FrancophonIA/ELRC3.0 huggingface dataset:
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækning af ansøgningen, kan ses under fanen "All documents".
English: • metastatic cancer of the ovary (when the cancer has spread to other parts of the body) after at least one other treatment has failed;
Danish: • metastatisk kræft i æggestokkene (når kræften har spredt sig til andre dele af kroppen), efter at mindst én anden behandling er slået fejl
English: This means that the CHMP was still evaluating the initial documentation provided by the company.
Danish: Det betyder, at CHMP stadig var i gang med at evaluere den oprindelige dokumentation, som virksomheden havde fremlagt.
English: It was also to be used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer had come back after radiotherapy, or when the disease was at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Danish: Det skulle ligeledes anvendes sammen med cisplatin (et andet lægemiddel mod kræft) til behandling af kvinder med livmoderhalskræft, når kræften var vendt tilbage efter strålebehandling, eller når sygdommen var på et fremskredent stadium (stadium IVB: kræften har spredt sig ud over livmoderhalsen).
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Danish: Da CHMP evaluerede den oprindelige dokumentation, som virksomheden havde fremlagt, havde CHMP endnu ikke givet nogen anbefalinger.
English: Topotecan SUN was developed as a ‘generic medicine'.
Danish: Topotecan SUN blev udviklet som et "generisk lægemiddel".
English: It contains the active substance topotecan.
Danish: Det indeholder det aktive stof topotecan.
English: Topotecan SUN was to be used on its own to treat patients with:
Danish: Topotecan SUN forventedes anvendt til behandling af patienter med:
English: No additional studies were needed as Topotecan SUN is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Danish: Der var ikke behov for yderligere undersøgelser, eftersom Topotecan SUN er et generisk lægemiddel, der gives som infusion og indeholder det samme aktive stof som referencelægemidlet Hycamtin.
English: What is Topotecan SUN?
Danish: Hvad er Topotecan SUN?
English: Topotecan SUN also affects non-cancer cells, which causes side effects.
Danish: Topotecan SUN påvirker også andre celler end kræftceller, hvilket giver bivirkninger.
English: This means that Topotecan SUN was intended to be similar to a ‘reference medicine' already authorised in the European Union called Hycamtin.
Danish: Det betyder, at Topotecan SUN skulle være identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Hycamtin.
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Danish: Det blokerer et enzym, der kaldes topoisomerase I, og som har betydning for delingen af DNA.
English: The active substance in Topotecan SUN, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Danish: Det aktive stof i Topotecan SUN, topotecan, er et lægemiddel mod kræft, der tilhører gruppen af "topoisomerase-hæmmere".
English: • small cell lung cancer, when the cancer has relapsed (come back).
Danish: • småcellet lungekræft, når kræften er vendt tilbage.
English: On 3 January 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Topotecan SUN for the treatment metastatic cancer of the ovary, small cell lung cancer and cervical cancer.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Topotecan SUN til behandling af metastatisk kræft i æggestokkene, småcellet lungekræft og livmoderhalskræft.
English: What was Topotecan SUN expected to be used for?
Danish: Hvad forventedes Topotecan SUN anvendt til?
English: How is Topotecan SUN expected to work?
Danish: Hvordan forventes Topotecan SUN at virke?
English: Topotecan SUN is a powder to be made up into a solution for infusion (drip into a vein).
Danish: Topotecan SUN er et pulver til infusionsvæske, opløsning (drop i en vene).
English: There are no specific risks for the user.
Danish: Der er ingen specifikke risici for brugeren.
English: This summary was last updated on 27 January 2011.
Danish: Dette sammendrag blev sidst ajourført i 27/01/2011.
English: Afterward a single ‘booster' can be given every six months to maintain the vaccine's effect.
Danish: Efterfølgende kan der gives en enkelt ”booster” hvert halve år for at opretholde vaccinens virkning.
English: Milk can be taken immediately.
Danish: Der kan malkes med det samme.
English: This slight swelling lasts for less than a day in most cases.
Danish: Denne lette hævelse varer i de fleste tilfælde mindre end en dag.
English: The rise in temperature is temporary and spontaneously resolved within two days without treatment.
Danish: Temperaturstigningen er forbigående og forsvinder spontant inden for to dage uden behandling.
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Danish: Hvor lang tid skal der gå, før dyret kan slagtes og kødet kan anvendes til menneskeligt konsum (tilbageholdelsestid)?
English: The virus is alive, but it has also been attenuated (weakened) to further lower its ability to cause infection.
Danish: Virussen er levende, men er også blevet svækket for yderligere at mindske dens evne til at fremkalde infektion.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod en sygdom.
English: This will help to protect against the disease.
Danish: Derved er dyrene bedre beskyttet mod sygdommen.
English: What is the time to allow before milk can be taken from the animal for human consumption?
Danish: Hvor lang tid skal der gå, før mælken fra dyret kan anvendes til menneskeligt konsum?
English: The efficacy of the vaccine was studied in three laboratory studies including one study looking at the duration of immunity.
Danish: Vaccinens virkning blev undersøgt i tre laboratorieundersøgelser, hvoraf den ene så på immunitetens varighed.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Hiprabovis IBR Marker Live to Laboratorios Hipra S.A. on 27 January 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Hiprabovis IBR Marker Live til Laboratorios Hipra S.A. den 27/01/2011.
English: The first injection can be given to calves from three months of age.
Danish: Den første injektion kan gives til kalve, når de er tre måneder gamle.
English: The injections should be preferably administered on the alternate sides of the neck.
Danish: Injektionerne skal helst gives i hver sin side af nakken.
English: Studies also looked at the safety of the vaccine in pregnant animals.
Danish: Undersøgelserne så også på vaccinens sikkerhed hos drægtige dyr.
English: This vaccine is a marker vaccine and can enable a differential testing of vaccinated and naturally infected cattle, which is a useful tool in eradication campaigns.
Danish: Vaccinen er en markørvaccine, som gør det muligt at foretage amplitudeprøver af vaccineret og naturligt smittet kvæg, hvilket er et nyttigt værktøj i udryddelseskampagner.
English: Live vaccine against infectious bovine rhinotracheitis (IBR)
Danish: Levende vaccine mod infektiøs bovin rhinotracheitis (IBR)
English: This increase can sometimes be higher (up to 1.6º C in adult cows and up to 2.2º C in calves).
Danish: I de første fire dage efter vaccination kan dyrene opleve en let stigning i kropstemperaturen på op til 1° C. Denne stigning kan undertiden være højere (op til 1,6º C hos voksne køer og op til 2,2º C hos kalve).
English: In the future, if the animals are exposed to the IBR virus, the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for IBR-virus, vil immunsystemet hurtigere kunne danne antistoffer mod dem.
English: The safety of Hiprabovis IBR Marker Live was investigated in a number of laboratory studies and in one field trial that included dairy cows and fattening cattle.
Danish: Sikkerheden ved Hiprabovis IBR Marker Live blev undersøgt i en række laboratorieundersøgelser og i en feltundersøgelse, som omfattede malkekøer og fedekvæg.
English: It is a powder for suspension for injection that contains a modified live infectious bovine rhinotracheitis (IBR) virus (also known as Bovine Herpes Virus type 1).
Danish: Det er et pulver til injektionsvæske, opløsning, som indeholder en modificeret levende infektiøs bovin rhinotracheitis (IBR)-virus (også kaldet bovin herpesvirus type 1).
English: Animals can also show a temporary inflammation at the site of injection in the 72 hours after-vaccination.
Danish: Der kan også forekomme forbigående betændelse på injektionsstedet hos kvæg i op til 72 timer efter vaccination.
English: Hiprabovis IBR Marker Live is a vaccine that contains an IBR virus that has been genetically modified to delete two genes so that the virus is less ‘pathogenic' (less able to cause a disease).
Danish: Hiprabovis IBR Marker Live er en vaccine, der indeholder en IBR-virus, som er blevet genetisk modificeret for at fjerne to gener og dermed gøre den mindre ”patogen” (dvs. begrænse dens evne til at fremkalde sygdom).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Hiprabovis IBR Marker Live exceed the risks for the active immunisation of cattle from three months of age against Bovine Herpes Virus type 1 to reduce the clinical signs of infectious bovine IBR and field virus excretion and recommended that Hiprabovis IBR Marker Live be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Hiprabovis IBR Marker Live opvejer risiciene ved aktiv immunisering af kvæg fra tre måneder og opad mod bovin herpesvirus type 1 for at mindske de kliniske symptomer på infektiøs bovin rhinotracheitis og udskillelse af naturligt forekommende virus og anbefalede udstedelse af markedsføringstilladelse for Hiprabovis IBR Marker Live.
English: Hiprabovis IBR Marker Live is used to vaccinate cattle (cows and calves) against the respiratory infections caused by IBR.
Danish: Hiprabovis IBR Marker Live anvendes til vaccination af kvæg (køer og kalve) mod respiratoriske infektioner forårsaget af IBR.
English: The vaccine is given to animals as two injections, three weeks apart, into the neck muscles.
Danish: Vaccinen gives som to injektioner med tre ugers mellemrum i nakkemusklerne.
English: The studies also showed that the vaccine can be used in pregnant cattle as well in the presence of maternally derived antibodies.
Danish: Undersøgelserne viste desuden, at vaccinen også kan anvendes til drægtige køer, når der er antistoffer erhvervet fra moderen tilstede.
English: The studies showed that the vaccine is safe for cattle from three months of age and that it reduces the clinical signs of IBR and field virus excretion.
Danish: Undersøgelserne viste, at vaccinen er sikker for kvæg fra tre måneder og opad, og at den mindsker de kliniske symptomer på IBR og udskillelsen af naturligt forekommende virus.
English: Hiprabovis IBR Marker Live is a vaccine.
Danish: Hiprabovis IBR Marker Live er en vaccine.
English: Other information about Hiprabovis IBR Marker Live:
Danish: Andre oplysninger om Hiprabovis IBR Marker Live:
English: The vaccine is used to reduce the clinical signs of IBR and the excretion (shedding) of the virus by the infected animals.
Danish: Vaccinen anvendes til at mindske de kliniske symptomer på IBR og virusudskillelse hos de smittede dyr.
English: When Hiprabovis IBR Marker Live is given to cattle, the animals' immune systems recognise the viruses as ‘foreign' and make defences against it.
Danish: Når kvæg vaccineres med Hiprabovis IBR Marker Live, opfatter deres immunsystem viraene som "fremmede" og producerer antistoffer mod dem.
English: A field study also looked at the efficacy of Hiprabovis IBR Marker Live, compared with a dummy vaccine, on reducing the clinical signs of the disease and virus excretion.
Danish: I en feltundersøgelse blev Hiprabovis IBR Marker Live desuden sammenlignet med en virkningsløs vaccine med hensyn til dets evne til at mindske de kliniske symptomer på sygdommen og virusudskillelse.
English: What is the risk associated with Hiprabovis IBR Marker Live?
Danish: Hvilken risiko er der forbundet med Hiprabovis IBR Marker Live?
English: Why has Hiprabovis IBR Marker Live been approved?
Danish: Hvorfor blev Hiprabovis IBR Marker Live godkendt?
English: How has Hiprabovis IBR Marker Live been studied?
Danish: Hvordan er Hiprabovis IBR Marker Live blevet undersøgt?
English: What is Hiprabovis IBR Marker Live?
Danish: Hvad er Hiprabovis IBR Marker Live?
English: What is Hiprabovis IBR Marker Live used for?
Danish: Hvad anvendes Hiprabovis IBR Marker Live til?
English: How does Hiprabovis IBR Marker Live work?
Danish: Hvordan virker Hiprabovis IBR Marker Live?
English: What benefit has Hiprabovis IBR Marker Live shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Hiprabovis IBR Marker Live?
English: The European Commission issued a decision on 14 July 2009.
Danish: Europa-Kommissionen traf en afgørelse den 14. juli 2009.
English: Ref. EMEA/CHMP/499991/2009 EMEA/H/A-29/1061
Danish: ref. EMEA/495500/2009 EMEA/H/A-29/1061
English: London, 16 July 2009 Doc.
Danish: London, den 16. juli 2009 Dok.
English: The company wanted the authorisation to be recognised in Latvia, Lithuania, Poland, Slovakia and Slovenia (the ‘concerned Member States').
Danish: Virksomheden ønskede, at markedsføringstilladelsen blev anerkendt i Letland, Litauen, Polen, Slovakiet og Slovenien (de berørte medlemsstater).
English: The review was carried out under an ‘Article 29' referral1.
Danish: Undersøgelsen blev gennemført i henhold til en ‘artikel 29'-indbringelse1.
English: The marketing authorisation in the Czech Republic should also be suspended.
Danish: Markedsføringstilladelsen i Den Tjekkiske Republik skal også suspenderes.
English: It can also be used in systemic infections (infections that affect the whole body), including tropical infections.
Danish: Det kan også anvendes ved behandling af systemiske infektioner (infektioner, som påvirker hele kroppen), herunder tropiske infektioner.
English: It can be used in local infections, such as infections of the vulva or vagina (female sexual organs) or infections of the skin or the eye.
Danish: Det kan anvendes til behandling af lokale infektioner som for eksempel infektioner i vulva eller vagina (de kvindelige kønsorganer) eller til hud- og øjeninfektioner.
English: However, because the concerned Member States were not able to reach an agreement, the Czech medicines regulatory agency referred the matter to the CHMP for arbitration on 31 July 2008.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den tjekkiske lægemiddelmyndighed henviste sagen til CHMP til voldgift den 31. juli 2008.
English: It is used to treat adults with infections caused by fungi.
Danish: Det anvendes til behandling af voksne med infektioner, som er forårsaget af svampe.
English: Questions and answers on the referral for Prokanazol capsules containing itraconazole 100 mg
Danish: Spørgsmål og svar vedrørende indbringelsen af sagen om Prokanazol kapsler, som indeholder itraconazol 100 mg
English: Prokanazol is also marketed under the name Prokanaz.
Danish: Prokanazol er også markedsført under navnet Prokanaz.
English: Prokanazol can be used against a range of fungi and yeasts, including Candida, Aspergillus and Cryptococcus.
Danish: Prokanazol kan anvendes til behandling af en række svampe og gærsvampe, herunder Candida, Aspergillus og Cryptococcus.
English: What is Prokanazol?
Danish: Hvad er Prokanazol?
English: Why was Prokanazol reviewed?
Danish: Hvorfor blev Prokanazol undersøgt?
English: The company PRO.MED.CS Praha a. s. submitted Prokanazol for mutual recognition on the basis of the initial authorisation granted by the Czech Republic on 30 July 2003.
Danish: Virksomheden PRO.MED.CS Praha a. s. indgav en ansøgning om gensidig anerkendelse af Prokanazol på grundlag af en oprindelig markedsføringstilladelse udstedt af Den Tjekkiske Republik den 30. juli 2003.
English: Prokanazol is a generic medicine that is based on a reference medicine authorised in the Czech Republic (Sporanox 100 mg capsules).
Danish: Prokanazol er et ‘generisk lægemiddel', som er baseret på et referencelægemiddel, som er godkendt i Den Tjekkiske Republik (Sporanox 100 mg kapsler).
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence to the reference medicinal product has not been shown.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og den faglige drøftelse i udvalget var CHMP af den opfattelse, at der ikke var påvist bioækvivalens mellem det generiske produkt og referencelægemidlet.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Prokanazol.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure som følge af uenighed blandt medlemsstater i Den Europæiske Union om godkendelsen af lægemidlet Prokanazol.
English: The grounds for the referral were that one of the concerned Member States, Poland, did not agree that enough evidence had been presented to show that Prokanazol was ‘bioequivalent' to the reference medicine.
Danish: Begrundelserne for indbringelsen af sagen var, at Polen, en af de berørte medlemsstater, ikke var enig i, at det var blevet tilstrækkeligt påvist, at, Prokanazol var bioækvivalent med referencelægemidlet.
English: Without ergosterol, the fungus is killed or prevented from spreading.
Danish: Svampen dør eller forhindres i at sprede sig uden ergosterol.
English: The active substance in Prokanazol, itraconazole, is an antifungal substance that belongs to the group ‘triazoles'.
Danish: Det aktive stof i Prokanazol, itraconazol, er et svampemiddel i triazolgruppen.
English: In addition, the Committee has also recommended that the marketing authorisation for Prokanazol in the Czech Republic should be suspended.
Danish: anbefalede udvalget, at markedsføringstilladelsen for Prokanazol i Den Tjekkiske Republik også blev suspenderet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Prokanazol do not outweigh its risks, and that the marketing authorisation granted in the Czech Republic cannot be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Prokanazol ikke opvejer risiciene, og at markedsføringstilladelsen, som er udstedt i Den Tjekkiske Republik, ikke kan anerkendes i andre medlemsstater af Den Europæiske Union.
English: The CHMP therefore concluded that the benefits of Prokanazol do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Prokanazol ikke opvejer risiciene, og at der derfor ikke bør udstedes markedsføringstilladelse i de berørte medlemsstater.
English: Prokanazol is an antifungal medicine.
Danish: Prokanazol er et svampemiddel.
English: Company responses provided on: 15 December 2008 Opinion date:
Danish: Svar afgivet af virksomheden:
English: Co-rapporteur:
Danish: Dato for udtalelsen:
English: Fiasp received a marketing authorisation valid throughout the EU on 9 January 2017.
Danish: Fiasp fik en markedsføringstilladelse med gyldighed i hele EU den 9. januar 2017.
English: Further information on Fiasp can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/fiasp.
Danish: Yderligere information om Fiasp findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/fiasp.
English: However, it is unclear whether this changes the risk of diabetic complications.
Danish: Det er imidlertid uklart, om dette medfører risiko for diabeteskomplikationer.
English: Other information about Fiasp
Danish: Andre oplysninger om Fiasp
English: (There was no direct comparison between Fiasp and another mealtime insulin in this study.)
Danish: (Der var ingen direkte sammenligning mellem Fiasp og et andet måltidsinsulin i dette studie.)
English: As for all medicines, data on the use of Fiasp are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Fiasp løbende overvåget.
English: Diabetes is a disease in which blood glucose is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Danish: Diabetes er en sygdom, hvor blodsukkerniveauet er forhøjet, enten fordi kroppen ikke kan producere insulin (type 1-diabetes), eller fordi kroppen ikke producerer nok insulin eller ikke kan anvende insulinet effektivt (type 2-diabetes).
English: It is usually injected under the skin of the belly or upper arm immediately before a meal, although it may be given up to 20 minutes after starting a meal if necessary.
Danish: Den indgives normalt under huden på maven eller overarmene umiddelbart før et måltid, men kan om nødvendigt indgives op til 20 minutter inde i et måltid.
English: Although Fiasp was not studied in children below 2 years of age, it is also expected to have a beneficial effect in younger children.
Danish: Fiasp ikke blev undersøgt hos børn under to år, men det forventes også at have en gavnlig virkning hos mindre børn.
English: The slightly higher risk of hypoglycaemia at night in children treated with Fiasp is addressed in the product information and is considered manageable.
Danish: Den lidt højere risiko for hypoglykæmi om natten hos børn behandlet med Fiasp behandles i produktinformationen og anses for at være håndterbar.
English: Fiasp is a medicine that is used to treat children from one year of age and adults with diabetes.
Danish: Fiasp er et lægemiddel, der anvendes til behandling af børn fra et år og opad og voksne med diabetes.
English: This controls the level of blood glucose and reduces the symptoms and complications of diabetes.
Danish: Dette regulerer blodsukkeret og nedsætter de symptomer og komplikationer, der er forbundet med diabetes.
English: What measures are being taken to ensure the safe and effective use of Fiasp?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fiasp?
English: In two studies Fiasp was at least as effective as another insulin, NovoRapid.
Danish: Det er i to studier påvist, at Fiasp er mindst lige så effektivt som et andet insulin, NovoRapid.
English: The European Medicines Agency therefore decided that Fiasp's benefits outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Fiasp opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Fiasp are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Fiasp vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The benefits of Fiasp were also shown in children.
Danish: Fordelene ved Fiasp blev også konstateret hos børn.