FrancophonIA/ELRC3.0 huggingface dataset:
English: It is strongly recommended that every time that Nuwiq is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Danish: For at bevare en forbindelse mellem patienten og den pågældende batch af lægemidlet anbefales det stærkt, at præparatets navn og batchnummer registreres, hver gang Nuwiq administreres til en patient.
English: 1 powder vial, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs
Danish: 1 hætteglas med pulver, 1 fyldt injektionssprøjte med 2,5 ml vand til injektionsvæsker, 1 hætteglasadapter, 1 butterfly-kanyle, 2 alkoholservietter
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 July 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Frequency of adverse drug reactions (ADRs) in clinical trials
Danish: Hyppigheden af bivirkninger i kliniske studier MedDRA Standard Systemorganklasse
English: Name and address of the manufacturer(s) responsible for batch release Octapharma AB
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: INFORMATION IN BRAILLE Nuwiq 2000
Danish: INFORMATION I BRAILLESKRIFT Nuwiq 2000
English: The posology is the same in adults and children and adolescents, however, shorter dose intervals or higher doses may be necessary for children and adolescents.
Danish: Det kan dog være nødvendigt at behandle børn og unge med kortere dosisintervaller eller højere doser.
English: What Nuwiq contains Powder: - The active substance is recombinant human coagulation factor VIII (simoctocog alfa).
Danish: Pulver: - Aktivt stof: rekombinant human koagulationsfaktor VIII (simoctocog alfa).
English: INFORMATION IN BRAILLE Nuwiq 250
Danish: INFORMATION I BRAILLESKRIFT Nuwiq 250
English: INFORMATION IN BRAILLE Nuwiq 2500
Danish: INFORMATION I BRAILLESKRIFT Nuwiq 2500
English: INFORMATION IN BRAILLE Nuwiq 1000
Danish: INFORMATION I BRAILLESKRIFT Nuwiq 1000
English: INFORMATION IN BRAILLE Nuwiq 4000
Danish: INFORMATION I BRAILLESKRIFT Nuwiq 4000
English: INFORMATION IN BRAILLE Nuwiq 500
Danish: INFORMATION I BRAILLESKRIFT Nuwiq 500
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Danish: PK parametre for Nuwiq (Dosis: 50 IE/kg) hos tidligere behandlede børn (i alderen 2 - 5 år) med svær hæmofili A (n = 13)
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection
Danish: Pulver og solvens til injektionsvæske, opløsning
English: INFORMATION IN BRAILLE Nuwiq 3000
Danish: INFORMATION I BRAILLESKRIFT Nuwiq 3000
English: Weight-adjusted PK parameters for Nuwiq (Dose: 50 IU/kg) in adult previously treated patients (age 18-65 years) with severe haemophilia A (n = 20)
Danish: Vægtjusterede PK-parametre for Nuwiq (Dosis: 50 IE/kg) hos voksne tidligere behandlede patienter (i alderen 18-65 år) med svær hæmofili A (n = 20)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 IU simoctocog alfa (800 IU/mL after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 2000 IE simoctocog alfa (800 IE/ml efter rekonstitution).
English: Nuwiq 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Nuwiq 2000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 2000 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: Nuwiq 2000 IU contains approximately 800 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Nuwiq 2000 IE indeholder ca. 800 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Danish: PK-parametre for Nuwiq (Dosis: 50 IE/kg) hos tidligere behandlede børn (i alderen 612 år) med svær hæmofili A (n = 12)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 IU simoctocog alfa (1200 IU/mL after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 3000 IE simoctocog alfa (1200 IE/ml efter rekonstitution).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 powder vial contains 250 IU simoctocog alfa (100 IU/mL after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 250 IE simoctocog alfa (100 IE/ml efter rekonstitution).
English: Nuwiq 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Nuwiq 250 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 250 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Nuwiq 250 IE indeholder ca. 100 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: Nuwiq 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Nuwiq 4000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 4000 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: Nuwiq 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Nuwiq 2500 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 2500 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: Nuwiq 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Nuwiq 1000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 1000 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: Nuwiq 2500 IU contains approximately 1000 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Nuwiq 2500 IE indeholder ca. 1000 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 IU simoctocog alfa (1000 IU/mL after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 2500 IE simoctocog alfa (1000 IE/ml efter rekonstitution).
English: Nuwiq 4000 IU contains approximately 1600 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Nuwiq 4000 IE indeholder ca. 1600 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: Nuwiq 3000 IU contains approximately 1200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Nuwiq 3000 IE indeholder ca. 1200 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: Nuwiq 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Nuwiq 3000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 3000 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 IU simoctocog alfa (200 IU/mL after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 500 IE simoctocog alfa (200 IE/ml efter rekonstitution).
English: Nuwiq 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Nuwiq 500 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 500 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: glass vial, closed with coated bromobutyl stopper and sealed with aluminium flip-off cap - Solvent: 1 borosilicate pre-filled glass syringe containing 2.5 mL water for injections - 1 sterile vial adapter for reconstitution with 1 butterfly needle and 2 alcohol swabs
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning 1 hætteglas med pulver, 1 fyldt injektionssprøjte med 2,5 ml vand til injektionsvæsker, 1 hætteglasadapter, 1 butterfly-kanyle, 2 alkoholservietter
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 IU simoctocog alfa (16000 IU/mL after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 4000 IE simoctocog alfa (1600 IE/ml efter rekonstitution).
English: Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Nuwiq 500 IE indeholder ca. 200 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Nuwiq 1000 IE indeholder ca. 400 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 IU simoctocog alfa (400 IU/mL after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 1000 IE simoctocog alfa (400 IE/ml efter rekonstitution).
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Nuwiq 2000 IE pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in adult previously treated patients (age 1865 years) with severe haemophilia A (n = 20)
Danish: PK-parametre for Nuwiq (Dosis: 50 IE/kg) i forbindelse med voksne tidligere behandlede patienter (i alderen 18-65 år) med svær hæmofili A (n = 20)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 250 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Nuwiq 250 IE pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Nuwiq 2000 IE pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII) Til intravenøs anvendelse efter rekonstitution.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Nuwiq 2500 IE pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Nuwiq 2500 IE pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII) Til intravenøs anvendelse efter rekonstitution.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Nuwiq 500 IE pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: If you use more Nuwiq than you should
Danish: Hvis du har taget for meget Nuwiq
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Nuwiq 500 IE pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII) Til intravenøs anvendelse efter rekonstitution.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 1000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Nuwiq 1000 IE pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Nuwiq 4000 IE pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 250 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Nuwiq 250 IE pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII) Til intravenøs anvendelse efter rekonstitution.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 4000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Nuwiq 4000 IE pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII) Til intravenøs anvendelse efter rekonstitution.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/936/007
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 3000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Nuwiq 3000 IE pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII) Til intravenøs anvendelse efter rekonstitution.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/936/005
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 3000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Nuwiq 3000 IE pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 1000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Nuwiq 1000 IE pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII) Til intravenøs anvendelse efter rekonstitution.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/936/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/936/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/936/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/936/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/936/003
English: Yervoy has been authorised since July 2011.
Danish: Yervoy har været godkendt siden juli 2011.
English: Opdivo has been authorised since June 2015.
Danish: Opdivo har været godkendt siden juni 2015.
English: Further information on Opdivo and Yervoy's current uses can be found on the Agency's website.
Danish: Yderligere oplysninger om den aktuelle anvendelse af Opdivo og Yervoy findes på agenturets websted.
English: The company that applied for the change to the authorisation is Bristol-Myers Squibb Pharma EEIG.
Danish: Virksomheden, der har indgivet ansøgningen om ændring af markedsføringstilladelsen, er Bristol-Myers Squibb Pharma EEIG.
English: During the re-examination, the CHMP looked again at all the data and consulted a group of cancer experts and patients with cancer.
Danish: I løbet af revurderingen undersøgte CHMP alle oplysningerne igen og konsulterede en gruppe kræftspecialister og patienter med kræft.
English: What were the CHMP's main concerns that led to the initial negative opinion?
Danish: Hvori bestod CHMP's vigtigste betænkeligheder, der førte til den negative udtalelse?
English: They contain the active substances nivolumab and ipilimumab respectively.
Danish: De indeholder henholdsvis de aktive stoffer nivolumab og ipilimumab.
English: It is used to treat adults with advanced melanoma.
Danish: Det anvendes til behandling af voksne med fremskredent melanom.
English: The study looked at the patients' response to treatment and how long patients lived, or lived without their disease getting worse.
Danish: Der blev i studiet set nærmere på, hvordan patienterne reagerede på behandlingen, og hvor lang tid patienterne overlevede eller levede uden sygdomsforværring.
English: The company presented the results of a main study involving 1,096 patients with previously untreated advanced renal cell carcinoma.
Danish: Virksomheden fremlagde resultaterne af et hovedstudie, der omfattede 1.096 patienter med tidligere ubehandlet fremskredent renalcellekarcinom.
English: The CHMP also discussed the possibility to request that further data be collected following the authorisation of the combination.
Danish: CHMP drøftede også, hvorvidt det var muligt at anmode om indsamling af yderligere oplysninger efter godkendelsen af kombinationen.
English: At the request of the company, the CHMP re-examined its opinion.
Danish: På anmodning af virksomheden tog CHMP udtalelsen op til en revurdering.
English: It is also used to treat the following other cancers: melanoma (a skin cancer), non-small cell lung cancer, classical Hodgkin lymphoma (a blood cancer), squamous cell cancer of the head and neck, and urothelial (bladder) cancer.
Danish: Det anvendes også til behandling af følgende kræftformer: melanom (hudkræft), ikke-småcellet lungekræft, klassisk Hodgkins lymfom (blodkræft), pladecellekræft i hovedet og halsen samt urotelial kræft (i blæren).
English: However, the company must conduct a study to determine the precise contribution of Yervoy in the combination and if the risks could be further minimised.
Danish: Virksomheden skal gennemføre et studie for at fastslå, hvad Yervoys præcist bidrager med til kombinationen, og om risiciene kan reduceres yderligere.
English: The CHMP was of the opinion that the benefits of the combination largely outweigh its risks and therefore recommended granting the change to the marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved kombinationen var langt større end risiciene, og anbefalede derfor at godkende ansøgningen om ændring af markedsføringstilladelsen.
English: What were the conclusions of the CHMP following the re-examination?
Danish: Hvilke konklusioner nåede CHMP frem til efter revurderingen?
English: At the same time it was clear that combination with Yervoy resulted in more side effects than are seen with Opdivo alone.
Danish: Samtidig var det tydeligt, at kombinationen med Yervoy gav flere bivirkninger end Opdivo alene.
English: Opdivo and Yervoy are cancer medicines.
Danish: Opdivo og Yervoy er lægemidler mod kræft.
English: The active substance in both medicines, nivolumab and ipilimumab, are monoclonal antibodies, a type of protein that has been designed to recognise and attach to a specific structure.
Danish: Det aktive stof i begge lægemidler, nivolumab og ipilimumab, er et monoklonalt antistof, en type protein, som er fremstillet, så det genkender og binder sig til et bestemt mål.
English: The change concerns the use of both medicines together to treat renal cell carcinoma (kidney cancer).
Danish: Ændringen vedrører anvendelsen af begge lægemidler sammen til behandling af nyrecellekarcinom (nyrekræft).
English: Therefore, at that point in time, the CHMP considered that the combination could not be approved because of the lack of knowledge of the contribution of Yervoy.
Danish: CHMP vurderede derfor på det tidspunkt, at kombinationen ikke kunne godkendes, fordi der manglede oplysninger om det, Yervoy bidrog med.
English: This means that the CHMP had no way to know if the addition of Yervoy to Opdivo treatment produced additional benefit.
Danish: Det betyder, at CHMP ikke kunne vide, om tilføjelsen af Yervoy til Opdivo gav en ekstra fordel.
English: Although the precise contribution of Yervoy was not clear, the CHMP reassessed data from other non-clinical and clinical studies, including studies with the combination in relevant other cancer types, and considered that the benefit of Yervoy in the combination has been sufficiently demonstrated.
Danish: Selvom det ikke var klart, hvad Yervoy præcist bidrog med, revurderede CHMP oplysningerne fra andre ikkekliniske og kliniske studier, herunder studier med kombinationen til andre relevante kræftformer, og anså Yervoys gavnlige virkning i kombinationen for at være tilstrækkeligt påvist.
English: Following the re-examination, the CHMP adopted a final positive opinion on 15 November 2018 recommending that the change to the marketing authorisation be granted for Opdivo and Yervoy, but requested the company to conduct a study to collect further data.
Danish: Efter re-vurderingen vedtog CHMP en endelig positiv udtalelse den 15. november 2018 og anbefalede at godkende ændringen af markedsføringstilladelsen for Opdivo og Yervoy, men anmodede virksomheden om at gennemføre et studie for at indsamle yderligere oplysninger.
English: It is already used on its own to treat renal cell carcinoma in patients who have previously been treated with other cancer medicines.
Danish: Det anvendes allerede alene til behandling af nyrecellekarcinom hos patienter, som tidligere er blevet behandlet med andre lægemidler mod kræft.
English: On 15 November 2018, the Committee for Medicinal Products for Human Use (CHMP) recommended that a change to the marketing authorisation for the medicinal products Opdivo (nivolumab) and Yervoy (ipilimumab) be granted.
Danish: Den 15. november 2018 anbefalede Udvalget for Lægemidler til Mennesker (CHMP) at godkende en ændring til markedsføringstilladelsen for Opdivo (nivolumab) og Yervoy (ipilimumab).
English: Nivolumab attaches to a receptor called PD-1 which is found on certain cells of the immune system called T cells.
Danish: Nivolumab binder sig til en receptor kaldet PD-1, som findes i de celler i immunsystemet, der kaldes Tceller.
English: Although improvements in survival were seen in previously untreated patients given the combination of Opdivo and Yervoy compared with sunitinib, there was no evidence showing if Yervoy contributed to these results and if so, how much.
Danish: Selvom overlevelsen blev forbedret hos tidligere ubehandlede patienter, som fik kombinationen af Opdivo og Yervoy, sammenlignet med sunitinib, var der ingen dokumentation for, at Yervoy bidrog til disse resultater, og i bekræftende fald i hvilket omfang.
English: Ipilimumab attaches to and blocks the activity of CTLA-4, a protein that controls the activity of T cells.
Danish: Ipilimumab binder sig til og blokerer aktiviteten af CTLA-4, et protein som styrer T-cellernes aktivitet.