Abevmy Unia Europejska - polski - EMA (European Medicines Agency)

abevmy

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Środki przeciwnowotworowe - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. w celu uzyskania dalszych informacji na temat statusu ludzkiego receptora naskórkowego czynnika wzrostu 2 (her2), patrz punkt 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. więcej informacji na temat statusu her2 można znaleźć w rozdziale 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Ronapreve Unia Europejska - polski - EMA (European Medicines Agency)

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - odporne surowicy i immunoglobuliny, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. zobacz rozdziały 4. 4 i 5.

Lextemy Unia Europejska - polski - EMA (European Medicines Agency)

lextemy

mylan ire healthcare limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Środki przeciwnowotworowe - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Vegzelma Unia Europejska - polski - EMA (European Medicines Agency)

vegzelma

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Środki przeciwnowotworowe - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. w celu uzyskania dalszych informacji na temat statusu ludzkiego receptora naskórkowego czynnika wzrostu 2 (her2), patrz punkt 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. więcej informacji na temat statusu her2 można znaleźć w rozdziale 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Evicel Unia Europejska - polski - EMA (European Medicines Agency)

evicel

omrix biopharmaceuticals n. v. - ludzki fibrynogen, ludzka trombina - hemostaza, chirurgiczna - antykrościeryczne - evicel stosuje się jako leczenie wspomagające w chirurgii, gdzie standardowe techniki chirurgiczne są niewystarczające, w celu poprawy hemostazy. evicel oraz wskazał jako szwów wsparcie hemostazy w dziedzinie chirurgii naczyniowej.

SonoVue Unia Europejska - polski - EMA (European Medicines Agency)

sonovue

bracco international b.v. - sześciofluorek siarki - ultrasonography; echocardiography - kontrastowe media - ten produkt leczniczy jest przeznaczony wyłącznie do celów diagnostycznych. sonovue jest przeznaczony do stosowania z ultradźwiękowe wizualizacji dla wzmocnienia эхогенности krwi lub płynu w drogach moczowych, co prowadzi do poprawy stosunków sygnału do szumu . sonovue należy stosować tylko u pacjentów, u których badanie bez kontrastu wzmocnienia jest неокончательным. echocardiographysonovue jest транспульмональная echocardiographic środka kontrastowego do stosowania u dorosłych pacjentów z przewidywanej lub siedzibę choroby sercowo-naczyniowe, aby zapewnić kontrast komór serca i zwiększają wsierdzia lewej komory wyznaczenie granicy. doppler macrovasculaturesonovue zwiększa dokładność wykrycia lub wykluczenia patologii w mózgu miażdżycy tętnic i экстракраниальных szyjnych lub tętnic obwodowych u dorosłych pacjentów poprzez poprawę doppler sygnału do szumu . sonovue zwiększa jakość obrazu doppler przepływu i czasu trwania klinicznie przydatne wzmocnienie sygnału w ocenie żyły wrotnej u pacjentów dorosłych. doppler microvasculaturesonovue poprawia wyświetlanie dopływu krwi do wątroby i porażek piersi w ciągu doppler u dorosłych pacjentów prowadzi do bardziej specyficznych porażką charakterystyka. usg, экскреторной pęcherza tractsonovue jest przeznaczony do stosowania w usg dróg wyprowadzających w pediatrycznych pacjentów od noworodka do 18 roku życia w celu wykrycia torbieli ureteric reflux. ograniczenia w interpretacji negatywnego urosonography.