks of interactions with other medicines.
Danish: Andre betænkeligheder omfattede risikoen for doseringsfejl, eftersom de forskellige tabletstyrker kunne forveksles, den måde, som stabiliteten af det aktive stof i tabletterne var blevet testet på, samt den utilstrækkelige information om lægemidlets virkningsmåde og fordeling i kroppen og risiciene for interaktioner med andre lægemidler.
English: What is Elmisol?
Danish: Hvad er Elmisol?
English: Elmisol is a medicine containing the active substance levamisole hydrochloride.
Danish: Elmisol er et lægemiddel, der indeholder det aktive stof levamisolhydrochlorid.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
English: The Committee was concerned about some elements of the way the main study was carried out and whether these were in accordance with the requirements of good clinical practice (GCP).
Danish: CHMP havde betænkeligheder med hensyn til visse aspekter af den måde, hovedundersøgelsen var blevet udført på, og hvorvidt disse var i overensstemmelse med kravene om god klinisk praksis (GCP).
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because there were concerns about the main study which would prevent its use to support the application.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak ansøgningen tilbage, fordi der var betænkeligheder med hensyn til hovedundersøgelsen, som gjorde, at den ikke kunne anvendes som støtte for ansøgningen.
English: On 29 May 2017, ACE Pharmaceuticals BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Elmisol, for the treatment of nephrotic syndrome.
Danish: Den 29. maj 2017 meddelte ACE Pharmaceuticals BV officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønskede at trække sin ansøgning om markedsføringstilladelse tilbage for Elmisol til behandling af nefrotisk syndrom.
English: Suppressing the immune system with corticosteroid medicines can bring the disease under control, but these medicines can have marked side effects and affect growth in young patients.
Danish: Ved at undertrykke immunsystemet med kortikosteroidholdige lægemidler kan sygdommen holdes under kontrol, men disse lægemidler kan have væsentlige bivirkninger og påvirke væksten hos unge patienter.
English: It is not completely understood how levamisole works in nephrotic syndrome, but it is known to affect the immune system (the body's natural defences).
Danish: Det vides ikke helt, hvordan levamisol virker ved nefrotisk syndrom, men det vides at have indvirkning på immunsystemet (kroppens naturlige forsvar).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Elmisol.
Danish: Virksomheden har oplyst CHMP om, at beslutningen ikke vil få konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Elmisol.
English: Nephrotic syndrome is a kidney disease that is marked by presence of large amounts of protein in the urine and results in fluid build-up in the body, with swelling (oedema), high blood pressure and weight gain.
Danish: Nefrotisk syndrom er en nyresygdom, som er kendetegnet ved store mængder protein i urinen, og som medfører væskeansamlinger i kroppen med hævelser (ødem), forhøjet blodtryk og vægtøgning.
English: Elmisol was to be used in patients in whom symptoms kept coming back after responding to initial treatment with corticosteroid medicines (steroid sensitive nephrotic syndrome).
Danish: Elmisol skulle have været anvendt til patienter, hvor symptomerne fortsatte med at vende tilbage, efter at patienterne havde responderet på indledende behandling med kortikosteroidholdige lægemidler (steroidfølsomt nefrotisk syndrom).
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Elmisol could not have been approved for the treatment of nephrotic syndrome.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP haft visse betænkeligheder og var af den foreløbige opfattelse, at Elmisol ikke kunne være blevet godkendt til behandling af nefrotisk syndrom.
English: Elmisol was to be used in children from 2 years of age to treat nephrotic syndrome.
Danish: Elmisol skulle have været anvendt til børn fra 2-årsalderen til behandling af nefrotisk syndrom.
English: The main study compared levamisole with placebo (a dummy treatment) in children with nephrotic syndrome that had been brought under control with corticosteroids.
Danish: I hovedundersøgelsen blev levamisol sammenlignet med placebo (en uvirksom behandling) hos børn med nefrotisk syndrom, der var blevet kontrolleret med kortikosteroider.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Elmisol in the proposed indication did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Elmisol ikke opvejede risiciene.
English: Elmisol was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for nephrotic syndrome.
Danish: Elmisol blev udpeget som "lægemiddel til sjældne sygdomme" den 28. oktober 2005 mod nefrotisk syndrom.
English: Levamisole is thought to modify the action of the immune system, helping to control the disease and so reducing the amount of corticosteroids the patient needs.
Danish: Levamisol menes at ændre immunsystemets virkning og hjælpe med at kontrollere sygdommen, så patienten har brug for en lavere dosis kortikosteroider.
English: In patients with nephrotic syndrome, the immune system is believed to attack the kidney in error, resulting in leakage of proteins out of the kidney into urine.
Danish: Man mener, at immunsystemet hos patienter med nefrotisk syndrom fejlagtigt angriber nyrerne, hvilket resulterer i, at der lækkes proteiner fra nyrerne ud i urinen.
English: How does Elmisol work?
Danish: Hvordan virker Elmisol?
English: Page 2/2
Danish: juni 2017
English: Invented name Strength Pharmaceutical
Danish: Særnavn Styrke Lægemiddel
English: 1 bottle
Danish: 500 ml 1 flaske
English: 10 bottles
Danish: 500 ml 10 flasker Nul døgn
English: Immediate Packaging Pack size
Danish: Administration Emballage Pakningsstørrelse
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform
English: --1 1 dose (0.5 ml) contains approximately:
Danish: --1 1 dosis (0,5 ml) indeholder ca.:
English: ² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology
Danish: L1 protein i form af viruslignende partikler produceret i gærceller (Saccharomyces cerevisiae CANADE 3C-5 (stamme 1895)) ved hjælp af rekombinant DNA-teknologi.
English: ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.5 milligrams Al)
Danish: Adsorberet på amorf aluminiumhydroxyphosphat-sulfat-adjuvans (0,5 milligram Al).
English: 10 syringes
Danish: 10 fyldte sprøjter
English: 10 syringes + 20 needles
Danish: 10 fyldte sprøjter + 20 nåle
English: 1 syringe + 2 needles
Danish: 1 fyldt sprøjte + 2 nåle
English: What is Perlinring?
Danish: Hvad er Perlinring?
English: The Agency concluded that the benefits of Perlinring outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Spain, Finland, France, Germany, Hungary, Ireland, Italy, Lithuania, Latvia, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia and Sweden, plus Iceland and Norway.
Danish: Agenturet konkluderede, at fordelene ved Perlinring opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i følgende EU-medlemsstater: Østrig, Belgien, Kroatien, Tjekkiet, Danmark, Estland, Spanien, Finland, Frankrig, Tyskland, Ungarn, Irland, Italien, Litauen, Letland, Nederlandene, Polen, Portugal, Rumænien, Slovenien, Slovakiet og Sverige samt Island og Norge.
English: The review of Perlinring was initiated at the request of the United Kingdom, under Article 29 of Directive 2001/83/EC.
Danish: Gennemgangen af Perlinring blev indledt på foranledning af Det Forenede Kongerige, jf. artikel 29 i direktiv 2001/83/EF.
English: The European Commission issued an EU-wide legally binding decision on 18 December 2018.
Danish: Europa-Kommissionen vedtog en afgørelse, der er retligt bindende i hele EU den 18. december 2018.
English: medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de giver de samme niveauer af det aktive stof i kroppen, og de forventes derfor at have samme effekt.
English: On 18 October 2018, the European Medicines Agency completed a review of Perlinring following a disagreement among EU Member States regarding its authorisation.
Danish: Den 18. oktober 2018 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Perlinring efter en uoverensstemmelse blandt medlemsstaterne om dets godkendelse.
English: Each ring contains two hormones, etonogestrel and ethinylestradiol, which are slowly released into the blood circulation and prevent the release of eggs from the ovaries.
Danish: Hver ring indeholder to hormoner, etonogestrel og ethinylestradiol, der langsomt frigives i blodkredsløbet, og forhindrer, at der frigives æg fra æggestokkene.
English: Perlinring is used for 21 days (3 weeks) in a row, followed by a 7-day break, after which a new ring should be used.
Danish: Perlinring anvendes i 21 dage (3 uger) i træk efterfulgt af en pause på 7 dage, hvorefter der bør tages en ny ring i brug.
English: The Agency therefore concluded that the benefits of Perlinring outweigh its risks and recommended that the marketing authorisation be granted in all concerned Member States.
Danish: Agenturet konkluderede derfor, at fordelene ved Perlinring opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse i alle berørte medlemsstater.
English: Perlinring was developed as a generic medicine.
Danish: Perlinring blev udviklet som et "generisk lægemiddel".
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 7 August 2018.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den britiske lægemiddelstyrelse indbragte den 7. august 2018 sagen for EMA med henblik på voldgift.
English: Actavis Group PTC EHF submitted Perlinring to the UK medicines agency for a decentralised procedure.
Danish: Actavis Group PTC EHF søgte Perlinring godkendt af Det Forenede Kongeriges lægemiddelagentur ved en decentraliseret procedure.
English: Why was Perlinring reviewed?
Danish: Hvorfor blev der foretaget en gennemgang af Perlinring?
English: Perlinring is a contraceptive vaginal ring used to prevent pregnancy.
Danish: Perlinring er en præventiv vaginalring, der anvendes til at forebygge graviditet.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned' Member States, see list above) where the company has applied for a marketing authorisation.
Danish: Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Det Forenede Kongerige) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de "berørte medlemsstater", jf. ovenfor), hvor virksomheden har ansøgt om en markedsføringstilladelse.
English: Bioequivalence data for week 4 were considered necessary by Germany, France and the Netherlands as Perlinring is expected to be used in the same way as Nuvaring.
Danish: Bioækvivalensdata for uge 4 blev anset for nødvendige af Tyskland, Frankrig og Nederlandene, da Perlinring forventes anvendt på samme måde som Nuvaring.
English: This means that Perlinring was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in the EU called Nuvaring.
Danish: Det betyder, at Perlinring skulle indeholde det samme aktive stof og virke på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Nuvaring.
English: The grounds for the referral relate to concerns raised by Germany, France and the Netherlands, that the Nuvaring product information for doctors and patients states that the product continues to be effective if it is used for an additional 4th week.
Danish: Begrundelsen for indbringelsen var betænkelighed rejst af Tyskland, Frankrig og Nederlandene ved, at Nuvarings produktoplysninger til læger og patienter fastslår, at produktet fortsat er effektivt, hvis det anvendes i en yderligere 4. uge.
English: Although the bioequivalence data submitted were sufficient to show that Perlinring is bioequivalent to Nuvaring over a period of 3 weeks, they did not cover the additional 4th week during which the contraceptive ring may still be used, even though this use is not recommended.
Danish: Selv om de fremlagte bioækvivalensdata var tilstrækkelige til at påvise, at Perlinring er bioækvivalent med Nuvaring i en periode på 3 uger, dækkede de ikke den ekstra 4. uge, hvor den præventive ring stadig kan anvendes, selv om denne anvendelse ikke anbefales.
English: Based on evaluation of the currently available data, the Agency considered that bioequivalence to the reference medicinal product has been shown for the authorised duration of treatment (3 weeks).
Danish: Efter vurdering af de foreliggende data fandt agenturet, at bioækvivalens med referencelægemidlet er påvist under behandlingens tilladte varighed (3 uger).
English: In addition, there is enough evidence to expect that Perlinring continues to be effective for an additional 4th week, as is the case for Nuvaring.
Danish: Der er desuden tilstrækkelig dokumentation for, at Perlinring fortsat er effektiv i yderligere en 4 .
English: In its application, the company for Perlinring provided data demonstrating that Perlinring is ‘bioequivalent' to Nuvaring over a period of 3 weeks, which is the authorised length of treatment.
Danish: Virksomheden, der søger om godkendelse af Perlinring, har vedlagt sin ansøgning dokumentation for, at Perlinring er "bioækvivalent" med Nuvaring i en periode på 3 uger, hvilket svarer til den godkendte
English: EMA/720896/2018 Rev 1
Danish: EMA anbefaler godkendelse af Perlinring (vaginalring med etonogestrel/ethinylestradiol) i EU EMA/720896/2018 Rev 1
English: The Marketing Authorisation Holder was requested: 1.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om: 1.
English: EMEA/458933/2008-EN
Danish: EMEA/458933/2008-DA
English: The CVMP Opinion was adopted on 11 October 2007 and the subsequent Commission Decision on 11 January 2008.
Danish: CVMP's udtalelse blev vedtaget den 11. oktober 2007 og efterfølgende afgørelse truffet af EuropaKommissionen den 11. januar 2008.
English: The CVMP started the referral procedure during its meeting of 12-14 September 2006.
Danish: CVMP indledte indbringelsesproceduren på sit møde den 12.-14. september 2006.
English: To provide the relevant parts of the dossier of each Member State where an application has been submitted and to detail the differences between the dossiers.
Danish: At fremskaffe de relevante dele af dossieret for hver medlemsstat, hvor en ansøgning er indsendt, og at give oplysninger om forskellene mellem dossiererne.
English: Methoxasol-T was authorised through a national procedure in The Netherlands in 1999, but a marketing authorisation was refused in Germany in 2001.
Danish: Methoxasol-T blev godkendt ved en national procedure í Nederlandene i 1999, men der blev givet afslag på en markedsføringstilladelse i Tyskland i 2001.
English: The CVMP recommended in relation to the pharmacokinetic properties described that the inclusion of environmental effects should be deleted.
Danish: CVMP anbefalede i forhold til de beskrevne farmakokinetiske egenskaber, at inklusionen om virkningerne på miljøet bør slettes.
English: Germany considered that the efficacy of Methoxasol-T as proposed by the applicant was not adequately justified, therefore resulting in a potential serious risk to the target animals.
Danish: Tyskland fandt, at virkningen af MethoxasolT som fremført af ansøgeren ikke var tilstrækkeligt begrundet og derfor kunne føre til en potentiel alvorlig risiko for måldyrene.
English: To justify compliance of the dossier with respect to the requirements for obtaining a marketing authorisation (Annex I of Directive 2001/82/EC, as amended).
Danish: At begrunde, at dossieret opfylder kravene til udstedelse af en markedsføringstilladelse (Bilag I til direktiv 2001/82/EF, med senere ændringer).
English: On the basis of the data provided, the CVMP agreed on the following harmonised indications for use:
Danish: På grundlag af de indsendte data godkendte CVMP følgende harmoniserede terapeutiske indikationer:
English: To consider in particular the issues mentioned in the referral notification as the grounds for refusing an authorisation in Germany.
Danish: At overveje især de spørgsmål, der er anført i indbringelsesanmeldelsen, som grundlag for afslag på en markedsføringstilladelse i Tyskland.
English: For poultry comment was required on the current use of the product, in particular on the dose used or prescribed under field conditions.
Danish: Vedrørende fjerkræ var der behov for kommentarer om den aktuelle anvendelse af lægemidlet, især med hensyn til den dosis, der anvendes eller ordineres i praksis.
English: An intended application for a marketing authorisation of a generic triggered Germany to submit the referral regarding the divergent decisions taken on Methoxasol-T.
Danish: En tilsigtet ansøgning om en markedsføringstilladelse til et generisk lægemiddel foranledigede Tyskland til at indbringe en sag i forbindelse med de afvigende beslutninger, der blev truffet om Methoxasol-T.
English: The CVMP also recommended that the use of the product should be based on culture and sensitivity testing of micro-organisms from diseased cases on farm or from recent previous experience on the farm, as resistance against potentiated sulphonamides may vary.
Danish: CVMP anbefalede også, at anvendelsen af midlet bør baseres på kultur- og følsomhedstest af mikroorganismer fra sygdomstilfælde eller nyere erfaringer på bedriften, da resistens mod forstærkede sulfonamider kan variere.
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concluded that the benefit/risk balance of the product is positive for use in both pigs and broilers subject to recommended changes to the Summary of Product Characteristics and product information, and that the concerns raised by Germany should not prevent the granting of a marketing authorisation.
Danish: Efter at have overvejet begrundelsen for indbringelsen og de svar, der blev givet af indehaveren af markedsføringstilladelsen, konkluderede CVMP, at lægemidlets benefit/risk-forhold er positivt til brug til både svin og slagtekyllinger under forudsætning af de anbefalede ændringer i produktresumeet og produktoplysningerne, samt at de betænkeligheder, som Tyskland rejste, ikke bør forhindre udstedelsen af en markedsføringstilladelse.
English: OPINION FOLLOWING AN ARTICLE 34 REFERRAL FOR METHOXASOL-T
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 34 VEDRØRENDE METHOXASOL-T
English: To propose and justify with data a suitable shelf life for the product, including an in-use shelf life where relevant.
Danish: Ved hjælp af data at foreslå og begrunde en passende opbevaringstid for lægemidlet, herunder en opbevaringstid under brug, når dette er relevant.
English: On 8 September 2006, Germany presented to the EMEA a referral under Article 34 of Directive 2001/82/EC, as amended, concerning Methoxasol-T (including associated names), containing trimethoprim and sulfamethoxazole as active ingredient.
Danish: Den 8. september 2006 indbragte Tyskland en sag for EMEA i henhold til artikel 34 i direktiv 2001/82/EF, med senere ændringer, vedrørende Methoxasol-T (inkl.
English: The Marketing Authorisation Holder submitted written responses, defending the indications, recommended dose and shelf life, and proposing a harmonised SPC text.
Danish: Indehaveren af markedsføringstilladelsen indsendte skriftlige svar med forsvar af indikationerne, den anbefalede dosis og opbevaringstid samt forslag til en harmoniseret tekst til produktresuméet.
English: To justify with field data, the use of the product and the adequacy of the recommended dose for each of the claimed indications in pigs and poultry.
Danish: At begrunde produktets anvendelse og den anbefalede dosis' tilstrækkelighed ved hjælp af feltundersøgelser for hver af de påståede indikationer til grise og fjerkræ.
English: To propose and justify a harmonised text of the Summary of Product Characteristics (SPC), including posology and method of administration as well as withdrawal periods for pigs and poultry.
Danish: At foreslå og begrunde en harmoniseret tekst til produktresuméet, herunder dosering og indgivelsesmåde samt tilbageholdelsestid for svin og fjerkræ.