Evropská unie - čeština - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/california/7/2009 (h1n1)-derived strain used nymc x-181 - influenza, human; immunization; disease outbreaks - chřipkové vakcíny - profylaxe chřipky způsobené virem a (h1n1v) 2009. focetria by měl být používán v souladu s oficiálními pokyny.

Evropská unie - čeština - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - mnohočetný myelom - antineoplastická činidla - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Evropská unie - čeština - EMA (European Medicines Agency)

serono europe limited - efalizumab - psoriáza - imunosupresiva - léčba dospělých pacientů se středně těžkou až těžkou chronickou ložiskovou psoriázou, kteří nedostatečně reagovali na, nebo kteří mají kontraindikovanou nebo netolerují léčbu včetně cyklosporinu, methotrexátu a puva (viz bod 5. 1 - klinická účinnost).

Evropská unie - čeština - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - další antineoplastické látky - removab je indikován pro intraperitoneální léčbu maligního ascitu u pacientů s epcam-pozitivním karcinomem, kde standardní léčba není dostupná nebo již není možná.

Evropská unie - čeština - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastická činidla - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. předchozí chemoterapie musí zahrnovat alespoň antracyklin a taxan, s výjimkou pacientů, jsou nevhodné pro tyto procedury. hormonální receptor pozitivní pacienti musí také selhala hormonální terapie, pokud pacienti jsou nevhodné pro tyto procedury.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. v kombinaci s docetaxelem k léčbě pacientů, kteří nedostávali předchozí chemoterapii k léčbě metastazujícího onemocnění. v kombinaci s inhibitorem aromatázy k léčbě postmenopauzálních pacientek s hormonální receptor pozitivní mbc, dosud neléčených trastuzumabem. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). po chirurgickém zákroku, chemoterapii (neoadjuvantní nebo adjuvantní) a radioterapii (pokud je to relevantní). po adjuvantní chemoterapii s doxorubicinem a cyklofosfamidem v kombinaci s paklitaxelem nebo docetaxelem. v kombinaci s adjuvantní chemoterapií skládající se z docetaxel a karboplatina. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. přesné a validované metody metody by měly být použity.

Evropská unie - čeština - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - mnohočetný myelom - antineoplastická činidla - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.

Evropská unie - čeština - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - mnohočetný myelom - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Evropská unie - čeština - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - mnohočetný myelom - antineoplastická činidla - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Evropská unie - čeština - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriáza - imunosupresiva - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Evropská unie - čeština - 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 - vakcíny - profylaxe chřipky způsobené virem a (h1n1) v roce 2009. přípravek celvapan by měl být používán v souladu s oficiálními pokyny.