Ayvakyt Uniunea Europeană - română - EMA (European Medicines Agency)

ayvakyt

blueprint medicines (netherlands) b.v. - avapritinib - tumorile stromale gastro-intestinale - alte medicamente antineoplazice, inhibitori de proteinkinază - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Arexvy Uniunea Europeană - română - EMA (European Medicines Agency)

arexvy

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - infecții ale virusului sincițial respirator - vaccinuri - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. utilizarea acestui vaccin ar trebui să fie în conformitate cu recomandările oficiale.

Kimmtrak Uniunea Europeană - română - EMA (European Medicines Agency)

kimmtrak

immunocore ireland limited - tebentafusp - uveal neoplasms - agenți antineoplazici - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Spikevax (previously COVID-19 Vaccine Moderna) Uniunea Europeană - română - 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 - vaccinuri - 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.

Libmeldy Uniunea Europeană - română - EMA (European Medicines Agency)

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - alte medicamente pentru sistemul nervos - 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.

Tecfidera Uniunea Europeană - română - EMA (European Medicines Agency)

tecfidera

biogen netherlands b.v. - fumarat de dimetil - scleroză multiplă - imunosupresoare - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Tysabri Uniunea Europeană - română - EMA (European Medicines Agency)

tysabri

biogen netherlands b.v. - natalizumab - scleroză multiplă - imunosupresoare selective - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 și 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Arikayce liposomal Uniunea Europeană - română - EMA (European Medicines Agency)

arikayce liposomal

insmed netherlands b.v. - amikacin sulfate - infecții ale tractului respirator - antibacteriene pentru uz sistemic, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.