Spikevax (previously COVID-19 Vaccine Moderna) Evropska unija - slovenščina - 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 - cepiva - 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.

Comirnaty Evropska unija - slovenščina - EMA (European Medicines Agency)

comirnaty

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna 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 - cepiva - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. uporaba tega cepiva mora biti v skladu z uradnimi priporočili.

DaTSCAN Evropska unija - slovenščina - EMA (European Medicines Agency)

datscan

ge healthcare b.v. - ioflupan (123l) - tomography, emission-computed, single-photon; lewy body disease; parkinson disease; alzheimer disease - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. datscan je označen za odkrivanje izguba funkcionalne dopaminergičnih nevronov terminalov v striatum:pri odraslih bolnikih s klinično negotova parkinsonian sindromov, na primer tistih z zgodnji simptomi, da bi razlikuje bistveno, tremor iz parkinsonian sindromov, povezanih z idiopatsko parkinsonovo boleznijo, bolezni, multiple sistemske atrofije in postopno supranuclear palsy. datscan se ne more razlikovati med parkinsonove bolezni, multiple sistemske atrofije in postopno supranuclear palsy. pri odraslih bolnikih, za pomoč pri razlikovanju verjetno, demenco z lewy organe, od alzheimerjeve bolezni. datscan se ne more razlikovati med demenco z lewy organov in parkinsonova bolezen, demenca.

PhotoBarr Evropska unija - slovenščina - EMA (European Medicines Agency)

photobarr

pinnacle biologics b.v.  - natrijev porfimer - barrett požiralnik - antineoplastična sredstva - fotodinamična terapija (pdt) z photobarr je indiciran za: ablacijo visoko-kakovostni razred displazija (hgd) pri bolnikih z barrett je požiralniku (eo).

Celvapan Evropska unija - slovenščina - EMA (European Medicines Agency)

celvapan

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 - cepiva - preprečevanje gripe, ki jo povzroča virus a (h1n1) v 2009. celvapan je treba uporabljati v skladu z uradnimi smernice.

Imbruvica Evropska unija - slovenščina - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Olanzapine Cipla (previously Olanzapine Neopharma) Evropska unija - slovenščina - EMA (European Medicines Agency)

olanzapine cipla (previously olanzapine neopharma)

cipla (eu) limited - olanzapin - schizophrenia; bipolar disorder - psiholeptiki - adultsolanzapine je primerna za zdravljenje shizofrenije. olanzapin je učinkovita pri ohranjanju klinično izboljšanje, med nadaljevanje terapije pri bolnikih, ki so pokazali začetni odziv zdravljenje. olanzapin je primerna za zdravljenje zmerno do hudo manične epizode. pri bolnikih, katerih manične epizode se je odzvala na olanzapin zdravljenje, olanzapin, je indicirano za preprečevanje ponovitve pri bolnikih z bipolarno motnjo.

Rapiscan Evropska unija - slovenščina - EMA (European Medicines Agency)

rapiscan

ge healthcare as  - regadenoson - myokardno perfuzijsko slikanje - srčna terapija - to zdravilo je samo za diagnostično uporabo. rapiscan je selektivno koronarnih vazodilatator za uporabo kot farmakološke stres agent za radionuklid miokardni perfuzijo imaging (mpi) pri odraslih bolnikih, ne more opraviti ustrezno uresničevanje stres.

Visudyne Evropska unija - slovenščina - EMA (European Medicines Agency)

visudyne

cheplapharm arzneimittel gmbh - verteporfin - myopia, degenerative; macular degeneration - oftalmologi - visudyne je primerna za zdravljenje:odrasli z exudative (mokro) starostna degeneracija rumene pege (amd) s pretežno klasičnih subfoveal choroidal neovascularisation (cnv) ali;za odrasle z subfoveal choroidal neovascularisation sekundarne patološke kratkovidnost.