FrancophonIA/ELRC3.0 huggingface dataset:
English: Meditop Pharmaceutical Co. Ltd submitted Myderison for mutual recognition on the basis of the initial authorisation granted by Hungary on 28 March 2006.
Danish: Meditop Pharmaceutical Co. Ltd indsendte en ansøgning om gensidig anerkendelse af Myderison på baggrund af den første markedsføringstilladelse, der blev udstedt af Ungarn den 28. marts 2006.
English: Committee also required that the marketing authorisation for Myderison in Hungary should be revocated.
Danish: Udvalget krævede endvidere, at markedsføringstilladelsen for Myderison i Ungarn blev tilbagekaldt.
English: Myderison is a medicine that is used to treat skeletal muscle spasticity (stiffness of voluntary muscles).
Danish: Myderison er et lægemiddel, der anvendes til behandling af spasticitet i skeletmuskulaturen (stivhed i de vilkårlige muskler).
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Myderison.
Danish: Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for Myderison.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Myderison do not outweigh its risks, and therefore the marketing authorisation should not be granted in the concerned Member States.
Danish: På basis af en vurdering af de tilgængelige data og de videnskabelige drøftelser i udvalget er CHMP af den opfattelse, at fordelene ved Myderison ikke opvejer risiciene, og at der derfor ikke bør udstedes markedsføringstilladelse for Myderison i de berørte medlemsstater.
English: The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Danish: Det vides ikke nøjagtigt, hvordan tolperison virker, men man mener, at det virker på hjernen og rygmarven, hvor det reducerer de nerveimpulser, der får musklerne til at trække sig sammen og blive stive.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Myderison do not outweigh its risks, and the marketing authorisation granted in Hungary cannot be recognised in other Member States of the EU.
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Myderison ikke opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Ungarn, ikke kan anerkendes i de øvrige EU-medlemsstater.
English: Company responses provided on: 4 May 2009 Opinion date:
Danish: Dato for virksomhedens svar:
English: In both studies,
Danish: I begge studier blev
English: The recommended dose is one capsule once a day at the same time each day.
Danish: Den anbefalede dosis er én kapsel én gang dagligt på samme tidspunkt hver dag.
English: Patients should not use more than one capsule in a day.
Danish: Patienterne må ikke tage mere end én kapsel dagligt.
English: Further information on Tovanor Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Tovanor Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: virkningen hovedsagelig målt på forbedringen af patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde en person kan udånde på et sekund).
English: Tovanor Breezhaler received a marketing authorisation valid throughout the EU on 28 September
Danish: Tovanor Breezhaler fik markedsføringstilladelse med gyldighed i hele EU den 28. september 2012.
English: What measures are being taken to ensure the safe and effective use of Tovanor Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tovanor Breezhaler?
English: For more information about using Tovanor Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Tovanor Breezhaler se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: After 12 weeks of treatment, Tovanor Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Danish: Efter 12 ugers behandling var forbedringen i FEV1 97 ml mere med Tovanor Breezhaler end med placebo i den første undersøgelse, og 108 ml mere i den anden.
English: As for all medicines, data on the use of Tovanor Breezhaler are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Tovanor Breezhaler løbende overvåget.
English: Side effects reported with Tovanor Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Tovanor Breezhaler vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency noted that Tovanor Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Tovanor Breezhaler havde en beskeden, men relevant gavnlig virkning hos patienterne med hensyn til forbedring af lungefunktionen, og at det også forbedrede symptomerne på KOL.
English: The most common side effects with Tovanor Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Danish: De hyppigste bivirkninger ved Tovanor Breezhaler (som optræder hos mellem 1 og 10 patienter ud af 100) er tørhed i munden, nasopharyngitis (betændelse i næse og hals), søvnløshed, muskel- og knoglesmerter og gastroenteritis (diarré og opkast).
English: Tovanor Breezhaler (glycopyrronium bromide) EMA/326862/2018
Danish: Tovanor Breezhaler (glycopyrroniumbromid) EMA/326862/2018
English: This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs.
Danish: Det betyder, at den udvider luftvejene ved at blokere visse muskarine receptorer (mål) i muskelcellerne i lungerne.
English: Therefore, the Agency decided that Tovanor Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Tovanor Breezhaler opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In addition, there were no major safety concerns with Tovanor Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Danish: Desuden var der ingen væsentlige sikkerhedsproblemer forbundet med Tovanor Breezhaler, og dets bivirkninger svarer til dem, der er forbundet med andre muskarine receptorantagonistlægemidler.
English: Tovanor Breezhaler is used for maintenance (regular) treatment.
Danish: Tovanor Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: Tovanor Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Danish: Tovanor Breezhaler viste sig at være mere effektivt end placebo (en uvirksom behandling) til at lindre symptomerne på KOL i to hovedstudier med i alt 1 888 patienter med KOL.
English: An overview of Tovanor Breezhaler and why it is authorised in the EU
Danish: Oversigt over Tovanor Breezhaler, og hvorfor det er godkendt i EU
English: Tovanor Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Tovanor Breezhaler er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Other information about Tovanor Breezhaler
Danish: Andre oplysninger om Tovanor Breezhaler
English: The active substance in Tovanor Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Danish: Det aktive stof i Tovanor Breezhaler, glycopyrroniumbromid, er en muskarin receptorantagonist.
English: Tovanor Breezhaler (glycopyrronium bromide)
Danish: Tovanor Breezhaler (glycopyrroniumbromid)
English: What is Tovanor Breezhaler and what is it used for?
Danish: Hvad er Tovanor Breezhaler, og hvad anvendes det til?
English: Why is Tovanor Breezhaler authorised in the EU?
Danish: Hvorfor blev Tovanor Breezhaler godkendt i EU?
English: Tovanor Breezhaler capsules, which contain a powder for inhalation, are only used with the Tovanor Breezhaler inhaler and must not be swallowed.
Danish: Tovanor Breezhaler-kapsler anvendes udelukkende med en Tovanor Breezhaler-inhalator og må ikke sluges.
English: For the full list of all side effects and restrictions with Tovanor Breezhaler, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Tovanor Breezhaler fremgår af indlægssedlen.
English: Tovanor Breezhaler can only be obtained with a prescription.
Danish: Tovanor Breezhaler udleveres kun efter recept.
English: Tovanor Breezhaler contains the active substance glycopyrronium bromide.
Danish: Tovanor Breezhaler indeholder det aktive stof glycopyrroniumbromid.
English: What are the risks associated with Tovanor Breezhaler?
Danish: Hvilke risici er der forbundet med Tovanor Breezhaler?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tovanor Breezhaler 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 Tovanor Breezhaler.
English: What benefits of Tovanor Breezhaler have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tovanor Breezhaler?
English: How does Tovanor Breezhaler work?
Danish: Hvordan virker Tovanor Breezhaler?
English: How is Tovanor Breezhaler used?
Danish: Hvordan anvendes Tovanor Breezhaler?
English: In all three studies, Parsabiv was given for 26 weeks.
Danish: I alle tre undersøgelser blev Parsabiv givet i 26 uger.
English: This is a summary of the European public assessment report (EPAR) for Parsabiv.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Parsabiv.
English: The full EPAR for Parsabiv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Parsabiv findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Parsabiv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Parsabiv opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The main measure of effectiveness was a reduction in parathyroid hormone by more than 30% after at least 20 weeks of treatment.
Danish: Det primære mål for virkning var en paratyroideahormon-reduktion på mere end 30 % efter mindst 20 ugers behandling.
English: Other information about Parsabiv
Danish: Andre oplysninger om Parsabiv
English: What measures are being taken to ensure the safe and effective use of Parsabiv?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Parsabiv?
English: Parsabiv etelcalcetide
Danish: Parsabiv etelcalcetid
English: What is Parsabiv and what is it used for?
Danish: Hvad er Parsabiv, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Parsabiv.
Danish: Det er ikke en praktisk vejledning i, hvordan Parsabiv bør anvendes.
English: The most common side effects with Parsabiv (which may affect more than 1 in 10 people) are low calcium level in the blood, muscle spasm, diarrhoea, nausea (feeling sick) and vomiting.
Danish: De hyppigste bivirkninger ved Parsabiv (som kan forekomme hos mere end 1 ud af 10 personer) er lavt kalciumniveau i blodet, muskelspasmer, diarré, kvalme og opkastning.
English: Treatment is started at a dose of 5 mg three times a week and the dose is then adjusted according to the patient's parathyroid hormone level or calcium level.
Danish: Behandlingen startes med en dosis på 5 mg tre gange om ugen, hvorefter dosen justeres ud fra patientens niveau af paratyroideahormon eller kalcium.
English: In some circumstances, it can be given by injection into a vein.
Danish: I nogle tilfælde kan dosen gives som en injektion i en blodåre.
English: It contains the active substance etelcalcetide.
Danish: Det indeholder det aktive stof etelcalcetid.
English: Why is Parsabiv approved?
Danish: Hvorfor blev Parsabiv godkendt?
English: Parsabiv is used in patients on haemodialysis (a technique for removing waste products from the blood using a blood filtration machine).
Danish: Parsabiv anvendes til patienter, der er i såkaldt hæmodialyse (en teknik til fjernelse af affaldsprodukter fra blodet ved brug af en blodfiltreringsmaskine).
English: Parsabiv can only be obtained with a prescription.
Danish: Parsabiv udleveres kun efter recept.
English: What are the risks associated with Parsabiv?
Danish: Hvilke risici er der forbundet med Parsabiv?
English: The first two studies compared Parsabiv with placebo (a dummy treatment), and the third study compared it with cinacalcet, another calcimimetic medicine.
Danish: De første to undersøgelser sammenlignede Parsabiv med placebo (et ikke-aktivt stof), og den tredje undersøgelse sammenlignede Parsabiv med cinacalcet, et andet calcimimetikum.
English: For more information about treatment with Parsabiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Parsabiv, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Parsabiv has been investigated in three main studies involving 1,706 patients on haemodialysis who had long-term kidney disease and secondary hyperparathyroidism.
Danish: Parsabiv er blevet vurderet i tre hovedundersøgelser med 1 706 patienter, der var i hæmodialyse, og som havde langvarig nyresygdom og sekundær hyperparatyreose.
English: Parsabiv must not be started if the patient's blood calcium level is below the normal range.
Danish: Behandling med Parsabiv må ikke påbegyndes, hvis patientens kalciumniveau i blodet ligger under det normale.
English: In the third study, Parsabiv was found to be at least as effective as cinacalcet: in 68% (232 out of 340) patients given Parsabiv compared with 58% (198 out of 343) patients given cinacalcet.
Danish: I den tredje undersøgelse var Parsabiv mindst lige så effektivt som cinacalcet, idet der sås en effekt hos 68 % af de Parsabiv-behandlede patienter (232 ud af 340), mens der sås en effekt hos 58 % af de cinacalcetbehandlede patienter (198 out of 343).
English: In the first two studies, Parsabiv was effective in 75% (380 out of 509) of patients compared with 9% (46 out of 514) of patients given placebo.
Danish: I de første to undersøgelser sås en effekt hos 75 % af de Parsabiv-behandlede patienter (380 ud af 509), mens der sås en effekt hos 9 % af de patienter, der fik placebo (46 ud af 514).
English: The active substance in Parsabiv, etelcalcetide, is a calcimimetic.
Danish: Det aktive stof i Parsabiv, etelcalcetid, er et såkaldt calcimimetikum.
English: Parsabiv is a medicine used to reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism).
Danish: Parsabiv er et lægemiddel, der anvendes til at nedsætte niveauet af paratyroideahormon hos voksne, der har for meget af dette hormon på grund af langvarig nyresygdom (sekundær hyperparatyreose).
English: High levels of parathyroid hormone can cause loss of calcium from the bones, bone pain and fractures, and heart and circulation problems.
Danish: Høje niveauer af paratyroideahormon kan forårsage tab af kalcium fra knoglerne, knoglesmerter og knoglebrud samt hjerte- og kredsløbsforstyrrelser.
English: For practical information about using Parsabiv, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Parsabiv, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Parathyroid hormone is produced by the parathyroid glands in the neck and regulates calcium and phosphate levels.
Danish: Paratyroideahormon produceres af biskjoldbruskkirtlerne i halsområdet og regulerer kalcium- og fosfatniveauerne.
English: For the full list of Parsabiv's side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Parsabiv fremgår af indlægssedlen.
English: It is given at the end of a haemodialysis session into the line that leads back from the dialysis machine to the patient's vein.
Danish: Ved afslutningen af en dialysesession gives dosen gennem den slange fra dialysemaskinen, der fører blodet tilbage til patientens kredsløb.
English: When cells in the parathyroid gland detect high levels of calcium in the blood, they reduce the amount of parathyroid hormone entering the blood.
Danish: Når biskjoldbruskkirtlens celler sporer høje niveauer af kalcium i blodet, nedsættes mængden af paratyroideahormon, der kommer ud i blodet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Parsabiv have 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 Parsabiv.
English: How is Parsabiv used?
Danish: Hvordan anvendes Parsabiv?
English: The medicine has been found effective for reducing parathyroid hormone in the blood in patients with kidney disease being treated with haemodialysis and its side effects are those expected of a calcimimetic substance.
Danish: Det er påvist, at lægemidlet er effektivt til at nedsætte niveauet af paratyroideahormon i blodet hos nyrepatienter, der er i hæmodialyse, og bivirkningerne svarer til bivirkningerne ved andre calcimimetika.
English: What benefits of Parsabiv have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Parsabiv?
English: Reduced parathyroid hormone decreases the levels of calcium in the blood.
Danish: Når niveauet af paratyroideahormon falder, nedsættes niveauet af kalcium i blodet.
English: Parsabiv is available as a solution for injection.
Danish: Parsabiv fås som en injektionsvæske.
English: This means that it mimics the action of calcium on these cells and in this way, it reduces the parathyroid hormone levels in the blood.
Danish: Det betyder, at det efterligner kalciums effekt på biskjoldbruskkirtlens celler, hvorved niveauet af paratyroideahormon i blodet nedsættes.
English: How does Parsabiv work?
Danish: Hvordan virker Parsabiv?
English: The other concerns remained.
Danish: De øvrige betænkeligheder blev fastholdt.
English: London, 19 March 2008 Doc.
Danish: London, den 19. marts 2008 Dok.
English: Ref. EMEA/CHMP/145497/2008
Danish: ref. EMEA/224479/2008
English: What is CIMZIA?
Danish: Hvad er CIMZIA?
English: The company that applied for authorisation is UCB Pharma SA.
Danish: Virksomheden, som ansøgte om tilladelse, er UCB Pharma SA.
English: In addition, the study of maintenance treatment did not last long enough to give meaningful information on the medicine's long-term effects.
Danish: Endvidere varede undersøgelsen af vedligeholdelsesbehandlingen ikke længe nok til at give meningsfulde oplysninger om lægemidlets langsigtede virkninger.
English: In addition, the Committee was concerned that the company had not demonstrated that it would have been able to monitor the quality of the medicine to an acceptable level.
Danish: Udvalget var derudover betænkeligt ved, at virksomheden ikke havde påvist, at den ville have været i stand til at overvåge kvaliteten af lægemidlet og holde den på et acceptabelt niveau.
English: It was to be used in patients who had not responded to a full and adequate course of therapy with a corticosteroid or an immunosuppressant medicine (a medicine that reduces the activity of the immune system) or who cannot take these therapies.
Danish: Det skulle anvendes til patienter, som ikke havde reageret på et fuldstændigt og hensigtsmæssigt behandlingsforløb med et corticosteroid eller et immunosuppressivt lægemiddel (et lægemiddel, som dæmper immunsystemets aktivitet), eller som ikke kan tåle disse terapier.
English: The effects of CIMZIA were first tested in experimental models before being studied in humans.
Danish: Virkningerne af CIMZIA blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for CIMZIA
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for CIMZIA
English: In March 2008, following the re-examination, the CHMP removed its concern regarding the ability to monitor the medicine's quality.
Danish: I marts 2008 fjernede CHMP efter genvurderingen sine betænkeligheder med hensyn til evnen til at overvåge lægemidlets kvalitet.
English: It also removed its concern over the possible increased risk of bleeding, but maintained a general concern over CIMZIA's safety.
Danish: Udvalget fjernede også sine betænkeligheder ved den mulige forøgede risiko for blødning, men fastholdt en generel betænkelighed ved CIMZIA's sikkerhed.
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 19 March 2008.
Danish: Efter at have drøftet begrundelserne for denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede anbefalingen af afslag på ansøgningen om markedsføringstilladelse den 19. marts 2008.
English: In November 2007, the CHMP was concerned that there was insufficient evidence to show a benefit of CIMZIA.
Danish: I november 2007 var CHMP betænkelig over, at der forelå utilstrækkelig dokumentation til at påvise en fordel ved CIMZIA.
English: By blocking TNF-alpha, certolizumab was expected to improve the inflammation and other symptoms of the disease.
Danish: Ved at blokere TNF-alpha forventedes certolizumab at bedre inflammationen og andre symptomer på sygdommen.
English: On 15 November 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product CIMZIA 200 mg powder and solvent for solution for injection, intended for the treatment of severe, active Crohn's disease.
Danish: Den 15. november 2007 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om markedsføringstilladelse for lægemidlet CIMZIA 200 mg pulver og solvens til injektionsvæske, opløsning, til behandling af svær aktiv Crohns sygdom.
English: The main measure of effectiveness was the proportion of patients whose symptoms had improved or disappeared after six and 26 weeks.
Danish: Den vigtigste målestok for virkningen var andelen af patienter, hvis symptomer var formindsket eller forsvundet efter 6 og 26 uger.