Den Europæiske Union - dansk - EMA (European Medicines Agency)

recordati rare diseases - betain vandfri - homocystinuri - andre alimentary tract and metabolism produkter, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

serb sa - betaine - homocystinuri - andre alimentary tract and metabolism produkter, - amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:•         cystathionine beta-synthase (cbs),•         5,10 methylene tetrahydrofolate reductase (mthfr),•         cobalamin cofactor metabolism (cbl).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparaginase - forløbercellelimfoblastisk leukæmi-lymfom - antineoplastiske midler - spectrila er angivet som en komponent af antineoplastisk kombinationsbehandling til behandling af akut lymfoblastær leukæmi, (alle) i pædiatriske patienter fra fødsel til 18 år og voksne.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

recordati netherlands b.v. - tivozanib - carcinom, nyrecelle - antineoplastiske midler - fotivda er angivet for den første linje behandling af voksne patienter med avanceret renalcellecarcinom (rcc) og til voksne patienter som er vegfr og mtor pathway inhibitor-naive følgende sygdomsprogression efter en forudgående behandling med cytokin terapi for avanceret rcc. behandling af fremskredent renalcellecarcinom.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - luftvejsinfektioner - antibakterielle midler til systemisk brug, - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazol - skizofreni - psykoleptika - vedligeholdelsesbehandling af skizofreni hos voksne patienter stabiliseret med oral aripiprazol.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

nanotherapeutics bohumil, s.r.o. - whole virion influenza vaccine, inactivated containing antigen of strain a/california/07/2009 (h1n1)v - disease outbreaks; influenza, human; immunization - vacciner - profylakse af influenza forårsaget af a (h1n1) v 2009 virus. celvapan bør anvendes i overensstemmelse med officielle retningslinjer.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinale stromale tumorer - andre antineoplastiske midler, protein kinase hæmmere - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - antineoplastiske midler - 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.