FrancophonIA/ELRC3.0 huggingface dataset:
English: The referral procedure started on 29 April 2005.
Danish: Proceduren for indbragte sager indledtes den 29. april 2005.
English: A Decision was issued by the European Commission on 10/04/06.
Danish: Europa-Kommissionen traf en afgørelse den 10/04/2006.
English: International Non-Proprietary Name (INN): Tacrolimus BACKGROUND INFORMATION
Danish: Internationalt fællesnavn (INN): Tacrolimus BAGGRUND
English: Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States.
Danish: Der var blevet godkendt forskellige produktresuméer (SPC) på grundlag af nationale beslutninger, der afveg fra tilladelserne i EU-medlemsstaterne.
English: Tacrolimus is a macrolide immunosuppressant belonging to the pharmacological class of the calcineurin inhibitors.
Danish: Tacrolimus er et immunosuppressivum af macrolid-typen, der farmakologisk tilhører klassen af calcineurin-hæmmere.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
Danish: Behandling af allotransplantat afstødning, der er resistent over for behandling med andre immunosuppressive lægemidler.
English: The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/risk ratio of Prograf and associated names is considered to be positive in the following indications:
Danish: Efter at CHMP havde behandlet vurderingsrapporterne fra rapportøren/medrapportøren, taget hensyn til den faglige drøftelse i udvalget og behandlet bemærkningerne fra indehaverne af markedsføringstilladelsen, var CHMP af den opfattelse, at Prograf og tilknyttede navne udviste et gunstigt benefit/risk-forhold til følgende indikationer:
English: London, 10 April 2006 EMEA/85997/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/83/EC FOR Prograf and associated names (See Annex I)
Danish: London, den 10. april 2006 EMEA/85968/2006 UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) SAMMENFATTENDE OPLYSNINGER OM UDTALELSEN OM DEN INDBRAGTE SAG I HENHOLD TIL ARTIKEL 30 I RÅDETS DIREKTIV 2001/83/EF OM Prograf og tilknyttede navne (se bilag I)
English: The CHMP gave a positive opinion on 26 January 2006 recommending the harmonisation of the SPC for Prograf and associated names.
Danish: Den 26. januar 2006 vedtog CHMP en positiv udtalelse, som anbefalede en harmonisering af produktresuméet for Prograf og tilknyttede navne.
English: Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.
Danish: Profylakse af transplantatafstødning hos patienter med nyre-, lever- og hjerteallotransplantat.
English: presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product Prograf and associated names.
Danish: I henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbragte Fujisawa GmbH den 23. marts 2005 på vegne af samtlige indehavere af markedsføringstilladelser (se bilag 1 til udtalelsen) en sag for EMEA med henblik på at harmonisere de nationale produktresuméer for lægemidlet Prograf og tilknyttede navne.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gyldige produktresumé, etiketteringen og indlægssedlen er de endelige versioner, der er opnået under koordinationsgruppens procedure.
English: Package sizes
Danish: Indhold Paknings-størrelse
English: Therefore, Annex III may not necessarily represent the current text.
Danish: Bilag III repræsenterer derfor ikke nødvendigvis den aktuelle tekst.
English: Benefit/ Risk considerations
Danish: Risk/benefit-overvejelser
English: The 4th analysis of the EPC data will also be provided when available.
Danish: Den fjerde analyse af EPC-data vil ligeledes blive fremlagt, når den foreligger.
English: Analysis population
Danish: Analysepopulation
English: There was no evidence of an overall excess mortality.
Danish: Der var ingen tegn på en total overdødelighed.
English: After the Commission Decision, the Member State competent authorities will update Annex III as required.
Danish: Efter Kommissionens afgørelse skal medlemsstaternes kompetente myndigheder ajourføre bilag III i overensstemmelse hermed.
English: In the clinical studies this was severe in around 5% of patients.
Danish: I de kliniske undersøgelser forekom denne bivirkning i svær grad hos omkring 5 % af patienterne.
English: However, the numbers of cases involved are relatively small, and there is no clear temporal relationship.
Danish: Det omhandlede antal tilfælde er imidlertid ret lille, og der er ingen klar tidsmæssig sammenhæng.
English: EL - Greece Dermos Meπε -pharmaceitica 25 Paraschou str.
Danish: EL - Grækenland Dermos Meπε -pharmaceitica 25 Paraschou str.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: Reports concerning pregnancy in partners of patients taking bicalutamide
Danish: Indberetninger vedrørende graviditet hos partnere til patienter, der får bicalutamid
English: These same data were considered by the UK, the Reference Member State (RMS) for the Mutual Recognition Procedure (MRP), in 2003.
Danish: Disse oplysninger blev gennemgået af Det Forenede Kongerige, der var referencemedlemsstat (RMS) for den gensidige anerkendelsesprocedure i 2003.
English: However, an association with bicalutamide cannot be ruled out.
Danish: En sammenhæng med bicalutamid kan imidlertid ikke udelukkes.
English: Therefore, Belgium referred the issue on 27 July 2006 for consideration by CHMP under Article 31 of Directive 2001/83/EC, as amended.
Danish: Belgien indbragte derfor den 27. juli 2006 sagen for CHMP til vurdering i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer.
English: For these reasons, the CHMP considers that the progression-free survival results are important and can be considered on their merits.
Danish: Af disse grunde finder CHMP, at resultaterne for progressionsfri overlevelse er vigtige og kan tages i betragtning ud fra de foreliggende oplysninger.
English: Radical prostatectomy
Danish: Radikal prostatektomi
English: How such patients are identified could be based on criteria such as PSA levels, Gleason score and stage of disease.
Danish: Udvælgelsen af sådanne patienter kan tænkes baseret på kriterier som PSA-niveau, Gleason-score og sygdomsstadium.
English: To address this concern, a new epidemiological study will be performed, as part of an agreed Risk Management Plan.
Danish: Med henblik på denne betænkelighed skal der udføres en ny epidemiologisk undersøgelse som led i en godkendt risikostyringsplan.
English: These results should of course be balanced against the well-known tolerability issues of Casodex (bicalutamide).
Danish: Disse resultater må selvfølgelig afvejes mod de velkendte tolerabilitetsproblemer med Casodex (bicalutamid).
English: In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16; 95% CI 0.99 to 1.37).
Danish: Hos disse patienter var der også en tendens til formindsket overlevelse i forhold til de patienter, der fik placebo (HR = 1,16; 95% CI 0,99 til 1,37).
English: Whilst the pattern of adverse events argues against a role for raised oestrogen levels, it is known that the myocardium has androgen receptors, and it might be affected by long-term androgen deprivation.
Danish: Skønt bivirkningsmønsteret taler imod, at det forhøjede østrogenniveau spiller en rolle, vides det, at myokardiet har androgenreceptorer og kan tænkes at blive påvirket ved længerevarende androgen deprivation.
English: HU - Hungary Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
Danish: Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
English: The median PSA levels on initiation of active therapy for each subgroup are above the thresholds in current European Association of Urology (EAU) guidance.
Danish: Ved påbegyndelse af aktiv behandling er medianværdien af PSA-niveauet i hver undergruppe over tærskelværdierne i de nuværende retningslinjer fra European Association of Urology (EAU).
English: With reference to heart failure mortality, the MAHs have submitted a limited amount of new data since this issue was last assessed, namely results from a further clinical study, an updated literature review and an updated review of their safety database.
Danish: Vedrørende dødeligheden ved hjertesvigt har indehaverne af markedsføringstilladelsen siden den sidste gennemgang af spørgsmålet forelagt en begrænset mængde nye oplysninger: Resultaterne af endnu en klinisk undersøgelse, en ajourført litteraturgennemgang og en ajourført gennemgang af sikkerhedsdatabasen.
English: NO - Norway AstraZeneca AS Boks 200 Vinderen 0319 Oslo
Danish: AstraZeneca AS Boks 200 Vinderen 0319 Oslo
English: National Competent Authorities (NCA), coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder sikrer med referencemedlemsstaten som koordinerende instans, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
English: However, it is not possible to entirely “rule out” thromboembolic events as contributory explanation of increased cardiovascular mortality.
Danish: Tromboemboliske hændelser kan dog ikke helt "udelukkes" som medvirkende til den øgede kardiovaskulære mortalitet.
English: The lack of broad consensus in the standard of care for early prostate cancer makes it difficult to study.
Danish: Manglen på bred konsensus om behandlingsstandarden ved tidlig prostatacancer gør det vanskeligt at foretage undersøgelser heraf.
English: For patients with localised disease receiving CASODEX alone, there was no significant difference in progression free survival.
Danish: Hos de patienter med lokaliseret prostatacancer, som modtog Casodex alene, var der ingen signifikant forskel i progressionsfri overlevelse.
English: These are also not arbitrary subgroups, but are implicit in the proposed indication, correspond to the way prostate cancer is classified, managed and studied, and the results are consistent with what might be expected.
Danish: De pågældende undergrupper er ikke arbitrære, men fremgår implicit af den ansøgte indikation og svarer til den måde, prostatacancer klassificeres, behandles og undersøges på, og resultaterne svarer til, hvad man kunne forvente.
English: FI - Finland Synthon B V Microweg 22
Danish: Synthon B V Microweg 22
English: However, some trends were apparent in exploratory subgroup analyses.
Danish: I nogle eksplorasive delanalyser var der dog nogle tendenser.
English: The need to further study cardiovascular morbidity and mortality remains.
Danish: Der er fortsat behov for yderligere undersøgelse af den kardiovaskulære morbiditet og mortalitet.
English: Progression-free survival and overall survival data for patients with locally advanced disease are summarised in the following tables:
Danish: Data for progressionsfri overlevelse og total overlevelse hos patienter med lokalt avanceret sygdom er opsummeret i de følgende tabeller:
English: CS - Czech Republic
Danish: CS - Tjekkiet
English: As regards the multiplicity issue raised, it is considered appropriate to look at subgroups from a statistical viewpoint, as they have helped to narrow the indication to patients with a more favourable benefit/risk balance for bicalutamide 150 mg.
Danish: Hvad angår det rejste spørgsmål om multiplicitet, anses det for hensigtsmæssigt at analysere undergrupperne statistisk, da dette har medvirket til at indsnævre indikationen til patienter med et gunstigere risk/benefitforhold for bicalutamid 150 mg.
English: Gynaecomastia and breast pain have been highlighted (mainly in the 1st year of intake) and can be managed in many patients.
Danish: Gynækomasti og smerter i brysterne er blevet fremhævet (navnlig i det første behandlingsår) og kan behandles hos mange patienter.
English: Patients and clinicians should decide on the most appropriate treatment on an individual basis, discussing efficacy and tolerability aspects of all available treatments, all available risk factors for disease progression, and taking into account the lifestyle of the patient.
Danish: Patienter og klinikere bør i hvert enkelt tilfælde vælge den mest hensigtsmæssige behandling ved at drøfte virkning og tolerabilitet af alle tilgængelige behandlingsmuligheder og alle foreliggende risikofaktorer for progression af sygdommen, idet patientens livsstil tages i betragtning.
English: Due to a small number of relevant subjects, no conclusions could be drawn regarding the contribution of tamoxifen or radiotherapy to cardiovascular outcomes, or on whether tamoxifen exposure had a synergistic effect on efficacy.
Danish: Som følge af det ringe antal relevante patienter kunne der ikke drages konklusioner om bidraget fra tamoxifen eller strålebehandling til de kardiovaskulære udfald eller om, hvorvidt eksponering for tamoxifen havde synergistisk gavnlig virkning.
English: In conclusion, the heart failure data remain a concern and are inconclusive, but do not significantly alter the benefit/risk balance in locally advanced prostate cancer patients.
Danish: Som konklusion giver data vedrørende hjertesvigt fortsat anledning til betænkelighed og de er inkonklusive, uden at de dog væsentligt ændrer risk/benefit-forholdet ved lokalt avanceret prostatacancer.
English: FI - Finland Avansor Pharma Oy Tekniikantie 14
Danish: Avansor Pharma Oy Tekniikantie 14
English: FI - Finland Alternova Oy Ab Rajatorpantie 41 C 01640 Vantaa
Danish: Alternova Oy Ab Rajatorpantie 41 C 01640 Vantaa
English: It is acknowledged that overall there is no statistically significant survival benefit in locally advanced prostate cancer.
Danish: Det erkendes, at der totalt ikke er nogen fordel i form af statistisk signifikant længere overlevelse ved lokalt avanceret prostatacancer.
English: However, these data do support the Committee's position that the indication should be restricted to selected patients with locally advanced prostate cancer at high risk of disease progression.
Danish: Disse data støtter imidlertid udvalgets standpunkt, dvs. at indikationen bør indskrænkes til udvalgte patienter med lokalt avanceret prostatacancer og høj risiko for progression af sygdommen.
English: No overall survival difference was seen at 7.4 years median follow up with 22.9% mortality (HR=0.99; 95% CI 0.91 to1.09).
Danish: Ved 7,4-årsmedianen var der ingen forskel i overlevelse, dødeligheden var 22,9 % (HR = 0,99 CI 0,91 til 1,09).
English: The numbers involved are relatively small, there is no consistent pattern for heart failure deaths over the longer term, and there is some unreliability in selecting this as a cause of death.
Danish: De forelagte tal er forholdsvis små, der er intet sammenhængende langsigtet mønster i dødsfaldene af hjertesvigt, og valget heraf som dødsårsag er forbundet med nogen usikkerhed.
English: How does the company justify the absence of adjustment for tests of multiplicity in the analysis of the EPC results?
Danish: Hvormed begrunder firmaet den manglende korrektion for test for multiplicitet i analysen af resultaterne for EPC?
English: At 7.4 years median follow up, 27.4% and 30.7% of all CASODEX and placebo-treated patients, respectively, had experienced objective disease progression.
Danish: Ved 7,4-årsmedianen observeredes der objektiv sygdomsprogression hos 27,4% og 30,7% af patienterne, der fik behandling med henholdsvis Casodex og placebo.
English: FR - France AstraZeneca 1, place Renault 92844 Rueil-Malmaison Cedex
Danish: AstraZeneca 1, place Renault 92844 Rueil-Malmaison Cedex
English: How does the company justify that the placebo arm did not receive an adequate treatment according to the present standard of care and why this is not taken into account in the analysis of the EPC results?
Danish: Hvormed begrunder firmaet, at placeboarmen ikke fik fornøden behandling svarende til den nuværende behandlingsstandard, og hvorfor blev dette ikke taget i betragtning ved analyse af resultaterne ved EPC?
English: Astrazeneca S.P.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (MI)
Danish: Palazzo Volta Via F. Sforza 20080 - Basiglio (MI)
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BICALUTAMIDE 150 mg CONTAINING MEDICINAL PRODUCTS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE BICALUTAMID, 150 mg (se bilag I)
English: The EPC study was an empirical design, that is to say, it generally compared Casodex (bicalutamide) to the standard of care in each region involved.
Danish: EPC-undersøgelsen var empirisk opbygget, dvs. at den generelt sammenlignede Casodex (bicalutamid) med behandlingsstandarden i hver af de pågældende regioner.
English: Based on the concerns raised, the following questions were posed to the Applicants/ MAHs as part of the consolidated CHMP List of Questions, the responses to which were the basis of the CHMP reassessment of the benefit/risk balance:
Danish: På grundlag af de rejste betænkeligheder blev der til ansøgerne/indehaverne af markedsføringstilladelserne stillet følgende spørgsmål, som indgik i den række spørgsmål fra CHMP, hvis besvarelse var grundlag for CHMP's revurdering af risk/benefit-forholdet:
English: Disease progression may be associated with problems such as painful bone metastases, cord compression, pathological fractures and urinary obstruction.
Danish: Progression af sygdommen kan være forbundet med problemer som smertefulde knoglemetastaser, rygmarvskompression, patologisk frakturer og urinvejsobstruktion.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bicalutamide 150 mg.
Danish: - Udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende bicalutamid, 150 mg.
English: FI - Finland Helm Pharmaceuticals GmbH Nordkanalstr.
Danish: Helm Pharmaceuticals GmbH Nordkanalstr.
English: Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs.
Danish: Ved lokalt avanceret prostatacancer forstås større tumorer eller tumorer med spredning til lymfeknuder, men uden spredning til andre organer.
English: None of the EPC trials mandated that treatment be withheld from patients in the placebo group until clinical progression.
Danish: Ingen af EPC-undersøgelserne forlangte, at placebogruppen skulle forholdes behandling indtil klinisk progression af sygdommen.
English: The majority of patients with heart failure had confounding factors at study entry, and the causality assessment of investigators for all deaths ascribed to heart failure was “not related”.
Danish: For størstedelen af patienterne med hjertesvigt var der konfunderende faktorer ved patientens indtræden i undersøgelsen, og for samtlige dødsfald tilskrevet hjertesvigt var investigatorernes kausalitetsvurdering "uden sammenhæng".
English: FI - Finland Peseri Trading Limited El Greco House
Danish: Peseri Trading Limited El Greco House
English: PT - Portugal AstraZeneca Produtos Farmacêuticos, Lda.
Danish: AstraZeneca Produtos Farmacêuticos, Lda.
English: Following their own review of these data carried out in 2004 and due to their resulting concerns over the benefit/risk balance of bicalutamide 150 mg in locally advanced prostate cancer, the Belgian Regulatory Authority suspended their national Marketing Authorisation for Casodex (bicalutamide) 150 mg in August
Danish: Efter egen gennemgang af disse oplysninger i 2004 og som følge af de resulterende betænkeligheder ved risk/benefit-forholdet for bicalutamid 150 mg ved lokalt avanceret prostatacancer suspenderede de belgiske tilsynsmyndigheder i august 2005 den nationale markedsføringstilladelse for Casodex (bicalutamid), 150 mg.
English: London W1K 1LN
Danish: London W1K 1LN United Kingdom
English: When the EPC programme was initiated more than 8 years ago, the aim was to document the benefit of early bicalutamide therapy versus placebo as monotherapy or adjuvant therapy to surgery or radiotherapy.
Danish: Da EPC-programmet blev indledt for mere end otte år siden, var målet at dokumentere fordelen af tidlig behandling med bicalutamid i forhold til placebo, anvendt som monoterapi eller adjuverende terapi til operation eller strålebehandling.
English: Gynaecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment.
Danish: Gynækomasti svinder ikke spontant efter ophør af behandlingen, navnlig ikke efter langvarig behandling.
English: In particular, there is a statistically significant and clinically meaningful improvement in progression-free survival in the patients with locally advanced prostate cancer who received Casodex (bicalutamide) as compared to placebo (58% versus 69% progressors in patients who were not receiving adjuvant surgery or radiotherapy).
Danish: Navnlig er der en statistisk signifikant og klinisk betydningsfuld længere progressionsfri overlevelse hos de patienter med lokalt avanceret prostatacancer, der fik Casodex (bicalutamid) end hos dem, der fik placebo (hhv. 58 % og 69 % progression hos patienter, der ikke desuden blev opereret eller fik strålebehandling).
English: H-2045
Danish: Törökbálint H-2045
English: DA - Denmark AstraZeneca A/S Roskildevej 22
Danish: AstraZeneca A/S Roskildevej 22
English: - For all MAHs, in addition to routine pharmacovigilance activities, identified and potential risks highlighted for increased monitoring and follow-up should include:
Danish: - Alle indehavere af markedsføringstilladelser skal ud over den rutinemæssige lægemiddelovervågning foretage forstærket overvågning og opfølgning af følgende konstaterede og potentielle risici:
English: In 2004, 2 publications were published detailing a pre-planned 2nd analysis of the Casodex (bicalutamide) Early Prostate Cancer (EPC) study programme.
Danish: I 2004 udkom to publikationer, der beskrev en på forhånd planlagt reanalyse af det kliniske udviklingsprogram for prostatacancer i tidligt stadium (Early Prostate Cancer (EPC)) for Casodex (bicalutamid).
English: How does the company justify the indication of bicalutamide 150 mg for locally advanced prostate cancer knowing the absence of statistically significant overall survival and the important side effects?
Danish: Hvormed begrunder firmaet indikationen for bicalutamid, 150 mg, til lokalt avanceret prostatacancer på baggrund af den manglende statistisk signifikante fordel i total overlevelse og de betydelige bivirkninger?
English: Regarding the heart failure deaths, the allocation of cause of death is known to be unreliable, and very few post-mortems were done.
Danish: For dødsfald som følge af hjertesvigt vides bestemmelsen af dødsårsagen at være upålidelig, og der blev kun udført meget få obduktioner.
English: In addition, the survival advantage observed in patients with locally advanced disease receiving radiotherapy appears to be consistent with that seen in previous studies, and a synergistic effect with radiotherapy is plausible.
Danish: Den øgede overlevelse hos patienter, der får strålebehandling mod lokalt avanceret sygdom, synes også at svare til resultaterne af tidligere undersøgelser, og en synergistisk virkning med strålebehandling er ret plausibel.
English: - A new pharmacoepidemiological study(ies) should be undertaken to get a better understanding of cardiovascular risk.
Danish: - Der gennemføres en ny farmakopidemiologisk undersøgelse med henblik på at skaffe bedre indsigt i den kardiovaskulære risiko.
English: EL - Greece Genepharm SA 18th klm Marathon Ave 153 44 Pallini Attiki
Danish: EL - Grækenland Genepharm SA 18th klm Marathon Ave 153 44 Pallini Attiki