Euroopan unioni - suomi - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - kaikki muut terapeuttiset tuotteet - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Euroopan unioni - suomi - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - prekursorisolujen lymfoblastinen leukemia-lymfooma - antineoplastiset aineet - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Euroopan unioni - suomi - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - tiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastiset aineet - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Euroopan unioni - suomi - 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).

Euroopan unioni - suomi - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - cedazuridine, decitabine - leukemia, myeloidi - antineoplastiset aineet - inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for standard induction chemotherapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hydrochloride - paksusuolen vajaatoiminta - antineoplastiset aineet - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonatsoli - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykoottiset aineet systeemiseen käyttöön - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 ja 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasiivinen aspergilloosi potilailla, joiden sairauteen, joka on tulenkestävä amfoterisiini b tai itrakonatsoli eivät tehonneet tai kun potilaat eivät sietäneet näitä lääkkeitä;- epäilty fusarioosi potilailla, joilla on sairaus, joka on tulenkestävä amfoterisiini b: tä tai potilailla, jotka eivät siedä amfoterisiini b;- kromoblastomykoosi ja mysetooman hoidossa potilailla, joilla on sairaus, joka on tulenkestävä itrakonatsoli tai potilailla, jotka eivät siedä itrakonatsoli;- koksidioidomykoosi potilailla, joilla on sairaus, joka on tulenkestävä amfoterisiini b, itrakonatsoli tai flukonatsoli, tai potilailla, jotka eivät siedä näitä lääkkeitä;- suunielun kandidiaasi: ensilinjan lääkkeenä potilaille, joiden sairaus on vakava tai joiden immuunipuolustus on heikentynyt, ja vastaus paikalliseen hoitoon odotetaan olevan heikon. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Euroopan unioni - suomi - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp & dohme b.v. - aprepitantin - vomiting; postoperative nausea and vomiting; cancer - pahoinvointilääkkeet, - emend 40 mg kovat kapselit on tarkoitettu aikuisten postoperatiivisen pahoinvoinnin ja oksentelun (ponv) estämiseen. emend on saatavana myös 80 ja 125 mg: n kova kapseli ehkäisy pahoinvointi ja oksentelu liittyvät hyvin ja kohtalaisesti pahoinvointia aiheuttavan syöpäsairauksien solunsalpaajalääkityksen yhteydessä aikuisilla ja yli 12-vuotiaat (ks. erillinen valmisteyhteenveto). emend on saatavilla myös 165 mg kovat kapselit ehkäisyyn akuutin ja viivästyneen pahoinvoinnin ja oksentelun voimakkaasti emeettistä sisplatiinin pohjainen syövän kemoterapian aikuisilla ja ehkäisy pahoinvointi ja oksentelu liittyy kohtalaisesti pahoinvointia aiheuttavan syöpäsairauksien solunsalpaajalääkityksen yhteydessä aikuisilla. emend on saatavana myös jauheena oraalisuspensiota varten ehkäisy pahoinvointi ja oksentelu liittyvät hyvin ja kohtalaisesti pahoinvointia aiheuttavan syöpäsairauksien solunsalpaajalääkityksen yhteydessä lapsille, taaperoille ja vauvoille iästä alkaen 6 kk-alle 12 vuotta. emend 80 mg ja 125 mg 165 mg kovat kapselit ja emend jauhe oraalisuspensiota annetaan osana yhdistelmähoitoa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - neutropenia - immunostimulantit, , kasvutekijät - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).