Keytruda यूरोपीय संघ - हंगेरियाई - EMA (European Medicines Agency)

keytruda

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 - daganatellenes szerek - 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. betegek egfr vagy lÚgos pozitív tumor mutációk is kapott célzott terápia átvétele előtt 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.

Lartruvo यूरोपीय संघ - हंगेरियाई - EMA (European Medicines Agency)

lartruvo

eli lilly nederland b.v. - olaratumab - sarcoma - daganatellenes szerek - lartruvo szereplő doxorubicin kezelésére a felnőtt betegek speciális lágyrész-szarkóma, akik nem támadható kuratív műtét vagy a sugárkezelés, és aki nem korábban kezelték a doxorubicin (lásd kombinálva 5. szakasz.

M-M-RVaxPro यूरोपीय संघ - हंगेरियाई - EMA (European Medicines Agency)

m-m-rvaxpro

merck sharp & dohme b.v.  - a kanyaró vírus, enders-edmonston törzs (élő, attenuált), mumpsz vírus jeryl lynn (b szint) törzs (élő, attenuált), rubeola vírus wistar ra 27/3 törzs (élő, attenuált) - rubella; mumps; immunization; measles - a vakcinák - m-m-rvaxpro-t javallott egyidejű elleni védőoltás kanyaró, mumpsz, rubeola, az egyének 12 hónapos vagy annál idősebb. használata kanyaró járvány, vagy expozíció utáni oltás, vagy használja a korábban oltásban 12 hónaposnál idősebb gyermekek esetében, akik kapcsolatba fogékony a terhes nők, valamint azok a személyek, valószínűleg hajlamos a mumpsz, rubeola.

ProQuad यूरोपीय संघ - हंगेरियाई - EMA (European Medicines Agency)

proquad

merck sharp & dohme b.v. - vírus, élő attenuált, kanyaró, vírus, élő attenuált, mumpsz, vírus, élő attenuált, rubeola, vírus, élő attenuált, varicella - chickenpox; rubella; measles; mumps; immunization - a vakcinák - a proquad a 12 hónapos korú egyedek egyidejű oltására vonatkozik a kanyaró, a mumpsz, a rubeola és a varicella ellen. a proquad-ot lehet beadni, hogy a magánszemélyek a 9 hónapos korban különleges körülmények között (pl.. ,, hogy az megfeleljen a nemzeti oltási menetrend, járvány helyzetekben, vagy utazik, hogy egy régió magas előfordulása a kanyaró.

Parareg यूरोपीय संघ - हंगेरियाई - EMA (European Medicines Agency)

parareg

dompé biotec s.p.a. - cinakalcetre - hypercalcemia; parathyroid neoplasms; hyperparathyroidism - kalcium homeosztázis - a másodlagos hyperparathyreosis (hpt) kezelése végstádiumú vesebetegségben (esrd) szenvedő betegeknél a fenntartó dialízis terápiában. a mimpara-t lehet használni, mint egy része a terápiás kezelés, beleértve a foszfát kötőanyagok és/vagy d-vitamin szterolok, mint megfelelő (lásd 5. hypercalcaemia csökkentése, a betegek:-mellékpajzsmirigy-carcinoma. - a primer hyperparathyreosis, akinek parathyroidectomy lenne feltüntetett alapján szérum calciumlevels (meghatározott vonatkozó kezelési irányelvek), de akiben parathyroidectomy klinikailag nem megfelelő, illetve ellenjavallt.

Rebetol यूरोपीय संघ - हंगेरियाई - EMA (European Medicines Agency)

rebetol

merck sharp and dohme b.v - a ribavirin - hepatitis c, krónikus - antivirals for systemic use, antivirals for treatment of hcv infections - a rebetol felnőttek krónikus hepatitis c (chc) kezelésére szolgáló egyéb gyógyszerkészítményekkel kombinációban szerepel. a rebetol feltüntetett kombinációban más gyógyszerekkel, a kezelés a krónikus hepatitis c (chc) a gyermekkorú (gyermek 3 éves, vagy annál idősebb, serdülők) korábban nem kezelt nélkül máj dekompenzáció.

Ytracis यूरोपीय संघ - हंगेरियाई - EMA (European Medicines Agency)

ytracis

cis bio international - yttrium (90y) chloride - radionuklid képalkotás - diagnosztikai radiofarmakonok - csak olyan hordozómolekulák radio-jelzésére használható, amelyeket kifejezetten kifejlesztettek és engedélyeztek radioaktívan jelzéssel ezen radionukliddal. radiopharmaceutical precursor - not intended for direct application to patients.