FrancophonIA/ELRC3.0 huggingface dataset:
English: The company requested a re-examination of the initial opinion.
Danish: Virksomheden anmodede om en revurdering af den oprindelige udtalelse.
English: Doxorubicin has been available since the 1960s.
Danish: Doxorubicin har været på markedet siden 1960'erne.
English: What consequences does this refusal have for patients in clinical trials?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske studier?
English: This means that cancer cells cannot divide and they eventually die.
Danish: Det betyder, at cellerne ikke kan dele sig og ender med at dø.
English: The company that applied for authorisation is TLC Biopharmaceuticals B.V.
Danish: Den virksomhed, der har indgivet ansøgningen, er TLC Biopharmaceuticals B.V.
English: What was Doxolipad expected to be used for?
Danish: Hvad forventedes Doxolipad anvendt til?
English: Refusal of the marketing authorisation for Doxolipad (doxorubicin) EMA/295022/2019
Danish: Afslag på ansøgningen om markedsføringstilladelse for Doxolipad (doxorubicin) EMA/295022/2019
English: The liposomes reduce the rate at which the active substance is broken down, allowing it to circulate in the blood for longer.
Danish: Liposomerne reducerer den hastighed, med hvilken det aktive stof nedbrydes, så stoffet kan cirkulere i blodet i længere tid.
English: Doxolipad was developed as a ‘hybrid medicine'.
Danish: Doxolipad blev udviklet som et "hybridt lægemiddel".
English: It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Danish: Det virker ved at forstyrre dna'et i cellerne, så de ikke kan lave flere dnakopier eller lave proteiner.
English: This means that Doxolipad was intended to be similar to a ‘reference medicine' already authorised in the European Union called Adriamycin.
Danish: Det betyder, at det var hensigten, at Doxolipad skulle være identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Adriamycin.
English: On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Doxolipad, intended for the treatment of breast and ovarian cancer.
Danish: Den 31. januar 2019 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Doxolipad, der er beregnet til behandling af bryst- og æggestokkræft.
English: The company informed the CHMP that there are no ongoing clinical trials with Doxolipad in the EU.
Danish: Virksomheden har oplyst CHMP om, at der i øjeblikket ikke gennemføres kliniske studier af Doxolipad i EU.
English: Doxolipad was expected to be used to treat metastatic breast cancer in patients at risk of heart problems (‘metastatic' means the cancer has spread to other parts of the body), and cancer of the ovary in women whose previous treatment including a platinum-based cancer medicine has stopped working.
Danish: Doxolipad skulle anvendes til behandling af metastatisk brystkræft hos patienter med risiko for hjerteproblemer ("metastatisk" betyder, at kræften har spredt sig til andre dele af kroppen) og til behandling af æggestokkræft hos kvinder, hvis tidligere behandling med bl.a. platinbaseret kræftmedicin ikke længere har nogen virkning.
English: For more information on hybrid medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om hybridlægemidler i dokumentet med spørgsmål og svar her.
English: What is Doxolipad?
Danish: Hvad er Doxolipad?
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 29 May 2019.
Danish: Efter en gennemgang af begrundelsen for anmodningen foretog CHMP en revurdering af den oprindelige udtalelse; den 29. maj 2019 bekræftede udvalget afslaget på ansøgningen om markedsføringstilladelse.
English: Doxolipad is a cancer medicine that contains the active substance doxorubicin.
Danish: Doxolipad er et kræftlægemiddel, der indeholder det aktive stof doxorubicin.
English: The applicant presented data from the scientific literature, and data from studies conducted in experimental models, including comparisons with another authorised doxorubicin medicine, Caelyx, which contains doxorubicin in pegylated liposomal form.
Danish: Ansøgeren fremlagde data fra den videnskabelige litteratur samt data fra studier af forsøgsmodeller, herunder sammenligninger med et andet godkendt doxorubicin-lægemiddel, Caelyx, der indeholder doxorubicin i en pegyleret liposomal formulering.
English: Because Doxolipad was developed as a hybrid medicine, the company also presented the results of a study carried out to investigate whether it is ‘bioequivalent' to Caelyx.
Danish: Da Doxolipad blev udviklet som et hybridt lægemiddel, fremlagde virksomheden også resultaterne af et studie til undersøgelse af, hvorvidt det er "bioækvivalent" med Caelyx.
English: Refusal of the marketing authorisation for Doxolipad (doxorubicin)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Doxolipad (doxorubicin)
English: Although the reference medicine for Doxolipad is Adriamycin, this could not be used in the bioequivalence study because it contains doxorubicin in a different form (not enclosed in pegylated liposomes).
Danish: Selvom referencelægemidlet for Doxolipad er Adriamycin, kunne det ikke anvendes i bioækvivalensstudiet, da det indeholder doxorubicin i en anden formulering (ikke indkapslet i pegylerede liposomer).
English: The results of the bioequivalence study showed that Doxolipad is comparable to Caelyx in terms of ‘liposome-encapsulated doxorubicin', but failed to show that the amount of ‘free doxorubicin' is the same for the two medicines.
Danish: Resultaterne af bioækvivalensstudiet viste, at Doxolipad er sammenligneligt med Caelyx, hvad angår liposom-indkapslet doxorubicin, men påviste ikke, at mængden af frit doxorubicin er den samme for de to lægemidler.
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Det skulle markedsføres som et koncentrat, der blandes til en opløsning til infusion (drop) i en blodåre.
English: Therefore, the CHMP was of the opinion that there was insufficient evidence to show that Doxolipad was bioequivalent to Caelyx, and it was not possible to establish that the benefits of Doxolipad outweigh its risks.
Danish: CHMP vurderede derfor, at der ikke var tilstrækkelig evidens for Doxolipads bioækvivalens med Caelyx, og at det ikke var muligt at påvise, at fordelene ved Doxolipad opvejer risiciene.
English: On that basis, the CHMP recommended that Doxolipad be refused marketing authorisation.
Danish: På den baggrund anbefalede CHMP afslag på ansøgningen om markedsføringstilladelse for Doxolipad.
English: How does Doxolipad work?
Danish: Hvordan virker Doxolipad?
English: They also reduce the medicine's effects on non-cancer cells, so it is less likely to cause some side effects.
Danish: Liposomerne mindsker også lægemidlets effekt på raske celler og nedsætter derved risikoen for visse bivirkninger.
English: The difference between the products is that in Doxolipad the active substance doxorubicin is enclosed in tiny fatty spheres called liposomes (see below for more details).
Danish: Forskellen på de to lægemidler er, at det aktive stof i Doxolipad (doxorubicin) er indkapslet i bittesmå fedtkugler, der kaldes liposomer (se mere nedenfor).
English: The active substance in Doxolipad, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Danish: Det aktive stof i Doxolipad, doxorubicin, er et cytotoksisk (cellegiftigt) lægemiddel, der tilhører gruppen af antracykliner.
English: In Doxolipad, it is enclosed in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Danish: Det aktive stof i Doxolipad er indkapslet i såkaldt pegylerede liposomer, der er bittesmå fedtkugler belagt med et kemisk stof, der hedder polyethylenglykol.
English: European Commission granted a marketing authorisation valid throughout the European Union for Oslif Breezhaler on 30 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Oslif Breezhaler den 30. november 2009.
English: The full EPAR for Oslif Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Oslif Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Danish: Den virker ved at binde sig til beta2-receptorer, som findes i muskelcellerne i mange organer, og som får musklerne til at slappe af.
English: This is a summary of the European public assessment report (EPAR) for Oslif Breezhaler.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Oslif Breezhaler.
English: Oslif Breezhaler is used for maintenance (regular) treatment.
Danish: Oslif Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: Therefore, the Agency decided that Oslif Breezhaler's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Oslif Breezhaler opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Danish: Dette får muskulaturen i luftvejene til at afslappes, så luftvejene bedre holdes åbne, og patienten får lettere ved at trække vejret.
English: On average, the increase in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Danish: Gennemsnitlig var forbedringen i FEV1 hos patienter, som fik Oslif Breezhaler, mellem 150 og 190 ml, mens ændringen i FEV1 hos patienter, som fik placebo, varierede fra et fald på 10 ml til en forøgelse på 20 ml.
English: Overall, the effects of the 150 and 300 microgram doses of Oslif Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Danish: Som helhed var virkningerne af 150- og 300-mikrogramsdoserne af Oslif Breezhaler ens, men resultaterne viste, at 300-mikrogramsdosen kan give en bedre lindring hos patienter med en svær grad af sygdommen.
English: The most common side effects with Oslif Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Danish: De hyppigste bivirkninger ved Oslif Breezhaler (som optræder hos mere end 1 ud af 10 patienter) er nasopharyngitis (betændelse i næse og svælg) og infektion i de øvre luftveje (infektion i næse og svælg).
English: In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Danish: I tre hovedundersøgelser, som omfattede over 4 000 patienter med KOL, blev Oslif Breezhaler sammenlignet med placebo (ikke-aktivt stof), tiotropium eller formoterol (andre inhalerede lægemidler, som anvendes til behandling af KOL).
English: When Oslif Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them.
Danish: Når Oslif Breezhaler inhaleres, når indacaterol frem til receptorerne i luftvejene og aktiverer dem.
English: Oslif Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Danish: Oslif Breezhaler er et lægemiddel, der anvendes til at holde luftvejene fri hos voksne med kronisk obstruktiv lungesygdom (KOL).
English: The active substance in Oslif Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Danish: Det aktive stof i Oslif Breezhaler, indacaterol, er en beta2-adrenerg receptoragonist.
English: For more information about treatment with Oslif Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Oslif Breezhaler, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Oslif Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Oslif Breezhaler?
English: The Agency also noted that there were no major safety concerns with Oslif Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Danish: CHMP bemærkede desuden, at der ikke var større sikkerhedsmæssige problemer med Oslif Breezhaler, idet bivirkningerne kan behandles og svarer til bivirkningerne af andre lægemidler med beta2-adrenerge receptoragonister.
English: Other information about Oslif Breezhaler
Danish: Andre oplysninger om Oslif Breezhaler
English: Oslif Breezhaler capsules, which contain a powder for inhalation, are only used with a Oslif Breezhaler inhaler and must not be swallowed.
Danish: Oslif Breezhaler-kapsler indeholder et pulver, der skal inhaleres, og må kun anvendes med en Oslif Breezhaler-inhalator.
English: Oslif Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Danish: Oslif Breezhaler var mere effektivt end placebo til at forbedre lungefunktionen hos patienter med KOL.
English: For the full list of all side effects and restrictions with Oslif Breezhaler, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Oslif Breezhaler fremgår af indlægssedlen.
English: What is Oslif Breezhaler and what is it used for?
Danish: Hvad er Oslif Breezhaler, og hvad anvendes det til?
English: Why is Oslif Breezhaler approved?
Danish: Hvorfor blev Oslif Breezhaler godkendt?
English: It is not intended to provide practical advice on how to use Oslif Breezhaler.
Danish: Det er ikke en praktisk vejledning i, hvordan Oslif Breezhaler bør anvendes.
English: For practical information about using Oslif Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Oslif Breezhaler, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What are the risks associated with Oslif Breezhaler?
Danish: Hvilke risici er der forbundet med Oslif Breezhaler?
English: The European Medicines Agency concluded that Oslif Breezhaler was shown to be effective at improving the lung function in COPD.
Danish: CHMP konkluderede, at Oslif Breezhaler var påvist at være effektivt til at bedre lungefunktionen ved KOL.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oslif Breezhaler have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der anført anbefalinger og forholdsregler, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Oslif Breezhaler.
English: How is Oslif Breezhaler used?
Danish: Hvordan anvendes Oslif Breezhaler?
English: What benefits of Oslif Breezhaler have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Oslif Breezhaler?
English: How does Oslif Breezhaler work?
Danish: Hvordan virker Oslif Breezhaler?
English: The full European Public Assessment Report for Ceprotin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Ceprotin findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: What is Ceprotin?
Danish: Hvad er Ceprotin?
English: Detailed information on the approved use of Ceprotin in the European Union (EU) can be found here.
Danish: Detaljerede oplysninger om den godkendte anvendelse af Ceprotin i EU kan findes her.
English: Ceprotin contains the active substance human protein C. It has been authorised in the EU since July
Danish: Ceprotin indeholder det aktive stof humant protein C. Det har været godkendt i EU siden juli 2001.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Danish: Da CHMP var i færd med at vurdere den dokumentation, som virksomheden havde fremlagt, havde det endnu ikke afgivet en udtalelse.
English: ‘Acquired' means that the disease is not inherited but develops during the patient's life and may occur for different reasons such as severe infection, liver disease or vitamin K deficiency.
Danish: Med “erhvervet” menes, at sygdommen ikke er arvelig, men opstår i patientens levetid og kan have forskellige årsager såsom svær infektion, leversygdom eller vitamin K-mangel
English: There are no consequences on the use of Ceprotin in its authorised indication.
Danish: Der er ingen konsekvenser ved brug af Ceprotin til den godkendte anvendelse.
English: The application was withdrawn while CHMP was still evaluating the initial documentation provided by the company.
Danish: Ansøgningen blev trukket tilbage, mens CHMP stadig var i gang med at vurdere den dokumentation, som virksomheden oprindelig havde fremlagt.
English: What was Ceprotin expected to be used for?
Danish: Hvad forventedes Ceprotin anvendt til?
English: The applicant presented data from 2 main studies involving a total of 52 children with protein C deficiency due to severe infection, where Ceprotin was compared with placebo (a dummy treatment).
Danish: Ansøgeren forelagde data fra to hovedundersøgelser med i alt 52 børn med protein C-mangel som følge af svær infektion, hvor Ceprotin blev sammenlignet med virkningsløs behandling (placebo).
English: On 22 October 2014, Baxter AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Ceprotin to treat acquired protein C deficiency.
Danish: Den 22. oktober 2014 meddelte Baxter AG officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om en ny anvendelse af Ceprotin til behandling af erhvervet protein C-mangel.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it withdrew the application because in its preliminary assessment the CHMP was requesting additional clinical data to support the claim that Ceprotin is also effective in patients with acquired protein C deficiency.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen oplyste virksomheden, at den trak ansøgningen tilbage, fordi CHMP i sin indledende vurdering anmodede om supplerende kliniske oplysninger til dokumentation af, at Ceprotin også er effektivt ved erhvervet protein C-mangel.
English: Results from a retrospective study based on medical records of 94 children with congenital or acquired protein C deficiency were also provided.
Danish: Der blev desuden forelagt resultater af en tilbageskuende (retrospektiv) undersøgelse af journalerne for 94 børn med medfødt eller erhvervet protein C-mangel.
English: How is Ceprotin expected to work?
Danish: Hvordan forventes Ceprotin at virke?
English: Protein C slows down the production of thrombin, and therefore slows down clotting.
Danish: Protein C nedsætter produktionen af trombin og hæmmer derfor blodets størkning.
English: Ceprotin contains human protein C, extracted and purified from human plasma (the liquid part of the blood).
Danish: Ceprotin indeholder ekstraheret, renset humant protein C fra menneskeligt plasma (blodets væskeformige del).
English: Ceprotin was also expected to be used in patients with ‘acquired' protein C deficiency.
Danish: Ceprotin forventedes også anvendt hos patienter med “erhvervet” protein C-mangel.
English: In the body, protein C controls the generation of thrombin, one of the proteins involved in blood clotting.
Danish: I kroppen kontrollerer protein C dannelsen af trombin, som er et af de proteiner, der medvirker ved blodets størkning.
English: An injection of Ceprotin produces an immediate but temporary increase in levels of protein C, controlling clotting problems in protein C-deficient patients.
Danish: En injektion at Ceprotin medfører en hurtig, men midlertidig stigning i indholdet af protein C. Dette giver kontrol over problemerne med blodets størkning hos patienter med protein Cmangel.
English: What is happening with Ceprotin for the treatment of patients with severe congenital protein C deficiency?
Danish: Hvad sker der med brugen af Ceprotin til behandling af patienter med svær medfødt protein C-mangel?
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes.
Danish: Virksomheden har til CHMP oplyst, at der ikke er nogen konsekvenser for patienter, som deltager i kliniske undersøgelser med Ceprotin eller i programmer for anvendelse af Ceprotin med særlig udleveringstilladelse.
English: Ceprotin is a medicine that is used to treat patients with severe congenital (hereditary) protein C deficiency and for the short-term prevention of blood clotting in patients with severe congenital protein C deficiency.
Danish: Ceprotin er lægemiddel, der anvendes til at behandle svær arvelig protein C-mangel og til kortvarig forebyggelse af blodpropper ved svær arvelig protein C-mangel.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Ceprotin eller i programmer for anvendelse af Ceprotin med særlig udleveringstilladelse?
English: 1 pre-filled pen pens (multipack)
Danish: 6 (3 x 2) fyldte penne (multipakning)
English: Pack size syringes (multipack)
Danish: 6 (3 x 2) fyldte injektionssprøjter (multipakning)
English: (Invented) name Strength Pharmaceutical form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage <Indhold (Koncentration)>
English: Invented name Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package size
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: 100 mg/4 ml (25 mg/ml)
Danish: Emballage Indhold (Koncentration) Paknings størrelse
English: Bear in mind that you could endanger yourself or others.
Danish: Husk, at De kan bringe Dem selv og andre i fare.
English: Please ask your doctor whether you can drive a car if you:
Danish: Spørg venligst Deres læge om De kan køre bil, hvis De:
English: Do not take this medicine if you are under 18 years of age.
Danish: Tag ikke dette lægemiddel hvis De er under 18 år.
English: If this happens, medical assistance is needed immediately.
Danish: Hvis dette sker, har De brug for øjeblikkelig lægehjælp.
English: The expiry date refers to the last date of that month.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
English: Your diabetes may get worse.
Danish: Deres diabetes kan muligvis forværres.
English: • If you have an infection or a fever
Danish: • Hvis De har en infektion eller feber
English: If any change of your treatment is necessary contact your doctor first.
Danish: Hvis ændring i Deres behandling er nødvendig, skal De først kontakte Deres læge.