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

viraferonpeg

merck sharp dohme ltd  - peginterferão alfa-2b - hepatite c, crônica - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. por favor, consulte a ribavirina e o boceprevir resumos das características do medicamento (smpcs) quando viraferonpeg é para ser usado em combinação com estes medicamentos. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg em combinação com a ribavirina (bitherapy) é indicado para o tratamento do chc infecção em pacientes adultos que anteriormente não tratados, incluindo pacientes com clinicamente estável co-infecção pelo hiv e em doentes adultos que não tiveram sucesso com o tratamento prévio com interferon alfa (peguilado ou não-peguilado) e terapia de combinação de ribavirina ou interferon alfa monoterapia. interferon monoterapia, incluindo viraferonpeg, é indicado, principalmente, em caso de intolerância ou contra-indicação à ribavirina. por favor, consulte a ribavirina smpc quando viraferonpeg é para ser usado em combinação com ribavirina. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. quando a decisão de não adiar o tratamento até a idade adulta, é importante considerar que a terapia de combinação induziu uma inibição do crescimento que pode ser irreversível em alguns pacientes. a decisão de tratamento deve ser feita caso-a-caso. por favor, consulte a ribavirina smpc para cápsulas ou solução oral quando viraferonpeg é para ser usado em combinação com ribavirina.

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

volibris

glaxosmithkline (ireland) limited - ambrisentan - hipertensão, pulmonar - antihipertensivos, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

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

xarelto

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - agentes antitrombóticos - xarelto, co-administrada com ácido acetilsalicílico (asa) sozinho ou com asa mais clopidogrel ou ticlopidina, é indicada para a prevenção de eventos aterotrombóticos em pacientes adultos, após uma síndrome coronária aguda (sca), com elevação de biomarcadores cardíacos. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. prevenção de tromboembolismo venoso (vte) em pacientes adultos submetidos à cirurgia eletiva de substituição de quadril ou joelho. tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Innovax-ND-IBD União Europeia - português - EMA (European Medicines Agency)

innovax-nd-ibd

intervet international b.v. - células associadas ao vivo recombinante turquia herpesvirus (strain hvp360), expressando a proteína de fusão de encontrar vírus e a proteína vp2 da dii vírus - aviária vírus do herpes (doença de marek) + aviária infecciosas radiação do vírus da doença (doença de gumboro) + vírus da doença de newcastle/paramyxovírus - chicken; embryonated chicken eggs - for active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (ibd) virus,to reduce mortality, clinical signs and lesions caused by marek’s disease (md) virus.

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

alkindi

diurnal europe b.v. - hidrocortisona - insuficiência adrenal - corticosteróides para uso sistêmico - a terapia de reposição de insuficiência adrenal em lactentes, crianças e adolescentes (a partir de nascimento para < 18 anos).

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

imfinzi

astrazeneca ab - durvalumab - carcinoma, pulmão de células não pequenas - agentes antineoplásicos - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

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

slenyto

rad neurim pharmaceuticals eec sarl - melatonina - sleep initiation and maintenance disorders; autistic disorder - psicolepticos - slenyto é indicado para o tratamento da insônia em crianças e adolescentes com idade 2-18 com transtorno do espectro do autismo (asd) e / ou de smith-magenis síndrome, onde a higiene do sono medidas têm sido insuficientes.

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

shingrix

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vacinas - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz. o uso de shingrix deve estar em conformidade com as recomendações oficiais.

Jcovden (previously COVID-19 Vaccine Janssen) União Europeia - português - EMA (European Medicines Agency)

jcovden (previously covid-19 vaccine janssen)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - vacinas - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. o uso desta vacina deve ser de acordo com as recomendações oficiais.

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) União Europeia - português - EMA (European Medicines Agency)

vaxzevria (previously covid-19 vaccine astrazeneca)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - vacinas - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older. o uso desta vacina deve ser de acordo com as recomendações oficiais.