FrancophonIA/ELRC3.0 huggingface dataset:
English: Belgium RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium
Danish: RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium
English: Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark
Danish: Danmark Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
Danish: D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef
Danish: Tyskland biomo pharma GmbH Josef-Dietzgen-Str. 3
English: Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Danish: Danmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
English: Netherlands Katwijk Farma B.V. Postbus 408
Danish: Katwijk Farma B.V.
English: FLUOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: FLUOXETIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsføringstilladelsen
English: Belgium MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
Danish: MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
Danish: KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
English: Oral suspension
Danish: Oral opløsning
English: ESCITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: ESCITALOPRAM indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedføringstilladelsen
English: Coated tablets
Danish: Overtrukket tablets
English: ATOMOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: ATOMOXETIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlemsland Indehaver af markedføringstilladelsen
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
Danish: KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten
Danish: D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten
English: FLUVOXAMINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: FLUVOXAMIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsføringstilladelsen
English: 1050 Bruxelles, Belgium
Danish: B-1080 Bruxelles
English: Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre, Denmark
Danish: Danmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre, Denmark
English: Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK
Danish: Storbritannien Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK
English: Denmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
Danish: Danmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
English: Alfred E Tiefenbacher (GmbH & Co. KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
Danish: KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
English: Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Danish: H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
English: Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
Danish: Storbritannien Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
English: H. LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK
Danish: Grœkenland H. LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten
Danish: D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten
English: Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
Danish: Storbritannien Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
English: Member State Marketing Authorisation Holder Invented Name
Danish: Medlemsland Indehaver af markedsføringstilladelsen
English: Denmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
Danish: Danmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
English: Denmark Actavis Nordic A/S, Hammervej 7, DK- 2970 Hørsholm, Denmark
Danish: Danmark Actavis Nordic A/S, Hammervej 7, DK- 2970 Hørsholm, Denmark
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 Overijse
Danish: Brusselsesteenweg 288 3090 Overijse
English: DOBUPAL RETARD 75 mg hard Capsules
Danish: DOBUPAL RETARD 75 mg
English: SANDOZ AUSTRIA Biochemiestrasse 10, A-6250 Kundl, Austria
Danish: Grœkenland SANDOZ AUSTRIA Biochemiestrasse 10, A-6250 Kundl, Austria
English: Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
Danish: Storbritannien Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
English: Lithuania Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Danish: Slovenien Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
English: Cipralex 5mg-Filmtabletten
Danish: Cipralex 5mg-Filmtabletten 5mg
English: Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK
Danish: Storbritannien Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK
English: Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
Danish: D-51377 Leverkusen
English: Denmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
Danish: Danmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
English: Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
Danish: Storbritannien Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
English: Belgium EUROGENERICS N.V. Heizel Esplanade B 22 1020 Brussel
Danish: Heizel Esplanade B 22 1020 Brussel
English: Belgium AKTUAPHARMA N.V. Ambachtenlaan 13, 3001 Heverlee, Belgium
Danish: Ambachtenlaan 13, 3001 Heverlee, Belgium
English: Denmark Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Danish: Danmark Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
English: Belgium TEVA PHARMA BELGIUM N.V. Laarstraat 16, 2610 WILRIJK, Belgium
Danish: Laarstraat 16, 2610 WILRIJK, Belgium
English: Orodispersible tablets
Danish: Opløselig tablet
English: SANDOZ AUSTRIA, Biochemiestrasse 10, A-6250 Kundl, Austria
Danish: Grœkenland SANDOZ AUSTRIA, Biochemiestrasse 10, A-6250 Kundl, Austria
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 OVERIJSE, Belgium
Danish: Brusselsesteenweg 288 3090 OVERIJSE, Belgium
English: ALFRED E. TIEFENBACHER (GMBH & CO. KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany
Danish: KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany
English: Netherlands Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
Danish: Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
English: Luxembourg EUROGENERICS N.V. Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium
Danish: Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium
English: Prolonged release capsule Oral use
Danish: Koncentrat til oral opløsning Intravenøs anvendelse
English: Modified Release Capsule, hard
Danish: Kapsel med modificeret udløsning
English: Limassol, Cyprus
Danish: Ljubljana, Slovenia
English: Netherlands GlaxoSmithKline B.V. Postbus 780
Danish: GlaxoSmithKline B.V.
English: SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: SERTRALIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union
English: Concentrate for Solution for Infusion
Danish: Koncentrat til infusionsvœske, opløsning
English: Cipramil 40 mg/ml, drops oral drops, solution Oral use
Danish: Cipramil 40 mg/ml, drops
English: Alfred E. Tiefenbacher GmbH & Co. KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany
Danish: KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany
English: Meat and offal: cattle: 22 days.
Danish: 1 hætteglas Slagtning: kvæg: 22 dage
English: Subcutaneous use Vial (glass) 500 ml
Danish: Subkutan anvendelse Hætteglas 500 ml
English: This summary was last updated on 14/03/2011.
Danish: Dette sammendrag blev sidst ajourført den 14/03/2011.
English: It is widespread in countries bordering the Mediterranean Sea.
Danish: Den er udbredt i landene omkring Middelhavet.
English: These reactions resolve spontaneously within two days to two weeks.
Danish: Disse reaktioner forsvinder spontant inden for en periode på fra to dage til to uger.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for CaniLeish til Virbac S.A. den 14/03/2011.
English: Afterward a single ‘booster' should be given every year to maintain the vaccine's effect.
Danish: Efterfølgende bør der gives en enkelt ‘booster' hvert år, for at vaccinen kan bevare sin effekt.
English: CaniLeish is a vaccine.
Danish: CaniLeish er en vaccine.
English: Allergic-type reactions are uncommon and if a dog shows signs of an allergic reaction, they should be given appropriate symptomatic treatment.
Danish: Allergiagtige reaktioner er usædvanlige, og hvis en hund viser tegn på en allergisk reaktion, bør den gives en behørig symptomatisk behandling.
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 sig mod en sygdom.
English: Other information about CaniLeish:
Danish: Andre oplysninger om CaniLeish:
English: The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended.
Danish: Vaccinens effekt på hunde, der allerede var inficerede, blev ikke blevet undersøgt og kan derfor ikke anbefales.
English: The risk of vaccine-induced infection can be excluded since the vaccine does not contain parasites.
Danish: Risikoen for vaccinefremkaldt infektion kan udelukkes, da vaccinen ikke indeholder parasitter.
English: The first injection can be given from six months of age, the second injection is given three weeks later and the third three weeks from the second one.
Danish: Den første injektion kan gives fra seksmånedersalderen, den anden injektion gives tre uger senere, og den tredje gives tre uger efter den anden vaccination.
English: The vaccine was generally well tolerated as shown by the absence of major adverse reactions.
Danish: Vaccinen tåltes generelt godt som påvist ved fraværet af større bivirkninger.
English: Infected dogs play a central role in the accidental transmission of parasites to humans.
Danish: Inficerede hunde spiller en central rolle i den utilsigtede overførsel af parasitter til mennesker.
English: In case of accidental self-injection, the advice of a doctor should be sought immediately.
Danish: I tilfælde af utilsigtet selvinjektion, skal der omgående søges lægehjælp.
English: The number of dogs developing an active infection and a symptomatic disease was significantly reduced in the vaccinated group.
Danish: Antallet af hunde, som udviklede en aktiv infektion og en symptomatisk sygdom var væsentligt lavere i den vaccinerede gruppe.
English: Dogs that have been infected may show no signs of infection, but some do (fever, hair and weight loss, skin sores) and in the latter case the outcome of active infection can be fatal.
Danish: Hunde, som er blevet inficeret, udviser muligvis ikke nogen tegn på infektion, men nogle gør (feber, hår- og vægttab), hudsår), og i sidstnævnte tilfælde kan udfaldet af den aktive infektion være fatal.
English: The parasite is transmitted from an infected dog to a non-infected dog by the bites of sand flies.
Danish: Parasitten overføres fra en inficeret hund til en ikke-inficeret hund via sandfluebid.
English: When CaniLeish is given to dogs the immune system recognises the proteins as ‘foreign' and make defences against it.
Danish: Når CaniLeish gives til hunde, genkender immunsystemet proteinerne som ‘fremmede' og producerer antistoffer mod dem.
English: A number of laboratory trials where dogs were submitted to experimental infection were also presented.
Danish: Der blev også fremlagt resultaterne af en række laboratorieundersøgelser, hvor hunde blev udsat for eksperimentel infektion.
English: CaniLeish contains an ‘adjuvant' (a highly purified fraction of Quillaja saponaria) to enhance the immune response.
Danish: CaniLeish indeholder en ‘adjuvans' (en højkoncentreret del af Quillaja saponaria), som styrker immunresponsen.
English: Leishmania infantum is a parasite that causes leishmaniosis.
Danish: Leishmania infantum er en parasit, som forårsager leishmaniose.
English: It contains Leishmania infantum excreted secreted proteins (ESP).
Danish: Den indeholder Leishmania infantum udskilte sekreterede proteiner (ESP).
English: CaniLeish is to be used only in ‘leishmania-negative' dogs.
Danish: CaniLeish anvendes udelukkende til ‘leishmania-negative' hunde.
English: The vaccine is given to dogs as three injections, three weeks apart, under the skin.
Danish: Vaccinen gives til hunde som tre injektioner under huden med tre ugers mellemrum.
English: Other temporary signs commonly seen following vaccination can also occur such as hyperthermia (raised body temperature), apathy (lack of vitality) and digestive disorders lasting one to six days.
Danish: Der kan også forekomme andre midlertidige tegn, som hyppigt ses efter vaccination, såsom hypertermi (øget kropstemperatur), apati (sløvhed) og fordøjelsesmæssige forstyrrelser, der varer i en til seks dage.
English: The studies showed that the vaccine is safe for both leishmania-negative and leishmania-infected dogs.
Danish: Undersøgelserne viste, at vaccinen er sikker til såvel leishmania-negative og leishmania-inficerede hunde.
English: It is available as a powder and solvent that is made up into suspension for injection.
Danish: Den fås som et pulver og en solvens, der blandes til en injektionsvæske, opløsning.
English: Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum.
Danish: Dyrlægerne bør vurdere benefit/risk-forholdet inden vaccinering af hunde i områder med lille eller ingen forekomst af Leishmania infantum.
English: The safety of the vaccine was studied in two main laboratory safety studies carried out in leishmania-free dogs (overdose and single and repeated administration) and one field trial.
Danish: Vaccinens sikkerhed blev undersøgt i to primære laboratoriesikkerhedsundersøgelser udført hos leishmania-frie hunde (overdosering og en enkelt og gentagne indgivelser) og i en feltundersøgelse.
English: CaniLeish is a vaccine that contains a number of proteins that are released from the Leishmania infantum parasite during its growth.
Danish: CaniLeish er en vaccine, som indeholder en række proteiner, der frigives fra Leishmania infantumparasitten under dennes vækst.
English: In the future, if the animals are exposed to Leishmania infantum parasite, the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for Leishmania infantum parasitter, vil immunsystemet hurtigere kunne danne antistoffer mod dem.
English: What is the risk associated with CaniLeish?
Danish: Hvilken risiko er der forbundet med CaniLeish?
English: The efficacy of the vaccine was studied in one main field trial that lasted for two years involving vaccinated and control dogs submitted to natural exposure to infection in zones where there is a high risk of infection.
Danish: Vaccinens virkning blev undersøgt i en hovedfeltundersøgelse, som varede i to år, og som omfattede både vaccinerede og kontrollerede hunde, der blev udsat for naturlig eksponering over for infektionen i områder, hvor der er høj infektionsrisiko.
English: After injection, some dogs can have moderate and temporary local reactions, such as swelling, nodule (hardening), pain on palpation or erythema (reddening).
Danish: Efter injektion kan nogle hunde havde moderate og forbigående lokale reaktioner såsom hævelse, knudedannelse, smerter ved berøring eller erytem (rødfarvning af huden).
English: Canine vaccine against Leishmania infantum adjuvanted
Danish: Hundevaccine mod Leishmania infantum adjuveret
English: Why has CaniLeish been approved?
Danish: Hvorfor blev CaniLeish godkendt?
English: What is CaniLeish?
Danish: Hvad er CaniLeish?
English: The CVMP concluded that the benefits of CaniLeish outweigh the risks for the active immunisation of leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum and recommended that CaniLeish be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved CaniLeish opvejer risiciene ved aktiv immunisering af leishmanianegative hunde fra seksmånedersalderen med henblik på at nedsætte risikoen for at udvikle aktiv infektion og klinisk sygdom efter kontakt med Leishmania infant, og anbefalede udstedelse af markedsføringstilladelse for CaniLeish.
English: The detection of Leishmania infection using a rapid diagnostic test is recommended before vaccination.
Danish: Det anbefales at udføre en test for tilstedeværelse af Leishmania-infektion før vaccination ved hjælp af en hurtig diagnostisk test.
English: CaniLeish is used to vaccinate dogs from six months of age to reduce the risk of developing an active infection and clinical disease after contact with Leishmania infantum.
Danish: CaniLeish anvendes til vaccinering af hunde fra seksmånedersalderen for at nedsætte risikoen for udvikling af aktiv infektion og klinisk sygdom efter kontakt med Leishmania infantum.
English: What is CaniLeish used for?
Danish: Hvad anvendes CaniLeish til?
English: The benefit of the vaccination was assessed in zones with a high risk of infection where it has been shown in leishmania free dogs to decrease the risk of developing an active infection and a symptomatic disease after contact with the parasite.
Danish: Effekten af vaccinen blev vurderet i områder med høj risiko for infektion, hvor det hos leishmania-frie hunde viste sig at mindske risikoen for at udvikle aktiv infektion og symptomatisk sygdom efter kontakt med parasitten.
English: How has CaniLeish been studied?
Danish: Hvordan blev CaniLeish undersøgt?
English: After vaccination transient antibodies against leishmania detected by immunofluorescence antibody test (IFAT) may appear but do not reflect an active infection.
Danish: Efter vaccinationen kan der forekomme transitoriske antistoffer mod leishmania påvist ved en immunofluorescens antistof test (IFAT).
English: What benefit has CaniLeish shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved CaniLeish?
English: In dogs developing leishmaniosis (active infection or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Danish: Der blev ikke påvist nogen effekt ved injektion af vaccinen i hunde, der udviklede leishmaniosis (aktiv infektion eller sygdom) på trods af vaccination.
English: How does CaniLeish work?
Danish: Hvordan virker CaniLeish?
English: The company presented data from three main studies involving over 3,000 patients.
Danish: Virksomheden fremlagde data fra tre hovedundersøgelser med over 3 000 patienter.
English: What was Plivensia expected to be used for?
Danish: Hvad forventedes Plivensia anvendt til?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that, given the need for additional clinical data and the fact that other treatments blocking the action of interleukin-6 are available, it wishes to prioritise other programs in its portfolio.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den i lyset af behovet for yderligere kliniske data og af det faktum, at der findes andre lægemidler, som blokerer interleukin-6, ønskede at prioritere andre programmer i sin portefølje.
English: What is Plivensia?
Danish: Hvad er Plivensia?
English: It was to be available as a solution for injection in pre-filled pens and syringes (50 mg).
Danish: Det skulle markedsføres som injektionsvæske i fyldte penne og sprøjter (50 mg).
English: Withdrawal of the marketing authorisation application for Plivensia (sirukumab)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Plivensia (sirukumab)
English: The main measure of effectiveness was a reduction in symptoms of 20% or more, based on a standard rating score (ACR-20), after 16 weeks of treatment.
Danish: Det primære mål for virkningen var en reduktion af symptomer på 20 % eller mere baseret på en standardskala (ACR20) efter 16 ugers behandling.
English: Withdrawal of the marketing authorisation application for Plivensia (sirukumab) EMA/727596/2017
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Plivensia (sirukumab) EMA/727596/2017
English: Plivensia is a medicine that contains the active substance sirukumab.
Danish: Plivensia er et lægemiddel, der indeholder det aktive stof sirukumab.
English: On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.
Danish: Den 26. oktober 2017 meddelte Janssen-Cilag International NV officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Plivensia til behandling af leddegigt (reumatoid artritis).
English: The CHMP's main concern was that the long-term safety of Plivensia had not been well characterised due to limitations in the design of the main studies.
Danish: CHMP's primære betænkelighed var, at den langsigtede sikkerhed ved Plivensia ikke var tilstrækkeligt karakteriseret på grund af begrænsninger i designet af hovedundersøgelserne.
English: Plivensia was to be used with methotrexate (a DMARD) or alone if the patient could not take methotrexate.
Danish: Plivensia skulle anvendes sammen med metotrexat (et DMARD) eller alene, hvis patienten ikke kunne tage metotrexat.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Plivensia could not have been approved for the treatment of moderate to severe rheumatoid arthritis.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Plivensia ikke ville kunne være blevet godkendt til behandling af moderat til svær leddegigt.
English: The active substance in Plivensia, sirukumab, is a monoclonal antibody, a type of protein which has been designed to block a molecule called interleukin-6.
Danish: Det aktive stof i Plivensia, sirukumab, er et såkaldt monoklonalt antistof, dvs. et protein, der er designet til at blokere molekylet interleukin-6.
English: By blocking interleukin-6, sirukumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
Danish: Ved at blokere interleukin-6 reducerer sirukumab betændelse og andre symptomer, der er forbundet med leddegigt.
English: The company informed the CHMP that it will discontinue the ongoing long-term extension study with Plivensia in patients with rheumatoid arthritis.
Danish: Virksomheden oplyste CHMP om, at den vil standse den igangværende langsigtede forlængelsesundersøgelse af Plivensia hos patienter med leddegigt.
English: How does Plivensia work?
Danish: Hvordan virker Plivensia?