natgillin/translations-raw huggingface dataset:
Der var observeret signifikante forbedringer i den samlede overlevelse hos patienter i Cotellic plus vemurafenib-armen sammenlignet med placebo plus vemurafenib-armen (Figur 1). 
Significant improvement in OS was observed in patients assigned to the Cotellic plus vemurafenib arm compared to the placebo plus vemurafenib arm (Figure 1).
Sikkerheden af Cotellic i kombination med vemurafenib er også evalueret i studie NO25395 hos 129 patienter med fremskreden BRAF-V600-muteret melanom. 
The safety of Cotellic in combination with vemurafenib has also been evaluated in 129 patients with advanced BRAF V600 mutated melanoma in Study NO25395.
Medianen for progressionsfri overlevelse for patienter, der ikke tidligere havde fået BRAF-hæmmer, var 13,8 måneder med en median opfølgningstid på 20,6 måneder. 
The median PFS for BRAFi-naïve patients was 13.8 months, with median follow-up time of 20.6 months.
Nedsat uddrivningsfraktion, forhøjet blod-bilirubin 
Ejection fraction decreased, Blood bilirubin increased
I toksicitetsstudier med rotter og hunde er der set generelt reversible, degenerative forandringer i knoglemarv, mave-tarmkanal, hud, thymus, binyrer, lever, milt, lymfeknuder, nyrer, hjerte, ovarier og vagina ved plasmaeksponering under det klinisk effektive niveau. 
Toxicity studies in rats and dogs identified generally reversible degenerative changes in the bone marrow, gastrointestinal tract, skin, thymus, adrenal gland, liver, spleen, lymph node, kidney, heart, ovary, and vagina at plasma exposures below clinical efficacious levels.
Anbefalet daglig dosis af Cotellic 
Recommended Cotellic daily dose
Tag altid medicinen nøjagtig efter lægens eller apotekspersonalets anvisning. 
Always take this medicine exactly as your doctor or pharmacist has told you.
Symptomer på rabdomyolyse kræver en passende klinisk vurdering og behandling som angivet, sammen med Cotellic dosisjustering eller afbrydelse i henhold til sværhedsgraden af bivirkningen (se pkt. 
Signs or symptoms of rhabdomyolysis warrant an appropriate clinical evaluation and treatment as indicated, along with Cotellic dose modification or discontinuation according to the severity of the adverse reaction (see section 4.2 and 4.4).
Hvad bruges Cotellic til? 
What Cotellic is used for
Ved grad ≤ 2 (tolerabelt) udslæt gives understøttende behandling. 
Grade ≤2 (tolerable) rash should be managed with supportive care.
Større blødninger (inklusiv intrakranial og gastrointestinale blødninger) blev rapporteret efter markedsføring. 
Major haemorrhagic events (including intracranial and gastrointestinal tract haemorrhage) were reported in the post-marketing setting.
I toksikologistudier er der observeret degenerative forandringer i reproduktive væv, inklusive øget apoptose/nekrose af corpus luteum og vesicula seminalis, epididymale og vaginale epitelceller hos rotter samt epididymale epitelceller hos hunde. 
In toxicology studies, degenerative changes were observed in reproductive tissues including increased apoptosis/necrosis of corpora lutea and seminal vesicle, epididymal and vaginal epithelial cells in rats, and epididymal epithelial cells in dogs.
Ved lysfølsomhedsreaktion grad ≤ 2 (tolerabel) bør der gives understøttende behandling. 
Grade ≤2 (tolerable) photosensitivity should be managed with supportive care.
Ved abnorme leverværdier grad 1 og 2 fortsættes behandlingen med Cotellic og vemurafenib med den ordinerede dosis. 
For Grade 1 and 2 liver laboratory abnormalities, Cotellic and vemurafenib should be continued at the prescribed dose.
Hvis serum kreatinkinase er forhøjet, skal der undersøges for symptomer på rabdomyolyse eller andre årsager. 
If serum CPK is elevated, check for signs and symptoms of rhabdomyolysis or other causes.
LVEF bør evalueres inden påbegyndelse af behandling med henblik på at fastlægge baseline-værdi, herefter efter 1 måneds behandling samt mindst hver 3. måned eller som klinisk indiceret, indtil behandlingen seponeres. 
LVEF should be evaluated before initiation of treatment to establish baseline values, then after the first month of treatment and at least every 3 months or as clinically indicated until treatment discontinuation.
Du skal straks kontakte lægen, hvis du oplever enhver usædvanlig blødning eller nogle af disse symptomer: hovedpine, svimmelhed, følelse af svaghed, blod i afføringen eller sort afføring og opkastning af blod. 
Tell your doctor straight away if you have any unusual bleeding or any of these symptoms: headaches, dizziness, feeling weak, blood in the stools or black stools and vomiting blood.
Lysoverfølsomhed blev ikke observeret, når Cotellic er anvendt som enkeltstof. 
No evidence of phototoxicity was observed with Cotellic as a single agent.
Dosis af vemurafenib bør reduceres som klinisk hensigtsmæssigt, se produktresuméet for vemurafenib for yderligere information. 
Vemurafenib dosing should be reduced as clinically appropriate, please refer to its SmPC for further information.
Cotellic i kombination med vemurafenib hos patienter med hjernemetastaser Sikkerhed og virkning af Cotellic i kombination med vemurafenib har ikke været undersøgt hos patienter med BRAF-V600-mutationspositivt melanom, som har hjernemetastaser. 
Cotellic in combination with vemurafenib in patients with brain metastases The safety and efficacy of the combination of Cotellic and vemurafenib have not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Den kliniske relevans af disse fund er ikke fastlagt. 
The clinical relevance of these findings has not been investigated.
Sjælden ≥ 1/10.000 til < 1/1000 
Rare ≥ 1/10,000 to < 1/1,000
Hvis samtidig administration af potente CYP3Ahæmmere ikke kan undgås, skal patienterne overvåges omhyggeligt med hensyn til sikkerhed. 
If concomitant use of a strong CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety.
Hvis du ammer, vil lægen snakke med dig om fordele og risici ved at tage Cotellic. 
Your doctor will discuss with you the benefits and risks of taking Cotellic, if you are breast-feeding.
Serøs retinopatia, sløret syn 
Serous retinopathya, Blurred vision
Der er kun ganske få data vedrørende Cotellic til patienter med svært nedsat nyrefunktion. 
There are minimal data for Cotellic in patients with severe renal impairment.
Grad 3 og 4 stigninger i kreatinkinase, som inkluderer asymptomatiske stigninger over baseline, forekom også hos patienter behandlet med Cotellic sammen med Vemurafenib i kliniske forsøg (se pkt. 
Grade 3 and 4 CPK elevations, including asymptomatic elevations over baseline, also occurred in patients receiving Cotellic with vemurafenib in clinical trials (see section 4.8).
Det vides ikke, hvordan Cotellic virker hos patienter, der er under 18 år gamle. 
The effects of Cotellic in people younger than 18 years old are not known.
Asymptomatisk stigning i blod-kreatinkinase observeredes hyppigere i Cotellic-plus-vemurafenibarmen sammenlignet med placebo-plus-vemurafenib-armen i studie GO28141 (se pkt. 
Asymptomatic increases in blood CPK levels were observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm in Study GO28141 (see section 4.2 and 4.4).
Der er ikke gennemført specifikke fertilitetsstudier med cobimetinib hos dyr. 
No dedicated fertility studies in animals have been performed with cobimetinib.
Den intrakranielle virkning af cobimetinib er endnu ukendt (se pkt. 
The intracranial activity of cobimetinib is currently unknown (see sections 5.1 and 5.2).
(eller ≥10% absolut fald fra baseline) 
(or ≥ 10% absolute decrease from baseline)
gange dagligt på dag 1-28, eller · Cotellic 60 mg 1 gang dagligt på dag 1-21 i hver 28 dages behandlingscyklus og 960 mg vemurafenib 2 gange dagligt på dag 1-28 
495 previously untreated patients with unresectable locally advanced or metastatic melanoma were randomised to receive either: · Placebo once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28, or · Cotellic 60 mg once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28
I studiet blev observeret et tilfælde af rabdomyolyse i hver behandlingsarm med samtidig stigning i blod-kreatinkinase. 
One event of rhabdomyolysis was observed in each treatment arm of the study with concurrent increases in blood CPK.
5.2) Abnorme laboratorieleverværdier kan forekomme med Cotellic og der skal udvises forsigtighed hos patienter med alle grader af nedsat leverfunktion (se pkt. 
Liver laboratory abnormalities can occur with Cotellic and caution should be used in patients with any degree of hepatic impairment (see section 4.4).
Lægen skal lave undersøgelser for at vurdere hjertets pumpeevne før og under din behandling med Cotellic. 
Your doctor should do tests before and during your treatment with Cotellic to check how well your heart can pump blood.
Hvis sværhedsgraden forbedres med mindst en grad inden for 4 uger, kan Cotellic-behandling genoptages ved en dosis reduceret med 20 mg, hvis det er klinisk indiceret. 
If severity is improved by at least one grade within 4 weeks, Cotellic could be restarted at a dose reduced by 20 mg, if clinically indicated.
Der findes ingen data om effekten af Cotellic- dosisjustering ved blødninger. 
There is no data on the effectiveness of Cotellic dose modification for haemorrhage events.
Basalcellekarcinom, kutant planocellulært karcinom**, keratoakantom** 
Basal cell carcinoma, Cutaneous squamous cell carcinoma**, Keratoacanthoma**
Dosisjustering anbefales ikke til patienter med nedsat leverfunktion (se pkt. 
No dose adjustment is recommended in patients with hepatic impairment (see section 5.2).
Der er ikke gennemført formelle farmakokinetiske studier hos patienter med nedsat nyrefunktion. 
No formal pharmacokinetic study has been conducted in patients with renal impairment.
Du skal straks kontakte lægen, hvis du oplever nogle af disse symptomer: muskelømhed, muskelkramper, svaghed eller mørk eller rødfarvet urin. 
Tell your doctor straight away if you get any of these symptoms: muscle aches, muscle spasms, weakness, or dark- or redcoloured urine.
Studie GO28141 er et randomiseret, dobbeltblindet, placebokontrolleret, fase III-multicenterstudie, der evaluerede sikkerheden og virkningen af Cotellic i kombination med vemurafenib sammenlignet med vemurafenib plus placebo hos tidligere ubehandlede patienter med BRAF-V600-mutationspositivt, ikke-operabelt, lokalt fremskredent (stadie IIIc) eller metastatisk (stadie IV) melanom. 
Study GO28141 is a multi-centre, randomised, double-blind, placebo-controlled, Phase III study to evaluate the safety and efficacy of Cotellic in combination with vemurafenib as compared to vemurafenib plus placebo, in previously untreated patients with BRAF V600 mutation-positive unresectable locally advanced (Stage IIIc) or metastatic melanoma (Stage IV).
Samtidig administration af potente CYP3A-hæmmere under behandling med Cotellic skal undgås. 
Concurrent use of strong CYP3A inhibitors during treatment with Cotellic should be avoided.
Hvis der konstateres serøs retinopati, afbrydes Cotellic-behandlingen, indtil symptomerne forbedres til grad ≤ 1. 
If serous retinopathy is diagnosed, Cotellic treatment should be withheld until visual symptoms improve to Grade ≤1.
Lægemiddelinteraktioner: CYP3A-hæmmere 
Drug-drug interactions: CYP3A inhibitors
Vemurafenibdosering kan fortsættes, mens Cotellic-behandling ændres. 
Vemurafenib dosing can be continued when Cotellic treatment is modified.
Cotellic kan svække hjertets pumpeevne (se også ”Hjerteproblemer” i afsnit 4). 
Cotellic can lower the amount of blood pumped by your heart (see also “Heart problems” in Section 4).
P-glykoprotein-hæmmere 
P-glycoprotein inhibitors
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder cobimetinibhemifumarat svarende til 20 mg cobimetinib. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
Der er observeret abnorme leverværdier, særligt stigning i alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) og alkalisk fosfatase (ALP), hos patienter behandlet med Cotellic og vemurafenib (se pkt. 
Liver laboratory abnormalities, specifically increases in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP), have been observed in patients treated with Cotellic plus vemurafenib (see section 4.8).
Vejledning i dosisændringer for Cotellic, når det bruges sammen med vemurafenib Abnorme leverværdier 
Dose modification advice for Cotellic when used with vemurafenib Liver laboratory abnormalities
Størstedelen af bivirkningerne er indrapporteret som korioretinopati eller nethindeløsning. 
The majority of events were reported as chorioretinopathy or retinal detachment.
Afhængig af sværhedsgraden af symptomer eller stigning i kreatinkinase; behandling afbrydes, reducering af dosis eller seponering af behandling kan være påkrævet (se pkt. 
Depending on the severity of symptoms or CPK elevation; treatment interruption, dose reduction or treatment discontinuation may be required (see section 4.2).
Cotellic-behandling skal seponeres permanent hvis blødninger tilskrives Cotellic. 
Cotellic treatment should be permanently discontinued for haemorrhage events attributed to Cotellic.
Svage CYP3A-hæmmere: Cobimetinib kan administreres samtidig med svage CYP3A-hæmmere uden dosisjustering. 
Mild CYP3A inhibitors: Cobimetinib can be co-administered with mild inhibitors of CYP3A without dose adjustment.
Ikke almindelig ≥ 1/1000 til < 1/100 
Uncommon ≥ 1/1,000 to < 1/100
Ved lysfølsomhedsreaktion grad 2 (intolerabel) eller grad ≥ 3: Behandling med Cotellic og vemurafenib afbrydes, indtil bivirkningen er reduceret til grad ≤ 1. 
Grade 2 (intolerable) or Grade ≥3 photosensitivity: Cotellic and vemurafenib should be interrupted until resolution to Grade ≤1.
Vemurafenibbehandlingen kan afbrydes midlertidigt og/eller dosis reduceres, se produktresuméet for vemurafenib for yderligere information. 
Vemurafenib dosing may be either temporarily interrupted and/or reduced, please refer to its SmPC for further information.
Ved kort tids brug (7 dage eller mindre) af potente CYP3A-hæmmere, bør det overvejes at afbryde behandlingen med cobimetinib, mens behandlingen med CYP3A-hæmmeren foregår. 
For strong CYP3A inhibitors used short-term (7 days or less), consider interrupting cobimetinib therapy during the duration of inhibitor use.
LVEF efter behandlingspause 
LVEF value following treatment break
Hvordan virker Cotellic? 
How Cotellic works
Der skal udvises forsigtighed, hvis moderate CYP3A-hæmmere administreres samtidig med Cotellic. 
Caution should be exercised if a moderate CYP3A inhibitor is co-administered with Cotellic.
Abnorme laboratorieværdier 
Liver laboratory abnormalities
Cotellic er, i kombination med vemurafenib, indiceret til behandling af voksne patienter med ikkeoperabelt eller metastatisk melanom med BRAF-V600-mutation (se pkt. 
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Hvis rabdomyolyse diagnosticeres, bør behandling med Cotellic afbrydes samt kreatinkinaseniveauer og andre symptomer overvåges indtil bivirkningen reduceres. 
If rhabdomyolysis is diagnosed, Cotellic treatment should be interrupted and CPK levels and other symptoms monitored until resolution.
Brug af anden medicin sammen med Cotellic 
Other medicines and Cotellic
Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller skraldespanden. 
· Do not throw away any medicines via wastewater or household waste.
Bivirkningerne er indsamlet i et randomiseret, dobbeltblindet, placebokontrolleret, fase IIImulticenterstudie (GO28141), der evaluerede sikkerheden og virkningen af Cotellic i kombination med vemurafenib sammenlignet med vemurafenib alene hos tidligere ubehandlede BRAF-V600mutationspositive patienter med ikke-operabelt, lokalt fremskredent (stadie IIIc) eller metastatisk melanom (stadie IV). 
ADRs are based on results from a multi-centre, randomised, double-blind, placebo-controlled, Phase III Study (GO28141) that evaluated the safety and efficacy of Cotellic in combination with vemurafenib as compared to vemurafenib alone in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced (Stage IIIc) or metastatic melanoma (Stage IV).
Baseret på en farmakokinetisk populationsanalyse med 210 kvinder og 277 mænd påvirker køn ikke eksponeringen af cobimetinib. 
Gender does not have an effect on the exposure of cobimetinib, based on a population pharmacokinetic analysis including 210 women and 277 men.
· visse former for hudkræft såsom basalcellekræft, pladecellekræft og keratoakantom · dehydrering, hvor kroppen mangler væske · fald i fosfat- eller natriumværdier (ses ved blodprøve) · forhøjede sukkerværdier (ses ved blodprøve) · forhøjet bilirubin (leverpigment) i blodet. 
Common (may affect up to 1 in 10 people) · some types of skin cancer such as basal cell carcinoma, cutaneous squamous cell carcinoma and keratoacanthoma · dehydration, when your body does not have enough fluid · decreased levels of phosphate or sodium (shown in blood tests) · increased sugar level (shown in blood tests) · increased liver pigment (called “bilirubin”) in the blood.
Moderate CYP3A-hæmmere (se pkt. 
Moderate CYP3A inhibitors (see section 4.4.
· Blødning 
· Bleeding
Patienter med nye eller forværrede synsforstyrrelser skal have foretaget oftalmologisk undersøgelse. 
For patients reporting new or worsening visual disturbances, an ophthalmologic examination is recommended.
· Opbevar lægemidlet utilgængeligt for børn. 
· Keep this medicine out of the sight and reach of children.
4.4): Der skal udvises forsigtighed, hvis cobimetinib administreres samtidig med moderate CYP3A-hæmmere. 
): Caution should be exercised if cobimetinib is coadministered with moderate CYP3A inhibitors.
Den gennemsnitlige tilsyneladende plasmaclearance efter en oral dosis på 60 mg til kræftpatienter var 
The mean apparent CL following oral dosing of 60 mg in cancer patients was 13.8 L/hr.
Dosisjustering anbefales ikke til patienter med nedsat leverfunktion. 
No dose adjustment is recommended in patients with hepatic impairment.
Hver filmovertrukken tablet indeholder cobimetinibhemifumarat svarende til 20 mg cobimetinib. 
Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
4.4): Undgå samtidig administration af potente CYP3A-hæmmere under behandling med cobimetinib. 
): Avoid concurrent use of strong CYP3A inhibitors during treatment with cobimetinib.
Abnorme leverværdier kan forekomme, når Cotellic anvendes i kombination med vemurafenib og med vemurafenib i enkeltstofbehandling (se produktresuméet for vemurafenib). 
Liver laboratory abnormalities can occur when Cotellic is used in combination with vemurafenib and with vemurafenib as a single agent (please refer to its SmPC).
LÆGEMIDLETS NAVN Cotellic 20 mg filmovertrukne tabletter cobimetinib 
NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets cobimetinib
Der er observeret abnorme leverværdier, specifikt ALAT, ASAT og ALP, hos patienter behandlet med Cotellic i kombination med vemurafenib (se pkt. 
Liver laboratory abnormalities, specifically ALT, AST, and ALP have been observed in patients treated with Cotellic in combination with vemurafenib (see section 4.4).
Hvis leverværdierne bedres til grad ≤ 1 inden for 4 uger, genoptages Cotellic i en reduceret dosis på 20 mg og vemurafenib i en klinisk hensigtsmæssigt dosis i overensstemmelse med dets produktresumé. 
If liver laboratory abnormalities improve to Grade ≤1 within 4 weeks, Cotellic should be restarted at a dose reduced by 20 mg and vemurafenib at a clinically appropriate dose, per its SmPC.
Ved grad 3 abnorme leverværdier skal vemurafenibbehandlingen afbrydes eller vemurafenibdosis reduceres. 
Grade 3 liver laboratory abnormalities should be managed with vemurafenib treatment interruption or dose reduction.
Brug af Cotellic sammen med mad og drikke Undgå at drikke grapefrugtjuice, så længe du tager Cotellic. 
Avoid taking Cotellic with grapefruit juice.
Baseret på en farmakokinetisk populationsanalyse med 133 patienter ≥ 65 år påvirker alder ikke eksponeringen af cobimetinib. 
Age does not have an effect on the exposure of cobimetinib, based on a population pharmacokinetic analysis including 133 patients ≥ 65 years of age.
Hjerteproblemer (almindelige: kan optræde hos op til 1 ud af 10 patienter) Cotellic kan nedsætte hjertets pumpeevne. 
Heart problems (common: may affect up to 1 in 10 people) Cotellic can lower the amount of blood pumped by your heart.
I Cotellic-plusvemurafenib-armen blev lysfølsomhedsreaktion grad ≥ 3 primært behandlet med topikale lægemidler sammen med behandlingsafbrydelse af såvel cobimetinib som vemurafenib (se pkt. 
Grade ≥3 photosensitivity events in the Cotellic plus vemurafenib arm were treated with primary topical medicinal products in conjunction with dose interruptions of both cobimetinib and vemurafenib (see section 4.2).
Der kan forekomme udslæt i forbindelse med behandling med såvel Cotellic som vemurafenib. 
Rash events may occur with either Cotellic or vemurafenib treatment.
Leverværdier bør kontrolleres inden påbegyndelse af kombinationsbehandling samt månedligt under behandling eller hyppigere, hvis klinisk indiceret (se pkt. 
Liver laboratory tests should be monitored before initiation of combination treatment and monthly during treatment, or more frequently if clinically indicated (see section 4.2).
Det skal du vide, før du begynder at tage Cotellic Sådan skal du tage Cotellic Bivirkninger 
What you need to know before you take Cotellic 3.
Sådan skal du tage Cotellic 
How to take Cotellic
Vemurafenibbehandlingen kan fortsættes uden dosisændring, når dosis af Cotellic er ændret (hvis dette er klinisk indiceret). 
Vemurafenib dosing can be continued when Cotellic treatment is modified (if clinically indicated).
Serøs retinopati kan håndteres med behandlingsafbrydelse, dosisreduktion eller seponering (se tabel 1 i pkt. 
Serous retinopathy can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Eksponeringen af frit cobimetinib var sammenlignelig hos forsøgspersoner med let og moderat nedsat leverfunktion og forsøgspersoner med normal leverfunktion, men forsøgspersoner med svært nedsat leverfunktion havde ca. 2 gange højere eksponering (se pkt. 
Unbound cobimetinib exposures were similar between subjects with mild and moderate hepatic impairment compared to subjects with normal hepatic function while subjects with severe hepatic impairment had approximately 2-fold higher exposures (see section 4.2).
Der er observeret serøs retinopati (væskeansamling i retina-lagene) hos patienter behandlet med MEKhæmmere, inklusive Cotellic (se pkt. 
Serous retinopathy (fluid accumulation within the layers of the retina) has been observed in patients treated with MEK-inhibitors, including Cotellic (see section 4.8).
4.4) b Kombinerede tal inkluderer indberetninger af lysfølsomhedsreaktioner, solskoldning, soleksem og aktinisk elastose 
Includes both chorioretinopathy and retinal detachment events indicative of serous retinopathy (see section 4.4) b Combined figure includes reports of photosensitivity reaction, sunburn, solar dermatitis, actinic elastosis
Cotellic, skal du fortsætte behandlingen med vemurafenib som foreskrevet af lægen. 
During this 7 day break in Cotellic treatment, you should keep taking vemurafenib as told by your doctor.
Vurderet og bekræftet af investigator ved hjælp af RECIST v1.1 
Assessed and confirmed by the investigator (INV) using RECIST v1.1 b Stratified analysis by geographic region and metastasis classification (disease stage)
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 20 November 2015