FrancophonIA/ELRC3.0 huggingface dataset:
English: Etidronic acid containing medicinal products with Marketing Authorisation in the European Union
Danish: ETIDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union
English: Frederic Mompou, 5 08960 Sant Just Desvern
Danish: Frederic Mompou, 5 08960
English: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet Oral use
Danish: 35,0 mg Risedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydrate
English: Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
Danish: Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria
English: NL - Netherlands Roche Nederland B.V. Beneluxlaan 2a
Danish: NL - Holland Roche Nederland B.V.
English: BG - Bulgaria ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
Danish: BG - Bulgarien ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
English: Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3º, 2740-244 Porto Salvo Portugal
Danish: Empreendimento Lagoas Park, Edifício 7 - 3º, 2740-244 Porto Salvo Portugal
English: Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
Danish: RISEDRONAT TEVA 35 mg film-coated tablets
English: BE - Belgium TEVA Pharma Belgium N.V, Laarstraat 16,
Danish: TEVA Pharma Belgium N.V, Laarstraat 16, B-2610 Wilrijk, Belgium
English: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película film coated tablets
Danish: RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película
English: ACTONEL 75 mg comprimidos recubiertos con película film coated tablets
Danish: ACTONEL 75 mg comprimidos recubiertos con película
English: ACREL 75 mg comprimidos recubiertos con película film coated tablets
Danish: ACREL 75 mg comprimidos recubiertos con película
English: Clodronic acid containing medicinal products with Marketing Authorisation in the European Union
Danish: CLODRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union
English: UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14566
Danish: HIGHWAY ATHENS-LAMIA KIFISSIA 14566
English: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Danish: MIOSEN SEMANAL 35 mg comprimidos recubiertos con película
English: OSODENS 35 mg film coated tablets film coated tablets
Danish: OSODENS 35 mg filmcoated tablets
English: Optinate Once a Week 35mg Film-coated Tablets film-coated tablets
Danish: Optinate Once a Week 35mg film-coated tablets
English: Bonefos 800 mg filmsko obložene tablete film-coated tablet
Danish: Bonefos 800 mg filmsko obložene tablete
English: BE - Belgium Eurogenerics N.V. Heizel Esplanade b22
Danish: Heizel Esplanade b22
English: Actonel 75 Milligram Film Coated Tablets film-coated tablets
Danish: Actonel 75 Milligram film-coated tablets
English: JUVERITAL 35 mg film coated tablets film coated tablets
Danish: JUVERITAL 35 mg film-coated tablets
English: GB-HA1 4HF NORTH
Danish: GB-HA1 4HF NORTH HARROW, MIDDLESEX
English: ACREL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Danish: ACREL SEMANAL 35 mg comprimidos recubiertos con película
English: UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14564
Danish: HIGHWAY ATHENS-LAMIA KIFISSIA 14564
English: ACTONEL 30 mg comprimidos recubiertos film coated tablets
Danish: ACTONEL 30 mg comprimidos recubiertos
English: SE - Sweden Orion Corporation, Orion Pharma
Danish: Orion Corporation, Orion Pharma PO Box 65
English: Riserdonat Galex 35 mg filmsko obložene tablete film-coated tablet Oral use
Danish: Riserdonat Galex 35 mg filmsko obložene tablete
English: Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel,Germany
Danish: Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany
English: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película film coated tablets
Danish: RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película
English: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé film-coated tablet Oral use
Danish: RISEDRONATE WINTHROP 75 mg, comprimé pelliculé
English: Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union
Danish: PAMIDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union
English: SE - Sweden Accord Healthcare Limited Sage House
Danish: RO - Rumænien ACCORD HEALTHCARE LIMITED, Sage house, 319
English: Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland
Danish: SI - Slovenien Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland
English: NL - Netherlands Bluefish Pharmaceuticals AB, Torsgatan 11
Danish: Bluefish Pharmaceuticals AB, Torsgatan 11
English: GA Haarlem, Nederlands
Danish: 2031 GA Haarlem Netherlands
English: Ridate Once a Week 35mg film-coated tablets film-coated tablets
Danish: Ridate Once a Week 35mg film-coated tablets
English: UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14565
Danish: HIGHWAY ATHENS-LAMIA KIFISSIA 14565
English: SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 BUILDING A KALITHEA 17678
Danish: EL - Grækenland SANOFI-AVENTIS AEBE SYNGROU AVENUE 348
English: DK - Denmark Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
Danish: Orion Corporation Orion Pharma, Orionintie 1, FI02200 Espoo, Finland
English: LORINE 35 mg film coated tablets film coated tablets
Danish: LORINE 35 mg filmcoated tablets
English: ACTONEL 5 mg comprimidos recubiertos film coated tablets
Danish: ACTONEL 5 mg comprimidos recubiertos
English: SE - Sweden STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
Danish: STADA Arzneimittel AG, Stadastrasse 2-18, DE61118 Bad Vilbel, Germany (DEU)
English: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Danish: RISEMYL SEMANAL 35 mg comprimidos recubiertos con película
English: Bonefos capsules 400 mg hard capsules
Danish: Bonefos capsules 400 mg
English: Risontel Once a week 35mg film-coated tablets film-coated tablets
Danish: Risontel Once a week 35mg film-coated tablets
English: EL - Greece
Danish: DE - Tyskland
English: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Danish: ACTONEL SEMANAL 35 mg comprimidos recubiertos con película
English: AREDIA DRY POWDER 15 mg
Danish: AREDIA DRY POWDER
English: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película film coated tablets
Danish: LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película
English: Actonel® 30 mg, filmomhulde tabletten filmcoated tablets Oral use
Danish: Actonel® 30 mg, filmomhulde tabletten
English: Disodium Clodronate 60mg/ml solution for Injection
Danish: Disodium Clodronate 60mg/ml
English: Apotex Europe B.V. Darwinweg 20.
Danish: Apotex Europe B.V.
English: ACTONEL OAW 35MG/TAB FILM COATED TABLET
Danish: ACTONEL OAW 35MG/TAB
English: Actonel Once A Week 35 mg film-coated tablets film-coated tablets
Danish: Actonel Once A Week 35 mg film-coated tablets
English: Actonel® 5 mg, filmomhulde tabletten filmcoated tablets Oral use
Danish: Actonel® 5 mg, filmomhulde tabletten
English: Risedronic acid containing medicinal products with Marketing Authorisation in the European Union
Danish: RISEDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union
English: KLEVA AFBEE PARNITHOS AVENUE 189 ACHARNES ATTIKIS 13675
Danish: ACHARNES ATTIKIS 13675
English: NL - Netherlands Actavis Group PTC ehf Reykjavikurvegur 76-78,220
Danish: RO - Rumænien Actavis Group PTC ehf Reykjavikurvegi 76-78, 220
English: Tiludronic acid containing medicinal products with Marketing Authorisation in the European Union
Danish: TILUDRONAT indeholder medicinsk product med markeføringstilladelse i den Europoeiske Union
English: DK - Denmark Gedeon Richter Plc., Gyömröí út 19-21, HU-1103
Danish: UK - Storbritannien Gedeon Richter Plc, Gyömrői Utca 19-21,
English: GU32 3QB, United Kingdom and Northern Ireland
Danish: GU23 3QB, United Kingdom alendronic acid
English: RATIOPHARM 3 mg/ml, solution à diluer pour perfusion
Danish: PAMIDRONATE DE SODIUM RATIOPHARM 3 mg/ml, solution à diluer pour perfusion
English: Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna,
Danish: LV - Letland Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna,
English: Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna AUSTRIA
Danish: ET - Estland Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna
English: North Harrow, Middlesex HA1 4HF
Danish: 319 Pinner Road North Harrow, Middlesex HA1 4HF
English: film-coated tablet and chewing tablet
Danish: Filmovertrukket tablet og Tyggetablet
English: Ácido Alendrónico Ecosis 70 mg
Danish: Ácido Alendrónico Ecosis 70 mg Comprimidos
English: NL - Netherlands Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
Danish: Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
English: ACTONEL 30 mg, comprimé pelliculé film-coated tablet Oral use
Danish: ACTONEL 30 mg, comprimé pelliculé
English: Bucureşti-Ploieşti, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, Bucureşti, România
Danish: 1A,Clădirea C1, Etaj
English: DK - Denmark Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104
Danish: Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 35 Stockholm, Sweden
English: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé film-coated tablet Oral use
Danish: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé
English: 30 mg Dry substanced and solvent Intravenous
Danish: 30 mg Pulver og solvens
English: BE - Belgium Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
Danish: Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
English: ANFARM HELLAS S.A.
Danish: EL - Grækenland S.J.A.
English: DE - Germany CT Arzneimittel GmbH Lengeder Str. 42a
Danish: CT Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
English: Actonel Plus Ca & D 35mg + 1000mg/880IU
Danish: Actonel Plus Ca & D 35mg + 1000mg/880IU Filmovertrukket tablet og
English: Prenteral
Danish: Sindronat
English: Apotex Europe, B.V. Darwinweg 20
Danish: Apotex Europe, B.V.
English: D-51377 Leverkusen
Danish: Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
English: Natriumrisedronaat 35 mg Ranbaxy filmcoated tablets Oral use
Danish: Natriumrisedronaat 35 mg Ranbaxy
English: Pamidronaat Actavis 3 mg/ml
Danish: Pamidronat-ratiopharm 3 mg/ml
English: DK - Denmark Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O.
Danish: UK - Storbritannien Actavis Group PTC EHF, Reykjavikurvegi 76-78,
English: Actonel® 75 mg, filmomhulde tabletten filmcoated tablets Oral use
Danish: Actonel® 75 mg, filmomhulde tabletten
English: Pamidronato Hikma 3 mg/ml
Danish: PAMIDRONATO RATIOPHARM 3 mg/ml
English: 9 mg Concentrate for solution for infusion
Danish: 9 mg Koncentrat til infusionsvaeske, opløsningg
English: ACTONEL 5 mg, comprimé pelliculé film-coated tablet Oral use
Danish: ACTONEL 5 mg, comprimé pelliculé
English: JUVERITAL 5 mg film coated tablets film coated tablets
Danish: JUVERITAL 5 mg filmcoated tablets
English: Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
Danish: Risedronaatnatrium Mylan Wekelijks 35 mg
English: ACTONEL 35 mg, comprimé pelliculé film-coated tablet Oral use
Danish: ACTONEL 35 mg, comprimé pelliculé
English: TH. PETALA 41
Danish: EL - Grækenland PHARMA LINE S.A. TH. PETALA 41
English: 35 mg + 500 mg/400 UI
Danish: 35 mg + 500 mg/400 UI Tablet
English: The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Danish: CHMP fandt, at denne oplysning er uden betydning for sikkerheds- og virkningsprofilen af MACI, men at kravene i artikel 41 i direktiv 2001/83/EF ikke længere er opfyldt i mangel af et godkendt
English: In view of the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 10 September 2014, requesting the Agency to give its opinion on whether the marketing authorisation for MACI should be suspended or revoked in accordance with Article 118 of
Danish: På denne baggrund indledte Europa-Kommissionen den 10. september 2014 en procedure i medfør af artikel 20 i forordning (EF) nr. 726/2004, idet agenturet blev anmodet om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelsen for MACI burde suspenderes eller inddrages i medfør af artikel
English: Grounds for the suspension of the marketing authorisation
Danish: Begrundelse for suspenderingen af
English: • The Committee considered the notification under Article 20 of Regulation (EC) No 726/2004 for
Danish: • udvalget behandlede den procedure, som var indledt i henhold til artikel 20 i forordning (EF) nr. 726/2004 for MACI og udkastet til CHMP's beslutning, der var udarbejdet af Udvalget for
English: For the suspension of the marketing authorisation to be lifted, the MAH shall register a site for manufacture of the active substance, finished product and batch release.
Danish: For at suspenderingen af markedsføringstilladelsen kan ophæves, skal indehaveren af markedsføringstilladelsen registrere et fremstillingssted for det aktive stof, det færdige lægemiddel og
English: • The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
Danish: • udvalget konkluderede, at kravene i artikel 41 i direktiv 2001/83/EF ikke længere er opfyldt i fravær af et godkendt fremstillingssted for det aktive stof, det færdige lægemiddel og anbefaler CHMP suspendering af markedsføringstilladelsen for MACI i medfør af artikel 118 i direktiv
English: This kills the bacteria causing the infection.
Danish: Dette dræber de bakterier, som forårsager infektionen.
English: There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Danish: Der var også betænkeligheder ved, om EXULETT kunne fremstilles, så det konsekvent var af god kvalitet.
English: International non-proprietary name (INN): dalbavacin
Danish: Internationalt fællesnavn (INN): dalbavancin
English: The effects of EXULETT were first tested in experimental models before being studied in humans.
Danish: Virkningerne af EXULETT blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It contains the active substance dalbavancin.
Danish: Det indeholder det aktive stof dalbavancin.
English: Questions and answers on the withdrawal of the marketing application for EXULETT
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for EXULETT
English: It is expected to work by stopping the bacteria making their cell walls.
Danish: Det forventes at virke ved at forhindre bakterierne i at opbygge deres cellevægge.
English: The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Danish: Firmaet fremlagde resultaterne af en hovedundersøgelse, hvori man sammenlignede virkningerne af EXULETT med virkningerne af linezolid (et andet antibiotikum) hos 873 voksne.
English: These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Danish: Disse bakterier omfatter Staphylococcus aureus (herunder ‘meticillin-resistente' former kendt som ‘MRSA') og Streptococcus pyogenes.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med EXULETT?
English: The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Danish: Det aktive stof i EXULETT, dalbavancin, er et antibiotikum, som tilhører gruppen af ‘glycopeptider'.
English: The CHMP was concerned that the results of the single main study were too limited to support the approval of the medicine because of the way the study had been carried out, and was of the opinion that another study would be needed to confirm the results.
Danish: CHMP var betænkelig ved, at resultaterne af den eneste hovedundersøgelse var for begrænsede til at underbygge godkendelsen af lægemidlet på grund af den måde, hvorpå undersøgelsen var blevet gennemført, og var af den opfattelse, at der var behov for endnu en undersøgelse til at bekræfte resultaterne.
English: What was EXULETT expected to be used for?
Danish: Hvad forventedes EXULETT anvendt til?
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Danish: ‘Kompliceret' betyder, at infektionen er vanskelig at behandle, fordi den har spredt sig til det dybereliggende væv under huden, fordi kirurgisk behandling kan blive nødvendig, eller for patienten har andre lidelser, som kan have indvirkning på behandlingsresponsen.
English: How is EXULETT expected to work?
Danish: Hvordan forventes EXULETT at virke?
English: The main measure of effectiveness was the number of patients whose infection was treated successfully and who did not need further treatment with any other antibiotics.
Danish: Den vigtigste målestok for virkningen var antallet af patienter, for hvilke behandlingen af infektionen var vellykket, og som ikke havde behov for yderligere behandling med noget andet antibiotikum.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of EXULETT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved EXULETT ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
Danish: EXULETT er et pulver, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: What is EXULETT?
Danish: Hvad er EXULETT?
English: On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Danish: Den 9. september 2008 meddelte Pfizer Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for EXULETT til behandling af komplicerede hud- og bløddelsinfektioner hos voksne, når de vides eller formodes at være forårsaget af modtagelige grampositive bakterier.
English: In addition, the CHMP was concerned over the relevance of the results of the main study, since not all of the patients included in the study seemed to have an infection that was severe enough to need antibiotic treatment given by infusion into a vein.
Danish: Endvidere havde CHMP betænkeligheder ved relevansen af resultaterne af hovedundersøgelsen, da ikke alle patienter, som indgik i undersøgelsen, syntes at have en infektion, der var tilstrækkelig alvorlig til at kræve antibiotikabehandling givet som infusion i en vene.
English: The patients included in this study were required to have complicated skin and soft tissue infections (such as abscesses or wound infections) that were due to Gram-positive bacteria.
Danish: Det krævedes, at patienterne, som indgik i denne undersøgelse, havde komplicerede hud- og bløddelsinfektioner (såsom bylder eller sårinfektioner), der skyldtes grampositive bakterier.
English: EXULETT was to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Danish: EXULETT skulle have været anvendt til behandling af voksne med komplicerede infektioner i huden og ‘bløddelene' under huden.
English: EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive' and that would be killed by the medicine.
Danish: EXULETT skulle udelukkende have været anvendt, når man vidste eller formodede, at infektionen var forårsaget af bakterietyper, der er klassificeret som ‘grampositive', og som ville blive dræbt af lægemidlet.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
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 EXULETT ikke kunne godkendes til behandling af komplicerede hud- og bløddelsinfektioner hos voksne, når de vides eller formodes at være forårsaget af modtagelige grampositive bakterier.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Danish: Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser med EXULETT.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: inden udvalget afgiver en udtalelse, stille eventuelle supplerende spørgsmål til virksomheden på dag 180.
English: Bilirubin elevation was below 3%.
Danish: Stigning af bilirubin var under 3%.
English: In the rest of this leaflet, we will use the abbreviations when talking about these diseases.
Danish: I resten af denne indlægsseddel, vil vi bruge forkortelserne, når vi omtaler disse sygdomme.
English: In addition, children have been treated in two phase I studies and one phase II study.
Danish: Derudover har børn været behandlet i 2 fase I-studier og et fase II studie.
English: • Stir with a spoon until the tablets have completely dissolved.
Danish: • Omrør med en ske indtil tabletterne er opløst fuldstændig.
English: % of patients (CI95%)
Danish: % patienter (CI95%)
English: The primary efficacy endpoint of the study is progression-free survival.
Danish: Undersøgelsens primære effektmål er progressionsfri overlevelse.
English: A limited number of patients were enrolled in phase I studies (n=10).
Danish: Der inkluderedes et begrænset antal patienter i fase I undersøgelser (n=10).
English: Molecular response**
Danish: Molekulær respons**
English: PVC/PE/PVdC/PE/PVC//Al blisters OPA/Al/PVC//Al blisters
Danish: PVC/PE/PVdC/PE/PVC//Al blister OPA/Al/PVC//Al blister
English: Response data are shown in Table 2.
Danish: Responsdata fremgår af Tabel 2.
English: very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Other adverse reactions were reported with lower or equal frequency.
Danish: Andre bivirkninger blev indberettet med lavere eller den samme hyppighed.
English: • Risk Management Plan (RMP) Not applicable.
Danish: • Risikostyringsplan (RMP)
English: In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of age.
Danish: I alle kliniske undersøgelser var 38-40% af patienterne ≥60 år, og 10-12% af patienterne var ≥70 år.
English: A major response (0-35%) combines both complete and partial responses.
Danish: Et større respons (0-35%) omfatter både fuldstændig og delvis respons.