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

pylclari

curium pet france - piflufolastat (18f) - prostatične neoplazme - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Nobilis Influenza H5N2 Evropska unija - slovenščina - EMA (European Medicines Agency)

nobilis influenza h5n2

intervet international bv - inaktiviran antigen virusa celokupne aviarne influence podtipa h5n2 (sev a / duck / potsdam / 1402/86) - imunologija za aves - piščanec - za aktivno imunizacijo piščancev proti aviarne influence tipa a, podtipa h5. učinkovitost je bila ovrednotena na podlagi predhodnih rezultatov pri piščancih. zmanjšanje kliničnih znakov, smrtnost in izločanje virusa po izzivu so pokazali tri tedne po cepljenju. po pričakovanju, da se serumska protitelesa vztrajajo vsaj 12 mesecev po uporabi dveh odmerkov cepiva.

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

locametz

novartis europharm limited  - gozetotide - radionuklidno slikanje - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) Evropska unija - slovenščina - EMA (European Medicines Agency)

adjupanrix (previously pandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals)

glaxosmithkline biologicals s.a. - deaktiviran virus gripe, ki vsebuje antigen: a / vietnam / 1194/2004 (h5n1), podoben sevu (nibrg-14) - influenza, human; immunization; disease outbreaks - cepiva - preprečevanje gripe v uradno prijavljeni pandemični situaciji. pandemije gripe cepiva je treba uporabljati v skladu z uradnimi smernice.

Twinrix Paediatric Evropska unija - slovenščina - EMA (European Medicines Agency)

twinrix paediatric

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - cepiva - twinrix pediatric je indiciran za uporabo pri neimunskih dojenčkih, otrocih in mladostnikih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo s hepatitisom a in hepatitisom b.

Twinrix Adult Evropska unija - slovenščina - EMA (European Medicines Agency)

twinrix adult

glaxosmithkline biologicals s.a. - hepatitis a virus (inaktivirano), hepatitis b površinski antigen - hepatitis b; hepatitis a; immunization - cepiva - zdravilo twinrix adult je indicirano za uporabo pri neimunskih odraslih in mladostnikih, starih 16 let ali več, ki jim grozi okužba s hepatitisom a in hepatitisom b.

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

tecartus

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - limfom, mantle cell - antineoplastična sredstva - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Zoonotic Influenza Vaccine Seqirus Evropska unija - slovenščina - EMA (European Medicines Agency)

zoonotic influenza vaccine seqirus

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - cepiva - active immunisation against h5 subtype of influenza a virus.

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals Evropska unija - slovenščina - EMA (European Medicines Agency)

prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals

glaxosmithkline biologicals s.a. - deaktiviran virus gripe, ki vsebuje antigen: a / vietnam / 1194/2004 (h5n1), podoben sevu (nibrg-14) - influenza, human; immunization; disease outbreaks - cepiva - aktivna imunizacija proti podtipu h5n1 virusa influenca a. ta navedba temelji na immunogenicity podatkov iz zdravih predmetov iz 18. leta starosti dalje po uporabi zdravila dva odmerka cepiva, pripravljeni iz a/vietnam/1194/2004 nibrg-14 (h5n1) (glej točko 5. prepandemic cepiva proti gripi (h5n1) (split virion, inaktivirano, adjuvanted) glaxosmithkline biologicals 3. 75 µg je treba uporabljati v skladu z uradnimi smernice.

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

vepacel

ology bioservices ireland ltd - virus gripe (cel virion, inaktiviran), ki vsebuje antigen: a / vietnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - cepiva proti gripi - aktivna imunizacija proti podtipu h5n1 virusa influence a. ta navedba temelji na immunogenicity podatkov iz predmetov, od starosti 6 mesecev dalje po uporabi zdravila dva odmerka cepiva, pripravljene s h5n1 podtipa sevi. vepacel je treba uporabljati v skladu z uradnimi smernice.