Európai Unió - lett - EMA (European Medicines Agency)

mabxience research sl - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiski līdzekļi - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys 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 alymsys in combination with capecitabine. alymsys, 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. alymsys, 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. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, 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. alymsys, 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. alymsys, 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. alymsys, 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.

Európai Unió - lett - EMA (European Medicines Agency)

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 - antineoplastiski līdzekļi - 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. papildinformāciju par cilvēka epidermas augšanas faktora 2 receptora (her2) statusu, lūdzu, skatiet 5. sadaļā. 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. sīkāku informāciju par her2 statusu, lūdzu, skatiet 5. sadaļā. 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.

Európai Unió - lett - EMA (European Medicines Agency)

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 - antineoplastiski līdzekļi - 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. papildinformāciju par cilvēka epidermas augšanas faktora 2 receptora (her2) statusu, lūdzu, skatiet 5. sadaļā. 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. sīkāku informāciju par her2 statusu, lūdzu, skatiet 5. sadaļā. 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.

Európai Unió - lett - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd. - palonosetron hydrochloride - vomiting; cancer - pretvemšanas un antinauseants, , serotonīns (5ht3) antagonisti - aloxi ir norādīts pieaugušajiem:novērst akūtas slikta dūša un vemšana, kas saistīta ar ļoti emetogenic vēža ķīmijterapija,profilakses, slikta dūša un vemšana, kas saistīta ar mēreni emetogenic vēža ķīmijterapija. aloxi ir norādīts pediatrijas pacientiem no 1 mēneša vecuma un vecākiem:novērst akūtas slikta dūša un vemšana, kas saistīta ar ļoti emetogenic vēža ķīmijterapija un novēršanu, slikta dūša un vemšana, kas saistīta ar mēreni emetogenic vēža ķīmijterapija.

Európai Unió - lett - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hipertensija - agents, kas iedarbojas uz renīna-angiotenzīna sistēmu - esenciālas hipertensijas ārstēšana. amlodipine/valsartan mylan ir norādīts pieaugušajiem, kuru asinsspiedienu nevar pienācīgi kontrolēt uz amlodipine vai valsartan monotherapy.

Európai Unió - lett - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin glulisine - cukura diabēts - cukura diabēts - pieaugušajiem, pusaudžiem un bērniem, kas ir seši vai vairāk gadus veci ar cukura diabētu, ārstēšana ar insulīnu ir nepieciešama.

Európai Unió - lett - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tipranavir - hiv infekcijas - pretvīrusu līdzekļi sistēmiskai lietošanai - aptivus, co-ievadīts ar zemu devu ritonavir, ir norādīts kombinācija antiretrovirālo terapiju hiv-1 infekciju ļoti pretreated pieaugušie un pusaudži 12 gadus veci vai vecāki ar vīrusu rezistenti pret vairākiem proteāzi inhibitori. aptivus vajadzētu izmantot tikai kā daļa no aktīva kombinācija antiretrovirālo režīms pacientiem, ar ne citas terapijas iespējas. Šī informācija ir balstīti uz rezultātiem, kas iegūti divās posms-iii pētījumiem, kas veikti, ļoti pretreated pieaugušiem pacientiem (vidējais skaits 12, pirms pretvīrusu vielas), ar vīrusu rezistenti pret proteāzi inhibitori un viens posms-ii studiju izmeklēšanas farmakokinētika, drošumu un iedarbīgumu aptivus galvenokārt ārstēšanas pieredzējuši pacientiem pusaudžu vecumā no 12 līdz 18 gadiem. pieņemot lēmumu uzsākt ārstēšanu ar aptivus, co-vienīgi ar mazu devu ritonavir, būtu rūpīgi jāapsver ārstēšanas vēsturi individuāla pacienta un modeļiem, kas mutāciju, kas saistīti ar dažādām aģentu. genotypic vai fenotipisko testēšana (ja pieejams) un no attīrīšanas vēsture būtu ceļvedis, lietošanas aptivus. sākta ārstēšana, būtu jāņem vērā kombinācijas mutācijas, kas var negatīvi ietekmēt virusoloģisko reakciju uz aptivus, co-ievadīts ar zemu devu ritonavir.

Európai Unió - lett - EMA (European Medicines Agency)

gilead sciences ireland uc - efavirenz, emtricitabine, tenofovir disoproxil fumarate - hiv infekcijas - pretvīrusu līdzekļi sistēmiskai lietošanai - atripla ir efavirenza, emtricitabīna un tenofovīra dizoproksila fumarāta fiksētas devas kombinācija. tas ir indicēts, lai ārstētu cilvēku imūndeficīta vīrusu " -1 (hiv-1) infekcijas pieaugušajiem ar virologic slāpēšanas hiv-1 rns līmenis < 50 kopijas/ml uz to pašreizējā kārtība, antiretrovirālo terapiju ilgāk nekā trīs mēnešus,. pacientiem nedrīkst būt pieredzējuši virusoloģijas ja pirms antiretrovirālo terapiju un ir zināms, lai nav harboured vīrusa celmi ar mutāciju, kas piešķir ievērojamu pretestību uz jebkuru no trīs komponentus, kas ietverti atripla pirms izmeklēšanas sākuma viņu pirmā antiretrovirālo terapiju režīms. demonstrējumu par labu atripla, galvenokārt pamatojoties uz 48 nedēļas datus, kas iegūti klīniskajā pētījumā, kurā pacientiem ar stabilu virologic slāpēšanas par kombināciju antiretrovirālā terapija jāmaina, lai atripla. nav datu, kas pašlaik ir pieejams no klīniskie pētījumi ar atripla attieksme-naiva vai stipri pretreated pacientiem. nav pieejami dati, lai atbalstītu kombinācija atripla un citiem antiretrovīrusu aģentu.

Európai Unió - lett - EMA (European Medicines Agency)

astrazeneca ab - tikagrelors - peripheral vascular diseases; acute coronary syndrome - antitrombotiskie līdzekļi - brilique, co ievadīts ar acetilsalicilskābi (asa), ir norādīts, lai novērstu atherothrombotic notikumiem pieaugušo pacientu withacute koronāro sindromu (acs) oras anamnēzē ir miokarda infarkts (mi), un ir augsts risks saslimt ar atherothrombotic eventbrilique, co-ievadīts ar acetil salicilskābe (asa), ir norādīts, lai novērstu atherothrombotic notikumiem pieaugušiem pacientiem, kam anamnēzē ir miokarda infarkts (mi notikusi vismaz gadu atpakaļ), un ir augsts risks saslimt ar atherothrombotic notikums.

Európai Unió - lett - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinakalceta hidrohlorīds - hyperparathyroidism, secondary; hypercalcemia - kalcija homeostāze - sekundāra hiperparatireoidisms (hpt) ārstēšana pacientiem ar nieru slimību beigu stadijā (esrd) uz apkopes dialīzes terapiju. cinacalcet mylan var izmantot kā daļu no terapijas shēmu, tostarp fosfātu saistvielām un/vai d vitamīna sterīni, pēc vajadzības. samazināt hypercalcaemia pacientiem ar:parathyroid carcinomaprimary hpt, par kurām parathyroidectomywould jānorāda, pamatojoties uz seruma kalcija līmeni (kā noteikts attiecīgās ārstēšanas vadlīnijas), bet kam parathyroidectomy nav klīniski atbilstošs, vai ir kontrindicēta.