Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedemas, hereditário - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - agentes antineoplásicos - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

orphelia pharma sas - clofarabina - leucemia linfoblástica com células precursoras - linfoma - agentes antineoplásicos - tratamento da leucemia linfoblástica aguda (all) em pacientes pediátricos que recaíram ou são refratários após receber pelo menos dois regimes anteriores e onde não há outra opção de tratamento prevista para resultar em uma resposta durável. a segurança e a eficácia foram avaliadas em estudos de pacientes ≤ 21 anos no diagnóstico inicial.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

immedica pharma ab - glicerol fenilbutirato - transtornos do ciclo da ureia, inato - outro aparelho digestivo e metabolismo produtos, - ravicti é indicado para uso como terapia adjuvante para a crônica manejo de pacientes com distúrbios do ciclo da uréia (ucds) incluindo as deficiências de carbamoyl fosfato-sintase-i (cps), ornitina carbamoyltransferase (otc), argininosuccinate sintetase (cu), argininosuccinate liase (asl), a arginase i (arg) e ornitina translocase deficiência hyperornithinaemia-hyperammonaemia homocitrullinuria síndrome (hhh) que não podem ser gerenciados pelo proteína dietética de restrição e/ou suplementação de aminoácidos sozinho. ravicti deve ser utilizado com dieta a restrição de proteína e, em alguns casos, suplementos dietéticos (e. , aminoácidos essenciais, arginina, citrulina, suplementos de calorias sem proteínas).

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - fibrose cística - outros produtos do sistema respiratório - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrose cística - outros produtos do sistema respiratório - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - imunossupressores - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - imune soros e imunoglobulinas, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumores do estromal gastrointestinal - agentes antineoplásicos - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Ευρωπαϊκή Ένωση - Πορτογαλικά - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - mieloma múltiplo - agentes antineoplásicos - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.