natgillin/translations-raw huggingface dataset:
Lynparza frarådes til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (kreatininclearance ≤ 30 ml/min), da sikkerhed og farmakokinetik ikke er undersøgt hos disse patienter.
Lynparza is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance ≤ 30 ml/min), as safety and pharmacokinetics have not been studied in these patients.
En pakning indeholder 448 kapsler (4 flasker a 112 kapsler).
One pack contains 448 capsules (4 bottles of 112 capsules).
Tidligere platinbaseret behandling (%) 60 (29) i (neo)adjuverende regi metastatisk regi i (neo)adjuverende og metastatisk regi Tidligere behandling med antracyklin i (neo)adjuverende regi metastatisk regi
Previous platinum-based therapy in (neo)adjuvant setting metastatic setting in (neo)adjuvant and metastatic setting 3 (1) Previous anthracycline treatment in (neo) adjuvant setting metastatic setting
Før behandling med Lynparza initieres til førstelinjevedligeholdelsesbehandling af high-grade epitelial ovariecancer (EOC), tubacancer (FTC) eller primær peritonealcancer (PPC), skal patienterne have bekræftet, at de har risikogivende eller formodet risikogivende germline- eller somatiske mutationer i de brystcancerdisponerede gener (BRCA) 1 eller 2 ved anvendelse af en valideret test.
Before Lynparza treatment is initiated for first-line maintenance treatment of high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) or primary peritoneal cancer (PPC), patients must have confirmation of deleterious or suspected deleterious germline and/or somatic mutations in the breast cancer susceptibility genes (BRCA) 1 or 2 using a validated test.
PFS (77 % modenhed) - DCO 9. december 2016
PFS (77% maturity) - DCO 09 December 2016
Study 19: Kaplan Meier-plot af OS i FAS (79 % modenhed) DCO 9. maj 2016
Figure 5 Study 19: Kaplan Meier plot of OS in the FAS (79% maturity) DCO 09 May 2016
Hos patienter med let nedsat leverfunktion (Child-Pugh klassifikation A) steg AUC med 15 % og Cmax med 13 % og hos patienter med moderat nedsat leverfunktion (Child-Pugh klassifikation B) steg AUC med 8 % og Cmax faldt med 13 % i sammenligning med patienter med normal leverfunktion.
In patients with mild hepatic impairment (Child-Pugh classification A), AUC increased by 15% and Cmax by 13% and in patients with moderate hepatic impairment (Child-Pugh classification B), AUC increased by 8% and Cmax decreased by 13% compared with patients with normal hepatic function.
TSST- en tilnærmelse af PFS2 (DCO 9. maj 2016)
TSST- an approximation of PFS2 (DCO 09 May
Hvis en patient, som allerede får Lynparza, har behov for behandling med en stærk eller moderat CYP3A-induktor, skal den ordinerende læge være opmærksom på, at effekten af Lynparza kan være væsentligt nedsat (se pkt.
In the event that a patient already receiving Lynparza requires treatment with a strong or moderate CYP3A inducer, the prescriber should be aware that the efficacy of Lynparza may be substantially reduced (see section 4.5).
Hvis du dyrker sex, skal du anvende to effektive former for beskyttelse mod graviditet, mens du tager denne medicin og i 1 måned efter du har taget den sidste dosis af Lynparza.
If you are having sex, you should use two effective methods of contraception while taking this medicine and for 1 month after taking the last dose of Lynparza.
Det anvendes efter kræften har reageret på tidligere behandling med standard kemoterapi baseret på platin.
It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
• Den normale anbefalede dosis er 300 mg (2 x 150 mg tabletter) to gange dagligt - i alt 4 tabletter hver dag.
• The usual recommended dose is 300 mg (2 x 150 mg tablets) twice a day - a total of 4 tablets each day.
Den gennemsnitlige PFS-forbedring var 6,9 måneder over placebo for olaparibbehandlede patienter (HR 0,18; 95 % CI 0,10-0,31; p<0,00001; gennemsnitligt 11,2 måneder versus 4,3 måneder).
The median PFS improvement was 6.9 months over placebo for olaparib-treated patients (HR 0.18; 95% CI 0.10-0.31; p<0.00001; median 11.2 months versus 4.3 months).
bd To gange dagligt; PFS Progressionsfri overlevelse; CI Konfidensinterval
bd Twice daily; PFS progression-free survival; CI confidence interval
I replikerende celler fører dette til DNA-dobbeltstrengsbrud (DSB), når replikationsgafler møder PARP-DNA-addukterne.
In replicating cells this also leads to the formation of DNA double-strand breaks (DSBs) when replication forks meet the PARP-DNA adducts.
Figur 8 OlympiAD: Kaplan-Meier-plot af OS hos patienter med gBRCA1/2-muteret HER2-negativ metastatisk brystcancer (64 % modenhed) DCO 25. september 2017
Figure 8 OlympiAD: Kaplan-Meier plot of OS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (64% maturity) DCO 25 September 2017
• Trykfarve på kapslen: shellac, jernoxid, sort (E172).
• Printing ink: shellac, iron oxide black (E172).
Patienter med germline- eller somatisk BRCA1/2-mutationer blev identificeret prospektivt enten via germline-test i blod via en lokal test (n=208) eller central test (n=181) eller ved test af en tumorprøve i en lokal test (n=2).
Patients with germline or somatic BRCA1/2 mutations were identified prospectively either from germline testing in blood via a local test (n=208) or central test (n=181) or from testing a tumour sample using a local test (n=2).
Jernoxid, sort (E172) (kun 150 mg tabletter)
(E172), iron oxide black (E172) (150 mg tablets only).
Amning under behandlingen og i 1 måned efter sidste dosis (se pkt.
Breast-feeding during treatment and for 1 month after the last dose (see section 4.6).
Dosisjustering af Lynparza anbefales til patienter med moderat nedsat nyrefunktion (se pkt.
Lynparza dose adjustment is recommended for patients with moderate renal impairment (see section 4.2).
Pakning med 448 kapsler (4 flasker a 112 kapsler).
Pack of 448 capsules (4 bottles of 112 capsules).
Investigatorvurderingen af PFS blev understøttet af en blindet, uafhængig, central radiologisk vurdering af PFS (HR 0,25; 95 % CI 0,18-0,35; p<0,0001; median 30,2 måneder for olaparib og 5,5 måneder for placebo).
The investigator assessment of PFS was supported with a blinded independent central radiological review of PFS (HR 0.25; 95% CI 0.18-0.35; p<0.0001; median 30.2 months for olaparib and 5.5 months placebo).
Hårde kapsler 448 kapsler (4 flasker a 112 kapsler)
Hard capsule 448 capsules (4 bottles of 112 capsules)
Filmovertrukne tabletter 56 filmovertrukne tabletter
Film-coated tablets 56 film-coated tablets
Den anbefalede dosisreduktion er til 250 mg (én 150 mg tablet og én 100 mg tablet) to gange dagligt (svarende til en samlet daglig dosis på 500 mg).
The recommended dose reduction is to 250 mg (one 150 mg tablet and one 100 mg tablet) twice daily (equivalent to a total daily dose of 500 mg).
Det er ikke nødvendigt med dosisjustering af Lynparza til patienter med let nedsat nyrefunktion.
No Lynparza dose adjustment is required for patients with mild renal impairment.
Bemærk, at Lynparza også findes som 100 mg og 150 mg tabletter.
Please note Lynparza is also available as a 100 mg and 150 mg tablet.
Patienter med BRCA1/2-mutationer blev identificeret enten ved germline-test i blod via en lokal test eller central test hos Myriad eller ved at teste en tumorprøve ved en lokal test. Der blev opdaget større strukturelle ændringer i BRCA1/2 generne hos 4,7 % (14/295) af de randomiserede patienter.
Patients with BRCA1/2 mutations were identified either from germline testing in blood via a local test or by central testing at Myriad or from testing a tumour sample using a local test. Large rearrangements in the BRCA1/2 genes were detected in 4.7% (14/295) of the randomised patients.
Du må ikke amme, hvis du tager Lynparza og indtil 1 måned efter du har taget din sidste dosis af Lynparza.
Do not breast-feed if you are taking Lynparza and for 1 month after taking the last dose of Lynparza.
Lynparza 50 mg hårde kapsler
Lynparza 50 mg hard capsules
Placebo bd To gange dagligt; DCO Skæringsdato for data; FAS Fuldt analysesæt; PFS progressionsfri overlevelse
Olaparib 400 mg bd Placebo bd Twice daily; DCO Data cut-off; FAS Full analysis set; PFS progression-free survival
Hos patienter med let nedsat nyrefunktion (kreatininclearance 51 til 80 ml/min) steg AUC med 24 % og Cmax med 15 % i sammenligning med patienter med normal nyrefunktion.
In patients with mild renal impairment (creatinine clearance 51 to 80 ml/min), AUC increased by 24% and Cmax by 15% compared with patients with normal renal function.
OS - DCO 09 maj 2016
OS - DCO 09 May 2016
• vedligeholdelsesbehandling af voksne patienter med fremskreden (FIGO stadie III og IV) BRCA1/2-muteret (germline og/eller somatisk) high-grade epitelial ovarie-, tuba- eller primær peritonealcancer, som responderer (fuldstændigt eller delvist) efter afslutning af platinbaseret førstelinjekemoterapi
• maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
• Tabletovertræk: hypromellose, macrogol 400, titandioxid (E171), jernoxid; gul (E172),
• Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow
I alt 32 (23,5 %) patienter modtog behandling i ≥ 2 år i olaparibgruppen sammenlignet med 5 (3,9 %) patienter i placebogruppen.
A total of 32 (23.5%) patients received treatment for ≥2 years in the olaparib group compared with 5 (3.9%) patients in the placebo group.
Advarsler og forsigtighedsregler Kontakt lægen, apoteketspersonalet eller sundhedspersonalet, før eller mens du tager Lynparza:
Warnings and precautions Talk to your doctor, pharmacist or nurse before or during treatment with Lynparza:
Kapselskal Hypromellose Titandioxid (E171) Gellangummi (E418) Kaliumacetat
Capsule shell Hypromellose Titanium dioxide (E171) Gellan gum (E418) Potassium acetate
Studiet sammenlignede effekten af vedligeholdelsesbehandling med Lynparza kapsler [400 mg (8 x 50 mg kapsler) to gange dagligt], som blev taget indtil progression, med placebobehandling hos 265 (136 olaparib og 129 placebo) patienter med PSR high-grade serøs ovariecancer, som havde respons (CR eller PR) efter fuldførelse af platinholdig kemoterapi.
The study compared the efficacy of Lynparza capsule maintenance treatment (400 mg [8 x 50 mg capsules] twice daily) taken until progression with placebo treatment in 265 (136 olaparib and 129 placebo) PSR high grade serous ovarian cancer patients who were in response (CR or PR) following completion of platinum-containing chemotherapy.
OlympiAD: Kaplan-Meier-plot af BICR PFS hos patienter med gBRCA1/2-muteret HER2-negativ metastatisk brystcancer (77 % modenhed) DCO 9. december 2016
Figure 6 OlympiAD: Kaplan-Meier plot of BICR PFS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (77% maturity) DCO 09 December 2016
HR (95% CI) P-værdi* (2-sidet)
HR (95% CI) P value* (2-sided)
I kliniske studier med Lynparza var forekomsten af skift i CTCAE grad ≥ 2 (stigninger) fra baseline i blodkreatinin ca. 10 %.
In clinical studies with Lynparza the incidence of CTCAE grade ≥ 2 shifts (elevations) from baseline in blood creatinine was approximately 10%.
Patienter med BRCA1/2-mutationer blev identificeret ved germline-test i blod via en lokal test eller central test hos Myriad.
Patients with BRCA1/2 mutations were identified from germline testing in blood via a local test or by central testing at Myriad.
Vigtige forskelle i dosering mellem Lynparza kapsler og tabletter Lynparza kapsler (50 mg) må ikke erstattes af Lynparza tabletter (100 mg og 150 mg) på milligram til milligram basis på grund af forskelle i dosering og biotilgængelighed af de individuelle formuleringer.
Lynparza capsules (50 mg) should not be substituted for Lynparza tablets (100 mg and 150 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
Der bruges en test til at bestemme, om du har BRCA-muteret kræft.
A test is used to determine whether you have BRCA-mutated cancer.
N Antal af hændelser/antal af randomiserede patienter; bd To gange dagligt; OS samlet overlevelse; PFS progressionsfri overlevelse; CI konfidensinterval; DCO Skæringsdato for data; TSST Tid fra randomisering til start af anden efterfølgende behandling eller død.
N Number of events/number of randomised patients; bd Twice daily; OS Overall survival; PFS Progression-free survival; CI Confidence interval; DCO Data cut off; TSST Time from randomisation to start of second subsequent therapy or death.
Toksicitet efter gentagne doser
Repeat-dose toxicity
Selvom antallet af patienter var begrænset, forblev 13,2 % (n=18/136) af patienterne i den olaparibbehandlede gruppe på behandlingen i ≥ 5 år sammenlignet med 0,8 % (n=1/128) i placebogruppen.
Although patient numbers were limited, 13.2% (n=18/136) of the patients in the olaparib-treated group remained on treatment for ≥5 years as compared with 0.8% (n=1/128) in the placebo group.
BRCA1/2-muteret
BRCA1/2-mutated
Figur 2 Study 19: Kaplan-Meier-plot af OS hos BRCA-muterede patienter (73 % modenhed)
Figure 2 Study 19: Kaplan-Meier plot of OS in BRCA-mutated patients (73% maturity)
Studiet sammenlignede virkningen af vedligeholdelsesbehandling med Lynparza [300 mg (2 x 150 mg tabletter) to gange daglig], som blev taget indtil progression med virkningen af placebobehandling hos 295 patienter med high-grade serøs eller endometrioid PSR-ovariecancer (2:1 randomisering: 196 olaparib og 99 placebo), som opnåede respons (CR eller PR) efter afslutning af platinholdig kemoterapi.
The study compared the efficacy of Lynparza maintenance treatment (300 mg [2 x 150 mg tablets] twice daily) taken until progression with placebo treatment in 295 patients with high-grade serous or endometrioid PSR ovarian cancer (2:1 randomisation: 196 olaparib and 99 placebo) who were in response (CR or PR) following completion of platinum-containing chemotherapy.
In vitro-data viser også, at olaparib ikke er et substrat for OATP1B1, OATP1B3, OCT1, BCRP eller MRP2 og ikke er en inhibitor for OATP1B3, OAT1 eller MRP2.
In vitro, data also show that olaparib is not a substrate for OATP1B1, OATP1B3, OCT1, BCRP or MRP2 and is not an inhibitor of OATP1B3, OAT1 or MRP2.
TFST - DCO 09 maj 2016
TFST - DCO 09 May 2016
P-værdi (2-sidet)
p-value (2-sided)
Lynparza fås som 100 mg og 150 mg tabletter.
Lynparza is available as 100 mg and 150 mg tablets.
Lynparza 150 mg tabletter er grønne til grågrønne, ovale, bikonvekse filmovertrukne tabletter markeret med "OP150" på den ene side og ingenting på den anden side.
Lynparza 150 mg tablets are green to green/grey, oval, bi-convex, film-coated tablets, marked with “OP150” on one side and plain on the other.
Tabel 2 Sammenfatning af nøglefund for virkning for patienter med BRCA-muteret PSR-ovariecancer i Study 19
Table 2 Summary of key efficacy findings for patients with BRCA-mutated PSR ovarian cancer in Study 19
I den olaparibbehandlede gruppe forblev 23,5 % (n=32/136) af patienterne på behandlingen i ≥ 2 år sammenlignet med 3,9 % (n=5/128) af patienterne på placebo.
In the olaparib-treated group, 23.5% (n=32/136) of patients remained on treatment for ≥2 years as compared with 3.9% (n=5/128) of the patients on placebo.
• Kapselskal: hypromellose, titandioxid (E171), gellangummi (E418), kaliumacetat.
• Capsule shell: hypromellose, titanium dioxide (E171), gellan gum (E418), potassium acetate.
bd To gange dagligt; DCO Skæringsdato for data; FAS Fuldt analysesæt; OS Samlet overlevelse
bd Twice daily; DCO Data cut off; FAS Full analysis set; OS Overall survival
Almindelig Træthed (inklusive asteni)
Common Fatigue (including asthenia)
Lynparza er indiceret som monoterapi til vedligeholdelsesbehandling af voksne patienter med platinsensitiv recidiverende BRCA-muteret (germline og/eller somatisk) high-grade serøs epitelial ovarie-, tuba- eller primær peritonealcancer, som responderer (fuldstændigt eller delvist) på platinbaseret kemoterapi.
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Lynparza 100 mg tabletter er gule til mørkegule, ovale, bikonvekse filmovertrukne tabletter markeret med "OP100" på den ene side og ingenting på den anden side.
Lynparza 100 mg tablets are yellow to dark yellow, oval, bi-convex, film-coated tablets, marked with “OP100” on one side and plain on the other.
I kliniske studier med Lynparza var forekomsten af skift i CTCAE grad ≥2 (fald) fra baseline i hæmoglobin 20 %, absolutte neutrofiler 20 %, trombocytter 5 %, lymfocytter 30 % og leukocytter 20 % (alle % omtrentlige).
In clinical studies with Lynparza the incidence of CTCAE grade ≥ 2 shifts (decreases) from baseline in haemoglobin was 20%, absolute neutrophils 20%, platelets 5%, lymphocytes 30% and leucocytes 20% (all % approximate).
Den anbefalede dosisreduktion er til 200 mg to gange dagligt (svarende til en samlet daglig dosis på 400 mg).
The recommended dose reduction is to 200 mg twice daily (equivalent to a total daily dose of 400 mg).
bd To gange dagligt; NR Ikke nået; CI Konfidensinterval; PFS Progressionsfri overlevelse; PFS2 Tid til anden progression eller død; OS Samlet overlevelse; TFST Tid fra randomisering til første efterfølgende anticancerbehandling eller død.
bd Twice daily; NR Not reached; CI Confidence interval; PFS Progression-free survival; PFS2 Time to second progression or death; OS Overall survival; TFST Time from randomisation to first subsequent anti-cancer therapy or death.
Mandlige patienter og deres kvindelige partnere i den fertile alder skal anvende sikker antikonception under behandlingen og i 3 måneder efter sidste dosis med Lynparza (se pkt.
Male patients and their female partners of childbearing potential should use reliable contraception during therapy and for 3 months after receiving the last dose of Lynparza (see section 4.6).
Anæmi omfatter de foretrukne termer for anæmi, makrocytisk anæmi, erytropeni, nedsat hæmatokrit, nedsat hæmoglobin, normokrom anæmi, normokrom normocytisk anæmi, normocytisk anæmi og nedsat antal røde blodlegemer; Neutropeni omfatter de foretrukne termer for agranulocytose, febril neutropeni, nedsat granulocyttal, granulocytopeni, idiopatisk neutropeni, neutropeni, neutropenisk infektion, neutropenisk sepsis og nedsat neutrofiltal; Trombocytopeni omfatter de foretrukne termer for nedsat antal trombocytter, nedsat trombocytproduktion, nedsat hæmatokrit og trombocytopeni; Leukopeni omfatter de foretrukne termer for leukopeni og nedsat antal hvide blodlegemer; Lymfopeni omfatter de foretrukne termer for nedsat antal B-lymfocytter, nedsat antal lymfocytter, lymfopeni og nedsat antal T-lymfocytter; Hoste omfatter de foretrukne termer for hoste og produktiv hoste; Udslæt omfatter de foretrukne termer for eksfoliativt udslæt, generaliseret erytem, udslæt, erytematøst udslæt, generaliseret udslæt, makulært udslæt, makulo-papuløst udslæt, papuløst udslæt og kløende udslæt; Hypersensitivitet omfatter de foretrukne termer for lægemiddelhypersensitivitet og hypersensitivitet; Dermatitis omfatter de foretrukne termer for dermatitis, allergisk dermatitis og eksfoliativ dermatitis.
Anaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decreased and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased; Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
bd To gange dagligt; OS Samlet overlevelse; DCO data cut off; CI konfidensinterval; TFST tid fra randomisering til start af første efterfølgende behandling eller død.
bd Twice daily; OS Overall survival; DCO data cut off; CI confidence interval; TFST time from randomisation to start of first subsequent therapy or death.
Derfor frarådes det at anvende kendte stærke inhibitorer (fx itraconazol, telithromycin, clarithromycin, proteaseinhibitorer boostet med ritonavir eller cobicistat, boceprevir, telaprevir) eller moderate inhibitorer (fx erythromycin, diltiazem, fluconazol, verapamil) af dette isozym sammen med Lynparza (se pkt.
Therefore, known strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir) or moderate (e.g. erythromycin, diltiazem, fluconazole, verapamil) inhibitors of this isozyme are not recommended with Lynparza (see section 4.4).
Tabel 2 Effektresultater for nyligt diagnosticerede patienter med fremskreden BRCA1/2m-ovariecancer i SOLO1
Table 2 Efficacy results for newly diagnosed patients with BRCA1/2m advanced ovarian cancer in SOLO1
Baselinetest, efterfulgt af månedlig monitorering, af komplet blodtælling anbefales i de første 12 måneders behandling og regelmæssigt derefter for at monitorere, om der sker klinisk signifikante ændringer i en eller flere parametre under behandlingen (se pkt.
Baseline testing, followed by monthly monitoring, of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment (see section 4.8).
• vedligeholdelsesbehandling af voksne patienter med platinsensitiv recidiverende high-grade epitelial ovarie-, tuba- eller primær peritonealcancer, som responderer (fuldstændigt eller delvist) på platinbaseret kemoterapi.
• maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Sikkerhed og virkning af olaparib som vedligeholdelsesbehandling blev undersøgt hos patienter med nyligt diagnosticeret fremskreden (FIGO stadie III-IV) high-grade serøs eller endometrioid BRCA1/2-muteret (BRCA1/2m) ovariecancer efter fuldførelse af platinbaseret førstelinjekemoterapi i et randomiseret, dobbeltblindet, placebokontrolleret, fase III-, multicenterstudie.
The safety and efficacy of olaparib as maintenance therapy were studied in patients with newly diagnosed advanced (FIGO Stage III-IV) high-grade serous or endometrioid BRCA1/2 mutated (BRCA1/2m) ovarian cancer following completion of first-line platinum-based chemotherapy in a Phase III randomised, double-blind, placebo-controlled, multicentre trial.
Lynparza 50 mg hårde kapsler olaparib
Lynparza 50 mg hard capsules olaparib