FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, according to the data submitted by the Marketing Authorisation Holder the majority of hepatic disorders (56%), occurred after two weeks of treatment, therefore a treatment period of not longer than 15 days may limit the risk of acute liver injury.
Danish: Endelig forekom størstedelen af leverforstyrrelserne (56 %) ifølge data fremlagt af indehaveren af markedsføringstilladelsen efter to ugers behandling, hvorfor en behandlingsperiode på højst 15 dage muligvis kan begrænse risikoen for akut leverskade.
English: Some of the cases reported were however confounded by concommittant disease/hepatotoxic medication and a clear causal relationship with nimesulide could not be concluded.
Danish: Visse af de indberettede tilfælde var imidlertid blevet forvekslet med sideløbende sygdom/hepatotoksisk medicin, og det kunne ikke konkluderes, at der var en klar årsagssammenhæng med nimesulide.
English: The hepatotoxic signal seen in Ireland showed that nimesulide was associated with more cases of nonA non-B non-paracetamol-related fulminant hepatic failure requiring liver transplantation in Ireland than any other medicinal product.
Danish: Det hepatotoksiske signal, som var observeret i Irland, viste, at nimesulide blev sat i forbindelse med flere tilfælde af non-A-, non-B- og non-paracetamolrelateret fulminant leversvigt, som krævede levertransplantation, end noget andet lægemiddel i Irland.
English: This referral concluded, with divergent positions submitted by Finland, Spain and Ireland, that the benefit/risk profile of nimesulide for systemic use remained positive, subject to revision of the product information, including a restriction of the maximum oral dose to 100 mg twice daily.
Danish: Med de forskellige holdninger, som var fremlagt af Finland, Spanien og Irland, var konklusionen på denne indbringelsesprocedure, at benefit/risk-forholdet for nimesulide til systematisk anvendelse fortsat var positivt, under forudsætning af en revision af produktoplysningerne, herunder en begrænsning af den maksimale orale dosis til 100 mg to gange dagligt.
English: The Irish Medicines Board informed the EMEA, other Member States and the Marketing Authorisation Holders in accordance with Article 107(2) of Directive 2001/83/EC, as amended.
Danish: Den irske lægemiddelstyrelse underrettede EMEA, andre medlemsstater og indehaverne af markedsføringstilladelsen herom i overensstemmelse med artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
English: This review focused on the hepatic safety of nimesulide in light of the significant concern arising from the Irish data and within the defined scope of the Article 107.
Danish: Denne gennemgang var fokuseret på leversikkerheden ved nimesulide i lyset af de væsentlige betænkeligheder, der var opstået som følge af de irske data, og den blev foretaget inden for rammerne af anvendelsesområdet for artikel 107.
English: Overall, the benefit-risk profile of nimesulide-containing medicinal products for systemic use remains favourable and the Marketing Authorisations for products containing nimesulide for systemic use should be maintained with the following restrictions: - The decision to prescribe nimesulide should be based on an assessment of the individual patient's overall risks.
Danish: Det samlede benefit/risk-forhold for lægemidler indeholdende nimesulide til systemisk anvendelse er fortsat gunstigt, og markedsføringstilladelserne for lægemidler indeholdende nimesulide til systemisk anvendelse bør opretholdes med følgende begrænsninger: - Beslutningen om at ordinere nimesulide bør baseres på en vurdering af de samlede risici for den enkelte patient.
English: On 15th May 2007, following new safety information regarding cases of fulminant hepatic failure associated with nimesulide, the Irish Medicines Board suspended the national marketing authorisations for all systemic medicinal products containing nimesulide available in Ireland.
Danish: Efter nye sikkerhedsoplysninger om tilfælde af fulminant leversvigt i tilknytning til nimesulide suspenderede den irske lægemiddelstyrelse den 15. maj 2007 de nationale markedsføringstilladelser for alle systemiske lægemidler indeholdende nimesulide i Irland.
English: Nimesulide was the subject of an Article 31 referral to the CHMP in 2002, following national suspension of its licence in Finland, and subsequently Spain, due to concerns regarding hepatotoxicity.
Danish: I 2002 fik CHMP forelagt en sag vedrørende nimesulide i henhold til indbringelsesproceduren i artikel 31 efter suspenderingen af markedsføringstilladelsen i Finland og dernæst også i Spanien på grund af frygt for hepatotoksicitet.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE MAINTENANCE OF THE MARKETING AUTHORISATIONS AND AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR OPRETHOLDELSEN AF MARKEDSFØRINGSTILLADELSERNE OG FOR ÆNDRINGERNE AF PRODUKTRESUMEET OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: The assessment of overall post-marketing spontaneous reporting data, clinical studies, and epidemiological data, show a higher frequency of severe adverse hepatic reactions with nimesulide compared with other NSAIDs.
Danish: Vurderingen af de samlede spontant indberettede data efter markedsføringen, dataene fra de kliniske undersøgelser og de epidemiologiske data viser en høj forekomst af svære leverreaktioner med nimesulide sammenlignet med andre NSAID.
English: However, with the exception of the signal of serious hepatic adverse reactions raised by Ireland, the review of the overall data submitted do not modify the safety profile of nimesulide as established after the previous CHMP opinion.
Danish: Med undtagelse af signalet om svære bivirkninger i form af leverreaktioner, som Irland har påpeget, ændrer gennemgangen af de samlede data ikke sikkerhedsprofilen for nimesulide, således som denne blev fastlagt i CHMP's foregående udtalelse.
English: - Nimesulide showed a higher frequency of severe adverse hepatic reactions but the overall safety profile of nimesulide is not modified.
Danish: - Nimesulide viser en høj forekomst af svære leverreaktioner, men den samlede sikkerhedsprofil for nimesulide er ikke ændret.
English: - The CHMP considered the gastrointestinal toxicity profile of nimesulide and the possible consequences of switching to other NSAIDs.
Danish: - CHMP undersøgte den gastrointestinale toksicitetsprofil for nimesulide og de mulige konsekvenser af at skifte til andre NSAID.
English: The CHMP has recommended the maintenance of the Marketing Authorisations for all medicinal products referred to in Annex I of the Opinion and to amend the relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of nimesulide, as set out in Annex III of the Opinion in accordance with Article 107(2) of Directive 2001/83/EC, as amended.
Danish: CHMP anbefalede at opretholde markedsføringstilladelserne for alle lægemidler anført i bilag I til beslutningen og at ændre de relevante afsnit i produktresuméet og indlægssedlen om systemiske formuleringer af nimesulide som anført i bilag III til beslutningen i overensstemmelse med artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
English: GROUNDS FOR THE MAINTENANCE OF THE MARKETING AUTHORISATIONS AND THE AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR OPRETHOLDELSEN AF MARKEDSFØRINGSTILLADELSERNE OG FOR ÆNDRINGERNE AF PRODUKTRESUMEET OG INDLÆGSSEDLEN
English: During its plenary meeting in May 2007, the CHMP considered the emerging safety data from Ireland on the risk of fulminant hepatic failure associated with nimesulide, as well as data available from published literature, and concluded that hepatotoxicity data on nimesulide should be reviewed in accordance with Article 107(2) of Directive 2001/83/EC, as amended.
Danish: CHMP behandlede på sit plenarmøde i maj 2007 de nyfremkomne sikkerhedsdata fra Irland om risikoen for fulminant leversvigt i tilknytning til nimesulide og de data, der forelå i den offentliggjorte faglitteratur, og konkluderede, at hepatotoksicitetsdataene for nimesulide skulle tages op til fornyet overvejelse i overensstemmelse med artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
English: Therefore pack sizes above 30 units should be withdrawn and not authorised - New contraindications and strengthened warnings have been added to the Summary of Product characteristics and Package Leaflet in order to limit exposure of nimesulide to those patients without risk factors for hepatic reactions.
Danish: - Der er tilføjet nye kontraindikationer og opstrammede advarsler til produktresuméet og indlægssedlen for at begrænse eksponeringen for nimesulide til de patienter, som er uden risikofaktorer for leverreaktioner.
English: NSAIDs, and the possible consequences of switching to other NSAIDs with a higher gastrointestinal risk.
Danish: CHMP undersøgte den gastrointestinale toksicitetsprofil for nimesulide sammenlignet med andre NSAID og de mulige konsekvenser af at skifte til andre NSAID med en større gastrointestinal risiko.
English: Annex II Conditions to the marketing authorisation(s)
Danish: Bilag II Betingelser for markedsføringstilladelsen/-tilladelserne
English: Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Danish: Candesartan 32 * Disse grænseværdier gælder ikke batcher, hvor mere end ét af ovenstående Nnitrosaminer er identificeret samtidigt; sådanne batcher bør afvises.
English: For N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Danish: For N-nitrosodimethylamin (NDMA) og N-nitrosodiethylamin (NDEA) skal indehaverne af markedsføringstilladelse indføre følgende specifikationer for stoffet: 1) De nedenfor angivne grænseværdier for NDMA og NDEA bør implementeres i løbet af en overgangsperiode på to år: Aktivt stof* Maksimal daglig dosis (mg)
English: Conditions to the MA
Danish: NDMA
English: 1 pre-filled pen + 7 NovoTwist needles
Danish: 1 pen + 7 NovoTwist nåle
English: 1 pre-filled pen + 7 NovoFine needles
Danish: 1 pen + 7 NovoFine nåle
English: Urokinase is considered to have a well-established use in the above indications within the European Union and on 29 September 2006, Syner-Kinase was granted a marketing authorisation in the UK according to Article 10(a) of Directive 2001/83/EC.
Danish: Urokinase anses for at være en velkendt behandling i de førnævnte indikationer inden for EU, og den 29. september 2006 fik Syner-Kinase markedsføringstilladelse i Det Forenede Kongerige i overensstemmelse med artikel 10, litra a), i direktiv 2001/83/EF.
English: The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Danish: Produktinformationen fastholdes i den endelige version som aftalt under koordinationsgruppens sagsbehandling, jf. bilag III til CHMP's udtalelse.
English: In January 2018, Syner-Medica Ltd sumitted a mutual recognition application for Syner-Kinase 10,000 IU, 25,000 IU, 100,000 IU, 250,000 IU and 500,000 IU powder for solution for injection or infusion in France, Germany, Spain and the Netherlands with the United Kingdom as the reference Member State (RMS).
Danish: I januar 2018 indsendte SynerMedica Ltd. en ansøgning via den gensidige anerkendelsesprocedure for Syner-Kinase 10.000 IE, 25.000 IE, 100.000 IE, 250.000 IE og 500.000 IE, pulver til injektions-/infusionsvæske, opløsning, i Frankrig, Tyskland, Spanien og Nederlandene med Det Forenede Kongerige som referencemedlemsstat.
English: • The Committee concluded that the purification process of the active substance is suitable for the removal of possible viral and prion impurities.
Danish: • Udvalget konkluderede, at rensningsprocessen for det aktive stof er egnet til fjernelse af mulige virus- og prionurenheder.
English: The UK therefore triggered a referral under Article 29(4) of Directive 2001/83/EC.
Danish: Det Forenede Kongerige iværksatte derfor en indbringelsesprocedure i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: • The Committee considered the totality of the data submitted by the MAH/applicant in relation to the objections raised as potential serious risk to public health.
Danish: • Udvalget vurderede alle de data, som indehaveren af markedsføringstilladelsen/ansøgeren havde fremsendt, i forhold til indvendingerne vedrørende en mulig alvorlig risiko for den offentlige sundhed.
English: The Committee, as a consequence, considers that the benefit-risk balance of Syner-Kinase and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Danish: Udvalget finder følgelig, at benefit/risk-forholdet for Syner-Kinase og relaterede navne er positivt, og anbefaler derfor udstedelse af markedsføringstilladelse for de lægemidler, der er anført i bilag 1 til CHMP's udtalelse.
English: The CHMP considered, as a consequence, that the benefit-risk balance of Syner-Kinase is favourable.
Danish: CHMP fandt som følge heraf, at benefit/risk-forholdet for Syner-Kinase er positivt.
English: A referral was thus triggered at the CMD(h) but at D60 of the procedure, the PSRPH issues remained unresolved.
Danish: Der blev derfor iværksat en indbringelsesprocedure i CMD(h), men ved dag 60 i proceduren var der stadig ikke fundet en løsning på den mulige alvorlige risiko for den offentlige sundhed.
English: Urokinase is a serine protease that catalyses conversion of plasminogen to plasmin with resultant fibrinolytic and thrombolytic properties.
Danish: Urokinase er en serinprotease, der katalyserer omdannelsen af plasminogen til plasmin med deraf følgende fibrinolytiske og trombolytiske egenskaber.
English: The MAH/applicant has successfully demonstrated that the virus removal/inactivation steps are appropriately controlled and will provide the final reports of the virus and TSE removal studies and the updated risk assessment analysis by 31 May 2019 to the relevant national competent authorities.
Danish: Indehaveren af markedsføringstilladelsen/ansøgeren har påvist, at processerne til fjernelse/inaktivering af virus kontrolleres på en hensigtsmæssig måde, og vil inden den 31. maj 2019 fremsende de endelige rapporter af undersøgelserne af fjernelse af virus og TSE og den opdaterede risikovurderingsanalyse til de relevante nationale kompetente myndigheder.
English: Finally, evidence has been provided that the manufacture of semi-purified urokinase is adequately validated and controlled and in compliance with good manufacturing practices and all concerns raised over the quality and manufacturing of Syner-Kinase are considered solved.
Danish: Endelig er der fremlagt evidens for, at fremstillingen af det delvist rensede urokinase er tilstrækkeligt valideret, kontrolleret og i overensstemmelse med god fremstillingspraksis, og alle betænkeligheder vedrørende kvalitet og fremstilling af Syner-Kinase anses for løst.
English: • The Committee concluded that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data available are adequate to support its proposed use.
Danish: • Udvalget konkluderede, at Syner-Kinase er sammenligneligt med de urokinase-lægemidler, der er nævnt i den publicerede litteratur, og at de tilgængelige data er tilstrækkelige til at understøtte den ansøgte brug.
English: • The Committee concluded that manufacture of the semi-purified urokinase is adequately validated and controlled, and that reassurance has been provided that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP).
Danish: • Udvalget konkluderede, at fremstillingen af delvist renset urokinase er tilstrækkeligt valideret og kontrolleret, og at der er afgivet forsikring om, at dette mellemprodukt fremstilles på et sted, der opfylder principperne og retningslinjerne for god fremstillingspraksis.
English: Urokinase is used for the lysis of blood clots in the following conditions: thrombosed intravascular catheters and cannulae; extensive acute proximal deep vein thrombosis; acute massive pulmonary embolism and acute occlusive peripheral arterial disease with limb threatening ischemia.
Danish: Urokinase anvendes til lyse af blodpropper ved følgende tilstande: tromboserede intravaskulære katetre og kanyler, omfattende akut proksimal dyb venetrombose, akut massiv lungeemboli og akut okklusiv perifer arteriesygdom med ekstremitetstruende iskæmi.
English: The mutual recognition procedure was closed on day 90, with the four concerned Member States raising potential serious risk to public health (PSRPH) in relation to the lack of bridging data between the product applied for and the product(s) described in literature that was used to demonstrate the benefit/risk of Syner-Kinase, the adventitious agent safety with respect to viral and prion clearance and the lack of adequate quality of the process validation of the semi-purified urokinase and lifetime of columns used for urokinase purification.
Danish: Den gensidige anerkendelsesprocedure blev afsluttet på dag 90, hvor de fire berørte medlemsstater udtrykte betænkelighed ved den mulige alvorlige risiko for den offentlige sundhed i forhold til manglen på data, der kan lukke hullet mellem data for det omhandlede lægemiddel og de lægemidler, der er beskrevet i litteraturen, og som var anvendt til at påvise benefit/risk-forholdet for Syner-Kinase og sikkerheden ved det fremmede stof med hensyn til virus- og prion-clearance, samt i forhold til manglen på tilstrækkelig kvalitet i valideringsprocessen for det delvist rensede urokinase og holdbarheden af de kolonner, der anvendes til rensning af urokinase.
English: The CHMP also requested the MAH/applicant to provide further information to support the viral and prion clearance capacity of the process and justify the adequacy of the procedures to support the suitability of viral and prion removal, including transmissible spongiform encephalopathies (TSE) infectivity reduction.
Danish: CHMP bad også indehaveren af markedsføringstilladelsen/ansøgeren om at fremsende yderligere oplysninger til godtgørelse af processens egnethed til at sikre virus- og prion-clearance og godtgøre procedurernes egnethed til at understøtte nytten af virus- og prionfjernelse, herunder reduktionen af infektioner med smitsomme spongiforme encefalopatier (TSE).
English: Furthermore, confirmation was required that the semi-purified urokinase is manufactured in accordance with GMP.
Danish: Desuden krævedes der en bekræftelse af, at det delvist rensede urokinase fremstilles i overensstemmelse med god fremstillingspraksis.
English: Based on the data provided, it is considered that the comparability of Syner-Kinase and urokinase products used in the literature studies cited in the submission has been sufficiently demonstrated.
Danish: På grundlag af de fremlagte data vurderes det, at sammenligneligheden mellem Syner-Kinase og de urokinase-lægemidler, der er nævnt i ansøgningens beskrivelse af litteraturundersøgelser, er tilstrækkeligt påvist.
English: As part of this procedure, the CHMP requested the applicant to justify that the available data on SynerKinase, including its comparison to the urokinase products mentioned in the literature, are adequate to support its positive benefit/risk balance in the proposed indications.
Danish: Som led i proceduren bad CHMP ansøgeren om at godtgøre, at de tilgængelige data for Syner-Kinase, herunder sammenligningen med de i litteraturen nævnte urokinase-lægemidler, er tilstrækkelige til at understøtte dets gunstige benefit/risk-forhold i de foreslåede indikationer.
English: The MAH/applicant has provided relevant data to justify the extrapolation of the data available in the literature on the benefit and risks of urokinase in the indications applied for.
Danish: Indehaveren af markedsføringstilladelsen/ansøgeren har fremlagt relevante data som begrundelse for ekstrapoleringen på grundlag af de tilgængelige data i litteraturen for fordele og risici ved urokinase i de ansøgte indikationer.
English: The MAH/applicant has provided further comparative studies between Syner-Kinase active ingredient (API) and the API's in the urokinase products used in the literature studies cited in the submission, as well as data demonstrating the consistency of the product overtime despite the changes made to the product during its lifecycle.
Danish: Indehaveren af markedsføringstilladelsen/ansøgeren har fremlagt yderligere komparative undersøgelser af det aktive stof i Syner-Kinase og de aktive stoffer i de urokinaselægemidler, der er nævnt i de litteratur-beskrevne undersøgelser, som var nævnt i ansøgningen, samt data for lægemidlets konsistens over tid på trods af de ændringer, som lægemidlet gennemgår i løbet af sin livscyklus.
English: Finally, the CHMP requested the MAH/applicant to provide further information to demonstrate that the manufacturing steps for semi-purified urokinase have been satisfactorily validated, and also that the control strategy for column lifetime during the manufacture of the active pharmaceutical ingredient is suitable.
Danish: Endelig bad CHMP indehaveren af markedsføringstilladelsen/ansøgeren om at fremlægge yderligere oplysninger til godtgørelse af, at fremstillingsprocessen for delvist renset urokinase er tilstrækkeligt valideret, og at kontrolstrategien for kolonnernes holdbarhed under fremstillingen af det aktive stof er egnet.
English: 1 September 2014
Danish: Den 1. september 2014
English: Written explanations were provided by the marketing authorisation holders on 17 June 2013, 10 January 2014 and 12 March 2014.
Danish: Indehaverne af markedsføringstilladelse afgav skriftlige redegørelser den 17. juni 2013, 10. januar 2014 og 12. marts 2014.
English: The Committee adopted a positive opinion by majority on 9 April 2014.
Danish: Udvalget vedtog ved en flertalsafgørelse en positiv udtalelse den 9. april 2014.
English: The referral procedure started on 7 November 2012.
Danish: Indbringelsesproceduren blev indledt den 7. november 2012.
English: The final opinion was converted into a Decision by the European Commission on 1 September 2014.
Danish: Den endelige udtalelse blev den 1. september 2014 omarbejdet til en beslutning af EuropaKommissionen.
English: The Committee appointed M. Holzhauser-Alberti as rapporteur and C. Muñoz Madero as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis M. Holzhauser-Alberti og C. Muñoz Madero.
English: Due to divergent national decisions taken by Member States with respect to target species, indications, posology and withdrawal periods concerning the authorisations of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names, on 26 October 2012 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the divergence in the product information of nationally authorised products across the European Union.
Danish: Som følge af, at medlemsstaterne havde truffet divergerende nationale afgørelser om måldyrearter, indikationer, dosering og tilbageholdelsestider i forbindelse med godkendelsen af Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne, indbragte Frankrig den 26. oktober 2012 sagen for CVMP i medfør af artikel 34, stk. 1, i direktiv 2001/82/EF for at ophæve divergenserne mellem de nationalt godkendte produktinformationer i EU.
English: Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.
Danish: Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne er injektionsvæsker, opløsning, der indeholder enrofloxacin i en koncentration af henholdsvis 25 mg/ml, 50 mg/ml og 100 mg/ml.