Euroopa Liit - eesti - EMA (European Medicines Agency)

mylan ireland limited - arseentrioksiid - leukeemia, promüelotsüütne, äge - antineoplastilised ained - arseentrioksiid mylan on näidustatud remissiooni induktsioon, ja konsolideerimise täiskasvanud patsientidel, kellel on:- hiljuti diagnoositud madala kuni keskmise riski ägeda promyelocytic leukeemia (avp) (valgete vereliblede arv, ≤ 10 x 103/µl) koos kõik-trans-retinoolhappe (atra)- taastekkinud/tulekindlad äge promyelocytic leukeemia (avp) (varasem ravi peab olema lisatud retinoid ja keemiaravi), mida iseloomustab juuresolekul, t(15;17) translokatsioon ja/või olemasolu promyelocytic leukeemia/retinoolhappe retseptori α (pml/rar alfa) geen. vastuse määr muude ägeda müeloidse leukeemia alatüüpi, et arseentrioksiid ei ole beenexamined.

Euroopa Liit - eesti - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rfp-lt) and avian encephalomyelitis virus, strain calnek 1143 (ae) - immunologicals for aves, live viral vaccines, domestic fowl - kana - for active immunisation of chickens of 8 to 13 weeks of age in order to reduce the skin lesions due to fowlpox, to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis and to prevent egg production losses due to avian encephalomyelitis.

Euroopa Liit - eesti - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevatsizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastilised ained - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. lisateavet inimese epidermaalse kasvufaktori retseptori 2 (her2) seisundi kohta vt palun 5. jaotisest. 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. her2 staatuse kohta lisateabe saamiseks lugege palun 5. jaotist. 1 of the smpc. aybintio, 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. aybintio, 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. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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. aybintio, in combination with 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Euroopa Liit - eesti - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevatsizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastilised ained - bevatsizumab kombinatsioonis fluoropürimidiinil põhineva kemoteraapiaga on näidustatud käärsoole või pärasoole metastaatilise kartsinoomi raviks täiskasvanud patsientidel. bevacizumab koos paclitaxel on näidustatud esimese rea raviks täiskasvanud patsientidel metastaatilise rinnavähi. lisateavet inimese epidermaalse kasvufaktori retseptori 2 (her2) seisundi kohta vt palun 5. jaotisest. bevacizumab koos capecitabine on näidustatud esimese rea raviks täiskasvanud patsientidel metastaatilise rinnavähi, kelle ravi teiste keemiaravi võimalusi, sealhulgas taxanes või anthracyclines ei ole asjakohane. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. her2 staatuse kohta lisateabe saamiseks lugege palun 5. jaotist. bevacizumab, 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. bevacizumab, koos erlotiniibi, on näidustatud esimese rea raviks täiskasvanud patsientidel, kellel unresectable kaugelearenenud, metastaatilise või korduv mitte-soomusrakuline non-small cell lung cancer, mille epidermaalse kasvufaktori retseptori (egfr) aktiveerivad mutatsioonid. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, 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 iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, 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. bevacizumab, koos paclitaxel ja cisplatin või, teise võimalusena, paclitaxel ja topotecan patsientidel, kes ei saa platinum ravi, on näidustatud ravi täiskasvanud patsientidel, kellel on püsivad, korduvad, või metastaatilise kartsinoomi, emakakaela.

Euroopa Liit - eesti - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevatsizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastilised ained - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. lisateavet inimese epidermaalse kasvufaktori retseptori 2 (her2) seisundi kohta vt palun 5. jaotisest. onbevzi 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 onbevzi in combination with capecitabine. her2 staatuse kohta lisateabe saamiseks lugege palun 5. jaotist. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, in combination with 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. onbevzi, 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

stada arzneimittel ag - bevatsizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastilised ained - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. lisateavet inimese epidermaalse kasvufaktori retseptori 2 (her2) seisundi kohta vt palun 5. jaotisest. oyavas 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 oyavas in combination with capecitabine. her2 staatuse kohta lisateabe saamiseks lugege palun 5. jaotist. oyavas, 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. oyavas, 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. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, 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. oyavas, 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. oyavas, in combination with 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. oyavas, 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevatsizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastilised ained - 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. lisateavet inimese epidermaalse kasvufaktori retseptori 2 (her2) seisundi kohta vt palun 5. jaotisest. 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. her2 staatuse kohta lisateabe saamiseks lugege palun 5. jaotist. 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevatsizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastilised ained - 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. lisateavet inimese epidermaalse kasvufaktori retseptori 2 (her2) seisundi kohta vt palun 5. jaotisest. 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. her2 staatuse kohta lisateabe saamiseks lugege palun 5. jaotist. 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

acino pharma gmbh  - klopidogreel - perifeersed veresoontehaigused - antitrombootilised ained - clopidogrel on näidatud täiskasvanute ennetamise atherothrombotic sündmused:kannatavate patsientide müokardiinfarkti (paar päeva kuni vähem kui 35 päeva), ischaemic insult (7 päeva kuni vähem kui 6 kuud) või väljakujunenud perifeersete arterite haigus. patsiendid, kes põevad äge koronaarsündroom:- mitte st segmendi elevatsiooniga äge koronaarsündroom (ebastabiilne stenokardia või mitte q laine müokardiinfarkt), k.a patsiendid toimumas stent paigutuse perkutaanse koronaarse interventsiooni, koos atsetüülsalitsüülhape (asa). - st segmendi elevatsiooniga ägeda müokardi infarkti korral kombinatsioonis asa on meditsiiniliselt ravitud patsientide abikõlblikud trombolüütiline ravi. täiendava teabe jaoks vt osa 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

acino pharma gmbh - klopidogreel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antitrombootilised ained - clopidogrel on näidatud täiskasvanute ennetamise atherothrombotic sündmused:kannatavate patsientide müokardiinfarkti (paar päeva kuni vähem kui 35 päeva), ischaemic insult (7 päeva kuni vähem kui 6 kuud) või väljakujunenud perifeersete arterite haigus;patsiendid, kes põevad äge koronaarsündroom:- mitte-st-segmendi elevatsiooniga äge koronaarsündroom (ebastabiilne stenokardia või mitte-q-wave müokardiinfarkt), k.a patsiendid toimumas stent paigutuse perkutaanse koronaarse interventsiooni, koos atsetüülsalitsüülhape (asa);- st segmendi elevatsiooniga ägeda müokardi infarkti korral kombinatsioonis asa on meditsiiniliselt ravitud patsientide abikõlblikud trombolüütiline ravi. täiendava teabe jaoks vt osa 5.