União Europeia - português - EMA (European Medicines Agency)

ucb pharma s.a.   - fenfluramine hydrochloride - epilepsies, myoclonic - antiepilépticos, - treatment of seizures associated with dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

União Europeia - português - EMA (European Medicines Agency)

idorsia pharmaceuticals deutschland gmbh - daridorexant hydrochloride - transtornos de iniciação e manutenção do sono - psicolepticos - quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

União Europeia - português - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - infecções por hiv - antivirais para uso sistêmico - a eviplera está indicada para o tratamento de adultos infectados com o vírus da imunodeficiência humana tipo 1 (hiv-1) sem mutações conhecidas associadas à resistência à classe de inibidores de transcriptase reversa não nucleósidos (nnrti), tenofovir ou emtricitabina e com carga viral ≤ 100,000 cópias de arn do hiv-1 / ml. tal como acontece com outros medicamentos anti-retrovirais, testes de resistência genotípica e / ou dados históricos de resistência devem orientar o uso de eviplera.

União Europeia - português - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibacterianos para uso sistémico, - tratamento de infecções bacterianas agudas da pele e da pele (absssi) em adultos.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tipo 2 - drogas usadas em diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

União Europeia - português - EMA (European Medicines Agency)

biomarin international limited - sapropterin dihydrochloride - fenilcetonurias - outro aparelho digestivo e metabolismo produtos, - kuvan é indicado para o tratamento da hiperfenilalaninemia (hpa) em adultos e pacientes pediátricos de todas as idades com fenilcetonúria (pku) que demonstraram ser sensíveis a esse tratamento. kuvan também é indicado para o tratamento de hyperphenylalaninaemia (hpa) em adultos e pacientes pediátricos de todas as idades, com tetrahydrobiopterin (bh4) a deficiência de que tem sido mostrado para ser ágil para tal tratamento.

União Europeia - português - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin, metformin hydrochloride - diabetes mellitus, tipo 2 - drogas usadas em diabetes - vokanamet é indicado em adultos com idade entre 18 e mais anos, com diabetes mellitus tipo 2, como adjuvante à dieta e ao exercício para melhorar o controlo glicémico:em pacientes não controlados adequadamente, em seus máximo tolerado em doses de metformina alonein pacientes em seu máximo tolerado em doses de metformina, juntamente com outros glicose reduzindo medicamentos, incluindo insulina, quando estes não fornecem adequado controlo glicémico. em doentes já a serem tratados com a combinação de canagliflozin e a metformina como separar tabletsfor resultados do estudo com relação a combinação de terapias, efeitos no controlo glicémico e eventos cardiovasculares, e as populações estudadas, consulte as secções 4. 4, 4. 5 e 5.

União Europeia - português - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - agentes antineoplásicos - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

União Europeia - português - 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.

União Europeia - português - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leucemia, myélogênico, crônico, bcr-abl positivo - agentes antineoplásicos - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.