FrancophonIA/ELRC3.0 huggingface dataset:
English: The worksharing procedure SE/H/xxxx/WS/190 started on 20 January 2018.
Danish: Arbejdsdelingsproceduren SE/H/xxxx/WS/190 blev indledt den 20. januar 2018.
English: Therefore the benefit/risk balance of the reformulated medicinal product isconsidered unfavourable.
Danish: Benefit/risk-forholdet for det reformulerede lægemiddel vurderes derfor at være ugunstigt.
English: The Committee, as a consequence, recommends the refusal of the variation to the terms of the marketing authorisation application for the medicinal products referred to in Annex I of the CHMP opinion.
Danish: Udvalget anbefaler følgelig afslag på ansøgningen om ændring af betingelserne formarkedsføringstilladelse for de lægemidler, der er anført i bilag I til CHMP's udtalelse.
English: Furthermore, the CHMP considered that the submitted in-vitro studies had several methodological limitations including the absence of a positive control, the duration, and the high heterogeneity among the donors.
Danish: Derudover vurderer CHMP, at de fremlagte in vitro-studier har flere metodemæssige begrænsninger, herunder fravær af en positiv kontrol, varigheden samt høj heterogenitet blandt donorerne.
English: As per the Note for Guidance on the clinical requirements for locally applied, locally acting products containing known constituents (EMA CPMP/EWP/239/95), clinical data are in principle necessary to establish therapeutic equivalence between two products.
Danish: Ifølge vejledningen om kliniske krav til produkter med kendte indholdsstoffer, der anvendes og virker lokalt (EMA CPMP/EWP/239/95), er kliniske data principielt nødvendige for at fastslå terapeutisk ækvivalens mellem to produkter.
English: The MAH conducted two in-vitro studies which showed that there were differences in the absorbed dose (35% lower absorbed dose) and less significant differences in the penetrated doses.
Danish: Indehaveren af markedsføringstilladelsen har gennemført to in vitro-studier, der viser, at der er forskelle i den absorberede dosis (35 % lavere absorberet dosis) og mindre signifikante forskelle i de indtrængte doser.
English: Day 60 of the CMDh procedure was on 25 October 2018 and as no agreement amongst member states could be reached, Sweden notified the European Medicines Agency on 26 October 2018 of a referral under Article 13 of Regulation EC No 1234/2008.
Danish: Dag 60 i CMDh-proceduren var den 25. oktober 2018, og da medlemsstaterne ikke kunne nå til enighed, indbragte Sverige sagen for Det Europæiske Lægemiddelagentur den 26. oktober 2018 i henhold til artikel 13 i forordning (EF) nr. 1234/2008.
English: Moreover the Committee noted that the in-vitro tests used were not validated for the therapeutic situation and that they had several methodological limitations.
Danish: Udvalget bemærker desuden, at de anvendte in vitro-test ikke var valideret til den terapeutiske situation, og at der var flere metodemæssige begrænsninger.
English: However, since the tests have not been validated for the therapeutic situation, the clinical relevance of the test results is unclear.
Danish: Da testene imidlertid ikke var valideret til den terapeutiske situation, er testresultaternes kliniske relevans uklar.
English: As documented in the scientific literature1 changes in the qualitative composition of semi-solid topical formulation can have an impact on drug release and efficacy of the topical products.
Danish: Som det er dokumenteret i den videnskabelige litteratur1, kan ændringer i den kvalitative sammensætning af halvfaste topiske formuleringer have betydning for lægemiddelfrigivelsen og virkningen af topiske produkter.
English: However, in support of this application neither clinical data nor validated non-clinical data have been submitted.
Danish: I forbindelse med denne ansøgning er der imidlertid hverken indsendt kliniske data eller validerede ikke-kliniske data.
English: In absence of clinical data, non-clinical validated models can be accepted.
Danish: I fravær af kliniske data kan ikke-kliniske validerede modeller accepteres.
English: The clinical relevance of the test results therefore could not be determined;
Danish: Den kliniske relevans af testresultaterne kan derfor ikke fastslås.
English: There may be differences in absorption and stability of the active substance between the Epiduo and the new Basiron formulation, which cannot be determined in the absence of relevant data for Basiron.
Danish: Der kan være forskelle i absorption og stabilitet for det aktive stof mellem Epiduo-formuleringen og den nye Basiron-formulering, som ikke kan fastslås i fravær af relevante data for Basiron.
English: In the clinical studies performed in support of the Epiduo gel, approximately 2500 subjects above 9 years of age were exposed to Simulgel 600 PHA.
Danish: I de kliniske studier, der blev gennemført til understøttelse af Epiduo-gelen, blev ca. 2.500 patienter over 9 år eksponeret for Simulgel 600 PHA.
English: The rationale for the change in the formulation was to extend the shelf-life of the products in Zone IV countries.
Danish: Begrundelsen for at ændre formuleringen er at forlænge produktets opbevaringstid i zone IV-lande.
English: Safety data of the new gelling agent Simulgel 600 PHA has been evaluated in 2008 for Epiduo 0.1%, which contains adapalene 0.1% and benzoyl peroxide 2.5%, in a vehicle containing Simulgel 600 PHA.
Danish: Sikkerhedsdataene for det nye geleringsmiddel Simulgel 600 PHA blev vurderet i 2008 for Epiduo 0,1 %, som indeholder adapalen 0,1 %, og benzoylperoxid 2,5 %, i et vehikel indeholdende Simulgel 600 PHA.
English: On 1 December 2017, a Quality type II variation application was submitted by Galderma Nordic AB in line with Article 10(1) of Commission Regulation (EC) No 1234/2008 under the worksharing procedure in accordance with Article 20 of Commission Regulation (EC) No 1234/2008 (SE/H/xxxx/WS/190) for the marketing authorisations for Basiron AC 5% w/w gel and 10% w/w gel to change the formulation by replacing the gelling agent excipient Carbomer 940 with Simulgel 600 PHA (acrylamide sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Danish: Den 1. december 2017 indsendte Galderma Nordic AB en ansøgning om en type II-kvalitetsændring under artikel 10, stk. 1, i Kommissionens forordning (EF) nr. 1234/2008 i henhold til arbejdsdelingsproceduren under artikel 20 i Kommissionens forordning (EF) nr. 1234/2008 (SE/H/xxxx/WS/190) vedrørende markedsføringstilladelserne for Basiron AC 5 % w/w gel og 10 % w/w gel med henblik på at ændre formuleringen ved at erstatte geleringsmidlet Carbomer 940 med Simulgel 600 PHA (acrylamidnatrium-acrylodimethyltaurat-copolymer, isohexadecan, polysorbat 80, sorbitanoleat og vand).
English: This variation relates to a change of formulation for Basiron in order to replace the gelling agent Carbomer 940 with Simulgel 600 PHA (acrylamide - sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Danish: Den omhandlede ændring af Basirons formulering har til formål at erstatte geleringsmidlet Carbomer 940 med Simulgel 600 PHA (acrylamidnatrium-acrylodimethyltaurat-copolymer, isohexadecan, polysorbat 80, sorbitanoleat og vand).
English: • Having assessed the totality of the data, the Committee was of the view that the available data were not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
Danish: • Efter at have gennemgået alle dataene vurderer udvalget, at de tilgængelige data ikke er tilstrækkelige til at påvise terapeutisk ækvivalens mellem den nye og den aktuelt markedsførte formulering.
English: The CHMP concluded that the submitted data are not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
Danish: CHMP vurderer, at de fremlagte data ikke er tilstrækkelige til at påvise terapeutisk ækvivalens mellem den nye og den aktuelt markedsførte formulering.
English: The change in composition due to the replacement of the gelling agent cannot be considered minor per se, and the available data from in-vitro tests are not considered suitable to fully elucidate the clinical impact of this reformulation.
Danish: Den sammensætningsændring, der sker ved udskiftning af geleringsmidlet, kan i sig selv ikke anses som mindre væsentlig, og de tilgængelige data fra in vitrotest vurderes ikke at være egnede til en fyldestgørende belysning af den kliniske betydning af den nye formulering.
English: The reformulation was focused on the gelling agent to improve physical stability in order to extend the shelf-life of the products in Zone IV countries where viscosity value tends to decrease due to higher temperature.
Danish: I den nye formulering fokuseres der på geleringsmidlet for at forbedre den fysiske stabilitet og forlænge produktets opbevaringstid i zone IV-lande, hvor viskositeten typisk falder på grund af højere temperaturer.
English: • The Committee considered the supportive clinical data of another medicinal product containing benzoyl peroxide 2.5% in combination with adapalene 0.1%, in a vehicle containing Simulgel 600 PHA, and concluded that data of the reformulated Basiron AC gels 5% w/w and 10% w/w could not be extrapolated from the dossier of another product in view of qualitative and quantitative differences between Basiron AC gels 5% w/w and 10% w/w and the other medicinal product;
Danish: • Udvalget har gennemgået de understøttende kliniske data fra et andet lægemiddel med indhold af benzoylperoxid 2,5 % i kombination med adapalen 0,1 %, i et vehikel indeholdende Simulgel 600 PHA, og vurderer, at dataene fra den reformulerede Basiron AC gel 5 % w/w og 10 % w/w ikke kan ekstrapoleres fra dataene for et andet lægemiddel, jf. de kvalitative og kvantitative forskelle mellem Basiron AC gel 5 % w/w og 10 % w/w og det andet lægemiddel.
English: Taking into consideration the qualitative and quantitative differences between Epiduo gel and the re-formulated Basiron, it cannot be concluded based on the data provided that the data from Epiduo gel can be extrapolated to the new formulation of Basiron AC
Danish: I betragtning af de kvalitative og kvantitative forskelle mellem Epiduo-gel og den nye Basiron-formulering kan det ud fra de fremlagte data ikke konkluderes, at dataene fra Epiduo-gel kan ekstrapoleres til den nye Basiron AC-formulering.
English: • The Committee considered the totality of the data submitted by the MAH in support of the type II quality variation for Basiron AC gels 5% w/w and 10% w/w;
Danish: • Udvalget har gennemgået alle de data, som indehaveren af markedsføringstilladelsen har fremlagt til understøttelse af en type II-kvalitetsændring for Basiron AC gel 5 % w/w og 10 % w/w.
English: • The Committee noted that the in-vitro tests indicated differences between the marketed formulation and the new proposed formulation containing the new gelling agent Simulgel 600 PHA.
Danish: • Udvalget bemærker, at in vitro-testene har vist forskelle mellem den markedsførte formulering og den nye formulering indeholdende geleringsmidlet Simulgel 600 PHA.
English: The procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh), under Article 13(1), paragraph 1 of Regulation EC No 1234/2008 by Sweden on 21 August 2018.
Danish: Den 21. august 2018 indbragte Sverige sagen for koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)), jf. artikel 13, stk. 1, første afsnit, i Kommissionens forordning (EF) nr. 1234/2008.
English: • The Committee noted the absence of clinical data generated with the reformulated product containing the gelling agent excipient Simulgel 600 PHA for Basiron and associated names;
Danish: • Udvalget bemærker, at der ikke er genereret kliniske data vedrørende det reformulerede produkt indeholdende geleringsmidlet Simulgel 600 PHA for Basiron og relaterede navne.
English: The clinical significance of the observed differences cannot be determined, since the criteria for the selected non-inferiority margins have not been adequately justified, and therefore these results cannot support the efficacy and safety of the new formulation.
Danish: Den kliniske signifikans af de observerede forskelle kan ikke fastslås, da kriterierne for de valgte noninferioritetsmarginer ikke er tilstrækkeligt begrundet.
English: • The Committee reviewed the available data submitted in support of the new formulation of Basiron containing the new gelling agent excipient Simulgel 600 PHA;
Danish: • Udvalget har gennemgået de tilgængelige data, der er fremlagt til understøttelse af den nye Basiron-formulering indeholdende det nye geleringsmiddel-hjælpestof Simulgel 600 PHA.
English: Therefore, the safety and the efficacy of the reformulated product cannot be considered established.
Danish: Den nye formulerings sikkerhed og virkning anses derfor ikke for at være påvist.
English: considered established.
Danish: Udtalelsen fremsættes ud fra følgende betragtninger:
English: Therefore, the safety and the efficacy of the re-formulated product cannot be
Danish: Resultaterne kan derfor ikke understøtte virkningen og sikkerheden ved den nye formulering.
English: Cashel Road, Dublin 12, Ireland.
Danish: Cashel Road, Dublin 12, Irland.
English: Very rare Not known (cannot be estimated from the available data)
Danish: Meget sjælden Ikke kendt (kan ikke estimeres ud fra de forhåndenværende data)
English: Off-white to yellow.
Danish: Off-white til gul.
English: The medicinal product should not be used in these areas”.
Danish: Lægemidlet bør ikke anvendes på disse områder”.
English: The potential risk for humans is uncertain.
Danish: Den potentielle risiko for mennesker er usikker.
English: Date opened: ____________________
Danish: Åbnet den: ______________________
English: However, in a number of member states alternative text has been included following the outcome of National Procedures.
Danish: I en række medlemsstater var der dog medtaget alternative tekster som følge af resultatet af de nationale procedurer.
English: The recommended treatment period is 4 weeks.
Danish: Den anbefalede behandlingstid er 4 uger.
English: Mean percentage reduction in PASI (SD)
Danish: Gennemsnitlig procentvis reduktion i PASI (SD)
English: The incidence of adverse events will increase because of this.
Danish: Hyppigheden af bivirkningerne vil stige på grund af dette.
English: It was therefore not possible to add additional wording to the statement in section 4.4.
Danish: Derfor var det ikke muligt at lave yderligere tilføjelser til ordlyden i punkt 4.4.
English: Protein binding is approx. 64 %.
Danish: Proteinbindingen er ca. 64 %.
English: After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Danish: Efter Kommissionens beslutning vil medlemslandets kompetente myndighed i samarbejde med referencemedlemslandet opdatere produktinformationen som påkrævet.
English: Overall summary of the scientific evaluation of Daivobet and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Daivobet og relaterede navne (se bilag I)
English: The bottles are placed in cartons.
Danish: Flaskerne er anbragt i kartoner.
English: % of patients with controlled disease
Danish: % patienter med kontrolleret sygdomsgrad
English: This is the proposed basis for its effect in psoriasis.
Danish: Dette er den foreslåede baggrund for dets virkning ved psoriasis.
English: Effects on endocrine system
Danish: Virkning på det endokrine system
English: There was no impairment of fertility.
Danish: Der var ingen forringelse af fertilitet.
English: Both treatments were applied once daily, intermittently as required, for up to 52 weeks.
Danish: Begge behandlinger blev påført en gang dagligt intermitterende efter behov i op til 52 uger.
English: Finally, the possibility of more frequent systemic effects “under occlusion” was not mentioned.
Danish: Endelig var muligheden for hyppigere systemiske virkninger “ved okklusion” ikke nævnt.
English: The statement “children and adolescents below the age of 18 years” has been simplified to “children below the age of 18 years”.
Danish: Ordlyden “børn og unge under 18 år” er blevet forenklet til “børn under 18 år”.
English: The CHMP endorsed these changes as they improve the definition of the target population and reflect the data offered in support of the indications.
Danish: CHMP godkendte disse ændringer, eftersom de forbedrer definitionen af målpopulationen og afspejler de data, der blev fremlagt til støtte for indikationerne.
English: Hands must be washed after each application to avoid accidental transfer to these areas.
Danish: Hænderne skal vaskes efter hver påsmøring for at undgå utilsigtet påføring i disse områder.
English: 2 x 60 g (valid for the packaging containing two 60 g bottles)
Danish: 2 x 60 g (gælder for den pakningsstørrelse der indeholder to 60 g flasker)
English: You may have to stop your treatment.
Danish: Du skal måske stoppe behandlingen:
English: Carton text:
Danish: Tekst på karton:
English: Rebound effect after end of treatment has been reported but the frequency of this is not known.
Danish: Rebound effekt efter afsluttet behandling er blevet rapporteret, men hyppigheden er ikke kendt.
English: What should I expect when I use Daivobet?
Danish: Hvad kan jeg forvente, når jeg bruger Daivobet?
English: This recommendation is based on non-clinical photo(co)carcinogenicity data.
Danish: Denne anbefaling er baseret på ikke-kliniske foto(co)carcinogenicitetsdata.
English: Vodopivceva 9 SI-4000 Kranj Slovenia
Danish: SI-4000 Kranj Slovenien
English: An almost clear, colourless to slightly off-white gel.
Danish: En næsten klar, farveløs til let off-white gel.
English: Write the date you first opened the tube in the space provided on the carton.
Danish: Skriv den dato, hvor du først åbner tuben, i det dertil angivne felt på æsken.
English: The following terminologies have been used in order to classify the frequencies of adverse reactions:
Danish: Følgende terminologi er blevet brugt til at klassificere hyppigheden af bivirkninger:
English: The percentage change in Psoriasis Severity and Area index (PASI) from baseline to week 4 and week 8 were secondary response criteria.
Danish: Den procentvise ændring i Psoriasis Severity and Area index (PASI) fra udgangspunktet til uge 4 og uge 8 var sekundære responskriterier.
English: Moreover, reduction in offspring survival, body weight and body weight gain was observed.
Danish: Desuden blev der set en reduktion af afkommets overlevelse, legemsvægt og vægtforøgelse.
English: The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes.
Danish: Patienten skal instrueres i korrekt brug af præparatet for at undgå applikation i og utilsigtet overførsel til ansigt, mund og øjne.
English: This medicine is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:
English: The MAH agreed, however, that this is not an absolute contraindication and proposed to move it to section 4.4.
Danish: Indehaveren af markedsføringstilladelsen var dog enig i, at det ikke er en absolut kontraindikation, og foreslog at flytte den til punkt 4.4.
English: After first opening: 3 months.
Danish: Efter åbning: 3 måneder.
English: SPECIAL STORAGE CONDITIONS Do not refrigerate.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares koldt.
English: Comparable adverse reactions were not observed in clinical studies.
Danish: Der blev ikke observeret sammenlignelige bivirkninger i kliniske undersøgelser.
English: Primary response criteria were controlled disease according to the IGA at week 4 and week 8.
Danish: De primære responskriterier var kontrolleret sygdomsgrad ifølge IGA i uge 4 og i uge 8.
English: Pustular psoriasis has been reported rarely.
Danish: Pustuløs psoriasis er blevet rapporteret sjældent.
English: Absorption through damaged skin is approx. 24 %.
Danish: Absorptionen gennem læderet hud er ca. 24 %.
English: Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point.
Danish: De fleste patienter opnår tydelige resultater efter 2 uger, selv om deres psoriasis ikke er helt afglattet på den tid.
English: % of patients with absent or very mild disease
Danish: % patienter med ingen eller meget mild sygdomsgrad
English: Plasma elimination half-life after intravenous application is 5-6 hours.
Danish: Plasmahalveringstiden efter intravenøs behandling er 5-6 timer.
English: week 8
Danish: uge 8
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
English: Burning sensation of skin
Danish: Brændende fornemmelse i huden
English: In three MS the SPC was more general and did not include any study results.
Danish: I tre medlemsstater var produktresuméet mere generelt og omfattede ikke nogen undersøgelsesresultater.
English: General disorders and administration site conditions Not known
Danish: Almene lidelser og reaktioner på administrationsstedet Ikke kendt
English: If you forget to use Daivobet Do not take a double dose to make up for forgotten individual doses.
Danish: Hvis du har glemt at bruge Daivobet Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Dette produktresumé, etikettering og indlægsseddel repræsenterer derfor ikke nødvendigvis den gældende tekst.
English: The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed.
Danish: Risikoen for hyperkalcæmi er minimal, når anbefalingerne vedrørende calcipotriol overholdes.
English: ATC Code: D05AX52
Danish: ATC-kode: D05AX52
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission Decision.
Danish: Note: Dette produktresumé, etikettering og indlægsseddel er den gyldige version på tidspunktet for Kommissionens beslutning.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) 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: Regarding precautions on the face and genitals the information “Long-term treatment of these parts of the body should be avoided” has been deleted because of the high risk local and systemic adverse reactions.
Danish: Hvad angår forsigtighedsreglerne med hensyn til ansigt og genitalier, er informationen “Langtidsbehandling af disse dele af kroppen bør undgås” blevet fjernet som følge af den høje risiko for lokale og systemiske bivirkninger.
English: Based on post marketing data, standard use of calcipotriol followed by average and standard UV-exposure does not seem to imply any special risk for patients using calcipotriol.
Danish: På baggrund af data efter markedsføringen lader det ikke til, at standardbrug af calcipotriol efterfulgt af gennemsnitlig og standard UV-eksponering indebærer nogen særlig risiko for patienter, der bruger calcipotriol.
English: Eye irritation
Danish: Irritation i øjnene
English: In several MS's SPC the warning for use on the face was “the ointment may/should/must not be used on the face region” rather than “to avoid application”.
Danish: I flere medlemsstaters produktresuméer stod der i advarslen vedrørende brugen, at “salven må/skal/bør ikke bruges i ansigtsregionen” i stedet for “undgå påførelse”.
English: It may be necessary for you to stop this medicine gradually, especially if you have used it for a long time.
Danish: Det kan være nødvendigt at stoppe behandlingen gradvist, specielt hvis behandlingen har varet i lang tid.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg lægen eller på apoteket til råds, før du tager nogen form for medicin.
English: Shake the bottle before use.
Danish: Ryst flasken før brug.