Elonva União Europeia - português - EMA (European Medicines Agency)

elonva

n.v. organon - corifollitropina alfa - reproductive techniques, assisted; ovulation induction; investigative techniques - hormônios sexuais e moduladores do sistema genital, - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).

Lixiana União Europeia - português - EMA (European Medicines Agency)

lixiana

daiichi sankyo europe gmbh - edoxaban tosilate - stroke; venous thromboembolism - agentes antitrombóticos - prevenção de acidente vascular cerebral e embolia sistêmica em pacientes adultos com fibrilação atrial não valvar (nvaf) com um ou mais fatores de risco, como insuficiência cardíaca congestiva, hipertensão, idade ≥ 75 anos, diabetes mellitus, acidente vascular cerebral prévio ou ataque isquêmico transitório (tia). tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos.

Noxafil União Europeia - português - EMA (European Medicines Agency)

noxafil

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimicóticos para uso sistêmico - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 e 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 e 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. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. 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 e 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 e 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 e 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. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. 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 e 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 e 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. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. 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):- aspergilose invasiva em pacientes com a doença de que é refratária a anfotericina b e itraconazol ou em pacientes que são intolerantes a esses medicamentos;- fusariosis em pacientes com a doença de que é refratária a anfotericina b ou em pacientes que são intolerantes a anfotericina b;- chromoblastomycosis e mycetoma em pacientes com doença refratária ao itraconazol ou em pacientes que são intolerantes itraconazol;- coccidioidomicose em pacientes com a doença de que é refratária a anfotericina b, itraconazol ou fluconazol ou em pacientes que são intolerantes a esses medicamentos;- candidíase orofaríngea: como terapia de primeira linha em pacientes que têm doenças graves ou são imunocomprometidos, nos quais a resposta a terapia tópica é esperado para ser pobre. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. 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.

Zepatier União Europeia - português - EMA (European Medicines Agency)

zepatier

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatite c, crônica - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 e 5. para o vírus da hepatite c (vhc) genótipo-actividade específica, consulte as secções 4. 4 e 5.

Steglatro União Europeia - português - EMA (European Medicines Agency)

steglatro

merck sharp & dohme b.v. - ertugliflozin l-ácido pyroglutamic - diabetes mellitus, tipo 2 - drugs used in diabetes, sodium-glucose co-transporter 2 (sglt2) inhibitors - steglatro 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:como monoterapia em doentes para os quais o uso de metformina é considerada inadequada, devido à intolerância ou contra-indicações. além de outros medicamentos para o tratamento da diabetes.

Rayvow União Europeia - português - EMA (European Medicines Agency)

rayvow

eli lilly nederland b.v. - lasmiditan succinate - transtornos da enxaqueca - analgésicos - rayvow is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.