Eiropas Savienība - latviešu - EMA (European Medicines Agency)

valneva austria gmbh - japānas encefalīta vīruss, inaktivēts (attenuēts sa14-14-2 celms, kas audzēts vero šūnās) - encephalitis, japanese; immunization - vakcīnas - ixiaro ir indicēts aktīvai imunizācijai pret japāņu encefalītu pieaugušajiem, pusaudžiem, bērniem un zīdaiņiem vecumā no diviem mēnešiem un vecākiem. ixiaro būtu jāuzskata par lietošanai personu riska iedarbības ar ceļojumu vai tās laikā savas profesionālās darbības.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

ology bioservices ireland ltd - gripas vīruss (viss virions, inaktivēts), kas satur antigēnu no: a / vietnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - influenza vaccines - aktīvās imunizācijas pret h5n1 apakštipa a gripas vīruss. Šī norāde ir balstīta uz immunogenicity datu subjektu vecumā no 6 mēnešu vecuma pēc administrācijas divas devas vakcīnas, kas sagatavoti ar h5n1 apakštipa vīrusa celmiem.. vepacel būtu jāizmanto saskaņā ar oficiālās vadlīnijas.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

amgen europe b.v. - evolokumabs - dyslipidemias; hypercholesterolemia - lipīdu modificējoši aģenti - hypercholesterolaemia un sajauc dyslipidaemiarepatha ir norādīts pieaugušajiem primārās hypercholesterolaemia (heterozigotu ģimenes un ārpus ģimenes) vai jaukta dyslipidaemia, kā palīglīdzekli, lai diēta:kopā ar statin vai statin ar citu lipīdu pazemināšanas terapijas pacientiem, kas nespēj sasniegt zbl-c mērķus ar maksimāli pieļaujama devu statin vai,atsevišķi, vai kombinācijā ar citām lipīdu pazemināšanas terapiju pacientiem, kam ir statin-nepanes vai kurām statin ir kontrindicēta. homozygous ģimenes hypercholesterolaemiarepatha ir norādīts pieaugušajiem un pusaudžiem vecumā no 12 gadiem un vairāk, ar homozygous ģimenes hypercholesterolaemia kopā ar citiem lipīdu pazemināšanas terapiju. reģistrēts aterosklerotisku sirds un asinsvadu diseaserepatha ir norādīts pieaugušajiem ar uzņēmējdarbību aterosklerotisku sirds un asinsvadu slimības (miokarda infarkts, insults vai perifēro artēriju slimību), lai mazinātu sirds-asinsvadu slimību risku samazinot zbl-c līmenim, kā palīglīdzekli, lai korekcijas citi riska faktori:kombinācijā ar maksimāli pieļaujama devu statin ar vai bez citu lipīdu pazemināšanas terapiju, vai,atsevišķi, vai kombinācijā ar citām lipīdu pazemināšanas terapiju pacientiem, kam ir statin-nepanes vai kurām statin ir kontrindicēta. par pētījuma rezultātiem attiecībā uz ietekmi uz zbl-c, sirds un asinsvadu notikumi un populācijas izpēte skatīt nodaĝā 5.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

amgen europe b.v. - etelcalcetide hydrochloride - hiperparatireoidisms, sekundārais - anti-parathyroid agents, calcium homeostasis - parsabiv ir indicēts sekundāra hiperparatireozes (shpt) ārstēšanai pieaugušiem pacientiem ar hronisku nieru slimību (ckd) hemodialīzes terapijā.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

biogen idec ltd - daclizumab - multiplā skleroze - imūnsupresanti - zinbrita ir indicēta pieaugušiem pacientiem recidivējošu multiplās sklerozes formu (rms) ārstēšanai.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

baxalta innovations gmbh - rurioktokogs alfa pegols - a hemofīlija - antihemorāģija - Ārstēšanas un profilakses asiņošanas pacientiem, 12 gadi un iepriekš ar hemofilijas (iedzimtas viii faktora deficīts).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - 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. papildinformāciju par cilvēka epidermas augšanas faktora 2 receptora (her2) statusu, lūdzu, skatiet 5. sadaļā. 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. sīkāku informāciju par her2 statusu, lūdzu, skatiet 5. sadaļā. 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).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - 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. papildinformāciju par cilvēka epidermas augšanas faktora 2 receptora (her2) statusu, lūdzu, skatiet 5. sadaļā. 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. sīkāku informāciju par her2 statusu, lūdzu, skatiet 5. sadaļā. 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

rhythm pharmaceuticals netherlands b.v. - setmelanotide - aptaukošanās - pretiekaisuma līdzekļi, izņemot diētas produkti - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

zoetis belgium sa - frunevetmab - pretsāpju līdzekļi - kaķi - for the alleviation of pain associated with osteoarthritis in cats.