Uniunea Europeană - română - EMA (European Medicines Agency)

accord healthcare s.l.u. - relugolix - prostate neoplasme - terapia endocrină - orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

Uniunea Europeană - română - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. , efectul de imatinib pe rezultatul de transplantul de măduvă osoasă nu a fost determinată. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. experiența cu imatinib la pacienții cu mds/mpd asociate cu genei fcdp-re-aranjamente este foarte limitat. nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.

Uniunea Europeană - română - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanomul - agenți antineoplazici - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 și 5. tratamentul adjuvant al melanomadabrafenib în combinație cu trametinib este indicat pentru tratamentul adjuvant al pacienților adulți cu etapa a iii-a melanom cu mutație braf v600, în urma rezecției complete. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Uniunea Europeană - română - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - agenți antineoplazici - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Uniunea Europeană - română - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - medicamente antineoplazice - lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Uniunea Europeană - română - EMA (European Medicines Agency)

stemline therapeutics b.v. - elacestrant - sânii neoplasme - terapia endocrină - orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (er) positive, her2-negative, locally advanced or metastatic breast cancer with an activating esr1 mutation who have disease progression following at least one line of endocrine therapy including a cdk 4/6 inhibitor.

Uniunea Europeană - română - EMA (European Medicines Agency)

biolitec pharma ltd - temoporfină - head and neck neoplasms; carcinoma, squamous cell - agenți antineoplazici - foscan este indicat pentru tratamentul pacienţilor cu avansate capului si gatului cu celule scuamoase în lipsa prealabilă terapii paliative şi improprii de radioterapie, chirurgia sau chimioterapia sistemică.

Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

novartis pharma ag - everolimus - comprimate - 2,5 mg

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

narodowe centrum badan jadrowych - polonia - tc 99m - pertechnetate - generator de radionuclizi - 8,0-175gbq - tiroida preparate pentru radiodiagnostic la nivelul tiroidei, varia

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

monrol europe s.r.l. - ungaria - natrii iodidum (131i) - sol. orala pt. uz terapeutic - 14,8-3700mbq - alte radiofarmaceutice de uz terapeutic compusi cu iod 131