FrancophonIA/ELRC3.0 huggingface dataset:
English: At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”
Danish: På tidspunktet for tilbagetrækningen af ansøgningen var CHMP var af den foreløbige opfattelse, at Corluxin ikke kunne godkendes til den brede indikation, som virksomheden havde ansøgt om, dvs. "behandling af voksne patienter med endogent Cushings syndrom, hos hvem operation ikke er mulig eller ikke har virket."
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Corluxin in the proposed indication did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Corluxin ikke opvejede risiciene.
English: The company informed the CHMP that, at the time of the withdrawal, there were no ongoing clinical trials or compassionate use programmes for Corluxin.
Danish: Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var nogen igangværende kliniske undersøgelser med Corluxin eller programmer for anvendelse med særlig udleveringstilladelse.
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone) EMA/261739/2015
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Corluxin (mifepriston) EMA/386100/2015
English: The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors.
Danish: Det aktive stof i Corluxin, mifepriston, blokerer receptorerne for kortisol (glukokortikoidreceptorer GRII).
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Corluxin eller i programmer for anvendelse af Corluxin med særlig udleveringstilladelse?
English: On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients.
Danish: Dette gjaldt bivirkninger forårsaget af den nedsatte aktivitet af cirkulerende kortisol, forstyrrelser i væske- og mineralbalancen (navnlig nedsat kaliumindhold i blodet og øget blodtryk hos nogle patienter) samt fortykkelse af livmoderen hos nogle kvindelige patienter.
English: Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.
Danish: Det var hensigten, at Corluxin skulle anvendes til behandling af Cushings syndrom, når operation ikke er mulig eller ikke har virket.
English: Communication Plan
Danish: Kommunikationsplan
English: The harmonised date for release of the letter is of 15 working days following the European Commission decision.
Danish: Den harmoniserede dato for offentliggørelsen af brevet er 15 arbejdsdage efter Europa-Kommissionens afgørelse.
English: The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) as agreed by the CHMP.
Danish: Indehaverne af markedsføringstilladelserne skal informere fagfolkene inden for sundhedssektoren om resultaterne af denne gennemgang af nimesulid via et ”Direct Healthcare Professional Communication” (DHPC) efter aftale med CHMP.
English: CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSERNE De kompetente nationale myndigheder, koordineret af referencemedlemsstaten, hvor dette er relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelserne:
English: Condition of the marketing authorisations
Danish: Bilag IV Betingelser for markedsføringstilladelserne
English: EMEA/457286/2008-EN
Danish: EMEA/457286/2008-DA
English: The established withdrawal periods are safe and can be retained.
Danish: De fastsatte tilbageholdelsestider er sikre og kan bibeholdes.
English: Having assessed the responses, the CVMP concluded that:
Danish: Efter vurdering af svarene konkluderede CVMP, at:
English: o The Periodic Safety Update Reports for at least the last 3 years.
Danish: o Periodiske, opdaterede sikkerhedsberetninger for mindst de sidste 3 år.
English: The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 11 March 2008.
Danish: CVMP vedtog sin udtalelse den 12. december 2007, og Kommissionen vedtog den efterfølgende beslutning den 11. marts 2008.
English: No dose could be established for the treatment of salmonellosis.
Danish: Der kunne ikke fastsættes en dosis til behandling af salmonellose.
English: The CVMP started the referral procedure during its meeting of 10-12 July 2007.
Danish: CVMP indledte indbringelsesproceduren på mødet den 10.-12. juli 2007.
English: France considered that the dosing regime of the product is not correct.
Danish: Efter Frankrigs opfattelse er dosisregimet for dette produkt ikke korrekt.
English: The Marketing Authorisation Holders were requested in a list of questions to provide:
Danish: Indehaverne af markedsføringstilladelsen blev på en liste med spørgsmål anmodet om at fremkomme med:
English: The use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Danish: Brugen af produktet bør baseres på følsomhedstest og tage højde for officielle og lokale antimikrobielle politikker.
English: • Justification of the withdrawal period, in case the recommended dose should increase.
Danish: • Begrundelse for tilbageholdelsestiden, hvis den anbefalede dosis skal øges.
English: Neither the Periodic Safety Update Reports of the products nor the literature presented included reports of lack of efficacy in the field.
Danish: Hverken produkternes periodiske, opdaterede sikkerhedsberetninger eller den fremlagte litteratur omfattede beretninger om manglende virkning på området.
English: The CVMP recommended varying the Marketing Authorisations of the concerned veterinary medicinal products in accordance with the conclusions where applicable.
Danish: CVMP anbefalede en ændring af markedsføringstilladelserne for de berørte veterinærlægemidler i overensstemmelse med konklusionerne efter relevans.
English: OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR VETERINARY MEDICINAL PRODUCTS WHICH CONTAIN THE ACTIVE SUBSTANCES TRIMETHOPRIM AND SULFADIAZINE
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 35 VEDRØRENDE VETERINÆRLÆGEMIDLER, SOM INDEHOLDER DE AKTIVE STOFFER TRIMETHOPRIM OG SULFADIAZIN
English: On 11 July 2007, France presented to the EMEA a referral under Article 35 of Directive 2001/82/EC, as amended, concerning Tribrissen Oral Paste for Horses (including associated names) and authorised products for which this product served as a reference product, containing trimethoprim and sulfadiazine as active ingredient.
Danish: I henhold til artikel 35 i direktiv 2001/82/EF, med senere ændringer, indbragte Frankrig den 11. juli 2007 en sag for EMEA, som vedrørte Tribrissen oral pasta til heste (inklusive tilknyttede navne) og godkendte produkter, for hvilke dette produkt tjener som referenceprodukt, indeholdende trimethoprim og sulfadiazin som aktive stoffer.
English: There is no documented evidence of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Danish: Der foreligger ingen dokumentation for problemer i forbindelse med manglende virkning eller en eventuel ændring i resistenssituationen for de relevante målpatogener, som ville udgøre et problem med henblik på dyrs eller menneskers sundhed.
English: The efficacy of a dose of 1x30 mg/kg body weight per day to be administered over a maximum period of 5 days has been substantiated for all indications, except for salmonellosis.
Danish: Virkningen af en dosis på 1 x 30 mg/kg kropsvægt pr. dag til indgivelse i højst 5 dage er dokumenteret for alle indikationer, undtagen for salmonellose.
English: • Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria.
Danish: • Begrundelse for den anbefalede dosis for hver angiven indikation med hensyn til virkning og potentiel selektion af bakterier, der er resistente over for antimikrobielle stoffer.
English: It considered that this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Danish: Opfattelsen var, at dette kan føre til manglende effektivitet og fremme resistensudviklingen i målpatogener, som muligvis kan medføre risici for menneskers sundhed for så vidt angår zoonotiske bakterier.
English: Marketing Authorisation Holders submitted written responses, defending the authorised dose of 1x30 mg/kg body weight per day for all indications but suggesting a higher dose may be required in the case of salmonellosis.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige svar, der forsvarede den godkendte dosis på 1 x 30 mg/kg kropsvægt pr. dag for alle indikationer, men med forslag om, at en højere dosis kan være nødvendig i tilfælde af salmonellose.
English: o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
Danish: o Hvis relevant, del IV Oplysninger om virkning, herunder oplysninger om farmakokinetik, farmakodynamik samt data om antimikrobiel resistens.
English: Treatment continued for up to two years.
Danish: Behandlingen fortsatte i op til to år.
English: The site of injection should be changed each week.
Danish: Injektionsstedet bør skiftes hver uge.
English: The company has not carried out any formal studies of patients under 16 years of age.
Danish: Virksomheden har ikke gennemført formelle studier af patienter under 16 år.
English: The side effects are similar in adults and in children.
Danish: Bivirkningerne er de samme hos voksne og børn.
English: Avonex received a marketing authorisation valid throughout the EU on 13 March 1997.
Danish: Avonex fik en markedsføringstilladelse med gyldighed i hele EU den 13. marts 1997.
English: The main measure of effectiveness was the number of patients whose disability got worse.
Danish: Det primære mål for virkning var antallet af patienter, hvis invaliditet blev værre.
English: Further information on Avonex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/avonex.
Danish: Yderligere information om Avonex findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/avonex.
English: • patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti-inflammatory medicines).
Danish: • patienter, der har haft et enkelt attak af demyelinisering, når dette er alvorligt nok til at nødvendiggøre behandling med injicerede kortikosteroider (antiinflammatoriske lægemidler).
English: These side effects decrease with continued treatment.
Danish: Hyppigheden af disse bivirkninger falder ved fortsat behandling.
English: As for all medicines, data on the use of Avonex are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Avonex løbende overvåget.
English: Other information about Avonex
Danish: Andre oplysninger om Avonex
English: To help patients adjust to treatment, the doctor may recommend that patients start with a lower dose once a week before increasing to the full dose.
Danish: For at hjælpe patienterne med at vænne sig til behandlingen kan lægen anbefale, at patienterne starter på en lavere dosis én gang om ugen, før de når op på fuld dosis.
English: Avonex has been compared with placebo (a dummy treatment) in two main studies.
Danish: Avonex blev sammenlignet med placebo (en uvirksom behandling) i to hovedstudier.
English: Avonex is a medicine used to treat:
Danish: Avonex er et lægemiddel til behandling af:
English: • patients with relapsing multiple sclerosis (MS).
Danish: • patienter med recidiverende multipel sklerose.
English: In adults (aged 18 years or over), the recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
Danish: Hos voksne i alderen 18 år eller derover er den anbefalede dosis Avonex 30 mikrogram givet ved injektion i en muskel én gang om ugen.
English: Side effects reported with Avonex are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Avonex vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: However, it presented information from published studies on the use of Avonex in patients aged between 12 and 18 years, which showed that they had a decrease in the rate of relapse, possibly due to Avonex treatment.
Danish: Den fremlagde imidlertid oplysninger fra offentliggjorte studier af brugen af Avonex hos patienter i alderen 12-18 år, som viste, at de havde oplevet et fald i hyppigheden af recidiver, muligvis på grund af Avonex-behandlingen.
English: After two years, 22% of the patients who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability.
Danish: Efter to år oplevede 22 % af de patienter, der fik Avonex, og 35 % af de patienter, der fik placebo, en forværring af invaliditeten.
English: What measures are being taken to ensure the safe and effective use of Avonex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Avonex?
English: The European Medicines Agency decided that Avonex's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Avonex opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
Danish: Den skønnede risiko ved at få et nyt attak af demyelinisering var lavere hos de patienter, der fik Avonex, end hos de patienter, der fik placebo: Med Avonex var risikoen 21 % i to år og 35 % i tre år, mens risikoen ved placebo var 39 % i to år og 50 % i tre år.
English: The most common side effects with Avonex (which may affect more than 1 in 10 people) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
Danish: De hyppigste bivirkninger ved Avonex (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, influenzalignende symptomer, feber, kulderystelser og svedtendens.
English: The first study involved 301 patients aged 16 years and older with relapsing MS who had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years.
Danish: Det første studie omfattede 301 patienter i alderen 16 år og derover med recidiverende multipel sklerose, som havde oplevet mindst to recidiver i de forgangne tre år eller mindst ét recidiv pr. år, hvis de havde haft sygdommen i mindre end tre år.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Danish: Multipel sklerose er en sygdom, hvor en betændelsesreaktion (inflammation) skader den beskyttende isolering omkring nerverne (demyelinisering) samt nerverne selv.
English: Avonex must not be used in patients who have severe depression or have thoughts of suicide.
Danish: Avonex må ikke anvendes hos patienter, der har svær depression eller selvmordstanker.
English: The second study involved 383 adults who had experienced a single attack of demyelination and compared the ability of Avonex and placebo to reduce the risk of a second attack.
Danish: Det andet studie omfattede 383 voksne, som havde oplevet ét attak af demyelinisering, og i studiet sammenlignedes Avonex' og placebos evne til at reducere risikoen for et nyt attak.
English: An overview of Avonex and why it is authorised in the EU
Danish: En oversigt over Avonex, og hvorfor det er godkendt i EU
English: For more information about using Avonex, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Avonex, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Avonex treatment should be stopped in patients who develop progressive (worsening) MS.
Danish: Behandlingen med Avonex bør ophøre hos patienter, der udvikler progressiv (forværret) multipel sklerose.
English: Each syringe and pen contains 30 micrograms of interferon beta-1a.
Danish: Hver sprøjte eller pen indeholder 30 mikrogram interferon beta-1a.
English: Why is Avonex authorised in the EU?
Danish: Hvorfor er Avonex godkendt i EU?
English: In relapsing MS, the patient has attacks (relapses) between periods with no symptoms.
Danish: Ved recidiverende multipel sklerose oplever patienten attakker (recidiver) mellem perioder uden symptomer.
English: Avonex slows the progression of disability and reduces the number of relapses;
Danish: Avonex forsinker de invaliderende virkninger og reducerer antallet af attakker
English: Avonex can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Danish: Avonex fås kun på recept, og behandlingen bør indledes af en læge med erfaring i behandling af multipel sklerose.
English: What is Avonex and what is it used for?
Danish: Hvad er Avonex, og hvad anvendes det til?
English: This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows the lower dose of Avonex to be injected.
Danish: Det kan kun gøres med den fyldte sprøjte, når et særligt udstyr er fastgjort til sprøjten, som gør det muligt kun at injicere den lavere dosis.
English: The active substance in Avonex is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Danish: Det aktive stof i Avonex er proteinet interferon beta-1a, der tilhører en gruppe interferoner, som dannes naturligt i kroppen for at hjælpe den med at bekæmpe bl.a. virusser.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Danish: Ved multipel sklerose opstår der fejl i immunsystemet (kroppens naturlige forsvar), som angriber dele af centralnervesystemet (hjernen, rygmarven og synsnerven), og det medfører betændelse, der beskadiger nerverne og det beskyttende lag omkring dem.
English: Avonex is available as a solution for injection in a pre-filled syringe or pre-filled pen.
Danish: Avonex fås som injektionsvæske i fyldte sprøjter eller fyldte penne.
English: What are the risks associated with Avonex?
Danish: Hvilke risici er der forbundet med Avonex?
English: The exact way that Avonex works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Danish: Det vides endnu ikke, præcist hvordan Avonex virker ved multipel sklerose, men det aktive stof, interferon beta-1a, synes at berolige immunsystemet og forebygger recidiver af multipel sklerose.
English: For the full list of side effects and restrictions with Avonex, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Avonex fremgår af indlægssedlen.
English: Avonex contains the active substance interferon beta-1a.
Danish: Avonex indeholder det aktive stof interferon beta-1a.
English: A painkiller that prevents fever can be given before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur during the first few months of treatment.
Danish: Patienterne kan godt selv injicere Avonex, når de er blevet instrueret i det. Et smertestillende lægemiddel, der forebygger feber, kan gives før hver injektion og indtil 24 timer efterfølgende for at reducere de influenzalignende symptomer, der kan forekomme i løbet af de første måneder af behandlingen.
English: It is used when the patient is considered to be at high risk of developing MS. Before using Avonex, doctors need to exclude other causes for the symptoms.
Danish: Før anvendelse af Avonex skal lægen udelukke andre årsager til symptomerne.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avonex have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Avonex.
English: How is Avonex used?
Danish: Hvordan anvendes Avonex?
English: What benefits of Avonex have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Avonex?
English: How does Avonex work?
Danish: Hvordan virker Avonex?
English: This period of deferral shall not exceed twenty-four months from the Commission Decision.
Danish: Perioden for udskydelsen kan ikke overstige 24 måneder regnet fra Kommissionens beslutning.
English: − Marketing authorisation applications for which no alternative data or a justification was submitted.
Danish: − ansøgninger om markedsføringstilladelse, for hvilke der ikke er fremlagt alternative data eller begrundelser.
English: Both the Chennai site and the Coimbatore site follow the same provisions.
Danish: Chennai-centret og Coimbatore-centret skal efterleve de samme regler.
English: Based on the submitted data during the procedure, the medicinal products Tadalafil Mylan 2.5 mg, 5 mg, 10 mg and 20 mg; Paracetamol DAWA 1000 mg film-coated tablets; Memantine Pharmascope 10 mg and 20 mg; Memantine DAWA 10 mg and 20 mg; Morysa 10 mg and 20 mg - SVUS Pharma a.s.; Bendroflumetiazid Alternova 2.5 mg and 5 mg tablets; the CHMP concluded that bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product and recommended the maintenance of these marketing authorisations.
Danish: Ud fra de data, der er indsendt under proceduren vedrørende lægemidlerne Tadalafil Mylan 2,5 mg, 5 mg, 10 mg og 20 mg, Paracetamol DAWA 1000 mg filmovertrukne tabletter, Memantine Pharmascope 10 mg og 20 mg, Memantine DAWA 10 mg og 20 mg, Morysa 10 mg og 20 mg (SVUS Pharma a.s.) samt Bendroflumetiazid Alternova 2,5 mg- og 5 mg-tabletter, vurderer CHMP, at bioækvivalens med EU-referencelægemidlet er påvist, og anbefaler, at de pågældende markedsføringstilladelser fastholdes.
English: • The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Micro Therapeutic Research Labs Limited;
Danish: • Udvalget har gennemgået alle foreliggende data og oplysninger fra indehaverne af markedsføringstilladelse/ansøgerne samt oplysninger fra Micro Therapeutic Research Labs Limited.