FrancophonIA/ELRC3.0 huggingface dataset:
English: These Member States and the applicant / MAH were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Disse medlemsstater og ansøgeren/indehaveren af markedsføringstilladelsen kunne ikke nå til enighed om gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Danish: Listen over de pågældende lægemiddelnavne findes i bilag I. De faglige konklusioner fremgår af bilag II, og produktresuméet af bilag III.
English: The data supporting this application, as interpreted according with the CHMP guidance, did not support authorization of regular daily doses in excess of 160 µg in the treatment populations, and this was considered to be of serious public health concern.
Danish: Oplysningerne til støtte for denne ansøgning som fortolket i overensstemmelse med CHMP's retningslinjer støttede ikke, at der blev givet tilladelse til regelmæssige daglige doser på over 160 µg i behandlingspopulationen, og dette gav anledning til alvorlig bekymring for folkesundheden.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alvesco and associated names International Non-Proprietary Name (INN): ciclesonide
Danish: UDTALELSE FRA UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Alvesco og tilknyttede navne Internationalt fællesnavn (INN): ciclesonid
English: The product contains ciclesonide which is delivered by a pressurized metered dose inhaler containing ethanolic hydrofluoroalkane-134A as a propellant.
Danish: Produktet indeholder ciclesonid, der administreres ved hjælp af en inhalationsspray med afmålte doser indeholdende ethanolhydrofluoroalkan-134A som drivmiddel.
English: In light of this, the applicant/MAH proposed a study which would resolve the outstanding question on the long term use of 320 µg and 640 µg daily.
Danish: I lyset heraf foreslog ansøgeren/indehaveren af markedsføringstilladelsen en undersøgelse, der skulle besvare det uafklarede spørgsmål om langtidsbrug af doser på 320 µg og 640 µg dagligt.
English: Additionally, the applicant/MAH was requested to commit to obtaining scientific advice in relation to exploring a suitable study design, and executing such study(ies) to provide further information on the use of the higher dose of Alvesco in the control of severe asthma.
Danish: Derudover blev ansøgeren/indehaveren af markedsføringstilladelsen bedt om at forpligte sig til at indhente videnskabelig rådgivning i forbindelse med udvikling af passende undersøgelser og gennemførelse af sådanne for at skaffe yderligere oplysninger om brugen af den højere dosis Alvesco i forbindelse med kontrol med svær astma.
English: Altana Pharma AG submitted applications for mutual recognition of Alvesco and associated names, 40µg, 80 µg and 160 µg pressurised inhalation, solution on the basis of the marketing authorisation granted by United Kingdom on 14 April 2004.
Danish: Altana Pharma AG indsendte ansøgninger om gensidig anerkendelse af Alvesco og tilknyttede navne, 40 µg, 80 µg og 160 µg inhalationsspray, opløsning på baggrund af den markedsføringstilladelse, som blev udstedt af de britiske registreringsmyndigheder den 14. april 2004.
English: During their March 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Alvesco and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: På sit møde i marts 2008 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at risk/benefit-forholdet var gunstigt for Alvesco og tilknyttede navne, at de af Frankrig rejste indsigelser ikke skulle forhindre udstedelse af en markedsføringstilladelse, og at
English: Significant difference have been identified with regard to the currently approved posology for the control of exacerbations in severe asthma, and the need for a study comparing 160 µg, 320 µg and 640 µg/daily to demonstrate a reduction in the frequency of exacerbations in patients with severe asthma at the higher doses.
Danish: Der er konstateret betydelige forskelle med hensyn til den aktuelt godkendte posologi for kontrol af forværringer af svær astma, og det er ligeledes konstateret, at der er behov for en undersøgelse, der sammenligner doser på 160 µg, 320 µg og 640 µg/dagligt, for at påvise en reduktion i hyppigheden af forværringer hos patienter med svær astma ved de højere doser.
English: Alvesco and associated names, 40 µg, 80 µg and 160 µg pressurised inhalation, solution is a glucocorticoid used to treat obstructive airway disease.
Danish: Alvesco og tilknyttede navne, 40 µg, 80 µg og 160 µg inhalationsspray, opløsning er et glukokortikoid, som anvendes til behandling af obstruktive luftvejslidelser.
English: In particular, the proposed wording for Section 4.2 at the end of CMDh procedure was amended to reflect that in severe asthmatics, a 12 week study provided by the applicant/MAH has shown that a dose of 640µg/d (given 320µg/d twice daily) demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
Danish: Især blev den foreslåede formulering i afsnit 4.2 ved afslutningen af proceduren i koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMD(h)) ændret, så den afspejler den omstændighed, at en 12-ugers undersøgelse, fremlagt af ansøgeren/indehaveren af markedsføringstilladelsen, har påvist, at en dosis på 640 µg/døgn (givet som 320 µg 2 gange daglig), givet ved svære tilfælde af astma, demonstrerer en reduktion i antallet af svære forværringer, dog uden en bedring af lungefunktionen.
English: The applicant/MAH also accepted an updated wording for Section 5.1, which includes more detail on Study M1-140, at the end of the CMDh procedure, and a fully updated Package Leaflet.
Danish: Efter afslutningen af proceduren i koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human accepterede ansøgeren/indehaveren af markedsføringstilladelsen ligeledes en opdateret formulering af afsnit 5.1, der indeholder flere oplysninger om undersøgelse M1-140, og en fuldstændig opdateret indlægsseddel.
English: The Applicant commits to the following:
Danish: Ansøgeren forpligter sig til:
English: The primary objective was to assess the efficacy and safety of this combination regimen over 12 months.
Danish: Det primære formål var at vurdere virkningen og sikkerheden af dette kombinationsregime over 12 måneder.
English: The National Health Authorities, coordinated by the Reference Member State, shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Danish: De nationale myndigheder skal koordineret af referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: The number of children treated was too limited to draw any reliable conclusions on safety.
Danish: Antallet af behandlede børn var for begrænset til at drage pålidelige konklusioner vedrørende sikkerheden.
English: Final height data were not available.
Danish: Sluthøjdedata var ikke tilgængelige.
English: Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up).
Danish: 13 af de 14 rekrutterede patienter gennemførte 12 måneder med kombinationsbehandlingen (en patient var tabt for opfølgning).
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION
Danish: BILAG III BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Long-term safety data in children and adolescents are not available.
Danish: Der er ingen tilgængelige data for langtidssikkerhed hos børn og unge.
English: • Submit a Risk Management Plan (or its update) for Arimidex at National level, taking into account the new paediatric data and the CHMP recommendations.
Danish: • at forelægge en risikostyringsplan (eller en ajourføring af risikoplanen) for Arimidex på nationalt plan under hensyntagen til de nye pædiatriske oplysninger og CHMP's anbefalinger
English: • Ensure that the Package Leaflet in all languages contains a statement referring to the fact that Arimidex should not be given to children.
Danish: • at sikre at indlægssedlen på alle sprog indeholder oplysninger om, at Arimidex ikke må gives til børn.
English: There was no significant difference in growth rate after 12 months of treatment, relative to the growth rate during the 6 months prior to entering the study.
Danish: Der var ingen signifikant forskel i vækstraten efter 12 måneders behandling i forhold til vækstraten i de seks måneder før deltagelsen i studiet.
English: The reduction was transient as all mating and fertility parameters were similar to control group values following a 9-week treatment-free recovery period.
Danish: Nedsættelsen var forbigående, eftersom alle parrings- og fertilitetsparametre svarede til kontrolgruppeværdierne efter en 9 ugers behandlingsfri restitutionsperiode.
English: Measured mean plasma concentrations were 44.4 (± 14.7) ng/ml and 165 (±90) ng/ml respectively.
Danish: De målte gennemsnitlige plasmakoncentrationer var 44,4 (±14,4) ng/ml og 165 (±90) ng/ml henholdsvis.
English: ANNEX II AMENDMENT TO SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG II ÆNDRING AF PRODUKTRESUME
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR ARIMIDEX.
Danish: ÆNDRINGERNE INDFØRES I DE RELEVANTE AFSNIT I PRODUKTRESUMEET FOR ARIMIDEX
English: No data on the potential long-term effects of anastrozole treatment in children are available (see also section 5.3).
Danish: Der foreligger ingen data om den potentielle langtidseffekt af anastrazolbehandling på børn (se også pkt.
English: Only 14 subjects on anastrozole completed 36 months.
Danish: Kun 14 forsøgspersoner på anastrozol gennemførte de 36 måneder.
English: Arimidex is not indicated for use in children.
Danish: Arimidex er ikke indiceret til børn.
English: No statistically significant difference with placebo was observed for the growth related parameters of predicted adult height, height, height SDS, and height velocity.
Danish: Der blev ikke observeret nogen statistisk signifikant forskel med placebo for de vækstrelaterede parametre for forventet voksenhøjde, højde, højde-SDS og væksthastighed.
English: Efficacy has not been established in the paediatric populations studied (see below).
Danish: Virkningen er ikke fastslået i den undersøgte pædiatriske population (se nedenfor).
English: While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the anastrozole arm compared to placebo.
Danish: Antallet af behandlede børn var for begrænset til at drage pålidelige konklusioner vedrørende sikkerhed, men der var en øget frakturrate og en tendens til reduceret knoglemineraltæthed i anastrozolarmen sammenlignet med placebo.
English: Mating indices were adversely affected in both dose groups, whilst a reduction in fertility was evident only at the 400 mg/l dose level.
Danish: Parringsindekset blev negativt påvirket hos begge dosisgrupper, mens nedsat fertilitet kun sås ved dosering med 400 mg/l.
English: In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
Danish: I et fertilitetsstudie blev fravænnede hanrotter doseret oralt med 50 eller 400 mg anastrozol/l via deres drikkevand i 10 uger.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arimidex in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome.
Danish: Det Europæiske Lægemiddelagentur har frafaldet pligten til at indsende resultater af studier med Arimidex i et eller flere subsæt af den pædiatriske population med manglende højdevækst på grund af væksthormonmangel (GHD), testotoksikose, gynækomasti og McCune-Albrights syndrom.
English: Children
Danish: Børn
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Testotoxicosis
Danish: Testotoksikose
English: Short stature due to growth hormone deficiency A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11-16 years inclusive) with GHD treated for 12 to 36 months with Arimidex 1 mg/day or placebo in combination with growth hormone.
Danish: Manglende højdevækst på grund af væksthormonmangel Et randomiseret, dobbeltblindet multicenterforsøg evaluerede 52 drenge i puberteten (11-16 år begge inklusive) med GHD behandlet i 12-36 måneder med Arimidex 1 mg/dag eller placebo i kombination med væksthormon.
English: In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Danish: I det grundlæggende kliniske forsøg blev der ikke demonstreret nogen effekt, og sikkerheden blev ikke klarlagt (se pkt.
English: An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2-9) with familial male-limited precocious puberty, also known as testotoxicosis, treated with combination of Arimidex and bicalutamide.
Danish: Et åbent, ikke-komparativt multicenterstudie evaluerede 14 drenge (alder 2-9 år) med familiær mandlig pubertas praecox, også kendt som testotoksikose, som blev behandlet med en kombination af Arimidex og bicalutamid.
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussel
Danish: NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussel
English: Paediatrics
Danish: Pædiatri
English: After 3 years anastrozole was found to statistically significantly slow bone maturation in pubertal boys on growth hormone therapy.
Danish: Efter 3 år fandt man, at anastrozol i statistisk signifikant grad hæmmer knoglemodningen hos pubertære drenge i behandling med væksthormon.
English: Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Danish: Arimidex bør ikke anvendes til drenge med væksthormonmangel som tillæg til behandling med væksthormon.
English: Arimidex is not recommended for use in children as safety and efficacy have not been established in this group of patients (see section 5.1).
Danish: Arimidex bør ikke anvendes til børn, da sikkerhed og virkning ikke er fastslået for denne patientgruppe (se pkt.
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi
Danish: Grækenland AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi
English: Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Navn Styrke Lægemiddelform Indgivelsesvej
English: Arimidex is not recommended for use in children due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Danish: Arimidex bør ikke anvendes til børn pga. utilstrækkelig dokumentation for sikkerhed og virkning (se pkt.
English: United Kingdom AstraZeneca UK Limited 600 Capability Green Luton
Danish: Storbritannien AstraZeneca UK Limited 600 Capability Green Luton
English: Lithuania
Danish: Lithuaen
English: Since anastrozole reduces oestradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Danish: Arimidex må ikke anvendes til piger med væksthormonmangel som tillæg til behandling med væksthormon, idet anastrozol reducerer østradiolniveauet.
English: These include:
Danish: Disse omfatter:
English: Basis for the recommendations
Danish: Grundlaget for anbefalingerne
English: Information for patients and healthcare professionals
Danish: Information til patienter og sundhedspersoner
English: The review of valproate medicines was initiated on 9 March 2017 at the request of the French medicines regulator ANSM, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende valproat blev indledt den 9. marts 2017 på anmodning af den franske lægemiddelstyrelse i henhold til artikel 31 i direktiv 2001/83/EF.
English: Member State representatives agree new restrictions and pregnancy prevention programme
Danish: Medlemsstatsrepræsentanterne vedtager nye begrænsninger og program til forebyggelse af graviditet
English: • Healthcare professionals will receive further information at national level in due course as the recommendations are implemented.
Danish: • Sundhedspersoner vil senere modtage yderligere oplysninger på nationalt plan, efterhånden som anbefalingerne gennemføres.
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek.
Danish: De markedsføres under en række handelsnavne, herunder: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro og Valprolek.
English: The programme is designed to ensure that patients are made fully aware of the risks and the need to avoid becoming pregnant.
Danish: Programmet er tilrettelagt med henblik på at sikre, at patienterne er helt klar over risiciene og over nødvendigheden af at undgå graviditet.
English: • It is important that patients discuss any concerns about their medication with an appropriate healthcare professional.
Danish: • Det er vigtigt, at patienten drøfter eventuelle betænkeligheder vedrørende sine lægemidler med en relevant sundhedsperson.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/145600/2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which has adopted a position.
Danish: PRAC's henstillinger blev overgivet til Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh), som vedtog et standpunkt.
English: The medicines authorities in the individual countries will approve appropriate details of the visual warning for their national situation.
Danish: De enkelte landes lægemiddelmyndigheder skal godkende de nærmere detaljer vedrørende den visuelle advarsel på baggrund af den nationale situation.
English: The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide.
Danish: Det aktive indholdsstof i disse lægemidler kan være valproinsyre, magnesiumvalproat, natriumvalproat, valproatseminatrium eller valpromid.
English: • Although steps had been taken previously to better inform women about these risks and discourage use of valproate in girls and women unless there was no alternative, the evidence shows that this information is still not getting to patients.
Danish: • Skønt der tidligere er taget skridt til at oplyse kvinder bedre om disse risici og fraråde brugen af valproat hos piger og kvinder, medmindre der ikke findes noget alternativ, må det konstateres, at disse oplysninger stadig ikke når ud til patienterne.
English: In addition, all companies marketing such medicines will need to have in place a risk management plan which details the measures taken to ensure that a medicine is used as safely as possible.
Danish: Alle virksomheder, der markedsfører sådanne lægemidler, skal derudover have indført en risikostyringsplan med beskrivelse af, hvilke forholdsregler der træffes for at sikre, at lægemidlet anvendes så sikkert som muligt.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.
Danish: Gennemgangen blev først foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt henstillinger.
English: The new measures endorsed by CMDh therefore strengthen previous restrictions on valproate use and requirements to inform women of the risk.
Danish: De nye forholdsregler, der er vedtaget af CMDh, skærper derfor tidligere begrænsninger af anvendelsen af valproat og kravene om at oplyse kvinder om risikoen.
English: During the review, the PRAC also consulted very widely with healthcare professionals and with patients, including women and their children who have been affected by valproate use during pregnancy, through written submissions, expert meetings, meetings with stakeholders (including healthcare professionals, patients organisations, patients and their families), and via a public hearing.
Danish: Under gennemgangen konsulterede PRAC desuden i meget vidt omfang sundhedspersonale og patienter, herunder kvinder og deres børn, der har været omfattet af anvendelse af valproat under graviditeten, gennem skriftlige indgivelser, ekspertmøder, møder med interessenter (herunder sundhedspersonale, patientorganisationer, patienter og deres familie) og via en offentlig høring.
English: The measures are based on a review of available scientific evidence, including drug utilisation studies and clinical and laboratory evidence of the effects of the medicine.
Danish: Forholdsreglerne er baseret på en gennemgang af foreliggende videnskabelige data, herunder undersøgelser af lægemiddelanvendelse og klinisk og laboratoriebaseret dokumentation for lægemidlets virkninger.
English: The new measures include a ban on the use of such medicines for migraine or bipolar disorder during pregnancy, and a ban on treating epilepsy during pregnancy unless there is no other effective treatment available.
Danish: De nye forholdsregler omfatter et forbud mod brug af sådanne lægemidler til migræne og bipolar sygdom under graviditet, og et forbud mod behandling af epilepsi under graviditet, medmindre der ikke findes nogen anden effektiv behandling.
English: In some EU Member States they are also authorised to prevent migraine headaches.
Danish: I nogle EUmedlemsstater er de desuden godkendt til forebyggelse af migræne.
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Danish: Lægemidler indeholdende valproat er godkendt via nationale procedurer i alle EU's medlemsstater samt Norge og Island.
English: Women and girls who have been prescribed valproate should not stop taking their medicine without consulting their doctor as doing so could result in harm to themselves or to an unborn child.
Danish: Kvinder og piger, som har fået ordineret valproate, må ikke holde op med at tage lægemidlet uden at have talt med lægen, da de derved kan påføre skader på sig selv og et eventuelt ufødt barn.
English: • Educational materials in the form of guides for patients and doctors will also be updated to reflect the current situation and provide age-appropriate advice.
Danish: • Oplysningsmateriale i form af vejledninger til patienter og læger skal ligeledes ajourføres, så det afspejler den nuværende situation, og skal indeholde alderstilpasset rådgivning.