FrancophonIA/ELRC3.0 huggingface dataset:
English: • moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over).
Danish: • moderat til svær rheumatoid arthritis (en sygdom i immunsystemet, der medfører inflammation i leddene) hos voksne (i alderen 18 år eller derover).
English: 78% of patients given Benepali (193 out of 247) achieved at least a 20% reduction in ACR scores after 24 weeks of treatment, compared with 80% of patients given Enbrel (188 out of 234).
Danish: Denne undersøgelse viste, at Benepali er lige så effektivt som Enbrel til at nedsætte symptomerne på rheumatoid artritis: 78 % af de patienter, der fik Benepali (193 ud af 247) opnåede mindst 20 % reduktion i ACR-score efter 24-ugers behandling, sammenholdt med 80 % af dem, der fik Enbrel (188 ud af 234).
English: • severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray;
Danish: • svær ikkeradiografisk aksial spondyloarthritis (en kronisk inflammatorisk sygdom i rygsøjlen), når der er objektive tegn på inflammation men ingen abnormiteter synlige ved røntgen
English: The active substance in Benepali, etanercept, is a protein designed to block the activity of a protein in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Benepali, etanercept, er et protein, der er udformet, så det blokerer virkningen af proteinet tumornekrosefaktor (TNF) i kroppen.
English: Benepali contains the active substance etanercept and is a ‘biosimilar medicine'.
Danish: Benepali, der indeholder det aktive stof etanercept, er et "biosimilært lægemiddel".
English: A study was carried out to show that Benepali produces similar levels of the active substance in the body to Enbrel.
Danish: Der er udført en undersøgelse, der skal vise, at Benepali frembringer samme mængde aktivt stof i kroppen som Enbrel.
English: − patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate;
Danish: − patienter i alderen 2-17 år, hvis sygdom berører mange led (polyarthritis, der er rheumatoidfaktor-positiv eller -negativ), eller hvis sygdom starter i få led og derefter breder sig til flere (oligoarthritis), og som ikke har responderet tilstrækkeligt på eller ikke kan tage methotrexat
English: − adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment;
Danish: − unge i alderen 12-17 år, der har enthesitisrelateret arthritis, og som ikke har responderet tilstrækkeligt på eller ikke kan få standardbehandling
English: Laboratory studies comparing Benepali with Enbrel have shown that the active substance in Benepali is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, hvori Benepali er blevet sammenlignet med Enbrel, har vist, at det aktive stof i Benepali minder meget om det aktive stof i Enbrel, hvad angår struktur, renhed og biologisk aktivitet.
English: Benepali treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Benepali is used to treat.
Danish: Behandling med Benepali bør iværksættes og overvåges af en speciallæge med erfaring i diagnose og behandling af de sygdomme, Benepali anvendes mod. Lægemidlet udleveres kun efter recept.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) with moderate to severe disease in adults and in patients from the age of six years with long-term severe disease.
Danish: • plaquepsoriasis (en sygdom, der giver røde skællende pletter på huden) hos voksne med moderat til svær sygdom og hos patienter fra seks år og derover med kronisk, svær sygdom.
English: Benepali is available as pre-filled syringes or pens containing a solution for injecting under the skin.
Danish: Benepali fås som fyldte sprøjter eller penne, der indeholder en opløsning, som gives ved indsprøjtning under huden.
English: In addition, a study comparing Benepali to Enbrel in adults with rheumatoid arthritis showed that both medicines are similarly effective.
Danish: Ydermere viste en undersøgelse hos voksne med rheumatoid arthritis, hvor Benepali blev sammenlignet med Enbrel, at lægemidlerne er lige effektive.
English: For practical information about using Benepali, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Benepali, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Benepali, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Benepali fremgår af indlægssedlen.
English: • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments;
Danish: • svær ankyloserende spondylitis (en sygdom, som medfører inflammation af leddene i rygsøjlen) hos voksne, der ikke har responderet tilstrækkeligt på andre behandlinger
English: − adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate;
Danish: − unge i alderen 12-17 år, der har arthritis psoriatica (en sygdom, der giver røde skællende pletter på huden og betændelse i leddene), og som ikke har responderet tilstrækkeligt på eller ikke kan få methotrexat
English: How is Benepali used?
Danish: Hvordan anvendes Benepali?
English: What benefits of Benepali have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Benepali?
English: How does Benepali work?
Danish: Hvordan virker Benepali?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benepali 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 Benepali.
English: Because Benepali is a biosimilar medicine, all the studies on effectiveness and safety of etanercept carried out with Enbrel do not need to be repeated for Benepali.
Danish: Det er derfor ikke nødvendigt at gentage de undersøgelser af etanercepts virkning og sikkerhed, som er foretaget for Enbrel.
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Danish: Dette protein findes i høje koncentrationer hos patienter med de sygdomme, Benepali anvendes mod. Ved at blokere TNF nedbringer etanercept inflammationen og de andre symptomer på sygdommen.
English: The European Commission issued a decision on:
Danish: Europa-Kommissionen offentliggjorde afgørelsen:
English: Why were these medicines reviewed?
Danish: Hvorfor blev disse lægemidler gennemgået på ny?
English: Outcome of four procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended
Danish: Resultatet af fire procedurer i henhold til artikel 20 i forordning (EF) nr. 726/2004 og én procedure i henhold til artikel 31 i direktiv 2001/83/EF, som ændret1
English: Hence, the results of the studies concerned could not be considered reliable.
Danish: Resultaterne af de pågældende undersøgelser kunne derfor ikke anses for pålidelige.
English: 20 February 2013 EMA/796016/2012 rev.1
Danish: 20. februar 2013 EMA/796016/2012 rev.1
English: The CHMP confirmed its previous conclusions on these medicines.
Danish: CHMP bekræftede sine tidligere konklusioner med hensyn til disse lægemidler.
English: More information on these medicines can be found on the EMA website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere oplysninger om disse lægemidler findes på EMA's websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Which medicines are affected by the Agency's review?
Danish: Hvilke produkter berøres af agenturets gennemgang?
English: • Patients and prescribers should note that there are no safety concerns with any of these medicines currently on the market.
Danish: • Patienter og ordinerende læger bør vide, at der ikke er sikkerhedsmæssige betænkeligheder ved nogen af disse lægemidler, som i øjeblikket markedsføres.
English: The CHMP also requested the companies to provide any additional relevant data, which had not been submitted as part of the initial applications.
Danish: CHMP anmodede desuden virksomhederne om at fremlægge eventuelle relevante supplerende data, der ikke var forelagt som en del af de oprindelige ansøgninger.
English: The Committee considered the importance of the data from these studies in the context of the overall data submitted in the applications.
Danish: Udvalget vurderede vigtigheden af data fra disse undersøgelser i sammenhæng med den samlede mængde data, der var forelagt i ansøgningerne.
English: Nevertheless the CHMP requested the company to update the product information with revised data.
Danish: CHMP anmodede dog virksomheden om at opdatere produktoplysningerne med reviderede data.
English: One of the studies is a ‘pharmacokinetic' study in children, whose results are included in the product information.
Danish: En af undersøgelse er en "farmakokinetisk" undersøgelse hos børn, hvis resultater indgår i produktoplysningerne.
English: This review was initiated by the European Commission for the centrally authorised medicines and by the UK Medicines Regulatory Agency for the nationally authorised medicines.
Danish: Denne gennemgang blev indledt af Europa-Kommissionen for de centralt godkendte lægemidler og af Det Forenede Kongeriges lægemiddelstyrelse for de nationalt godkendte lægemidler.
English: At the request of the company that markets Fenofibrato Pensa and Fenofibrato Ranbaxy, the CHMP reexamined the initial opinion for these medicines, and confirmed its previous recommendation on 13 December 2012.
Danish: På anmodning af den virksomhed, der markedsfører Fenofibrato Pensa og Fenofibrato Ranbaxy, revurderede CHMP den oprindelige udtalelse om disse lægemidler og bekræftede sin tidligere henstilling den 13. december 2012.
English: For more information, see: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf
Danish: Yderligere information findes på: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf pågældende lægemidler.
English: Consequently, the European Commission asked the CHMP to assess whether the identified issues have an impact on the benefit-risk balance of the centrally authorised medicines concerned, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Danish: Europa-Kommissionen anmodede derfor CHMP om at udtale sig om, hvorvidt de konstaterede problemer havde indvirkning på benefit/risk-forholdet for de pågældende centralt godkendte lægemidler, og tage stilling til, om markedsføringstilladelserne for lægemidlerne bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: • Fenofibrato Pensa and Fenofibrato Ranbaxy: 20 February 2013
Danish: • Fenofibrato Pensa og Fenofibrato Ranbaxy: den 20. februar 2013
English: • Patients who are taking any of the generic medicines that have been suspended should be aware that alternative treatments are available.
Danish: • Patienter, der får nogen af de generiske lægemidler, for hvilke markedsføringstilladelsen er suspenderet, bør vide, at der er andre behandlingsmuligheder.
English: In addition, the UK Medicines Regulatory Agency requested the CHMP to carry out the same assessment for the concerned nationally authorised medicines.
Danish: Det Forenede Kongeriges lægemiddelstyrelse anmodede endvidere CHMP om at foretage samme vurdering af de berørte nationalt godkendte lægemidler.
English: In July 2012, the CHMP had concluded a similar review for three other concerned centrally authorised medicines: Conbriza, PecFent and Torisel.3
Danish: I juli 2012 havde CHMP foretaget en lignende gennemgang for tre andre berørte centralt godkendte lægemidler: Conbriza, PecFent og Torisel.3
English: In July 2012, the CHMP had already completed a similar review of three other medicines (Conbriza, PecFent and Torisel) and concluded that there is no impact on the benefit-risk balance of these medicines and that the marketing authorisation should be maintained.
Danish: I juli 2012 havde CHMP allerede foretaget en tilsvarende gennemgang af tre andre lægemidler (Conbriza, PecFent og Torisel) og konkluderet, at der ikke er nogen indvirkning på benefit/riskforholdet for disse lægemidler, og at markedsføringstilladelsen bør opretholdes.
English: During a re-examination procedure for Fenofibrato Pensa and Fenofibrato Ranbaxy, the company submitted new data, which is not permitted in the context of a re-examination.
Danish: Under en genvurderingsprocedure for Fenofibrato Pensa og Fenofibrato Ranbaxy fremlagde virksomheden nye data, hvilket ikke er tilladt i forbindelse med en genvurdering.
English: As the results of these studies could not be considered reliable, the CHMP concluded that the marketing authorisation of these medicines should be suspended until the companies provide adequate data.
Danish: Da resultaterne af disse undersøgelser ikke kunne anses for pålidelige, konkluderede CHMP, at markedsføringstilladelsen for disse lægemidler bør suspenderes, indtil virksomhederne fremlægger fyldestgørende oplysninger.
English: On 20 September 2012, the European Medicines Agency completed a review of nine centrally and nationally authorised medicines2, following concerns over the conduct of laboratory analyses of certain studies submitted as part of their marketing authorisation applications.
Danish: Den 20. september 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af ni centralt og nationalt godkendte lægemidler2, efter at der var rejst betænkelighed ved udførelsen af laboratorieanalyserne for visse undersøgelser, der indgår i ansøgningerne om markedsføringstilladelse for de pågældende lægemidler.
English: However, as Tygacil is not approved for use in this population, no specific action was considered necessary.
Danish: Tygacil er imidlertid ikke godkendt til anvendelse hos denne patientgruppe, og der blev derfor ikke fundet behov for særlige tiltag.
English: The studies concerned were all conducted at the Cetero Research facility in Houston, Texas, USA.
Danish: Alle de pågældende undersøgelser var udført på Cetero Researchs afdeling i Houston, Texas, USA.
English: In the absence of reliable data, the CHMP recommended that their marketing authorisation should be suspended until adequate data are provided.
Danish: I mangel af pålidelige data anbefalede CHMP, at markedsføringstilladelserne suspenderes, indtil der foreligger fyldestgørende oplysninger.
English: Although the Committee noted that no problems have been identified with the products currently on the market, bioequivalence studies are a mandatory part of the marketing authorisation application for generic medicines.
Danish: Selv om udvalget bemærkede, at der ikke var konstateret problemer med de markedsførte produkter, er bioækvivalensundersøgelser obligatoriske i en ansøgning om markedsføringstilladelse for et generisk lægemiddel.
English: For Temodal and Tygacil the findings have no impact on the benefit-risk balance of these medicines and no further action is needed.
Danish: For Temodal og Tygacil har resultaterne ingen indvirkning på benefit/risk-forholdet, og der er ikke behov for yderligere tiltag.
English: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.
Danish: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva og Ribavirin Teva Pharma B.V.
English: For these generic medicines, the studies conducted at the Texas-based Cetero Research facility were bioequivalence studies, to demonstrate that they produce the same levels of the active substance in the body as their reference medicines.
Danish: For disse generiske lægemidler var der på Cetero Researchs afdeling i Texas udført bioækvivalensundersøgelser, der skulle påvise, at lægemidlerne frembringer samme koncentration af det aktive stof i kroppen som de tilsvarende referencelægemidler.
English: • Temodal: 26 November 2012
Danish: • Temodal: den 26 november 2012
English: • Ribavirin Teva and Ribavirin Teva Pharma B.V., generic medicines containing ribavirin, used for the treatment of hepatitis C (a disease of the liver due to an infection with the hepatitis C virus); 1 Procedure numbers: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
Danish: 1 Procedurernes numre: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
English: Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility
Danish: Spørgsmål og svar om gennemgangen af lægemidler, for hvilke der er udført undersøgelser på Cetero Researchs afdeling i Texas
English: • Ribavirin Teva Pharma B.V: 06 December 2012
Danish: • Ribavirin teva Pharma B.V: den 06 december 2012
English: The Committee noted that the studies conducted at this facility do not support any indication or prescribing recommendation for Tygacil.
Danish: Udvalget bemærkede, at undersøgelserne på det pågældende anlæg ikke tjener til dokumentation af indikationerne eller produktoplysningerne for Tygacil.
English: The CHMP reviewed the bio-analytical studies performed at Texas-based Cetero Research facility that had been submitted as part of the marketing authorisation applications of the medicines concerned.
Danish: CHMP gennemgik de bioanalytiske undersøgelser, der var udført på Cetero Researchs anlæg i Texas, og som var blevet forelagt som en del af ansøgningerne om markedsføringstilladelse for de
English: • Tygacil: 30 November 2012
Danish: • Tygacil: den 30. november 2012
English: The EMA was made aware that recent inspections of the Texas-based Cetero Research facility by the US Food and Drug Administration had raised concerns over the way laboratory analyses of certain studies, called ‘bio-analytical' studies, were conducted at this facility in the period from April 2005 to June 2010.
Danish: EMA blev gjort opmærksom på, at den amerikanske fødevare- og lægemiddelstyrelse for nylig havde foretaget inspektioner af Cetero Researchs afdeling i Texas, og at dette havde givet anledning til betænkelighed ved udførelsen af laboratorieanalyserne for såkaldte bioanalytiske undersøgelser i perioden fra april 2005 til juni 2010.
English: The Agency's review covers the following centrally authorised medicines, whose marketing authorisation applications included studies conducted at the Cetero Research facility in Houston, Texas, USA:
Danish: Agenturets gennemgang omfatter følgende centralt godkendte lægemidler, for hvilke der i ansøgningen om markedsføringstilladelse indgik undersøgelser, der var udført på Cetero Researchs anlæg i Houston, Texas, USA:
English: The CHMP noted that the studies conducted at this facility were two studies submitted in support of the approval of Temodal solution for infusion.
Danish: CHMP bemærkede, at der på det omhandlede anlæg var udført to undersøgelser til støtte for godkendelsen af Temodal, injektionsvæske, opløsning.
English: • Ribavirin Teva: 06 December 2012
Danish: • Ribavirin teva: den 06 december 2012
English: In total, seven centrally authorised medicines and five nationally authorised medicines were identified, whose marketing authorisation applications included data from studies conducted at this Cetero Research facility.
Danish: I alt fandtes der syv centralt godkendte lægemidler og fem nationalt godkendte lægemidler, for hvilke ansøgningen om markedsføringstilladelse omfattede undersøgelser, der var udført på Cetero Researchs ovennævnte anlæg.
English: • Cilazapril Teva and associated names: 10 December 2012
Danish: • Cilazapril Teva og relaterede navne: den 10. december 2012
English: • Tygacil, an antibiotic containing tigecycline, used for the treatment of complicated infections of the skin and soft tissue (the tissue below the skin), and complicated infections in the abdomen.
Danish: • Tygacil, et antibiotikum, der indeholder tigecyclin og anvendes til behandling af komplicerede infektioner af huden og det underliggende væv samt komplicerede infektioner i de indre organer i maveregionen.
English: • Leflunomide Actavis and Leflunomide Apotex, generic medicines containing the active substance leflunomide, used for the treatment of rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Danish: • Leflunomide Actavis og Leflunomide Apotex, generiske lægemidler, der indeholder det aktive stof leflunomid og anvendes til behandling af leddegigt (en sygdom i immunsystemet, der medfører beskadigelse og inflammation af leddene).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that for seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.) some of the studies that supported their authorisation could not be considered reliable.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der var syv lægemidler (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva og Ribavirin Teva Pharma B.V.
English: • Leflunomide Apotex and associated names: 30 November 2012
Danish: • Leflunomide Apotex og relaterede navne: den 30. november 2012
English: • Fenofibrato Pensa and Fenofibrato Ranbaxy, generic medicines containing fenofibrate, used to control the levels of cholesterol and other lipids (fats) in the blood;
Danish: • Fenofibrato Pensa og Fenofibrato Ranbaxy, generiske lægemidler, der indeholder fenofibrat og anvendes til at regulere blodets indhold af kolesterol og andre lipider (fedtstoffer)
English: • Temodal, anticancer medicine containing temozolomide, used for the treatment of malignant glioma (brain tumours);
Danish: • Temodal, kræftmedicin, der indeholder temozolomid og anvendes til behandling af hjernesvulster af typen malignt gliom
English: • Leflunomide Actavis and associated names: 30 November 2012
Danish: • Leflunomide Actavis og relaterede navne: den 30. november 2012
English: In addition, the Agency reviewed the following nationally authorised medicines, whose marketing authorisation applications also included studies conducted at this Cetero Research facility:
Danish: Desuden gennemgik agenturet følgende centralt godkendte lægemidler, der ligeledes var godkendt på grundlag af undersøgelser udført på Cetero Researchs ovennævnte anlæg:
English: • Cilazapril Teva, a generic medicine containing cilazapril, used for the treatment of hypertension
Danish: • Cilazapril Teva, et generisk lægemiddel, der indeholder cilazapril og anvendes til behandling af forhøjet blodtryk og hjertesvigt (nedsat hjertefunktion)
English: The Committee concluded that the data from these studies were confirmed by other studies conducted elsewhere, and therefore that there is no impact on the benefit-risk balance of Temodal and no further action is needed.
Danish: Der har derfor indvirkning på benefit/risk-forholdet for Temodal, og der er ikke behov for yderligere tiltag.
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddel form
English: Packaging Package size Withdrawal period
Danish: Indgivelsesvej Emballage Pakningsstørrelse
English: 90 (3x30) tablets
Danish: 90 (3x30) tabletter