FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Cilazapril Teva and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Danish: • udvalget er af den opfattelse, at det på baggrund af de alvorlige tvivl med hensyn til dokumentationen af bioækvivalens ikke er muligt at fastlægge benefit/risk-forholdet for Cilazapril Teva og relaterede navne, anbefalede udvalget, at markedsføringstilladelserne for Cilazapril Teva og relaterede navne suspenderes i henhold til artikel 116 i direktiv 2001/83/EF, eftersom: a. benefit/risk-forholdet ikke kan anses for tilfredsstillende, og b. oplysningerne til støtte for ansøgningen som omhandlet i artikel 10 i direktiv 2001/83/EF ikke kan ikke anses for at være korrekte.
English: The MAH considered that the satisfactory results of these re-analyses suggest that the final outcome of the Cilazapril Teva study was not influenced by the bioanalytical analyses carried out at Cetero Research, Houston.
Danish: Disse nye analyser gav tilfredsstillende resultater, hvilket indehaveren af markedsføringstilladelsen opfattede som et tegn på, at det endelige udfald af undersøgelsen af Cilazapril Teva ikke var påvirket af de bioanalytiske analyser, der blev udført hos Cetero Research, Houston.
English: The highly soluble nature of the drug substance over the physiological pH range and the dissolution similarity between Cilazapril Teva and the reference product was also acknowledged.
Danish: Udvalget anerkendte endvidere lægemiddelstoffets høje opløselighed i hele det fysiologiske pH-område og ligheden mellem opløselighedsegenskaberne for Cilazapril Teva og referencelægemidlet.
English: However, the CHMP did not consider these general data to be sufficient to provide re-assurances specifically regarding the bioequivalence of Cilazapril Teva to its EU reference product.
Danish: CHMP fandt imidlertid ikke disse generelle oplysninger tilstrækkelige til specifikt at sikre, at Cilazapril Teva er bioækvivalent med det tilsvarende EU-referencelægemiddel.
English: In response to the CHMP list of questions, the MAH stated that the pivotal bioequivalence study 2005980 conducted for Cilazapril Teva met the bioequivalence criteria (point estimates of 93.4% and 100% for AUC0-4h and Cmax, respectively) with respect to the Guideline on the Investigation of Bioequivalence.
Danish: I sin besvarelse af CHMP's liste med spørgsmål anførte indehaveren af markedsføringstilladelsen, at bioækvivalenshovedundersøgelse 2005-980 af Cilazapril Teva opfyldte bioækvivalenskriterierne i “Guideline on the Investigation of Bioequivalence” (punktestimaterne var 93,4 % og 100 % for henholdsvis AUC0-4h og Cmax).
English: However, for Cilazapril Teva, the MAH stated that no study samples were available for study 2005-980 and that there is therefore no possibility to reanalyse the data.
Danish: Indehaveren af markedsføringstilladelsen oplyste imidlertid, at der ikke forelå nogen tilgængelige prøver fra undersøgelse 2005-980 for Cilazapril Teva, og at det således ikke er muligt at foretage nye analyser af dataene.
English: The CHMP assessed the MAH responses and noted that the MAH had repeated a number of studies, producing data in line with that obtained by Cetero Research, although no details of these studies were included in the response documentation to support this.
Danish: CHMP gennemgik svarene fra indehaveren af markedsføringstilladelsen og bemærkede, at denne ved at gentage en række undersøgelser havde opnået resultater svarende til Cetero Researchs resultater, men at der ikke var redegjort nærmere for disse undersøgelser i svardokumentationen.
English: • The Committee considered that the responses of the MAH are not adequate to refute the serious doubts as to the evidence of the bioequivalence of Cilazapril Teva and associated names with the EU reference product.
Danish: • udvalget fandt, at besvarelsen fra indehaveren af markedsføringstilladelsen ikke fyldestgørende afviser de alvorlige betænkeligheder vedrørende dokumentationen for, at Cilazapril Teva og relaterede navne er bioækvivalent med EU-referencelægemidlet,
English: In addition, the MAH stated that it had already carried out a number of repeats or re-assays of bioanalytical studies potentially affected by the Cetero Research findings for other Teva products in response to the concerns raised by the FDA.
Danish: Desuden anførte indehaveren af markedsføringstilladelsen, at der for at imødekomme FDA's betænkeligheder allerede var udført en række gentagelser eller nye analyser af bioanalytiske undersøgelser, som potentielt var berørt af resultaterne fra Cetero Research, for andre Tevalægemidler.
English: The resulting solution is not expected to precipitate at higher pH values later in the intestine, due to the good aqueous solubility of the compound.
Danish: På grund af stoffets gode opløselighed i vand forventes der ikke udfældning fra den resulterende opløsning ved de højere pH-værdier længere nede i tarmen.
English: The initial marketing authorisations applications for the Cilazapril Teva tablets were supported by a single pivotal bioequivalence study (Study 2005-980), comparing Cilazapril Teva with the EU reference product Vascace, for which samples were analysed by BA Research International (now Cetero Research) between May 26th 2005 and December 20th 2005.
Danish: De første ansøgninger om markedsføringstilladelse for Cilazapril Teva-tabletter var baseret på en enkelt bioækvivalenshovedundersøgelse (undersøgelse 2005-980), hvor Cilazapril Teva blev sammenlignet med EU-referencelægemidlet Vascace.
English: The CHMP also noted that due to the lack of availability of samples, it was not possible to reanalyse the samples from the clinical study in order to check the validity of the original findings, but the CHMP acknowledged the MAH intention to repeat the study, with final results expected to be available by the end of June 2013.
Danish: CHMP konstaterede endvidere, at det, idet der ikke fandtes prøver fra den kliniske undersøgelse, ikke var muligt at foretage en ny analyse heraf for at efterprøve de oprindelige resultater.
English: London, 19 July 2007 Doc.
Danish: London, den 19. juli 2007 Dok.
English: The main measure of effectiveness was survival.
Danish: Det primære effektmål var overlevelse.
English: International non-proprietary name (INN): oblimersen
Danish: Internationalt fællesnavn (INN): oblimersen
English: What is Genasense?
Danish: Hvad er Genasense?
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for GENASENSE
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALING AF AFSLAG PÅ MARKEDSFØRINGSTILLADELSE for GENASENSE
English: The company that applied for authorisation is Genta Development Limited.
Danish: Virksomheden, som søgte om markedsføringstilladelse, er Genta Development Limited.
English: This was expected to slow down the growth of the tumour.
Danish: Dette skulle nedsætte hastigheden af tumorens vækst.
English: The CHMP refusal was confirmed after reexamination.
Danish: CHMP's afslag blev bekræftet efter revurderingen.
English: Genasense has also been studied in 771 patients with advanced or metastatic melanoma.
Danish: Genasense er også blevet undersøgt hos 771 patienter med fremskredet eller metastatisk melanom.
English: The effects of Genasense were first tested in experimental models before being studied in humans.
Danish: Genasenses effekt blev undersøgt i eksperimentelle modeller, før det blev undersøgt hos mennesker.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, skal du kontakte den læge, som står for behandlingen.
English: This protein normally allows skin cancer cells to stay alive by preventing them from committing suicide (apoptosis).
Danish: Dette protein holder normalt hudkræftceller i live ved at forhindre dem i at begå selvmord (apoptose).
English: The applicant requested a re-examination of the opinion.
Danish: Ansøgeren anmodede om en revurdering af afslaget.
English: What was Genasense expected to be used for?
Danish: Hvad forventedes Genasense anvendt til?
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 July 2007.
Danish: Efter at have overvejet årsagerne til denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede afslaget på markedsføringstilladelsen den 19. juli 2007.
English: Genasense was to be used to treat patients with melanoma (a type of skin cancer affecting cells called ‘melanocytes') whose disease is advanced (it cannot be removed by surgery alone) or metastatic (has spread to other parts of the body).
Danish: Genasense skulle anvendes til behandling af patienter med melanom (en form for hudkræft, som rammer celler, der kaldes melanocytter), hvis sygdom er fremskreden (den kan ikke fjernes ved operation alene) eller metastatisk (den har spredt sig til andre dele af kroppen).
English: On 26 April 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Genasense 30 mg/ml concentrate for solution for infusion, intended for the treatment of advanced or metastatic melanoma.
Danish: Den 26. april 2007 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse og anbefalede afslag på markedsføringstilladelse for lægemidlet Genasense 30 mg/ml koncentrat til opløsning til infusion, der var beregnet til behandling af fremskredet eller metastatisk melanom.
English: It is made up into a solution that is given as an intravenous infusion (drip into a vein).
Danish: Det fremstilles som en opløsning, der administreres som en intravenøs infusion (drop i en vene).
English: It attaches to the ‘messenger RNA' (mRNA) that normally instructs the cell how to make Bcl-2.
Danish: Det binder sig til messenger-RNA (mRNA), som normalt fortæller cellen, hvordan den skal danne Bcl-2.
English: By blocking the production of Bcl-2, Genasense was expected to make the cancer cells more sensitive to factors that cause cell death, including anticancer medicines such as dacarbazine.
Danish: Ved at blokere for dannelsen af Bcl-2 forventedes det, at Genasense ville gøre kræftceller mere følsomme over for faktorer, som forårsager celledød, herunder lægemidler mod kræft som for eksempel dacarbazin.
English: Genasense is a medicine containing the active substance oblimersen.
Danish: Genasense er et lægemiddel, der indeholder det aktive stof oblimersen.
English: Therefore, the study did not demonstrate that Genasense was effective in treating melanoma.
Danish: Derfor blev det ikke påvist i undersøgelsen, at Genasense havde en effekt i behandlingen af melanom.
English: There were side effects associated with treatment with Genasense.
Danish: Der var bivirkninger ved behandlingen med Genasense.
English: Genasense was to be used in combination with dacarbazine (another anticancer medicine).
Danish: Genasense skulle benyttes i kombination med dacarbazin (et andet lægemiddel mod kræft).
English: At that point in time, the CHMP was of the opinion that the benefits of Genasense in the treatment of advanced or metastatic melanoma did not outweigh its risks.
Danish: På daværende tidspunkt var CHMP af den opfattelse, at fordelene ved Genasense til behandling af fremskredet eller metastatisk melanom ikke opvejede risiciene.
English: This stimulates the cell to destroy the mRNA, blocking the production of the protein.
Danish: Herved stimuleres cellen til at ødelægge mRNA'et og blokerer for dannelsen af proteinet.
English: How is Genasense expected to work?
Danish: Hvordan forventes Genasense at virke?
English: The active substance in Genasense, oblimersen, is an antineoplastic medicine.
Danish: Det aktive stof i Genasense, oblimersen, er et antineoplastisk lægemiddel.
English: It is thought to work by preventing cells from producing the protein Bcl-2.
Danish: Det menes at virke ved at forhindre celler i at danne proteinet Bcl-2.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Genasense.
Danish: Virksomheden orienterede CHMP om, at der ikke er nogen konsekvenser for de patienter, der på nuværende tidspunkt er inddraget i kliniske undersøgelser eller programmer for anvendelse af Genasense med særlig udleveringstilladels.
English: The effects of Genasense in combination with dacarbazine were compared with those of dacarbazine taken alone.
Danish: Effekten af Genasense i kombination med dacarbazin blev sammenlignet med effekten af dacarbazin alene.
English: In the main study of patients with melanoma, survival rates were very similar in the patients receiving Genasense with dacarbazine and those receiving dacarbazine alone.
Danish: I hovedundersøgelsen af patienter med melanom var overlevelsesprocenten hos de patienter, der fik Genasense med dacarbazin, af samme størrelsesorden som hos de patienter, der fik dacarbazin alene.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Genasense?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Genasense eller i programmer for anvendelse med særlig udleveringstilladelse?
English: Oblimersen is an ‘anti-sense oligonucleotide' medicine.
Danish: Oblimersen er et antisense-oligonukleotid.
English: Hence, the CHMP recommended that Genasense be refused marketing authorisation.
Danish: Derfor anbefalede CHMP afslag på ansøgningen om markedsføringstilladelse for Genasense.
English: 2 February 2016 EMA/824095/2015
Danish: Den 2. februar 2016 EMA/824095/2015
English: Centaury should only be used in adults and elderly.
Danish: Tusindgylden bør kun bruges hos voksne og ældre.
English: Studies in laboratory tests indicate an effect as appetite and digestion stimulant, although the data available are very limited.
Danish: Undersøgelser i laboratorietest viser appetit- og fordøjelsesstimulerende virkning, men de foreliggende data er meget begrænsede.
English: If symptoms last longer than 2 weeks during use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomerne varer længere end to uger under brug af lægemidlet, bør der søges råd hos en læge eller kvalificeret sundhedspersonale.
English: In some cases the solvent is partially evaporated to obtain a soft extract.
Danish: I nogle tilfælde bliver opløsningsmidlet delvis inddampet, så der fås et blødt ekstrakt.
English: Centaury EMA/824095/2015
Danish: Tusindgylden EMA/824095/2015
English: Centaury is the common name for the plant Centaurium erythraea Rafn.
Danish: Tusindgylden er det almindelige navn for planten Centaurium erythraea Rafn.
English: Any applications for the licensing of medicines containing centaury have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder tusindgylden, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Centaury medicines should not be taken by people with ulcers in the stomach.
Danish: Lægemidler indeholdende tusindgylden bør ikke indtages af personer med mavesår.
English: They are also obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol or water) to form a liquid extract or tincture (an alcoholic extract).
Danish: Præparaterne kan desuden fremstilles med en teknik til ekstraktion af stoffer fra plantedelene ved opløsning i ethanol eller vand, hvorved der dannes et flydende ekstrakt eller tinktur (et alkoholisk ekstrakt).
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing centaury.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder tusindgylden.
English: The HMPC conclusions are therefore based on the long-standing use of centaury.
Danish: HMPC's konklusioner er derfor baseret på den mangeårige anvendelse af tusindgylden.
English: Information on the use and licensing of centaury medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder tusindgylden, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: The HMPC noted the lack of clinical studies with centaury.
Danish: HMPC bemærkede, at der savnes kliniske undersøgelser med tusindgylden.
English: Further information on the HMPC assessment of centaury medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder tusindgylden, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instructions on how to take centaury medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med tusindgylden bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The HMPC concluded that, on the basis of its long-standing use, centaury can be used for mild indigestion or other stomach and gut disorders as well as for temporary loss of appetite.
Danish: HMPC konkluderede, at tusindgylden på baggrund af sin langvarige anvendelse kan anvendes til let fordøjelsesbesvær eller andre former for mave-tarmbesvær samt til forbigående appetitløshed.
English: Other information about centaury medicines
Danish: Andre oplysninger om lægemidler, der indeholder tusindgylden
English: Further information on the risks associated with centaury medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder tusindgylden, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of centaury.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af tusindgylden.
English: This summary is not intended to provide practical advice on how to use medicines containing centaury.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder tusindgylden, skal anvendes.
English: The HMPC conclusions on the use of centaury medicines for indigestion or other stomach and gut disorders, and in temporary loss of appetite are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler indeholdende tusindgylden ved fordøjelsesbesvær, mave-tarmbesvær og forbigående appetitløshed bygger på lægemidlernes "traditionelle anvendelse".
English: How are centaury medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder tusindgylden, i EU?
English: Herbal medicines containing centaury are usually available as herbal teas to be drunk, or in liquid or solid forms to be taken by mouth.
Danish: Plantelægemidler med tusindgylden fås sædvanligvis som urtete til drikkebrug eller i flydende eller fast form til indtagelse gennem munden.
English: What evidence supports the use of centaury medicines?
Danish: Hvilken dokumentation underbygger anvendelsen af lægemidler med tusindgylden?
English: What is centaury?
Danish: Hvad er tusindgylden?
English: For more information about treatment with centaury medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder tusindgylden, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What are the risks associated with centaury medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder tusindgylden?
English: For practical information about using centaury medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med tusindgylden, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Centaury can also be found in combination with other herbal substances in some herbal medicines.
Danish: I visse plantelægemidler er tusindgylden desuden kombineret med andre plantestoffer.
English: Centaury preparations are obtained by drying and comminuting (reducing into tiny pieces) or powdering the aerial parts.
Danish: Præparater af tusindgylden fremstilles ved tørring og findeling eller pulverisering af de overjordiske dele.
English: Centaury
Danish: Tusindgylden
English: Content (concentration) Pack size
Danish: Lægemiddelform Administration Emballage Indhold (koncentration)
English: Packaging Package size bottle (HDPE) 168 (4 x 42) tablets bottle (HDPE) 42 tablets
Danish: 168 (4 x 42) tabletter
English: - you are planning to have a baby.
Danish: - planlægger at få et barn.
English: This applies to both men and women.
Danish: Dette gælder både for mænd og kvinder.
English: No specific studies have been carried out in the elderly.
Danish: Der er ikke udført specifikke undersøgelser hos ældre.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/727/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/727/001
English: Talk to your child´s doctor if this happens.
Danish: Kontakt barnets læge, hvis det sker.
English: This is excreted in the urine.
Danish: Den udskilles i urinen.
English: They therefore cannot fight infections and may cause bleeding.
Danish: Derfor kan de ikke bekæmpe infektioner og kan forårsage blødning.
English: - If you have diarrhoea
Danish: Hvis du har diarré
English: After first opening: 56 days.
Danish: Efter første anbrud: 56 dage.
English: This is to check the number and type of cells in your blood and to ensure your liver is working correctly.
Danish: Dette sker for at kontrollere antal og type af celler i dit blod og for at sikre, at din lever fungerer korrekt.
English: The infectious disease and complications may be more severe in these patients than in non-treated patients.
Danish: Den infektiøse sygdom og komplikationer kan være mere alvorlig hos disse patienter end hos patienter, der ikke er blevet behandlet.
English: • Risk Management Plan (RMP) Not applicable
Danish: • Risikostyringsplan (RMP) Ikke relevant.
English: It is important to take Xaluprine in the evening to make the medicine more effective.
Danish: Det er vigtigt at tage Xaluprine om aftenen for at gøre medicinen mere effektiv.
English: Discard 56 days after first opening.
Danish: Kasseres 56 dage efter første åbning.