União Europeia - português - EMA (European Medicines Agency)

leo pharma a/s - tacrolimus - dermatite, atopic - outras preparações dermatológicas - flare treatmentadults and adolescents (16 years of age and above)treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. children (two years of age and above)treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. maintenance treatmentmaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i. ocorrência de quatro ou mais vezes por ano), que tiveram uma resposta inicial a um máximo de seis semanas de tratamento duas vezes ao dia, pomada de tacrolimus (lesões limpo, quase limpo ou levemente afetados).

União Europeia - português - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - drogas para tratamento de doenças ósseas - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - agentes antitrombóticos - 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. (see section 4. 4 for haemodynamically unstable pe patients. tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos. (see section 4. 4 para haemodynamically instável pe pacientes). 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. tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment 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. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 e 5. rivaroxaban accord, 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. 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. tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment 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.

Portugal - português - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

generis farmacêutica, s.a. - aciclovir - comprimido - 200 mg - aciclovir 200 mg - aciclovir - genérico - duração do tratamento: longa duração

União Europeia - português - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hemoglobinúria, paroxística - imunossupressores - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

União Europeia - português - EMA (European Medicines Agency)

csl behring gmbh - imunoglobulina normal humana (scig) - síndromes de deficiência imunológica - imune soros e imunoglobulinas, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

União Europeia - português - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - narcolepsia - outros medicamentos do sistema nervoso - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

União Europeia - português - EMA (European Medicines Agency)

pharmaand gmbh - peginterferão alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 e 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. com relação à decisão de iniciar o tratamento em pacientes pediátricos consulte as secções 4. 2, 4. 4 e 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 e 5. para o vírus da hepatite c (vhc) genótipo atividade específica, consulte as secções 4. 2 e 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. quando decidir iniciar o tratamento na infância, é importante considerar inibição do crescimento induzido por terapia de combinação. a reversibilidade da inibição do crescimento é incerto. a decisão de tratamento deve ser feita em uma base de caso a caso (ver secção 4,.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferão alfa-2b - hepatite c, crônica - immunostimulants, - adults (tritherapy)pegintron 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 pegintron é para ser usado em combinação com estes medicamentos. adults (bitherapy and monotherapy)pegintron 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. pegintron 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 anterior com interferon-alfa (peguilado ou não-peguilado) e terapia de combinação de ribavirina ou interferon-alfa monoterapia. interferon monoterapia, incluindo pegintron, é indicado, principalmente, em caso de intolerância ou contra-indicação à ribavirina. por favor, consulte a ribavirina smpc quando pegintron é para ser usado em combinação com ribavirina. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, 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 pegintron é para ser usado em combinação com ribavirina.

União Europeia - português - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - outros medicamentos do sistema nervoso - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.