Poljska - poljščina - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

ever valinject gmbh - cabazitaxelum - koncentrat do sporządzania roztworu do infuzji - 10 mg/ml

Evropska unija - poljščina - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesylate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Środki przeciwnowotworowe - imatinib koanaa is indicated for the treatment ofadult and 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. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric 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-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacjenci, którzy mają niskie lub bardzo niskie ryzyko nawrotu, nie powinni otrzymywać leczenie uzupełniające. 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. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. za wyjątkiem zdiagnozowanych fazie przewlekłej cml, nie ma kontrolowanych badań, które wykazują efekt kliniczny lub zwiększa przeżywalność przy tych chorobach.

Evropska unija - poljščina - EMA (European Medicines Agency)

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - Środki przeciwnowotworowe - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Evropska unija - poljščina - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - guzy stromal żołądkowo-jelitowe - Środki przeciwnowotworowe - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Poljska - poljščina - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

zentiva, k.s. - acidum thiocticum - tabletki powlekane - 600 mg

Evropska unija - poljščina - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - rak, niedrobnokomórkowe płuca - Środki przeciwnowotworowe - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Evropska unija - poljščina - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - rak, niedrobnokomórkowe płuca - Środki przeciwnowotworowe - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

Evropska unija - poljščina - EMA (European Medicines Agency)

amgen europe bv - sotorasib - rak, niedrobnokomórkowe płuca - Środki przeciwnowotworowe - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

Evropska unija - poljščina - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - Środki przeciwnowotworowe - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Evropska unija - poljščina - EMA (European Medicines Agency)

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