Unia Europejska - polski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacytydyna - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Środki przeciwnowotworowe - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.

Polska - polski - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

berlin-chemie ag - dexketoprofenum - roztwór doustny w saszetce - 25 mg

Polska - polski - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

accord healthcare polska sp. z o.o. - paracetamolum - tabletki musujące - 500 mg

Polska - polski - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

accord healthcare polska sp. z o.o. - paracetamolum - tabletki musujące - 1000 mg

Unia Europejska - polski - EMA (European Medicines Agency)

celgene europe bv - azacytydyna - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Środki przeciwnowotworowe - azacitidine celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification,aml with >30% marrow blasts according to the who classification.

Unia Europejska - polski - EMA (European Medicines Agency)

mylan ireland limited - azacytydyna - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Środki przeciwnowotworowe - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Unia Europejska - polski - 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.

Unia Europejska - polski - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Unia Europejska - polski - EMA (European Medicines Agency)

accord healthcare s.l.u. - octan kaspofunginy - candidiasis; aspergillosis - Środki przeciwgrzybicze do stosowania ogólnego - leczenie inwazyjnej kandydozy u dorosłych i pacjentów pediatrycznych. leczenie inwazyjnej aspergilozy u dorosłych i pacjentów pediatrycznych, które są oporne na lub nietolerancji amfoterycyna b, preparaty lipidowe amfoterycyna b b i/lub itrakonazol. odporność na ogień jest zdefiniowany jako progresję zakażenia lub brak poprawy po co najmniej 7 dni przed dawki terapeutyczne skuteczne leczenie przeciwgrzybicze. do terapii empirycznej rzekomej infekcji grzybiczych (np. candida lub kropidlak) w szalony, jeszcze неоткупоренных dla dorosłych i pacjentów pediatrycznych.

Unia Europejska - polski - EMA (European Medicines Agency)

instituto grifols s.a. - immunoglobuliny ludzkiej normalnej - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - odporne surowicy i immunoglobuliny, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.