Evropská unie - čeština - EMA (European Medicines Agency)

ucb pharma s.a.   - fenfluramine hydrochloride - epilepsies, myoclonic - antiepileptika, - treatment of seizures associated with dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Evropská unie - čeština - EMA (European Medicines Agency)

pacira ireland limited - bupivacaine - acute pain - amides, anesthetics, local - exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Evropská unie - čeština - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirotika pro systémové použití - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 a 5. tecovirimat siga should be used in accordance with official recommendations.

Evropská unie - čeština - EMA (European Medicines Agency)

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.

Evropská unie - čeština - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuklidové zobrazování - terapeutické radiofarmaky - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Evropská unie - čeština - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - imunosupresiva - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Evropská unie - čeština - EMA (European Medicines Agency)

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - antianemické přípravky - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Evropská unie - čeština - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - cytostatika - lytgobi monotherapy is indicated for the treatment of adult patients 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.

Evropská unie - čeština - EMA (European Medicines Agency)

merck sharp & dohme b.v. - gefapixant - cough - kašel a studené přípravky - lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.

Evropská unie - čeština - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, kobicistat, emtricitabin, tenofovir alafenamide - hiv infekce - antivirotika pro systémové použití - genvoya je indikován k léčbě dospělých a dospívajících (ve věku 12 let a starších s tělesné hmotnosti nejméně 35 kg) infikovaných virem lidské imunodeficience 1 (hiv-1) bez jakékoli známých mutací spojených s rezistencí na inhibitoru integrázy emtricitabinem nebo tenofovir.