Kesatuan Eropah - Finland - EMA (European Medicines Agency)

novartis europharm limited - nilotinib - leukemia, myelogeeninen, krooninen, bcr-abl positiivinen - antineoplastiset aineet - tasigna on tarkoitettu hoitoon:aikuis-ja lapsipotilailla, joilla on vasta diagnosoitu philadelphia-kromosomin suhteen positiivinen krooninen myelooinen leukemia (kml) kroonisessa vaiheessa,lapsipotilailla, joilla on philadelphia-kromosomipositiivinen kroonisen vaiheen kml vastus tai suvaitsemattomuuden ennen hoidon, mukaan lukien imatinibi. tasigna on tarkoitettu hoitoon:aikuis-ja lapsipotilailla, joilla on vasta diagnosoitu philadelphia-kromosomin suhteen positiivinen krooninen myelooinen leukemia (kml) kroonisessa vaiheessa,aikuisilla potilailla, joilla on kroonisessa vaiheessa ja akseleraatiovaiheessa olevan philadelphia-kromosomipositiivinen kml vastus tai suvaitsemattomuuden ennen hoidon, mukaan lukien imatinibi. tiedot tehosta potilailla, joilla on kml on blastikriisivaiheessa eivät ole käytettävissä,lapsipotilailla, joilla on kroonisen vaiheen philadelphia-kromosomipositiivinen kml vastus tai suvaitsemattomuuden ennen hoidon, mukaan lukien imatinibi.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - ruoansulatuskanavan stromal-kasvaimet - antineoplastiset aineet - 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.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinibi - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastiset aineet - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

bayer pharma ag - regorafenib - paksusuolen vajaatoiminta - antineoplastic agents, protein kinase inhibitors - stivarga on tarkoitettu monoterapiana aikuispotilaille, joilla on:metastaattinen kolorektaalisyöpä (crc), jotka on aiemmin käsitelty, tai ei pidetä ehdokkaita, käytettävissä olevat hoidot - nämä ovat fluoropyrimidiini-pohjaista kemoterapiaa, anti-vegf-hoito ja anti-egfr-hoito;leikkaushoitoon tai metastaattisen ruoansulatuskanavan tukikudosten kasvaimet (gist), joka eteni tai jotka eivät siedä aikaisempi hoito imatinibi ja sunitinibi;maksasolusyövän (hcc), joka on aiemmin hoidettiin sorafenibilla.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatinibin - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiset aineet - sprycel on tarkoitettu hoitoon lapsipotilailla, joilla on:äskettäin diagnosoitu philadelphia-kromosomi-positiivinen krooninen myelooinen leukemia kroonisessa vaiheessa (ph+ kml cp) tai ph+ kml cp resistenttejä tai intolerantteja, kun aiempi hoito, mukaan lukien imatinibihoito. vasta diagnosoitu ph+ akuutti lymfaattinen leukemia (kaikki) yhdessä solunsalpaajahoidon kanssa. sprycel on tarkoitettu aikuisille potilaille, joilla on:äskettäin diagnosoitu philadelphia-kromosomi-positiivinen (ph+) kroonisen myelooisen leukemian (kml) kroonisessa vaiheessa;kroonisessa, akseleraatio-tai blastikriisivaiheessa oleva kml, jossa vastus tai suvaitsemattomuuden ennen hoidon mukaan lukien imatinib mesilate;ph+ akuutti lymfaattinen leukemia (all) ja lymfaattisen blastikriisivaiheen kml: n vastus tai suvaitsemattomuuden ennen hoidon. sprycel on tarkoitettu hoitoon lapsipotilailla, joilla on:äskettäin diagnosoitu ph+ kml: n krooninen vaihe (ph+ kml-cp) tai ph+ kml-cp resistenttejä tai intolerantteja, kun aiempi hoito, mukaan lukien imatinibihoito.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

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. katso kohdat 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastiset aineet - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - karsinooma, ei-pienisoluinen keuhko - antineoplastiset aineet - 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.

Kesatuan Eropah - Finland - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinibin - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiset aineet - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.