Den Europæiske Union - finsk - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastiset aineet - 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. potilaat, joilla on alhainen tai hyvin alhainen riski toistumisen pitäisi saada adjuvanttihoitona. 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. paitsi äskettäin diagnosoitu kroonisen vaiheen kml, ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

biomarin international limited - vosoritide - achondroplasia - lääkkeet luusairauksien hoitoon - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

amivas ireland ltd - artesunate - malaria - antiprototsooisia - artesunate amivas is indicated for the initial treatment of severe malaria in adults and children. on otettava huomioon viralliset ohjeet antibioottien asianmukaisesta käytöstä malarian aineet.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimetyylifumaraatti - multippeliskleroosi, relapsoiva-remittoiva - immunosuppressantit - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - leuprorelin mesilate - prostatiset kasvaimet - endokriinihoito - camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doksorubisiinihydrokloridia - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastiset aineet - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Den Europæiske Union - finsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostatiset kasvaimet - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - kapesitabiini - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - kapesitabiini - kapesitabiini on tarkoitettu iii-vaihe-leikkauksen (dukes 'stage-c) paksusuolisyövän leikkauksen jälkeiseen adjuvanttikäsittelyyn. kapesitabiini on tarkoitettu käytettäväksi metastasoituneen kolorektaalisyövän hoitoon. kapesitabiinin kanssa on tarkoitettu ensilinjan hoito on edennyt mahasyöpä yhdessä platina-pohjainen hoito. kapesitabiinin yhdistelmähoidossa dosetakselin kanssa on tarkoitettu niiden potilaiden hoitoon, joilla on paikallisesti edennyt tai metastasoitunut rintasyöpä, kun sytotoksinen solunsalpaajahoito. aiempaan hoitoon olisi pitänyt sisältyä antrasykliini. kapesitabiini on tarkoitettu myös monoterapiana potilaille, joilla on paikallisesti edennyt tai metastasoitunut rintasyöpä, sen jälkeen kun vika taksaaneja ja antrasykliiniä sisältävä solunsalpaajahoito on tai joille edelleen antrasykliini-hoitoa ei ole tarkoitettu.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

a.c.o.m. - advanced center oncology - kupari (64cu) kloridi - radionuklidien kuvantaminen - various diagnostic radiopharmaceuticals - cuprymina on radiofarmaseuttinen prekursori. sitä ei ole tarkoitettu suoraan potilaille. tätä lääkevalmistetta on käytettävä vain radioaktiiviseen merkintään, joka on erityisesti kehitetty ja sallittu radiolabeloitavaksi tällä radionuklidilla.

Den Europæiske Union - finsk - EMA (European Medicines Agency)

viiv healthcare b.v. - abakaviiri - hiv-infektiot - antiviraalit systeemiseen käyttöön - ziagen on merkitty antiretroviraalisessa yhdistelmähoidossa ihmisen immuunikatoviruksen (hiv) infektioiden hoitoon aikuisilla, nuorilla ja lapsilla. sen osoittaminen, hyöty ziagen perustuu pääosin tulokset tutkimukset suoritettiin kahdesti vuorokaudessa, aikaisemmin hoitamatonta potilasta yhdistelmähoitoa. ennen hoidon aloittamista abakaviirin kanssa, seulonta kuljetettavaksi hla-b*5701-testaus tulisi suorittaa kaikille hiv-potilaille, riippumatta etnisestä taustasta. abakaviiria ei pidä käyttää potilaille, joiden tiedetään kantavan hla-b*5701-alleelia.