FrancophonIA/ELRC3.0 huggingface dataset:
English: According to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 rev 1), a drug substance is considered as highly soluble if the highest single dose administered as immediate release formulation(s) is completely dissolved in 250 ml of buffers within the range of pH 1 - 6.8 at 37±1 °C.
Danish: Ifølge CHMP's “Guideline on the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 rev 1) anses et lægemiddelstof for letopløseligt, hvis den højeste enkeltdosis, administreret som formulering(er) med hurtig udløsning, er fuldstændig opløselig i 250 ml buffer med pH mellem 1 og 6,8 ved 37±1 °C.
English: Based on the submitted in-vitro Caco-2 monolayer cell model (permeability assay model), published literature and the oral explanation by the MAH on 26 June 2013, the CHMP considers that the biowaiver is acceptable, and therefore concluded that the benefit-risk balance for Okrido in the applied indications is favourable.
Danish: På grundlag af den forelagte in vitro-model med monolag af Caco-2-celler (assay-model for permeabilitet), den publicerede litteratur og markedsføringstilladelsesindehaverens mundtlige forklaring den 26. juni 2013 finder CHMP en biowaiver berettiget, hvorfor udvalget konkluderede, at benefit/risk-forholdet er positivt for Okrido til de ansøgte indikationer.
English: Crushed prednisolone tablets were compared to prednisolone syrup (with sorbitol), in children with acute asthma, using dyspnoea as clinical end point.
Danish: Knuste prednisolontabletter blev sammenlignet med prednisolonsyrup (med sorbitol) hos børn med akut astma, idet det kliniske endepunkt var dyspnø.
English: Both Okrido and the reference product are dissolved in water before administration and are considered to be oral solutions, which exhibit high solubility across the gastrointestinal physiological pH range.
Danish: Både Okrido og referenceproduktet opløses i vand før administration og anses for at være orale opløsninger, der udviser høj opløselighed i hele det fysiologiske gastrointestinale pH-område.
English: Indeed Chen et al3 (2007)4 showed that in the presence of sorbitol, Cmax and AUC of ranitidine (BCS class III, low permeability substance) were significantly reduced while only the Cmax of metoprolol (BCS class I
Danish: Chen et al3 (2007)4 viste således, at tilstedeværelse af sorbitol medførte væsentligt lavere Cmax og AUC af ranitidin (BCS klasse III- stof med lav permeabilitet), mens det samme kun gjorde sig gældende for Cmax for metoprolol (BCS klasse I-stof med høj permeabilitet).
English: The MAH has submitted published clinical data (Lucas-Bouwmann 20011) to support the lack of a clinically relevant effect of sorbitol on prednisolone absorption.
Danish: Indehaveren af markedsføringstilladelsen har forelagt publicerede kliniske data (Lucas-Bouwmann 20011) for at påvise fravær af klinisk relevant virkning af sorbitol på absorptionen af prednisolon.
English: The same requirements for similarity in excipients apply for oral solutions as for Biowaivers (see Appendix III, Section IV.2 Excipients).'
Danish: For orale opløsninger gælder samme krav om ensartethed af hjælpestofferne som for en biowaiver (se tillæg III, punkt IV.2, Hjælpestoffer).”
English: The applicant has submitted the results of an in vitro investigation of the permeability of prednisolone using validated methodology involving the Caco-2 monolayer cell model.
Danish: Ansøgeren har forelagt resultaterne af en in vitro-undersøgelse af permeabiliteten for prednisolon med en valideret metode i en model bestående af et monolag af Caco-2-celler.
English: The indications and posology are consistent with those of the cited reference medicinal product Prednisolone Tablets Sovereign (5 mg soluble tablet).
Danish: Indikationer og dosering svarer til det anførte referencelægemiddel Prednisolone Tablets Sovereign (opløselige tabletter, 5 mg).
English: The Scientific Expert Statements provided by the MAH, suggest that prednisolone is rapidly and almost completely absorbed passively from the upper gastrointestinal tract (stomach, duodenum and small intestines) before reaching the colon, where sorbitol at a sufficiently high concentration may exert some osmotic laxative effect.
Danish: I den videnskabelige ekspertudtalelse forelagt af markedsføringstilladelsesindehaveren peges der på, at prednisolon optages hurtigt og næsten fuldstændigt ved passiv absorption fra den øvre del af mave-tarmkanalen (ventriklen, duodenum og tyndtarmen) før den når frem til colon, hvor sorbitol i tilstrækkelig koncentration kan have nogen osmotisk laksativ virkning.
English: Okrido is an oral solution containing 6 mg/ml of the glucocorticoid prednisolone, as prednisolone sodium phosphate (PSP).
Danish: Okrido er en oral opløsning, som indeholder 6 mg/ml af glukokortikoidet prednisolon som prednisolonnatriumphosphat.
English: The MAH has provided solubility data which show that prednisolone sodium phosphate (PSP) is completely dissolved in water at a concentration of ~ 8.9 mg/ml, and that prednisolone remains in solution across the pH range of 1 to 8.
Danish: Indehaveren af markedsføringstilladelsen har forelagt opløselighedsdata, der viser, at prednisolonnatriumphosphat er fuldstændig opløseligt i vand i en koncentration på ~ 8,9 mg/ml, og at prednisolon forbliver i opløsning i hele pH-området fra 1 til 8.
English: Solubility and/or dissolution are therefore not considered to be a limiting factor in terms of in vivo absorption.
Danish: Opløselighed og/eller opløsning anses derfor ikke for at være en absorptionsbegrænsende faktor in vivo.
English: The MAH has also provided the abstract of an observational study (Staubach 20102) to support the clinical efficacy of the oral prednisolone solution containing sorbitol on emergency care patients presenting with urticaria and/or Quincke´s oedema.
Danish: Indehaveren af markedsføringstilladelsen har desuden forelagt sammendraget af en observationsundersøgelse (Staubach 20102) for at underbygge den kliniske virkning af den orale sorbitolholdige prednisolonopløsning til patienter, der ankommer til akutafsnit med urticaria og/eller Quinckes ødem.
English: therapy with prednisolone, and safety and tolerability were shown.
Danish: Der opnåedes samme hurtige resolution af symptomer som med intravenøst prednisolon, og sikkerheden og tolerabilitet blev dokumenteret.
English: Solubility and dissolution are not considered to be a limiting factor in terms of in vivo absorption.
Danish: Opløselighed og opløsning anses derfor ikke for at være en absorptionsbegrænsende faktor in vivo.
English: Following transport across the Caco-2 cell monolayer, prednisolone was recovered in the range of 84% to 106% of the applied dose, whether as prednisolone sodium phosphate, Okrido oral solution or the reference medicinal product Prednisolone Sovereign soluble tablet.
Danish: celler blev 84-106 % af den tilførte prednisolondosis genfundet, hvad enten der var tale omprednisolonnatriumphosphat, Okrido, oral opløsning, eller referencelægemidlet Prednisolone Sovereign, opløselige tabletter.
English: The permeability data is reflective of the available literature data, which indicate that prednisolone is rapidly and almost completely absorbed passively from the upper gastrointestinal tract.
Danish: Permeabilitetsdataene afspejler de foreliggende litteraturdata, som viser, at prednisolon hurtigt og næsten fuldstændigt absorberes passivt fra den øvre del af mave-tarmkanalen.
English: The permeability data is reflective of the available literature, which indicates that prednisolone is rapidly and almost completely absorbed across the upper gastrointestinal tract.
Danish: Permeabilitetsdataene afspejler de foreliggende litteraturdata, som viser, at prednisolon hurtigt og næsten fuldstændigt absorberes fra den øvre del af mave-tarmkanalen.
English: In summary, the results of the in vitro investigation of the permeability of prednisolone using the Caco-2 cell model showed that prednisolone exhibits high permeability, characteristic of BCS class I substances, and also that the permeability of prednisolone is not affected by the excipient sorbitol in Okrido.
Danish: Sammenfattende viser undersøgelsens resultater med in vitro-modellen med Caco-2-celler, at prednisolon udviser høj permeabilitet kendetegnende for stoffer af BCS klasse I, og at permeabiliteten for prednisolon ikke påvirkes af hjælpestoffet sorbitol i Okrido.
English: Permeability has been investigated using in vitro Caco-2 monolayer cell model and the results showed that prednisolone exhibits high permeability characteristic of BCS class I substances, and also that the permeability of prednisolone is not significantly affected by the excipient sorbitol in Okrido.
Danish: En model med et monolag af Caco-2 celler viste, at prednisolon har høj permeabilitet kendetegnende for stoffer af BCS klasse I, og at permeabiliteten for prednisolon ikke påvirkes nævneværdigt af hjælpestoffet sorbitol i Okrido.
English: - Both Okrido and the reference product are dissolved in water before administration and are considered to be oral solutions, which exhibits high solubility across the gastrointestinal physiological pH range.
Danish: • udvalget fandt, at den biowaiver, der var anvendt i stedet for en in vivobiotilgængelighedsundersøgelse for Okrido, kunne godtages, eftersom: - både Okrido og referenceproduktet opløses i vand før administration og betragtes som orale opløsninger, der udviser høj opløselighed i hele det gastrointestinale fysiologiske pH-område.
English: - Prednisolone (as sodium phosphate) exhibits high permeability as determined by the in vitro Caco-2 cell permeability model, and the permeability of Okrido is unaffected by the excipient sorbitol.
Danish: Opløselighed og/eller opløsning anses derfor ikke for at være en absorptionsbegrænsende faktor in vivo, - prednisolon (som natriumphosphat) udviser høj permeabilitet, bestemt ved in vitromodellen for permeabilitet med Caco-2-celler, og permeabiliteten for Okrido påvirkes ikke af hjælpestoffet sorbitol, - prednisolon optages hurtigt og næsten fuldstændigt i den øvre del af mavetarmkanalen.
English: A positive opinion was therefore adopted on 20 January 2005.
Danish: Der blev afgivet en positiv udtalelse den 20. januar 2005.
English: The final opinion was converted into a Decision by the European Commission on 10 May 2005.
Danish: Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa-Kommissionen den 10 maj
English: The arbitration procedure started on 16 September 2004.
Danish: Voldgiftsproceduren indledtes den 16. september 2004.
English: London, 10 May 2005 EMEA/CHMP/94618/2005
Danish: London, 10 maj 2005 EMEA/CHMP/94618/2005
English: The application for Mutual Recognition for Rigevidon was submitted to Denmark and the Mutual Recognition Procedure started on 30 April 2004.
Danish: Ansøgningen for Rigevidon om gensidig anerkendelse blev indgivet til Danmark, og proceduren for gensidig anerkendelse indledtes den 30. april 2004.
English: During its January 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that a marketing authorisation should be granted.
Danish: På sit møde i januar 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at der skulle udstedes en markedsføringstilladelse.
English: The referral procedure was triggered by the Netherlands, in relation to the acceptance criteria, in bioequivalence studies, of pharmacokinetics parameters, which may need to be tightened, if Rigevidon could be considered as a medicinal product with a narrow therapeutic range.
Danish: Indbringelsesproceduren blev foranlediget af Nederlandene i forbindelse med kriterierne i bioækvivalensundersøgelser for godkendelse af de farmakokinetiske parametre, som muligvis burde strammes, hvis Rigevidon kunne betragtes som et lægemiddel med snæver terapeutisk virkningsbredde.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og produktresuméet i bilag III.
English: International Non-Proprietary Name (INN): levonorgestrel and ethinylestradiol
Danish: Internationalt fællesnavn ( INN): levonorgestrel og ethinylestradiol
English: OPINION FOLLOWING AN ARTICLE 29(2) REFERRAL Rigevidon
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 2 Rigevidon
English: Rigevidon is a combined oral contraceptive (COC) containing 150µg levonorgestrel (LNG) and 30µg ethinylestradiol (EE2).
Danish: Rigevidon er et kombineret oralt kontraceptivum (COC), som indeholder 150µg levonorgestrel (LNG)
English: A Marketing Authorisation for Rigevidon was granted to Medimpex France SA by Denmark on 10
Danish: Danmark udstedte den 10. marts 2003 en markedsføringstilladelse for Rigevidon til Medimpex France SA.
English: The company that markets these medicines is Mundipharma GmbH.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Mundipharma GmbH.
English: Outcome of a procedure under Article 13(2) of Regulation (EC) 1234/2008
Danish: Resultatet af en procedure i medfør af artikel 13, stk. 2, i forordning (EF) nr.
English: The European Commission issued an EU-wide legally binding decision to implement this change on 22 December 2014.
Danish: Europa-Kommissionen vedtog en afgørelse, der er retligt bindende i hele EU, den 22. december 2014.
English: The Committee looked at the study presented by the company to support its application.
Danish: Udvalget gennemgik den undersøgelse, virksomheden havde forelagt som dokumentation for ansøgningen.
English: However, the Member States were unable to reach agreement on whether to accept this new indication and on 2 May 2014, Germany referred the matter to the CHMP for arbitration.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed om, hvorvidt de skulle godkende denne nye anvendelse, og den 2. maj 2014 indbragte Tyskland sagen for CHMP til voldgift.
English: On 23 October 2014, the European Medicines Agency completed an arbitration procedure for Oxynal, Targin and associated names.
Danish: Den 23. oktober 2014 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure for Oxynal, Targin og relaterede navne.
English: What are Oxynal and Targin?
Danish: Hvad er Oxynal og Targin?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 December 2014 EMA/300/2015
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Oxynal, Targin and associated names are marketed in all EU Member States except Croatia, Greece, Lithuania and Malta.
Danish: Oxynal, Targin og relaterede navne markedsføres i alle EU's medlemsstater undtagen Kroatien, Grækenland, Litauen og Malta.
English: Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Danish: “Restless legs syndrom” er en lidelse med uimodståelig trang til at bevæge lemmerne for at standse ubehagelige, smertefulde eller mærkelige fornemmelser i kroppen, sædvanligvis om natten.
English: Oxynal and Targin have been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by Germany.
Danish: Oxynal og Targin er godkendt i EU ved den gensidige anerkendelsesprocedure på grundlag af en første godkendelse i Tyskland.
English: Why was Oxynal and Targin reviewed?
Danish: Hvorfor blev Oxynal og Targin gennemgået på ny?
English: Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride)
Danish: Spørgsmål og svar om Oxynal, Targin og relaterede navne (oxycodonhydrochlorid / naloxonhydrochlorid)
English: Regarding the safety, the CHMP concluded that overall the risk of tolerance and misuse is considered low and that the proposed measures to reduce this risk are appropriate.
Danish: Hvad sikkerheden angår, konkluderede CHMP, at risikoen for tolerans og misbrug overordnet anses for lav, og at de påtænkte foranstaltninger til mindskelse af denne risiko er tilstrækkelige.
English: The company wanted the authorisation for the additional use in restless legs syndrome to be recognised in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ønskede den ekstra anvendelse ved “restless legs syndrom” godkendt i følgende medlemsstater: Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Ungarn, Irland, Italien, Letland, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige (“de berørte medlemsstater”).
English: The CHMP therefore concluded that the benefits of Oxynal and Targin for restless legs syndrome outweigh their risks and recommended that the change to the marketing authorisation be granted in Germany and the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Oxynal og Targin til “restless legs syndrom” overstiger risiciene, og anbefalede ændring af markedsføringstilladelsen i Tyskland og de berørte medlemsstater.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for these medicines to include a new use in the treatment of restless legs syndrome.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) var blevet anmodet om at fungere som voldgift i forbindelse med en ansøgning om at ændre markedsføringstilladelsen for disse lægemidler ved tilføjelse af en ny anvendelse: behandling af “restless legs syndrom”.
English: Oxynal and Targin contain two active substances: oxycodone hydrochloride, an opioid painkiller, and naloxone hydrochloride, an opioid antagonist, which is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors found locally in the gut.
Danish: Oxynal og Targin indeholder to aktive stoffer: oxycodonhydrochlorid, der er et smertestillende middel af opioidtypen, og naloxonhydrochlorid, der er tilsat for at modvirke den forstoppende virkning af opioider ved at blokere virkningen af oxycodon på de opioidreceptorer, der findes lokalt i tarmen.
English: The Committee concluded that the benefits of Oxynal, Targin and associated names outweigh their risks in the new use and the change to the marketing authorisation can be granted in Germany and the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Danish: Udvalget konkluderede, at fordelene ved Oxynal, Targin og relaterede navne overstiger risiciene til den nye anvendelse, og anbefalede udstedelse af en ændret markedsføringstilladelse i Tyskland og følgende medlemsstater: Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Ungarn, Irland, Italien, Letland, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige.
English: In particular, there were concerns that the use of Oxynal and Targin could lead to tolerance and misuse and that this was not adequately studied in the clinical trial and the proposed measures to reduce the risk of tolerance and misuse were not considered sufficient.
Danish: Navnlig var der bekymring for, at anvendelse af Oxynal og Targin kunne medføre aftagende virkning (tolerans) og misbrug, at dette ikke var tilstrækkeligt undersøgt i den kliniske undersøgelse, og at de påtænkte foranstaltninger til mindskelse af risikoen for tolerans og misbrug ikke var tilstrækkelige.
English: Oxynal and Targin are medicines used to treat severe pain that can only be managed with opioids.
Danish: Oxynal og Targin er lægemidler til behandling af svære smerter, hvor kun opioider virker.
English: In November 2012, the company for Oxynal and Targin applied for an additional use in Germany: treatment of symptoms of severe to very severe restless legs syndrome when treatment with other medicines called dopaminergics has failed.
Danish: I november 2012 ansøgte virksomheden om en ny anvendelse af Oxynal Targin i Tyskland: behandling af symptomerne på svært til meget svært “restless legs syndrom”, hvor behandling med dopaminerge lægemidler har slået fejl.
English: Based on the evaluation of the available data and the scientific discussion within the Committee, the CHMP agreed that the study had convincingly shown that Oxynal and Targin are beneficial in the treatment of symptoms of severe to very severe restless legs syndrome when standard therapy has failed.
Danish: Efter vurdering af de foreliggende oplysninger og de videnskabelige drøftelser i udvalget fandt CHMP, at undersøgelsen på overbevisende måde havde vist, at Oxynal og Targin er til fordel ved behandling af symptomer på svært til meget svært “restless legs syndrom”, når sædvanlig behandling har slået fejl.
English: The grounds for the referral were concerns from the Netherlands that the data on Oxynal and Targin submitted in the application were not sufficient to demonstrate a positive benefit-risk balance in restless legs syndrome.
Danish: Begrundelsen for indbringelsen var Nederlandenes betænkelighed ved, at de data for Oxynal og Targin, der var indsendt med ansøgningen, ikke var tilstrækkelige til at påvise, at fordelene oversteg risikoen ved “restless legs syndrom”.
English: Overall summary of the scientific evaluation of Novosis Goserelin 3,6 mg Implantat and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Novosis Goserelin 3,6 mg implantat og relaterede navne (se bilag I)
English: Furthermore, the MAH has adapted the study design.
Danish: Desuden har indehaveren af markedsføringstilladelsen tilpasset undersøgelsens design.
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Novosis Goserelin and associated names as listed in Annex I.
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 36 i direktiv 2001/83/EF for Novosis Goserelin 3,6 mg implantat og relaterede navne som anført i bilag 1.
English: In spite of the fact that patient safety and product efficacy was always ensured, the MAH decided to clinically reinvestigate the current goserelin 1-month product.
Danish: Til trods for at patientsikkerheden og lægemiddelvirkningen hele tiden var sikker, besluttede indehaveren af markedsføringstilladelsen at foretage en klinisk undersøgelse af den aktuelle 1måneds-formulering af goserelin.
English: The issue has been solved
Danish: Spørgsmålet er løst.
English: Based on this data, the tolerability would be expected to be similar between those two groups.
Danish: På grundlag af disse data forventes tolerabiliteten at være ens for disse to grupper.
English: Sessions 4.5, 5.1, and 5.2 have been updated in order to guarantee the safety of the medicine.
Danish: Afsnit 4.5, 5.1 og 5.2 er blevet ajourført for at garantere lægemidlets sikkerhed.
English: • sudden loss of consciousness
Danish: • pludseligt tab af bevidsthed
English: • the use of Diovan in children and adolescents is not recommended (below the age of 18 years).
Danish: • brug af Diovan til børn og unge (under 18 år) kan ikke anbefales.
English: Method of administration Diovan may be taken independently of a meal and should be administered with water.
Danish: Administrationsmetode Diovan kan tages uafhængigt af måltider og bør administreres sammen med vand.
English: 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON France
Danish: 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON Frankrig