União Europeia - português - EMA (European Medicines Agency)

ecuphar nv - enflicoxib - produtos antiinflamatórios e anti-reumáticos - cães - for the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs.

União Europeia - português - EMA (European Medicines Agency)

koanaa healthcare gmbh - o imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agentes antineoplásicos - 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. os pacientes que têm um baixo ou muito baixo risco de recorrência não deve receber tratamento adjuvante. 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. exceto em recém-diagnosticados lmc em fase crónica, não há ensaios clínicos controlados demonstrando um benefício clínico ou aumento da sobrevivência para essas doenças.

União Europeia - português - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - cães - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

União Europeia - português - EMA (European Medicines Agency)

laboratorios farmacéuticos rovi, s.a. - risperidone - esquizofrenia - psicolepticos - treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

União Europeia - português - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - outro aparelho digestivo e metabolismo produtos, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

União Europeia - português - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - leucemia linfoblástica com células precursoras - linfoma - agentes antineoplásicos - 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.

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

blau farmacÊutica s.a. - carboplatina - antineoplasicos citotoxicos

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

ranbaxy farmacÊutica ltda - cloridrato de nortriptilina - antidepressivos

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

sanofi medley farmacÊutica ltda. - cloridrato de nortriptilina - antidepressivos

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

zydus nikkho farmacÊutica ltda - antidepressivos