România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

ebewe pharma ges.m.b.h nfg. kg - austria - pemetrexedum - conc. pt. sol. perf. - 25mg/ml - antimetaboliti analogi ai acidului folic

Uniunea Europeană - română - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - respingerea grefei - imunosupresoare - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Uniunea Europeană - română - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilat - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agenți antineoplazici - 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. pacienții care au un risc scăzut sau foarte scăzut de recidivă nu trebuie să primească tratament adjuvant. 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. cu excepția nou diagnosticate în faza cronică a lgc, nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pliva hrvatska d.o.o. (pliva croatia ltd.) - croatia - sorafenibum - compr. film. - 200mg - inhibitori de protein-kinaza alti inhibitori de protein kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

remedica ltd. - cipru - sorafenibum - compr. film. - 400mg - inhibitori de protein-kinaza alti inhibitori de protein kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synoptis industrial sp. z o.o. - polonia - pemetrexedum - sol. perf. - 10mg/ml - antimetaboliti analogi ai acidului folic

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

universal farma, s.l. - spania - icatibantum - sol inj. in seringa preumpluta - 30mg - alti agenti hematologici medicamente utilizate in angioedemul ereditar

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania, s.l. - spania - pemetrexedum - conc. pt. sol. perf. - 25mg/ml - antimetaboliti analogi ai acidului folic

Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

krka d.d., novo mesto - amiodaronum - soluţie injectabilă - 150 mg/3 ml