FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral explanations were given by a group of marketing authorisation holders on 8 February 2012.
Danish: Der blev fremsat mundtlige redegørelser af en gruppe af markedsføringstilladelsesindehavere den 8. februar 2012.
English: Written explanations were provided by a group of marketing authorisation holders on 11 January 2012.
Danish: Der blev forelagt skriftlige redegørelser af en gruppe af markedsføringstilladelsesindehavere den 11. januar 2012.
English: The CVMP was therefore requested to give its opinion as to whether measures are necessary to ensure that the use, during the non-lactating period, of veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole, would not lead to residues in milk that, combined with residues of these flukicidal substances from other foodstuffs, would result in consumer exposure exceeding the acceptable daily intake.
Danish: CVMP blev derfor anmodet om at fremsætte en udtalelse om, om der er behov for foranstaltninger til at sikre, at anvendelse uden for laktationsperioden af veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid og triclabendazol ikke medfører restkoncentrationer i mælk, som sammen med rester af sådanne trematodemidler fra andre fødemidler medfører større eksponering af forbrugerne end svarende til ADI-værdien.
English: On 14 February 2011, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk intended for use in all ruminants producing milk for human consumption.
Danish: Den 14. februar 2011 indledte Europa-Kommissionen en indbringelse i henhold til artikel 35 i direktiv 2001/82/EF, som ændret, for alle veterinærlægemidler indeholdende aktive stoffer tilhørende klassen trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer i mælk, og som er bestemt til anvendelse hos alle drøvtyggere, der producerer mælk til konsum.
English: The issues considered during the reexamination related to the recommended amendments of section 4.11 Withdrawal period(s) of the summaries of product characteristics for the veterinary medicinal products containing nitroxinil that are administered to cattle.
Danish: Den fornyede overvejelsesprocedure blev indledt den 3. maj 2012 og vedrørte de anbefalede ændringer af punkt 4.11, tilbageholdelsesperiode(r), i produktresuméerne for veterinærlægemidler, der indeholder nitroxinil og administreres til kvæg.
English: On 14 June 2012 the CVMP adopted a final opinion confirming the recommendation, included in its opinion of 8 March 2012, that variations are necessary in the marketing authorisations for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as a single active substance and for the veterinary medicinal products administered as pour-on to cattle containing triclabendazole and moxidectin in order to amend the summaries of product characteristics and package leaflets in line with recommended by the CVMP changes in the product information.
Danish: Den 14. juni 2012 vedtog CVMP en endelig udtalelse, der bekræftede anbefalingen i udtalelsen af 8. marts 2012 om, at der bør foretages ændringer af markedsføringstilladelserne for veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol som eneste aktive stof og for pour-on veterinærlægemidler indeholdende triclabendazol og moxidectin, således at produktresuméerne og indlægssedlerne ændres i henhold til de ændringer af produktinformationen, der anbefales af CVMP.
English: Based on the evaluation of the available data, the CVMP adopted, on 8 March 2012, an opinion recommending variations of the marketing authorisations for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as a single active substance and for the veterinary medicinal products administered as pour-on to cattle containing triclabendazole and moxidectin.
Danish: Efter vurdering af de foreliggende data vedtog CVMP den 8. marts 2012 i en udtalelse, der anbefalede ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol som eneste aktive stof og for veterinærlægemidler, der administreres som pour-on til kvæg og indeholder triclabendazol og moxidectin.
English: Opinion following an Article 351 referral for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption
Danish: Udtalelse efter en artikel 351-indbringelse for veterinærlægemidler, som indeholder aktive stoffer tilhørende klassen trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer, og som er bestemt til brug hos drøvtyggere, der producerer mælk til konsum.
English: The referral procedure was initiated on 13 December 2012.
Danish: Indbringelsesproceduren blev indledt den 13. december 2012.
English: Additional supportive data
Danish: Supplerende støttende data
English: Available from: http://www.ginasthma.org/.
Danish: Kan rekvireres på: http://www.ginasthma.org/
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 23 November 2012, Germany triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Danish: Da referencemedlemsstaten og de berørte medlemsstater ikke kunne nå til enighed om ændringsansøgningen, indledte Tyskland den 23. november 2012 en indbringelse i henhold til artikel 13 i Kommissionens forordning (EF) nr. 1234/2008.
English: Overall summary of the scientific evaluation of Kantos Master and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Kantos Master og relaterede navne (se bilag I)
English: Study CT07
Danish: Undersøgelse CT07
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelser for ændringen af betingelserne for markedsføringstilladelserne
English: • The Committee considered the referral under article 13(2) of Regulation No 1234/2008
Danish: • udvalget behandlede indbringelsen i henhold til artikel 13, stk. 2, i forordning nr.
English: The extrapolation of data from Symbicort SMART was questionable as the similarity of these two products in the MART regimen has not been established.
Danish: Ekstrapolationen af data fra Symbicort SMART var problematisk, da ligheden mellem disse to produkter i MART-regimet ikke er godtgjort.
English: On the basis of the questions raised by Sweden the points to be considered by the CHMP were:
Danish: På grundlag af de spørgsmål, der var rejst af Sverige, blev CHMP anmodet om at tage stilling til følgende punkter:
English: Post hoc analysis of data from study CT07
Danish: Post hoc-analyse af data fra undersøgelse CT07
English: The concept of this “early intervention” is clearly advocated in the 2011 GINA guidelines1 where it is stated that “The benefit in preventing exacerbations appears to be the consequence of early intervention at a very early stage of a threatened exacerbation”.
Danish: Konceptet i denne "tidlige intervention" anbefales klart i GINA-retningslinjerne fra 20111, hvor det anføres, at fordelen i form af forebyggelse af eksacerbationer synes at skyldes intervention i et meget tidligt stadium af en truende eksacerbation.
English: In addition, both components have been developed as an extrafine formulation, which means they reach the most peripheral airways where most of the inflammatory process takes place during asthma exacerbation.
Danish: Desuden er begge komponenter udviklet i en ekstrafin formulering, dvs. de når derfor frem til de mest perifere dele af luftvejene, hvor størstedelen af den inflammatoriske proces finder sted under forværring af astma.
English: group taking salbutamol, and the difference between groups was statistically significant (p<0.001).
Danish: Forskellen mellem grupperne var statistisk signifikant (p<0,001).
English: However, it has never been demonstrated that a small increase in total ICS dose would have an impact on the lung function or on the clinical outcomes.
Danish: Det er imidlertid aldrig påvist, at en lille stigning i total dosis inhalationskortikosteroid har indvirkning på lungefunktionen eller på det kliniske udfald.
English: The disease severity was based on lung function (FEV1) and use of rescue medication at entry to the study.
Danish: Sygdommens sværhedsgrad blev baseret på lungefunktion (FEV1) og anvendelsen af redningsmedicin ved inklusion i undersøgelsen.
English: Literature data
Danish: Data fra litteraturen
English: The similar particle size of the two components also leads to co-deposition in the same regions of the lung, favouring a synergistic interaction.
Danish: Den ens partikelstørrelse af de to komponenter bevirker desuden, at de afsættes sammen i samme områder af lungen, hvilket fremmer deres synergistiske interaktion.
English: This comparability has also been confirmed in a comparative clinical study between Kantos Master and associated names (Foster 10/6) and Symbicort 200/6 (budesonide/formoterol)3.
Danish: Denne sammenlignelighed bekræftes desuden af en klinisk undersøgelse, hvor Kantos Master og relaterede navne (Foster 10/6) sammenlignes med Symbicort 200/6 (budesonid/formoterol)3.
English: A post hoc analysis was conducted with two subgroups of patients in order to demonstrate that both groups of patients in the study CT07 were not overtreated or undertreated.
Danish: Der blev udført en post hoc-analyse med to undergrupper af patienter for at påvise, at ingen af de to patientgrupper i undersøgelse CT07 var overbehandlet eller underbehandlet.
English: In the Symbicort MART development program, marked improvements in asthma control have been obtained when part of the dose was given on an as-needed basis.
Danish: I udviklingsprogrammet for Symbicort MART opnåedes markant bedre astmakontrol, når en del af dosis blev givet efter behov.
English: Kantos Master has received marketing authorisation in the European Union through the Mutual Recognition Procedure (MRP).
Danish: Der er udstedt markedsføringstilladelse i EU for Kantos Master ved den gensidige anerkendelsesprocedure.
English: This additional analysis further demonstrated that Kantos Master in MART is not associated with under-treatment of patients in case of uncontrolled asthma.
Danish: Denne supplerende analyse viste desuden, at Kantos Master i MART ikke er forbundet med underbehandling af patienter ved ukontrolleret astma.
English: It was concluded that the key factor of the MART approach is not the overall amount of ICS given, but when the dose is given.
Danish: Det blev konkluderet, at den vigtigste faktor i MART-tilgangen ikke var den samlede indgivne mængde inhalationskortikosteroid, men tidspunktet for indgivelsen.
English: Further evidence in the literature has suggested that dose reduction from high to moderate maintenance ICS does not affect outcomes of MART treatment.
Danish: Yderligere evidens fra litteraturen tyder på, at nedsættelse af dosis fra høj til moderat vedligeholdelsesdosis af inhalationskortikosteroid ikke påvirker udfaldet af MART-behandlingen.
English: • The Committee is of the opinion that the data of the pivotal study CT07 indicated a significant reduction in the risk of severe exacerbations of asthma and significant longer time to exacerbation can be obtained when Kantos Master dose is given as needed.
Danish: • det er udvalgets opfattelse, at hovedundersøgelse CT07 viste, at der kan opnås signifikant nedsat risiko for svære eksacerbationer af astma og signifikant længere tid til eksacerbation, når Kantos Master gives efter behov
English: Significant improvements were also observed in the secondary efficacy variables (Forced Expiratory Volume in the 1st second (FEV1), asthma symptoms, medication free days etc.) in both treatment arms.
Danish: I begge behandlingsarme iagttoges ligeledes signifikante bedringer i de sekundære virkningsvariabler (forceret ekspiratorisk volumen i første sekund (FEV1), astmasymptomer, medicinfrie dage m.v.).
English: Therefore, the CHMP recommended the granting of the variation to the terms of the marketing authorisations for the medicinal products referred to in Annex I for which the valid Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III.
Danish: anbefalede CHMP godkendelse af ændring af markedsføringstilladelsen for de i bilag I anførte lægemidler, for hvilke det gældende produktresumé og den gældende etikettering og indlægsseddel fortsat er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III.
English: The CHMP also took into account the suitability of Kantos Master (in terms of its components and its formulation) for the MART approach.
Danish: CHMP tog desuden stilling til Kantos Masters egnethed til MART-behandlingen (hvad angår dets komponenter og dets formulering).
English: The daily maintenance dose, in both arms of the study was 200µg of extrafine beclometasone, which is clinically equivalent to 500µg of non extrafine beclometasone.
Danish: Den daglige vedligeholdelsesdosis i begge arme af undersøgelsen var 200 µg ekstrafint beclometason, som er klinisk ækvivalent med 500 µg ikke-ekstrafint beclometason.
English: • The Committee noted that there was no comparison with the standard of care, according to the GINA guideline.
Danish: • udvalget bemærkede, at der ikke var sammenlignet med standardbehandling svarende til GINA-retningslinjerne.
English: Kantos Master in MART was also significantly efficacious regarding the mean number of rescue medication at entry to the study (>0 and ≤1, >1 and ≤2, and >2) in the three groups (similar hazard ratio of 0.51, 0.64 and 0.52, respectively).
Danish: Virkningen af Kantos Master i MART var desuden signifikant i forhold til det gennemsnitlige antal administrationer af redningsmedicin ved inklusion i undersøgelsen (>0 og ≤1, >1 og ≤2 og >2 i de tre grupper) (omtrent samme risikoforhold på henholdsvis 0,51, 0,64 og 0,52).
English: To further demonstrate that the patients in the MART treatment arm were not overtreated or undertreated and to support the results of the study CT07, the MAH conducted post hoc analysis of data and made reference to additional supportive data.
Danish: For yderligere at eftervise, at patienterne i MART-behandlingsarmen ikke blev overbehandlet eller underbehandlet, og for at underbygge resultaterne af undersøgelse CT07 udførte indehaveren af markedsføringstilladelsen en post hoc-dataanalyse og henviste til supplerende støttende data.
English: Both components (BDP and FF) have been shown to be effective in the case of asthma exacerbation due to their anti-inflammatory and bronchodilating effects, and their effects are enhanced if they are administered in combination.
Danish: Begge komponenter (beclometasondipropionat og formoterolfumarat) er påvist at være effektive ved eksacerbationer af astma på grund af deres antiinflammatoriske og bronkodilaterende virkning, og deres virkning øges, hvis de gives i kombination.
English: Although a reduction to the mean ICS dose was observed in patients at entry to the study, the results showed that the mean FEV1 improved in both groups of patients during the run-in period and further improvement were observed during the 48-week treatment period, with a change from baseline to the end of the study of about 100mL in both groups.
Danish: Skønt der blev iagttaget et fald i den gennemsnitlige dosis inhalationskortikosteroid ved inklusion i undersøgelsen, var der bedring i den gennemsnitlige FEV1 hos begge patientgrupper i indkøringsperioden og yderligere bedring i løbet af behandlingsperioden på 48 uger, idet ændringen fra baseline til undersøgelsens slutning var ca. 100 ml i begge grupper.
English: Therefore, the CHMP considered that the positive therapeutic effect of MART with Kantos Master has been demonstrated in patients who had a reduction in the daily ICS dose and in patients who did not have any step down treatment (i.e. the subgroup of patients taking up to 500 µg daily at entry and during treatment).
Danish: CHMP fandt derfor, at den positive terapeutiske virkning af MART med Kantos Master er godtgjort hos patienter, som fik reduceret den daglige dosis af inhalationskortikosteroid, og hos patienter, som ikke fik nogen nedtrapning (dvs. den undergruppe, der fik op til 500 µg dagligt ved inklusionen og under behandlingen).
English: Moreover, the onset of action of formoterol as a bronchodilator is faster compared to other LABAs such as salmeterol, and is therefore well suited for the acute relief of bronchospasm.
Danish: Endvidere har formoterol hurtigere indsættende bronkodilaterende virkning end andre langtidsvirkende beta2-agonister såsom salmeterol og er derfor velegnet til akut lindring af bronkospasme.
English: The CHMP noted that there was no comparison with the standard of care, according to the GINA guideline.
Danish: CHMP bemærkede, at der ikke blev sammenlignet med standardbehandling i henhold til GINA-retningslinjerne.
English: These results were irrespective of the type of fixed ICS/LABA comparator (budesonide/formoterol or salmeterol/fluticasone), and irrespective of whether the maintenance dose of the comparator was similar or up to two fold higher.
Danish: Disse resultater var uafhængige af den pågældende type fast kombination af inhalationskortikosteroid/langtidsvirkende beta2-agonist (budesonid/formoterol eller salmeterol/fluticason) og uafhængige af, om vedligeholdelsesdosis af sammenligningspræparatet var den samme eller op til den dobbelte.
English: The aim of the MART approach is to reduce the rate of asthma exacerbations by “early intervention”, i.e. by giving additional doses of ICS plus FF in response to an increase in symptoms (2011 GINA Guidelines1).
Danish: Formålet med MART-tilgangen er at mindske forekomsten af eksacerbationer af astma gennem "tidlig intervention", hvorved forstås, at der ved symptomforværring gives supplerende doser af inhalationskortikosteroid plus formoterolfumarat (GINA-retningslinjer fra 20111).
English: This treatment approach of using a maintenance dose of a fixed combination of ICS and LABA and additional doses of the same combination in case of symptom worsening instead of a separate short acting beta2-agonist (SABA) is called “Maintenance And Reliever Therapy” (MART).
Danish: Denne behandlingstilgang, hvor der anvendes en vedligeholdelsesdosis af en fast kombination af et inhalationskortikosteroid og en langtidsvirkende beta2-agonist samt ved symptomforværring supplerende doser af samme kombination i stedet for en separat korttidsvirkende beta2-agonist, kaldes "vedligeholdelses- og behovsbehandling" ("Maintenance And Reliever Therapy" (MART)).
English: The primary endpoint is a clinically important measure of the long-term asthma control, and was clearly in favour of Kantos MART in comparison with Kantos plus SABA treatment.
Danish: Det primære endepunkt er et klinisk vigtigt mål for langsigtet astmakontrol og var klart til fordel for Kantos MART sammenlignet med Kantos plus en kortvirkende beta2-agonist.
English: However, the Committee agreed that there was no evidence that patients in the comparator group were under-treated as patients in both group had shown clinical benefit from their maintenance treatment.
Danish: Udvalget fandt imidlertid, at intet tydede på, at patienterne i sammenligningsgruppen var underbehandlede, da patienterne i begge grupper havde udvist klinisk fordel af vedligeholdelsesbehandlingen
English: As Kantos Master contain formoterol and beclometasone and in view of the results of the study, the Committee considered the published data to be relevant in the applied regimen.
Danish: Da Kantos Master indeholder formoterol og beclometason, fandt udvalget på baggrund af resultaterne af den forelagte undersøgelse, at de offentliggjorte data er relevante for det ansøgte regime.
English: The results of the study have shown that the risk of experiencing a severe asthma exacerbation was reduced by 36% (CI: 18% - 51%) in the group taking Kantos Master as reliever compared to the
Danish: Undersøgelsen viste, at risikoen for en svær eksacerbation af astma blev reduceret med 36 % (SI: [18 %; 51 %]) i den gruppe, der fik Kantos Master ved behov, i forhold til den gruppe, der fik salbutamol.
English: This suggested that the ICS-LABA maintenance therapy was adequate to control both lung function and symptoms.
Danish: Dette tydede på, at vedligeholdelsesbehandling med inhalationskortikosteroid/langtidsvirkende beta2-agonist var adækvat til kontrol af både lungefunktion og symptomer.
English: Therefore, the CHMP was of the opinion that the positive effect of Kantos Master on exacerbations was not achieved through a simple increase in daily ICS dose but with the timely delivery of a small dose of BDP together with the bronchodilator, when patient's symptoms worsened.
Danish: CHMP var derfor af den opfattelse, at Kantos Masters positive virkning på eksacerbationer ikke blev opnået alene ved en stigning i den daglige dosis inhalationskortikosteroid, men gennem den rettidige dosering af en lille dosis beclometasondipropionat sammen med bronkodilatoren ved forværring af symptomerne.
English: On 20 January 2012, the MAH submitted a type II variation via the MRP for Kantos Master and associated names (DE/H/0873/001/II/024), to request the inclusion of “Maintenance and reliever therapy taken as regular maintenance treatment and as needed in response to asthma symptoms”.
Danish: Den 20. januar 2012 indgav indehaveren af markedsføringstilladelsen en type IIændringsansøgning via den gensidige anerkendelsesprocedurer for Kantos Master og relaterede navne (DE/H/0873/001/II/024) om godkendelse af indikationen "vedligeholdelses- og behovsbehandling af astmasymptomer".
English: A further additional analysis of the study CT07 has been conducted in patients with severe asthma as it was considered that if under-treatment with Kantos Master in MART occurred, it should be most evident in this population who requires higher ICS doses to control their asthma.
Danish: Der blev foretaget endnu en supplerende analyse af undersøgelse CT07 hos patienter med svær astma, da det antoges, at eventuel underbehandling med Kantos Master i MART ville være lettest at konstatere hos den population, som kræver højere doser inhalationskortikosteroid til astmakontrol.
English: For instance, in the SMILE study2, the dose of budesonide (400µg/day) was in line with the ICS dose administrated in the study CT07 (500µg BDP non-extrafine equivalent).
Danish: For eksempel var dosis af budesonid i SMILE-undersøgelsen2 (400 µg dagligt) på linje med den dosis inhalationskortikosteroid, der blev givet i undersøgelse CT07 (ækvivalent med 500 µg ikkeekstrafint beclometason).
English: Grounds for the variation to the terms of the marketing authorisations
Danish: Begrundelser for ændringen af betingelserne for markedsføringstilladelserne Ud fra følgende betragtninger:
English: The CHMP was therefore of the opinion that the effectiveness of Kantos Master in MART was not due to a potential under-treatment of the comparator arm in the study CT07, and that the maintenance administration of Kantos Master at one inhalation twice daily had a clinically significant benefit in these patients.
Danish: Det var derfor CHMP's opfattelse, at virkningen af Kantos Master i MART ikke skyldtes underbehandling af sammenligningsarmen i undersøgelse CT07, og at vedligeholdelsesbehandling med Kantos Master, én inhalation to gange dagligt, var til væsentlig klinisk fordel for disse patienter.