ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastiska medel - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. patienter med egfr eller alk-positiv tumör mutationer bör också ha fått riktad terapi innan du tar emot keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

astellas pharma europe b.v. - micafungin - candidiasis - antimykotika för systemisk användning - mycamine är indicerat för:vuxna, ungdomar ≥ 16 år samt elderlytreatment av invasiv candidiasis behandling av esofageal candidiasis hos patienter för vilka intravenös behandling är lämplig profylax av candida-infektion hos patienter som genomgår allogen hematopoetisk stamcellstransplantation eller patienter som förväntas ha neutropeni (absolut antal neutrofila granulocyter < 500 celler/µl) för 10 eller fler dagar. barn (inklusive nyfödda) och ungdomar < 16 år agetreatment av invasiv candidiasis. profylax av candida-infektion hos patienter som genomgår allogen hematopoetisk stamcellstransplantation eller patienter som förväntas ha neutropeni (absolut antal neutrofila granulocyter < 500 celler/µl) för 10 eller fler dagar. beslutet att använda mycamine bör ta hänsyn till den potentiella risken för utveckling av levertumörer. mycamine ska därför endast användas om andra antimykotika inte är lämpliga.

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

cis bio international - depreotidtrifluoracetat - radionuklid imaging - diagnostiska radioaktiva läkemedel - detta läkemedel är endast för diagnostisk användning. för scintigraphic avbildning av misstänkt maligna tumörer i lungan efter första upptäckt, incombination med datortomografi eller chest x-ray, i patienter med solitär lung noduli.

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

hospira uk limited - docetaxeltrihydrat - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastiska medel - bröst cancertaxespira i kombination med doxorubicin och cyklofosfamid är indicerat för adjuvant behandling av patienter med operabel node-positiv bröstcancer, som kan manövreras node-negativ bröstcancer. för patienter med operabel node-negativ bröstcancer adjuvant behandling bör begränsas till patienter som är berättigade att få kemoterapi enligt internationellt vedertagna kriterier för primär behandling av tidig bröstcancer. taxespira i kombination med doxorubicin är indicerat för behandling av patienter med lokalt avancerad eller metastaserad bröstcancer som inte tidigare fått cytotoxisk behandling för detta tillstånd. taxespira monoterapi är indicerat för behandling av patienter med lokalt avancerad eller metastaserande bröstcancer efter ett misslyckande av cytotoxisk behandling. tidigare kemoterapi skulle ha inkluderat ett antracyklin eller ett alkyleringsmedel. taxespira kombination med trastuzumab är indicerat för behandling av patienter med metastaserad bröstcancer vilkas tumörer över snabb her2 och som tidigare inte fått kemoterapi mot metastaserad sjukdom. taxespira i kombination med capecitabin är indicerat för behandling av patienter med lokalt avancerad eller metastaserande bröstcancer efter ett misslyckande av cytotoxisk kemoterapi. tidig behandling bör ha inkluderat en antracyklin. icke-småcellig lungcancer taxespira indicerat för behandling av patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer efter ett misslyckande av tidigare kemoterapi. taxespira i kombination med cisplatin är indicerat för behandling av patienter med unresectable, lokalt avancerad eller metastaserad icke-småcellig lungcancer hos patienter som inte tidigare fått kemoterapi mot detta villkor. prostatacancer taxespira i kombination med prednison eller prednisolon är indicerat för behandling av patienter med hormon eldfasta metastaserande prostatacancer. gastric adenocarcinom taxespira i kombination med cisplatin och 5-fluorouracil är indicerat för behandling av patienter med metastaserande magcancer adenocarcinom, inklusive adenocarcinom i den gastroesofagala korsning, som inte fått före kemoterapi mot metastaserad sjukdom. cancer i huvud och hals taxespira i kombination med cisplatin och 5-fluorouracil är indicerat för induktion behandling av patienter med lokalt avancerad skivepitelcancer i huvud och hals.

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - zoledronsyramonohydrat - fractures, bone; cancer - läkemedel för behandling av bensjukdomar - förebyggande av skelettrelaterade händelser (patologiska frakturer, ryggradskompression, strålning eller operation till ben eller tumörinducerad hyperkalcemi) hos vuxna patienter med avancerade maligniteter som involverar ben. behandling av vuxna patienter med tumör-inducerad hypercalcaemia (tih).

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastiska medel - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

amgen europe b.v. - denosumab - fractures, bone; neoplasm metastasis - läkemedel för behandling av bensjukdomar - förebyggande av skelett liknande händelser (patologisk fraktur, strålning och ben, ryggmärgen komprimering eller kirurgi till ben) hos vuxna med avancerad maligniteter involverar ben (se avsnitt 5. behandling av vuxna och skeletalt gammal ungdomar med giant cell tumör i ben, som är unresectable eller där kirurgisk resektion är sannolikt att resultera i svår sjukdom. .

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastiska medel - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

novartis europharm limited - everolimus - tuberös skleros - antineoplastiska medel - renal angiomyolipoma i samband med tuberös skleros complex (tsc)votubia är indicerat för behandling av vuxna patienter med njursvikt angiomyolipoma i samband med tuberös skleros complex (tsc) som är i riskzonen för komplikationer (baserat på faktorer som tumörens storlek eller förekomst av aneurysm, eller förekomst av flera eller bilaterala tumörer) men som inte kräver omedelbar operation. bevisen bygger på analys av förändring i summan av angiomyolipoma volym. subependymalt giant cell astrocytom (sega) i samband med tuberös skleros complex (tsc)votubia är indicerat för behandling av patienter med subependymalt giant cell astrocytom (sega) i samband med tuberös skleros complex (tsc) som kräver terapeutisk intervention, men inte lämpar sig för kirurgi. bevisen bygger på analys av förändring i sega volym. ytterligare klinisk nytta, såsom förbättring av sjukdomsrelaterade symtom, har inte visats.

ইউরোপীয় ইউনিয়ন - সুইডিশ - EMA (European Medicines Agency)

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - diagnostiska radioaktiva läkemedel - detta läkemedel är endast för diagnostisk användning. efter den radioaktiva märkningen med gallium (68ga) klorid lösning av gallium (68ga) edotreotide som erhålls är indicerat för positron emissions tomografi (pet) avbildning av somatostatin receptor överuttryck hos vuxna patienter med konstaterad eller misstänkt väl differentierade mag-enteropancreatic neuroendokrina tumörer (gep-net) för att lokalisera primära tumörer och deras metastaser.