Alsitek Unia Europejska - polski - EMA (European Medicines Agency)

alsitek

ab science - masitinib mesilate - amyotroficzne stwardnienie boczne - Środki przeciwnowotworowe - leczenie bocznego амиотрофического rozsianego.

Masiviera Unia Europejska - polski - EMA (European Medicines Agency)

masiviera

ab science - masitinib - nowotwory trzustki - inhibitory białka kinazy - leczenie działać lokalnie-postępowym lub przerzutowym rakiem trzustki .

Masican Unia Europejska - polski - EMA (European Medicines Agency)

masican

masitinib - guzy stromal żołądkowo-jelitowe - inhibitory białka kinazy - leczenie działać i/lub rozsiana złym стромальной nowotworów przewodu pokarmowego (gist).

Sprycel Unia Europejska - polski - EMA (European Medicines Agency)

sprycel

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - Środki przeciwnowotworowe - sprajsel jest wskazany do leczenia pacjentów pediatrycznych:po raz pierwszy ujawnione przez filadelfii chromosomów-pozytywne chroniczna myeloid białaczki w fazie przewlekłej (ph+ cml sr) lub ph+ cml sr odpornością lub nietolerancją na wcześniejsze leczenie, tym imatinib. niedawno zdiagnozowano poziom ph+ ostra białaczka limfoblastyczna (all) w połączeniu z chemioterapią. sprajsel jest wskazany do leczenia dorosłych pacjentów z po raz pierwszy zidentyfikowane filadelfii chromosomów-pozytywne (ph+) chroniczna myeloid białaczka (cml) w fazie przewlekłej;przewlekłe, przyspieszone lub wybuch fazie cml z opornością lub nietolerancją na wcześniejsze leczenie, tym imatinib mesylate;poziom ph+ ostra białaczka limfoblastyczna (all) i limfoidalnych wybuchu cml w przypadku oporności lub nietolerancji wcześniejszej terapii. sprajsel jest wskazany do leczenia pacjentów pediatrycznych z po raz pierwszy zidentyfikowane ph+ cml w fazie przewlekłej (ph+ cml-cp) lub ph+ cml-cp z odpornością lub nietolerancją na wcześniejsze leczenie, tym imatinib.

Inlyta Unia Europejska - polski - EMA (European Medicines Agency)

inlyta

pfizer europe ma eeig  - aksytynib - rak, komórka nerek - inhibitory białka kinazy - inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) after failure of prior treatment with sunitinib or a cytokine.

Keytruda Unia Europejska - polski - EMA (European Medicines Agency)

keytruda

merck sharp & dohme b.v. - Пембролизумаб - 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 - Środki przeciwnowotworowe - 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. pacjenci z egfr lub АЛК pozytywnej guza mutacje muszą także otrzymywali таргетную terapię aż do uzyskania Кейтруда. 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.

Bosulif Unia Europejska - polski - EMA (European Medicines Agency)

bosulif

pfizer europe ma eeig - bosutynib (w postaci jednowodnej) - białaczka, szpikowe - antineoplastic agents, protein kinase inhibitors - bosulif jest wskazany do leczenia dorosłych pacjentów z nowo zdiagnozowaną przewlekłą fazą (sr) chromosomów-pozytywne filadelfia przewlekłej миелогенной białaczki (ph+ cml). Śr, przyspieszonej fazy (ap), i blastnom (bp) ph+ cml, wcześniej leczonych jeden lub więcej inhibitora kinazy tyrozynowej(z) [tgc(y)] i dla kogo imatinib, nilotinib jest i dasatinib nie traktować odpowiednie opcje leczenia .

Iclusig Unia Europejska - polski - EMA (European Medicines Agency)

iclusig

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. zobacz rozdziały 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.