natgillin/translations-raw huggingface dataset:
Der blev ikke observeret tilfælde af symptomatisk LVD hos patienter i gruppen behandlet med Perjeta plus trastuzumab og 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af Perjeta plus trastuzumab og docetaxel.
No patients in the group treated with Perjeta plus trastuzumab and FEC followed by Perjeta plus trastuzumab and docetaxel experienced symptomatic LVD.
• Tør, kløende eller uren hud
Dry, itchy or acne like skin
Inters titiel lungesygdom Pleuraeffusion
Interstitial lung disease Pleural effusion
• 4 serier af doxorubicin og cyclophosphamid eller epirubicin og cyclophosphamid efterfulgt af 3 eller 4 serier af docetaxel eller 12 serier af ugentlig paclitaxel
• 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
I NEOSPHERE-studiet oplevede 8,4% af patienterne, som blev behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel, febril neutropeni sammenlignet med 7,5% af patienterne behandlet med trastuzumab og docetaxel.
In the NEOSPHERE trial, 8.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 7.5% of patients treated with trastuzumab and docetaxel.
Placebo + trastuzumab + kemoterapi N=2404
Placebo + trastuzumab + Chemotherapy N=2404
Startdosis på 840 mg pertuzumab genadministreres som 60 minutters infusion, herefter administreres vedligeholdelsesdosis på 420 mg i.v.
The 840 mg loading dose of pertuzumab should be re-administered as a 60 minute infusion, followed by a maintenance dose of 420 mg IV administered every 3 weeks thereafter.
^ Tabel 2 viser de samlede data fra hele behandlingsperioden i CLEOPATRA (dataskæringspunkt 11. februar 2014, det mediane antal Perjeta-serier var 24), og fra den neoadjuverende behandlingsperiode i NEOSPHERE (det mediane antal Perjeta-serier var , på tværs af alle behandlingsarmene) og TRYPHAENA (det mediane antal Perjeta-serier var 3-6, på tværs af behandlingsarmene) og fra behandlingsperioden i APHINITY (det mediane antal Perjeta-s erier var 18).
(median number of cycles of Perjeta was 4, across all treatment arms) and TRYPHAENA (median number of cycles of Perjeta was 3 - 6 across treatment arms) and from the treatment period of APHINITY (median number of cycles of Perjeta was 18).
• Svaghedsfølelse, følelsesløshed, prikken og stikken i især ben og fødder
Weak, numb, tingling or prickling sensations mainly affecting the feet and legs Nose bleeds
I den neoadjuverende behandlingsperiode af BERENICE-studiet var hyppigheden af NYHA klasse III/IV symptomatisk LVD (kongestiv hjerteinsufficiens ifølge NCI-CTCAE version 4) 1,5% i gruppen behandlet med kemoterapi (doxorubicin og cyclophosphamid) med kortere intervaller (dose-dense) efterfulgt af Perjeta plus trastuzumab og paclitaxel.
In the neoadjuvant period of the BERENICE trial, the incidence of NYHA Class III/IV symptomatic LVD (congestive heart failure according to NCI-CTCAE v.4) was 1.5% in the group treated with dose dense doxorubicin and cyclophosphamide (AC) followed by Perjeta plus trastuzumab and paclitaxel and none of the patients (0%) experienced symptomatic LVD in the group treated with FEC followed by Perjeta in combination with trastuzumab and docetaxel.
Lymfeknude-status Positiv Negativ Hormonereceptor-status Negativ Positiv Præ-specificerede subgruppe-analyser uden at justere for flere sammenligninger, og derfor betragtes res ultaterne for des kriptive
Prespecified subgroup analyses without adjusting for multiple comparisons, therefore, results are considered descriptive.
LÆGEMIDLETS NAVN Perjeta 420 mg koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion
• Nedsat antal røde blodlegemer - måles i blodprøve
Inflammation of your digestive tract (e.g. sore mouth) Decrease in the number of red blood cells - shown in a blood test Joint or muscle pain, muscle weakness
Vaskulære sygdomme Hedeture Luftveje, thorax og mediastinum
Respiratory, thoracic and medias tinal dis orders
Febril neutropeni forekom hos 13,7% i Perjeta-gruppen og hos 7,6% i placebo-gruppen.
Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients.
Antal patienter, der responderer***
Responders***
Patienter, der kun fik Perjeta plus trastuzumab inden operation fik efter operation både 5-fluoruracil, epirubicin og cyclophosphamid og docetaxel.
Patients who only received Perjeta plus trastuzumab prior to surgery subsequently received both FEC and docetaxel post surgery.
Infusionsreaktion ºº, * Overfølsomhedº, * Lægemiddeloverfølsomhedº, *
Immune system disorders Infusion reaction°°, * Hypersensitivity°, *
Forekomsten af diarré var meget lavere efter ophør af kemoterapi, hvilket påvirkede 18,1% af patienterne i Perjeta-armen vs. 9,2% af patienterne i placebo-armen i forsøgsbehandlingsperioden efter kemoterapi.
18.1% of patients in the Perjeta arm vs. 9.2% of patients in the placebo arm in the post-chemotherapy targeted therapy period.
Patient-rapporterede resultater
Patient Reported Outcomes (PRO)
(vs. Perjeta trastuzumab docetaxel)
(vs. Trastuzumab +Docetaxel)
Laboratorieafvigelser
Laboratory abnormalities
For at undgå skumdannelse skal posen vendes forsigtigt, når infusionsvæsken blandes.
The bag should be gently inverted to mix the solution in order to avoid foaming.
Uåbnede hætteglas
Unopened vial
• Gruppe B - 4 serier af 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af 4 serier af Perjeta i kombination med trastuzumab og docetaxel
• Cohort B - 4 cycles of FEC followed by 4 cycles of Perjeta in combination with trastuzumab and docetaxel.
Navn og adresse på fremstilleren af det biologisk aktive stof
Name and address of the manufacturer of the biological active substance(s) Genentech, Inc.
epirubicin og cyclophosphamid efterfulgt af Perjeta plus trastuzumab og docetaxel, 9,3% i gruppen behandlet med Perjeta plus trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid, og 6,6% i gruppen behandlet med Perjeta i kombination med docetaxel, carboplatin og trastuzumab.
was 8.3% in the group treated with Perjeta plus trastuzumab and FEC (5-fluorouracil, epirubicin, cyclophosphamide) followed by Perjeta plus trastuzumab and docetaxel; 9.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC; and 6.6% in the group treated with
I TRYPHAENA-studiet opstod der febril neutropeni hos 17,1% af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 9,3% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter 5fluoruracil, epirubicin og cyclophosphamid.
In the TRYPHAENA trial, febrile neutropenia occurred in 17.1% of patients treated with neoadjuvant Perjeta + TCH, and 9.3% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Pertuzumabs effekt på farmakokinetikken af de cytotoksiske lægemidler docetaxel, paclitaxel, gemcitabin, capecitabin, carboplatin og erlotinib ved samtidig administration er undersøgt i fem kliniske studier.
Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib.
genadministreres over ca. 90 minutter, herefter administreres vedligeholdelsesdosis på 6 mg/kg i.v.
The loading dose of 8 mg/kg of trastuzumab IV should be readministered over approximately 90 minutes, followed by a maintenance dose of 6 mg/kg IV administered every 3 weeks thereafter.
Obstipation Dyspepsi Abdominalsmerter
Gastrointestinal disorders Diarrhoea Vomiting
I TRYPHAENA-studiet forekom diarré hos 72,3% af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 61,4% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid.
In the TRYPHAENA trial, diarrhoea occurred in 72.3% of patients treated with neoadjuvant Perjeta+TCH and 61.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Ændring i diarrésymptomer øgedes til +22,3 (95% konfidensinterval - 21,0; 23,6) i Perjeta-armen vs. +9,2 (95% konfidensinterval - 8,2; 10,2) i placeboarmen.
21.0, 23.6) in the Perjeta arm versus +9.2 (95% CI 8.2, 10.2) in the placebo arm.
• Hårtab
Hair loss
p-værdi (med Simes korr.
p-value (with
En populationsfarmakokinetisk analyse blev udført med data fra 481 patienter med forskellige typer af avanceret malignitet fra forskellige kliniske studier (fase I, II og III).
A population pharmacokinetic analysis was performed with data from 481 patients across different clinical trials (phase I, II and III) with various types of advanced malignancies who had received Perjeta as a single agent or in combination at pertuzumab doses ranging from 2 to 25 mg/kg administered every 3 weeks as a 30-60 minutes intravenous infusion.
I TRYPHAENA-studiet forekom udslæt hos 36,8% af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 20,0% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter behandling med 5-fluoruracil, epirubicin og cyclophosphamid.
In the TRYPHAENA trial, rash occurred in 36.8% of patients treated with neoadjuvant Perjeta + TCH and 20.0% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Perjeta + trastuzumab + docetaxel N=107
Perjeta+ Trastuzuma b+ Docetaxel N=107
Invasiv sygdomsfri overlevelse Antal (%) patienter med hændelse Hazard ratio [95% konfidensinterval] p-værdi (Log-Rank-test, stratificeret1) Antal patienter uden hændelse efter tre år3 [95% konfidensinterval]
p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI] Overall Survival (OS)3
Figur 2
Due date
Ud fra et toksicitetsstudie med gentagen dosering hos cynomolgus-aber kan der ikke drages en endelig konklusion om påvirkningen af hanners reproduktionssystem.
No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Anafylaktisk reaktionº, * Cytokinfrigivelsessyndromºº
Cytokine release syndrome°°
91,2% efter 3 år og 91,0% vs. 88,7% efter 4 år hos henholdsvis Perjeta-behandlede patienter og placebo-behandlede patienter.
96.2% versus 96.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Perjeta indeholder:
What is in this leaflet:
Forskel i objektiv responsrate:
Difference in ORR:
Sekundære virkningsendepunkter var klinisk respons rate, brystbevarende operationsrate (kun T2-3 tumorer), sygdomsfri overlevelse og progressionsfri overlevelse.
Secondary efficacy endpoints were clinical response rate, breast conserving surgery rate (T2-3 tumours only), disease-free survival (DFS), and PFS. Additional exploratory pCR rates included nodal status (ypT0/isN0 and ypT0N0).
I NEOSPHERE-studiet var hyppigheden af NCI-CTCAE (version 3) grad 3-4 neutropeni 74,5% hos patienter behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel sammenlignet med 84,5% af patienter behandlet med trastuzumab og docetaxel inklusive henholdsvis 50,9% og 60,2% grad 4 neutropeni.I TRYPHAENA-studiet var hyppigheden af NCI-CTCAE (version 3) grad 3-4 neutropeni 85,3% hos patienter behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og 77,0% hos patienter behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter behandling med 5-fluoruracil, epirubicin og cyclophosphamid, inklusive henholdsvis 66,7% og 59,5% grad 4 neutropeni.
In the TRYPHAENA trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 85.3% in patients treated with neoadjuvant Perjeta + TCH and 77.0% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC, including 66.7% and 59.5% Grade 4 neutropenia,
Hud og subkutane væv Alopeci Udslæt
Skin and subcutaneous tissue disorders
Hazard ratio [95% konfidensinterval] p-værdi (Log-Rank-test, stratificeret1)
p-value (Log-Rank test, stratified1) 3 year event-free rate3 [95% CI] Secondary Endpoints1
Infektioner og parasitære sygdomme
Infections and infestations Nasopharyngitis
Perjeta tilhører en gruppe lægemidler, der kaldes monoklonale antistoffer.
Perjeta is a type of medicine called a “monoclonal antibody” which attaches itself to specific targets in your body and on the cancer cells.
• Feber forbundet med faretruende lave niveauer af hvide blodlegemer (neutrofilocytter)
Fever associated with dangerously low levels of a type of white blood cell (neutrophils) Pain in the body, arms, legs, and belly
Opkastning Stomatitis Kvalme
Hepatic impairment
Sekundære effektendepunkter var pCR-rate i brystet (ypT0/is), sygdomsfri overlevelse, progressionsfri overlevelse og samlet overlevelse.
Secondary efficacy endpoints were pCR rate in the breast (ypT0/is), DFS, PFS and OS.
Trastuzumab + docetaxel N=107
Trastuzum ab +Docetaxel N=107
Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
Ask your doctor or nurse to give you information about these other medicines.
Hyppigheden af asymptomatisk LVD (ejektionsfraktionfald ifølge NCI-CTCAE version 4) var 7% i gruppen behandlet med kemoterapi (doxorubicin og cyclophosphamid) med kortere intervaller (dose-dense) efterfulgt af Perjeta plus trastuzumab og paclitaxel, og 3,5% i gruppen behandlet med 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af Perjeta plus trastuzumab og docetaxel.
(ejection fraction decrease according to NCI-CTCAE v.4) was 7% in the group treated with dose dense AC followed by Perjeta plus trastuzumab and paclitaxel and 3.5% in the group treated with FEC
Tør hud
Hot flush
• 3 serier bestående af 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af 3 serier docetaxel, alle givet sideløbende med Perjeta og trastuzumab
• 3 cycles of FEC followed by 3 cycles of docetaxel, all given concurrently with Perjeta and trastuzumab
Du kan finde information om disse lægemidler i de tilhørende indlægssedler.
As well as Perjeta you will also receive trastuzumab and medicines called chemotherapy Information about these medicines is described in separate package leaflets.
Hyppigheden af symptomatisk LVD (kongestiv hjerteinsufficiens) var 1,3% i gruppen behandlet med Perjeta plus trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid (det er set bort fra en patient, som oplevede symptomatisk LVD under behandling med 5-fluoruracil, epirubicin og cyclophosphamid inden Perjeta plus trastuzumab og docetaxel blev givet) og ligeledes 1,3% i gruppen behandlet med Perjeta i kombination med docetaxel, carboplatin og trastuzumab.
The incidence of symptomatic LVD (congestive heart failure) was 1.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC (this excludes a patient who experienced symptomatic LVD
Nasopharyngitis
Dysgeusia
Perjeta er et koncentrat til infusionsvæske, opløsning.
PHARMACEUTICAL FORM Concentrate for solution for infusion.
Perjeta + tras tuzumab + FEC Perjeta + tras tuzumab + docetaxel N=73
Perjeta+ Trastuzumab+ FEC Perjeta+ Trastuzumab
Der henvises til produktresumé for trastuzumab for yderligere oplysninger om dette produkt.
For details regarding trastuzumab, please refer to the summary of product characteristics (SmPC).
• Forstoppelse
Paraesthesia
I det neoadjuverende studie TRYPHAENA var hyppigheden af LVD (i den samlede behandlingsperiode) 8,3% i gruppen behandlet med Perjeta plus trastuzumab og 5-fluoruracil,
In the neoadjuvant trial NEOSPHERE, in which patients received 4 cycles of Perjeta as neoadjuvant treatment, the incidence of LVD (during the overall treatment period) was higher in the Perjeta,
Den 8. marts 2010 meddelte Mylan S.A.S.
On 8 March 2010, Mylan S.A.S.
Det skulle anvendes alene eller i kombination med andre lægemidler mod kræft.
It was to be used on its own or with other anticancer medicines.
Det betyder, at CHMP har vurderet den oprindelige dokumentation fremlagt af virksomheden og opstillet en liste med spørgsmål.
This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Virksomheden havde endnu ikke besvaret spørgsmålene på tidspunktet for tilbagetrækningen af ansøgningen.
The company had not yet responded to the questions at the time of the withdrawal.
Virksomheden har fremlagt data om docetaxel fra den offentliggjorte litteratur.
The company provided data on docetaxel from the published literature.
Når celleskelettet hele tiden er intakt, kan cellerne ikke dele sig og vil til sidst dø.
With the skeleton still in place, the cells cannot divide and they eventually die.
Andre stoffer blev føjet til docetaxel for at hjælpe det med at danne små kugleformede strukturer kaldet 'miceller', som er egnet til injektion.
Other substances are added to docetaxel to help it form small spherical structures called ‘micelles' that are suitable for injection.
Det betyder, at det var hensigten, at Docetaxel Mylan skulle være identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Taxotere.
This means that Docetaxel Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
Docetaxel påvirker også andre celler end kræftcellerne, f.eks. blodcellerne, hvilket kan medføre bivirkninger.
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Derfor og på grund af micellernes komplekse karakter besluttede udvalget, at det var nødvendigt at foretage yderligere undersøgelser af Docetaxel Mylan, herunder blandt andet undersøgelser af, hvordan kroppen ville reagere på lægemidlet, og af dets sikkerhed.
Because of this and the complex nature of micelles themselves, the Committee had concluded that additional studies on Docetaxel Mylan were necessary, including studies on how the medicine would be treated by the body and its safety.
De stoffer, der blev føjet til Docetaxel Mylan og Taxotere for at danne miceller, er dog ikke de samme.
However, the substances added in Docetaxel Mylan and Taxotere to form the micelles are not the same.
Da Docetaxel Mylan indeholder det samme aktive stof som Taxotere og skulle indgives direkte i en vene, anså virksomheden, at det i overensstemmelse med bestemmelserne i EU ikke var nødvendigt med yderligere undersøgelser af Docetaxel Mylan.
Because Docetaxel Mylan contains the same active substance as Taxotere and was to be given directly into a vein, the company did not consider additional studies on the Docetaxel Mylan to be necessary according to EU rules.
På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Docetaxel Mylan ikke kunne være blevet godkendt.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Mylan could not have been approved.
officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Docetaxel Mylan, som er beregnet til behandling af brystkræft, ikke-småcellet lungekræft, prostatakræft, kirtelkræft i maven og kræft i hoved- og halsregionen.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Hvad er Docetaxel Mylan?
What is Docetaxel Mylan?
Det fås som et pulver, der blandes til en opløsning til infusion (drop i en vene).
It was to be available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Docetaxel Mylan er et lægemiddel, der indeholder det aktive stof docetaxel.
Docetaxel Mylan is a medicine that contains the active substance docetaxel.
Docetaxel Mylan blev udviklet som et generisk lægemiddel.
Docetaxel Mylan was developed as a ‘generic medicine'.
Det aktive stof i Docetaxel Mylan, docetaxel, tilhører en gruppe kræftlægemidler, der kaldes taxaner.
The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Docetaxel blokerer cellens evne til at nedbryde det indvendige celleskelet, der gør det muligt for cellerne at dele og formere sig.
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
CHMP var derfor af den opfattelse, at virksomheden på tidspunktet for tilbagetrækningen ikke havde forelagt tilstrækkelig dokumentation til at understøtte brugen af Docetaxel Mylan.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Mylan.
Docetaxel Mylan forventedes anvendt til behandling af brystkræft, ikke-småcellet lungekræft, prostatakræft, kirtelkræft i maven og kræft i hoved- og halsregionen.
Docetaxel Mylan was expected to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and head and neck cancer.
Hvad forventedes Docetaxel Mylan anvendt til?
What was Docetaxel Mylan expected to be used for?
Hvordan forventes Docetaxel Mylan at virke?
How is Docetaxel Mylan expected to work?
Ansøgningsproceduren var ved dag 180, da virksomheden trak sin ansøgning tilbage..
The application was withdrawn at ‘day 120'.
Den fuldstændige europæiske offentlige vurderingsrapport for Javlor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full European Public Assessment Report for Javlor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Virksomheden kan anmode om, at udtalelsen tages op til fornyet overvejelse inden for 15 dage efter modtagelsen af underretningen om denne negative udtalelse.
It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Hvad er Javlor?
What is Javlor?
Javlor er et lægemiddel mod kræft, som har været godkendt i EU siden september 2009.
Javlor is a cancer medicine that has been authorised in the EU since September 2009.
Den virksomhed, som ansøgte om ændringen, er Pierre Fabre Médicament.
The company that applied for the change to the authorisation is Pierre Fabre Médicament.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 September 2014
Der var bedring i den progressionsfrie overlevelse, men bedringen blev anset for at være lille.
Although there was an improvement in progression-free survival, this was considered to be small.
Hvis du deltager i en klinisk undersøgelse med Javlor og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Desuden var der ingen fordel bedømt på andre vigtige mål for virkningen, herunder den totale overlevelse (hvor længe patienterne levede).
In addition, there was no benefit in terms of other important measures of effectiveness, including overall survival (how long patients lived).
Hvad forventedes Javlor anvendt til?
What was Javlor expected to be used for?
Afgørelsen vil ikke få konsekvenser for anvendelsen af Javlor til den godkendte indikation.
There are no consequences on the use of Javlor in its authorised indication.
At kræften er metastatisk vil sige, at den har bredt sig til andre dele af kroppen.
‘Metastatic' means that the cancer has spread to other parts of the body.
Afslag på ansøgningen om ændring af markedsføringstilladelsen for Javlor (vinflunin) EMA/587197/2014
Refusal of a change to the marketing authorisation for Javlor (vinflunine) EMA/587197/2014
Hvordan forventes Javlor at virke?
How is Javlor expected to work?
Afslag på ansøgningen om ændring af markedsføringstilladelsen for Javlor (vinflunin)
Refusal of a change to the marketing authorisation for Javlor (vinflunine)