Vegzelma Euroopa Liit - eesti - EMA (European Medicines Agency)

vegzelma

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.

Rivastigmine 3M Health Care Ltd Euroopa Liit - eesti - EMA (European Medicines Agency)

rivastigmine 3m health care ltd

3m health care limited - rivastigmiin - alzheimeri tõbi - psychoanaleptics, , anticholinesterases - kerge kuni mõõdukalt raskekujulise alzheimeri tõve sümptomaatiline ravi.

Imatinib Koanaa Euroopa Liit - eesti - EMA (European Medicines Agency)

imatinib koanaa

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastilised ained - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patsientidel, kellel on madal või väga madal risk kordumise ei tohiks saada abiaine ravi. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Torisel Euroopa Liit - eesti - EMA (European Medicines Agency)

torisel

pfizer europe ma eeig - temsirolimus - carcinoma, renal cell; lymphoma, mantle-cell - antineoplastilised ained - neeru-cell carcinomatorisel on näidustatud esimese rea ravi täiskasvanud patsientidel, kellel on arenenud neeru-raku kartsinoomi (rcc), kellel on vähemalt kolm kuuest prognostic riskitegurid. mantlit-cell lymphomatorisel on näidustatud ravi täiskasvanud patsientidel, kellel on taastekkinud ja / või tulekindlad mantlit-raku lümfoom (mcl).

Sunitinib Accord Euroopa Liit - eesti - EMA (European Medicines Agency)

sunitinib accord

accord healthcare s.l.u. - sunitiniib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastilised ained - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Pemetrexed Accord Euroopa Liit - eesti - EMA (European Medicines Agency)

pemetrexed accord

accord healthcare s.l.u. - pemetrekseedi dinaatrium-hemipentahüdraat - carcinoma, non-small-cell lung; mesothelioma - antineoplastilised ained - pleura pahaloomulise mesotheliomapemetrexed kokkuleppel koos cisplatin on näidustatud ravi keemiaravi naiivne patsientidel unresectable pleura pahaloomulise mesotelioomi. non-small cell lung cancerpemetrexed kokkuleppel koos cisplatin on näidustatud esimese rea raviks patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi raviks, v.a peamiselt soomusrakuline rakkude histoloogia. pemetrexed kokkuleppel on märgitud monotherapy hooldus-ravi lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi raviks, v.a peamiselt soomusrakuline rakkude histoloogia patsientidel, kelle haigus ei ole jõudnud kohe pärast plaatina-põhinevat keemiaravi. pemetrexed kokkuleppel on märgitud monotherapy teise rea ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi raviks, v.a peamiselt soomusrakuline rakkude histoloogia.

Plerixafor Accord Euroopa Liit - eesti - EMA (European Medicines Agency)

plerixafor accord

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

AMPICILLIN/SULBACTAM BAUSCH HEALTH süste-/infusioonilahuse pulber Eesti - eesti - Ravimiamet

ampicillin/sulbactam bausch health süste-/infusioonilahuse pulber

bausch health ireland limited - ampitsilliin+sulbaktaam - süste-/infusioonilahuse pulber - 2000mg+1000mg 10tk

AMPICILLIN/SULBACTAM BAUSCH HEALTH süste-/infusioonilahuse pulber Eesti - eesti - Ravimiamet

ampicillin/sulbactam bausch health süste-/infusioonilahuse pulber

bausch health ireland limited - ampitsilliin+sulbaktaam - süste-/infusioonilahuse pulber - 1000mg+500mg 10tk

Paxene Euroopa Liit - eesti - EMA (European Medicines Agency)

paxene

norton healthcare ltd. - paklitakseel - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - antineoplastilised ained - paxene on näidustatud patsientide raviks:• kaugelearenenud aids-iga seotud kaposi on sarkoom (aids-ks), kes on jätnud enne liposomal anthracycline ravi;• metastaatilise kartsinoomi, rinnanäärme (mbc), kes ei ole suutnud või ei ole kandidaadid standard anthracycline sisaldavad ravi;• kaugelearenenud kartsinoomi on munasarjadele (aoc) või koos ülejäänud haigus (> 1 cm) pärast esialgse laparotoomia, koos cisplatin kui esimese rea ravi;• metastaatilise kartsinoomi on munasarjadele (mop) pärast ebaõnnestumist plaatina sisaldavate kombineeritud ravi ilma taxanes kui teise rea ravi;• mitteväikerakk-kopsu kartsinoomi (mitteväikerakk-kopsuvähi), kes ei ole kandidaadid potentsiaalselt tervendav kirurgia ja/või kiiritusravi, koos cisplatin. piiratud efektiivsuse andmed toetavad seda näidustust (vt lõik 5).