Sialanar Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sialanar

proveca pharma limited - glycopyrronium bromide - sialorrea - drogi għal disturbi gastro-intestinali funzjonali - trattament sintomatiċi tal sialorrhoea severa (drooling kronika patoloġiċi) fit-tfal u adolexxenti li għandhom 3 snin u aktar antiki b ' diżordni newroloġika kronika.

Symkevi Unjoni Ewropea - Malti - EMA (European Medicines Agency)

symkevi

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - 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.

Atazanavir Krka Unjoni Ewropea - Malti - EMA (European Medicines Agency)

atazanavir krka

krka, d.d., novo mesto - atazanavir (as sulfate) - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - atazanavir krka kapsuli, mogħti flimkien ma 'doża baxxa ta' ritonavir, huma indikati għat-trattament ta 'l-hiv-1 infettati-adulti u pazjenti pedjatriċi minn 6 snin ta' età u anzjani f'kombinazzjoni ma ' prodotti mediċinali antiretrovirali oħra. ibbażat fuq disponibbli viroloġiku u kliniku minn pazjenti adulti, m'hu mistenni ebda benefiċċju f'pazjenti b'razez reżistenti għall-inibituri ta'proteasi multipliċi (≥ 4 mutazzjonijet pi). l-għażla ta ' atazanavir krka fit-trattament bl-esperjenza fl-adulti u pazjenti pedjatriċi għandu jkun ibbażat fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjent.

Isturisa Unjoni Ewropea - Malti - EMA (European Medicines Agency)

isturisa

recordati rare diseases - osilodrostat phosphate - is-sindromu ta 'cushing - kortikosterojdi għal użu sistemiku - isturisa huwa indikat għall-kura ta ' l-sindromu ta'cushing fl-adulti.

Spikevax (previously COVID-19 Vaccine Moderna) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

spikevax (previously covid-19 vaccine moderna)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vaċċini - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Pemazyre Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pemazyre

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - aġenti antineoplastiċi - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Ontozry Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ontozry

angelini pharma s.p.a - cenobamate - epilessija - anti-epilettiċi, - adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Efmody Unjoni Ewropea - Malti - EMA (European Medicines Agency)

efmody

diurnal europe b.v. - hydrocortisone - adrenal hyperplasia, congenital - kortikosterojdi għal użu sistemiku - treatment of congenital adrenal hyperplasia (cah) in adolescents aged 12 years and over and adults.

Oxbryta Unjoni Ewropea - Malti - EMA (European Medicines Agency)

oxbryta

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Beyfortus Unjoni Ewropea - Malti - EMA (European Medicines Agency)

beyfortus

astrazeneca ab - nirsevimab - sera immuni u immunoglobulini, - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in neonates and infants during their first rsv season. beyfortus should be used in accordance with official recommendations.