Akynzeo Európai Unió - magyar - EMA (European Medicines Agency)

akynzeo

helsinn birex pharmaceuticals ltd - netupitant, a palonozetron-hidroklorid - vomiting; neoplasms; nausea; cancer - hányáscsillapítók, antinauseants, - akynzeo javallt felnőtteknél a:megelőzése az akut, késleltetett hányinger, majd hányás társul erősen emetogén hatású cisplatin-alapú rák, kemoterápia. megelőzése az akut, késleltetett hányinger, majd hányás társul közepesen emetogén hatású rák, kemoterápia.

Ciambra Európai Unió - magyar - EMA (European Medicines Agency)

ciambra

menarini international operations luxembourg s.a. - pemetrexed dinátrium-hemipentahidrátot - carcinoma, non-small-cell lung; mesothelioma - daganatellenes szerek - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ciambra az monoterápiában a fenntartó kezelés lokálisan előrehaladott vagy áttétes nem-kissejtes tüdőrák más, mint túlnyomórészt laphámsejtes szövettani olyan betegeknél, akiknél a betegség még nem fejlődött követően azonnal platina-alapú kemoterápiához. ciambra az monoterápiában a második vonalbeli kezelés a betegek, lokálisan előrehaladott vagy áttétes nem-kissejtes tüdőrák más, mint túlnyomórészt laphámsejtes szövettan.

Emend Európai Unió - magyar - EMA (European Medicines Agency)

emend

merck sharp & dohme b.v. - aprepitant - vomiting; postoperative nausea and vomiting; cancer - hányáscsillapítók, antinauseants, - emend 40 mg kemény kapszula a postoperatív hányinger és hányás megelőzésére javallt felnőtteknél (ponv). az emend-et is kapható 80 mg, 125 mg kemény kapszula a megelőzés, a hányinger, majd hányás társul magas, közepesen emetogén hatású rák, kemoterápia felnőtteknél valamint serdülőknél éves kortól 12 (lásd külön alkalmazási előírását). az emend-et is kapható 165 mg kemény kapszula a megelőzés, az akut, késleltetett hányinger, majd hányás társul erősen emetogén hatású cisplatin-alapú rák, kemoterápia, felnőttek, valamint a megelőzés, a hányinger, majd hányás társul közepesen emetogén hatású rák, kemoterápia felnőttek. az emend-et is kapható por belsőleges szuszpenzióhoz a megelőzés, a hányinger, majd hányás társul magas, közepesen emetogén hatású rák, kemoterápia, a gyermekek, a kisgyermekek, csecsemők 6 hónapos kor kevesebb, mint 12 év. az emend-et 80 mg, 125 mg, 165 mg kemény kapszula, valamint az emend-et por belsőleges szuszpenziót adott kombinációs terápia részeként.

Cerenia Európai Unió - magyar - EMA (European Medicines Agency)

cerenia

zoetis belgium sa - maropitáns citrát - táplálkozási bélrendszer, anyagcsere - dogs; cats - tabletta kutyák: a kemoterápia által kiváltott hányinger megelőzésére. a mozgási betegség által kiváltott hányás megelőzésére. a hányás megelőzésére és kezelésére, a cerenia oldatos injekcióval együtt és más támogató intézkedésekkel együtt. megoldás injectiondogs:a kezelés, illetve megelőzése, a kemoterápia okozta hányinger. a hányás megelőzésére, kivéve a mozgássérültség okozta. a hányás kezelésére, más támogató intézkedésekkel együtt. a megelőzés, a perioperatív hányinger, hányás, javulás a kilábalás altatás után használja a μ-opiát receptor agonista morfium. macskák: a hányás megelőzésére és az émelygés csökkentésére, kivéve a mozgássérültség által kiváltott eseteket. a hányás kezelésére, más támogató intézkedésekkel együtt.

Keytruda Európai Unió - magyar - 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.

Potactasol Európai Unió - magyar - EMA (European Medicines Agency)

potactasol

actavis group ptc ehf - topotecan - uterine cervical neoplasms; small cell lung carcinoma - daganatellenes szerek - topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5. a topotekán ciszplatinnal kombinációban javallott a betegek carcinoma a méhnyak visszatérő sugárkezelés után, a betegek színpadon ivb betegség. patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.

Pemetrexed Pfizer (previously Pemetrexed Hospira) Európai Unió - magyar - EMA (European Medicines Agency)

pemetrexed pfizer (previously pemetrexed hospira)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - daganatellenes szerek - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.