FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the duration of immunity of the Erysipelas component following mixed use has not been investigated.
Danish: Dog er varigheden af immuniteten for erysipelaskomponenten efter blandet anvendelse ikke undersøgt.
English: Very common adverse reactions: - Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies.
Danish: Meget almindelige bivirkninger: - Mild til moderat inflammation på injektionsstedet, som typisk aftager inden for få dage men i visse tilfælde kan vare i op til 12 dage efter vaccinationen, er set i sikkerhedsstudier.
English: No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose.
Danish: Der kan ikke forventes andre bivirkninger end dem, der allerede er nævnt i afsnittet "Bivirkninger", efter indgivelse af en dobbelt vaccinedosis.
English: Sodium hydroxide Water for injections
Danish: Natriumhydroxid Vand til injektionsvæske
English: Common adverse reactions: - A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours was observed in safety studies.
Danish: Almindelige bivirkninger: - En forbigående forhøjet legemstemperatur i de første 6 timer efter vaccinationen, som ophører spontant inden for 24 timer, er set i sikkerhedsstudier.
English: The second injection should be administered 3-4 weeks before mating.
Danish: Den anden injektion skal gives 3-4 uger før løbning.
English: Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer, adjuvanserne eller et eller flere af hjælpestofferne.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Danish: Kontakt Deres dyrlæge eller apotkespersonalet vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: The vials are closed with a rubber stopper and aluminium cap.
Danish: Hætteglassene er lukket med en gummiprop og aluminiumshætte.
English: To stimulate active immunisation against porcine parvovirus and swine erysipelas.
Danish: Til stimulering af aktiv immunisering mod porcin parvovirus og svine-erysipelas.
English: Shelf life after first opening the container: use immediately.
Danish: Opbevaringstid efter første åbning af beholderen: Anvendes straks.
English: Disodium phosphate dodecahydrate Ginseng
Danish: Dinatriumphosphatdodecahydrat Ginseng
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), see section 4.9.
Danish: E. rhusiopathiae: Vaccination beskytter mod svine-erysipelas indtil tidspunktet for den anbefalede revaccination (cirka seks måneder efter basisvaccinationsplanen), se afsnit 4.9.
English: The following instructions should be used: the contents of a single vial of UNISTRAIN PRRS should be reconstituted with the contents of a single vial of ERYSENG PARVO.
Danish: Følgende instruktioner skal anvendes: Indholdet af et enkelt hætteglas med UNISTRAIN PRRS skal rekonstitueres med indholdet af et enkelt hætteglas med ERYSENG PARVO.
English: Do not mix with any other veterinary medicinal product, except with UNISTRAIN PRRS.
Danish: Må ikke blandes med andre lægemidler til dyr, undtagen med UNISTRAIN PRRS.
English: Porcine parvovirus: vaccination provides foetal protection for the duration of gestation.
Danish: Porcin parvovirus: Vaccination giver føtal beskyttelse i hele drægtighedsperioden.
English: Revaccination should be performed prior to each gestation, refer to section “Dosage for each species, route(s) and method of administration”.
Danish: Revaccination bør udføres før hver drægtighed, se afsnit ”Dosering for hver dyreart, anvendelsesmåde og indgivelsesvej(e)”.
English: Major incompatibilities: Do not mix with any other veterinary medicinal product except with UNISTRAIN PRRS.
Danish: Uforligeligheder: Må ikke blandes med andre lægemidler til dyr undtagen med UNISTRAIN PRRS.
English: For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.
Danish: Til aktiv immunisering af søer til beskyttelse af afkom mod transplacental infektion forårsaget af porcin parvovirus.
English: Store and transport refrigerated (2 ºC - 8 ºC).
Danish: Opbevares og transporteres nedkølet (2ºC - 8ºC).
English: Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
Danish: Der indgives en dosis på 2 ml ved intramuskulær injektion i halsmusklerne ifølge nedenstående skema:
English: For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Danish: Til aktiv immunisering af han- og hungrise for at reducere kliniske tegn (hudlæsioner og feber) på svine-erysipelas forårsaget af Erysipelothrix rhusiopathiae, serotype 1 og serotype 2.
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), refer to section “Dosage for each species, route(s) and method of administration”.
Danish: E. rhusiopathiae: Vaccination beskytter mod svine-erysipelas indtil tidspunktet for den anbefalede revaccination (cirka seks måneder efter basisvaccinationsplanen), se afsnit ”Dosering for hver dyreart, anvendelsesmåde og indgivelsesvej(e)”.
English: Polyethylene (PET) bottles of 20, 50, 100 and 250 ml.
Danish: Polyethylenflasker (PET) a 20, 50, 100 og 250 ml.
English: 10 doses
Danish: 10 doser
English: The mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.
Danish: Administration af blandingen af UNISTRAIN PRRS og ERYSENG PARVO bør kun anvendes, når dyrene vaccineres før parring.
English: For simultaneous use with UNISTRAIN PRRS in sows for reproduction from 6 months of age, the mixed administration of ERYSENG PARVO and UNISTRAIN PRRS should only be used when vaccinating animals prior to mating.
Danish: For samtidig brug med UNISTRAIN PRRS hos søer for reproduktion fra 6 måneders alderen bør blandet administration af ERYSENG PARVO og UNISTRAIN PRRS kun foretages, når dyrene vaccineres før parring.
English: EXP {month/year} Once broached use immediately.
Danish: {måneder/år} Anvendes omgående efter anbrud.
English: * IE50% - Inhibition ELISA 50%.
Danish: ** hæmning ELISA - 50 %
English: Special precautions for use in animals: None.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Ingen.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF (FER) OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: 50 doses
Danish: 50 doser
English: PACKAGE LEAFLET: ERYSENG PARVO suspension for injection for pigs
Danish: INDLÆGSSEDDEL: ERYSENG PARVO injektionsvæske, suspension til grise
English: Type I colourless glass vials of 20, 50 and 100 ml.
Danish: Farveløse type I-hætteglas à 20, 50 ml og 100 ml.
English: ERYSENG PARVO suspension for injection for pigs
Danish: ERYSENG PARVO injektionsvæske, suspension til grise
English: IMMUNOLOGICAL PROPERTIES
Danish: EGENSKABER IMMUNOLOGISKE GENSKABER
English: 25 doses
Danish: 25 doser
English: In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr I tilfælde af bivirkninger efter utilsigtet selvinjektion søges omgående lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
Danish: 10 doser (20 ml) 25 doser (50 ml) 50 doser (100 ml) 125 doser (250 ml)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles, (20 ml, 50 ml) and vials (20 ml, 50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER FLASKEETIKET (20 ml, 50 ml), HÆTTEGLASETIKET (20 ml, 50 ml)
English: For mixed use, the onset and duration of immunity of the parvovirus component and the onset of immunity of the Erysipelas component have been demonstrated to be equivalent to those determined for ERYSENG PARVO when used alone.
Danish: For blandet brug er det påvist, at begyndelsen og varigheden af parvoviruskomponentens immunitet og begyndelsen af erysipelaskomponenten svarer til ERYSENG PARVO, når det anvendes alene.
English: Name and address of the manufacturers of the biological active substances:
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer)
English: Aluminium hydroxide .............................................................................. 5.29 mg (aluminium) DEAE-Dextran
Danish: Aluminiumhydroxid ............................................................................................. 5,29 mg (aluminium) DEAE-dextran
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) Bottles (100 ml, 250 ml) and vials (100 ml)
Danish: KARTONÆSKE (20 ml, 50 ml, 100ml, og 250ml), FLASKEETIKET (100 ml, 250 ml) OG HÆTTEGLASETIKET (100 ml)
English: Potassium chloride Potassium dihydrogen phosphate Simethicone
Danish: Kaliumdihydrogenphosphat Simethicon
English: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminium) DEAE-Dextran
Danish: ............................................... 5,29 mg (aluminium) DEAE-dextran
English: Aluminium hydroxide DEAE-dextran
Danish: DEAE-dextran
English: Suspension for injection Whitish suspension
Danish: Injektionsvæske, suspension Hvidlig suspension
English: + 10 doses (20 ml)
Danish: + 10 doser (20 ml)
English: + 50 doses (100 ml)
Danish: + 50 doser (100 ml)
English: 10 doses (20 ml) 25 doses (50 ml)
Danish: 10 doser (20 ml) 25 doser (50 ml)
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated viral and bacterial vaccines.
Danish: Inaktiverede virale og bakterielle vacciner.
English: Disposal: read the package leaflet.
Danish: Bortskaffelse: Læs indlægssedlen
English: + 25 doses (50 ml)
Danish: + 25 doser (50 ml)
English: Inactivated porcine parvovirus, strain NADL-2, ..................................................... RP > 1.15 * Inactivated Erysipelothrix rhusiopathiae, strain R32E11, .............. ELISA > 3.34 log2 IE50%** * RP - relative potency (ELISA).
Danish: Inaktiveret porcin parvovirus, stamme NADL-2 .................................................... RP > 1,15 * Inaktiveret Erysipelothrix rhusiopathiae, stamme R32E11 .......... ELISA > 3,34 log2 IE50 %** * RP, relativ potens (ELISA) ** IE50 % hæmning ELISA - 50 %
English: Name and address of the manufacturer responsible for batch release:
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig for batchfrigivelse
English: Cardboard box with 1 PET bottle of 125 doses (250 ml).
Danish: Kartonæske med 1 PET-flaske a 125 doser (250 ml).
English: Inactivated porcine parvovirus, strain NADL-2, ..................................................... RP* > 1.15, Inactivated Erysipelothrix rhusiopathiae, strain R32E11, .............. ELISA > 3.34 log2 IE50%**
Danish: Inaktiveret porcin parvovirus, stamme NADL-2 ....................................................... RP > 1,15 inaktiveret Erysipelothrix rhusiopathiae, stamme R32E11 ........... ELISA > 3,34 log2 IE50 % * * IE50 % hæmning ELISA - 50 %
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a 2-fold vaccine dose.
Danish: 4.6, efter indgivelse af en dobbelt vaccinedosis.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter første åbning af den indre emballage: nvendes straks Holdbarhed efter blanding med UNISTRAIN PRRS: 2 timer.
English: Cardboard box with 1 PET bottle of 10 doses (20 ml).
Danish: Kartonæske med 1 PET-flaske a 10 doser (20 ml).
English: Cardboard box with 1 glass vial of 10 doses (20 ml).
Danish: Kartonæske med 1 hætteglas a 10 doser (20 ml).
English: Cardboard box with 1 PET bottle of 50 doses (100 ml).
Danish: Kartonæske med 1 PET-flaske a 50 doser (100 ml).
English: Cardboard box with 1 PET bottle of 25 doses (50 ml).
Danish: Kartonæske med 1 PET-flaske a 25 doser (50 ml).
English: Cardboard box with 1 glass vial of 50 doses (100 ml).
Danish: Kartonæske med 1 hætteglas a 50 doser (100 ml).
English: Cardboard box with 1 glass vial of 25 doses (50 ml).
Danish: Kartonæske med 1 hætteglas a 25 doser (50 ml).
English: Inactivated porcine parvovirus, strain NADL-2, ....................................................... RP > 1.15, inactivated Erysipelothrix rhusiopathiae, strain R32E11, ................. ELISA > 3.34 log2 IE50%.
Danish: Inaktiveret Erysipelothrix rhusiopathiae, stamme R32E11 .......... ELISA > 3,34 log2 IE50 %**
English: Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: With regards to the risks observed, there were also strong new unfavourable safety signals.
Danish: Hvad angår de iagttagne risici var der desuden stærke nye negative sikkerhedssignaler.
English: Scientific conclusions and grounds for suspension of the marketing authorisation presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelse for suspendering af markedsføringstilladelsen fremlagt af Det Europæiske Lægemiddelagentur
English: • The CHMP noted that no additional risk minimisation measures could be recommended at this point in time,
Danish: • CHMP bemærkede, at der på nuværende tidspunkt ikke kunne anbefales yderligere risikominimeringsforanstaltninger,
English: Conditions for lifting the suspension
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen
English: The PRAC issued a recommendation to the CHMP on 10 January 2013.
Danish: Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelovervågning fremsatte en anbefaling til CHMP den 10. januar 2013.
English: Overall summary of the scientific evaluation of nicotinic acid/laropiprant
Danish: Samlet resumé af den videnskabelige vurdering af nikotinsyre/laropiprant
English: Preliminary results of this study became available and were submitted by the MAH for review end of December 2012.
Danish: Undersøgelsens foreløbige resultater blev indsendt af indehaveren af markedsføringstilladelse ved udgangen af december 2012.
English: Grounds for CHMP opinion Whereas,
Danish: Begrundelse for CHMP's udtalelse Ud fra følgende betragtninger:
English: Previously available data on laropiprant/nicotinic acid included nine studies where a total of 5,782 patients were exposed to the medicine.
Danish: De allerede foreliggende data om laropiprant/nikotinsyre bestod af ni undersøgelser, hvor i alt 5 782 patienter blev eksponeret for lægemidlet.
English: The available evidence provided by the MAH in writing and at an oral explanation was reviewed by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: De foreliggende data, som markedsføringstilladelsesindehaveren havde redegjort for skriftligt og mundtligt, blev gennemgået af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: The HSP2-THRIVE study was a very large randomised trial, enrolling 25,673 patients considered to be at high risk of cardiovascular events.
Danish: HSP2-THRIVE-undersøgelsen var en meget stor randomiseret undersøgelse, der omfattede 25 673 patienter, som blev anset for at have høj risiko for kardiovaskulære hændelser.
English: 1 HPS2-THRIVE: Hearth Protection Study 2 - Treatment of HDL (high density lipoprotein) to Reduce the Incidence of Vascular Events.
Danish: 1 HPS2-THRIVE: Hjertebeskyttelsesundersøgelse 2 - Behandling af HDL (højdensitetslipoprotein) for at minimere forekomsten af vaskulære hændelser.
English: Furthermore, no additional risk minimisation measures were identified or proposed by the marketing authorisation holder to minimise the newly identified safety concerns.
Danish: Indehaveren af markedsføringstilladelsen har desuden ikke fundet eller foreslået yderligere risikominimeringsforanstaltninger med henblik på de nyligt konstaterede sikkerhedsmæssige betænkeligheder.
English: The HPS2-THRIVE study was conducted by the Clinical Trial Service Unit at the University of Oxford and funded by the MAH.
Danish: HPS2-THRIVE-undersøgelsen blev udført af Oxford-universitetets Clinical Trial Service Unit og var finansieret af indehaveren af markedsføringstilladelsen.
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP recommends the suspension of the marketing authorisations for nicotinic acid/laropiprant (see Annex A).
Danish: I henhold til bestemmelserne i artikel 20 i forordning (EF) nr. 726/2004 anbefaler CHMP suspendering af markedsføringstilladelserne for nikotinsyre/laropiprant (se bilag A).
English: The product is authorised as modified release tablets containing 1000mg of nicotinic acid and 20mg of laropiprant.
Danish: Produktet er godkendt som tabletter med modificeret udløsning, der indeholder 1 000 mg nikotinsyre og 1 000 mg laropiprant.
English: Identified risks were reflected in the product information and the risk management plan and included myopathy, glucose intolerance and abnormal liver function.
Danish: De konstaterede risici afspejlede sig i produktinformationen og risikostyringsplanen og bestod i myopati, glukoseintolerance og abnorm leverfunktion.
English: It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Danish: Som monoterapi kan det kun anvendes til patienter, hos hvem HMG-CoA-reduktasehæmmere ikke har virkning eller ikke tåles.
English: • The CHMP considered the notification under Article 20 of Regulation (EC) No 726/2004 for nicotinic acid/laropiprant (approved in the EU as Tredaptive, Trevaclyn and Pelzont) initiated by the European Commission,
Danish: • CHMP behandlede den procedure, som var indledt af Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004, for nikotinsyre/laropiprant (i EU godkendt under navnene Tredaptive, Trevaclyn og Pelzont),
English: The PRAC therefore considered that the results demonstrate that nicotinic acid/laropiprant has no additional efficacy in terms of cardiovascular outcome as an add-on treatment to statins.
Danish: PRAC fandt derfor, at resultaterne viser, at nikotinsyre/laropiprant ikke har yderligere virkning på kardiovaskulært udfald som tillægsbehandling til statiner.
English: Important missing information, such as the effects of long-term exposure, bleeding and thrombotic cardiovascular events was expected to be clarified through routine pharmacovigilance and through monitoring of patients in clinical trials, in particular the HPS2-THRIVE study.
Danish: Vigtige manglende oplysninger, såsom virkninger af langtidseksponering og forekomst af blødningsepisoder og trombotiske kardiovaskulære hændelser, forventedes at fremgå af rutinemæssig lægemiddelovervågning og af overvågning af patienterne i de kliniske undersøgelser, navnlig HPS2THRIVE-undersøgelsen.
English: Nicotinic acid/laropiprant (authorised in the EU as Tredaptive, Trevaclyn and Pelzont) is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia and in adult patients with primary hypercholesterolaemia in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Danish: Nikotinsyre/laropiprant (godkendt i EU under navnene Tredaptive, Trevaclyn og Pelzont) er indiceret til behandling af dyslipidæmi hos voksne, navnlig kombineret blandet dyslipidæmi, samt, kombineret med HMG-CoA-reduktasehæmmere (statiner), primær hyperkolesterolæmi hos voksne, når der ikke kan opnås tilstrækkelig kolesterolsænkende virkning ved monoterapi med HMG-CoA reduktasehæmmere.
English: Considering the lack of clinically relevant efficacy and the negative safety profile (including the newly identified serious safety concerns) associated with the use of nicotinic acid/laropiprant, the PRAC considered that the benefit-risk balance has shifted towards a negative balance.
Danish: I betragtning af den manglende klinisk relevante virkning og den negative sikkerhedsprofil (herunder de nylige konstaterede alvorlige sikkerhedsmæssige betænkeligheder), der er forbundet med anvendelse af nikotinsyre/laropiprant, fandt PRAC benefit/risk-forholdet forrykket i negativ retning.
English: Having noted all of the above, the CHMP considers that the benefit-risk balance for nicotinic acid/laropiprant is not favourable in the approved indication and recommends the suspension of the marketing authorisation of the products containing laropiprant/nicotinic acid.
Danish: På baggrund af alt det ovenfor anførte fandt CHMP, at benefit/risk-forholdet for nikotinsyre/laropiprant ikke er positivt til den ansøgte indikation, og anbefaler suspendering af markedsføringstilladelsen for produkter indeholdende laropiprant/nikotinsyre.
English: The PRAC concluded that data from the HPS2-THRIVE study has confirmed the previously known safety profile of nicotinic acid/laropiprant and additionally revealed new safety concerns.
Danish: PRAC konkluderede, at data fra HPS2-THRIVE-undersøgelsen har bekræftet den allerede kendte sikkerhedsprofil af nikotinsyre/laropiprant og desuden afsløret nye sikkerhedsmæssige betænkeligheder.
English: The studies were not designed to evaluate cardiac effects but it was noted that serious cardiac disorders occurred more often in the nicotinic acid/laropiprant group compared to placebo.
Danish: Undersøgelserne var ikke tilrettelagt med henblik på vurdering af kardiale virkninger, men det bemærkedes, at alvorlige kardiale sygdomme forekom oftere i nikotinsyre/laropiprant-gruppen end i placebogruppen.
English: Over the 3.9 years median follow-up, treatment with nicotinic acid/laropiprant compared to placebo did not achieve its primary endpoint.
Danish: I løbet af opfølgningsperioden, der havde en median varighed på 3,9 år, resulterede behandling med nikotinsyre/laropiprant ikke i opfyldelse af det primære endepunkt ved sammenligning med placebo.
English: Although the population studied in HPS2-THRIVE was not selected based on high LDL cholesterol levels, the safety results observed in the 25,673 patients were considered to be of relevance to the current approved indication as there is no evidence to suggest that patients currently indicated for treatment with nicotinic acid/laropiprant would be protected from the adverse events observed in
Danish: Skønt den undersøgte population i HPS2-THRIVE ECHA ikke var udvalgt på grundlag af højt LDLkolesteroltal, blev de iagttagne sikkerhedsresultater hos de 25 673 patienter anset for relevante for den aktuelt godkendte indikation, da der ikke er evidens for, at de patienter, som nikotinsyre/laropiprant aktuelt er indiceret til, vil være beskyttet mod de bivirkninger, der ses i HPS2-THRIVE-undersøgelsen.
English: • The CHMP considered the totality of the data available for laropiprant/nicotinic acid, including the emerging preliminary data from the HPS2-THRIVE study, which was not available at the time of the original marketing authorisation, the MAH responses, the PRAC assessment and the discussions within the CHMP,
Danish: • CHMP tog hensyn til samtlige foreliggende data vedrørende laropiprant/nikotinsyre, herunder de nye foreløbige data fra HPS2-THRIVE-undersøgelsen, der ikke forelå på tidspunktet for den oprindelige godkendelse, besvarelsen fra indehaveren af markedsføringstilladelsen, vurderingen foretaget af Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelovervågning samt drøftelserne i CHMP,