Visudyne Європейський Союз - латвійська - EMA (European Medicines Agency)

visudyne

cheplapharm arzneimittel gmbh - verteporfin - myopia, degenerative; macular degeneration - oftalmoloģiskie līdzekļi - visudyne ir indicēts, lai ārstētu:pieaugušajiem ar exudative (wet) vecuma saistīto makulas deģenerāciju (amd) ar pārsvarā klasisko subfoveal choroidal neovascularisation (cnv) vai;pieaugušajiem ar subfoveal choroidal neovascularisation vidusskolas patoloģiskas tuvredzība.

Vaxchora Європейський Союз - латвійська - EMA (European Medicines Agency)

vaxchora

bavarian nordic a/s - vibrio cholerae, celms cvd 103-hgr, dzīvot - holera - vakcīnas - vaxchora is indicated for active immunisation against disease caused by vibrio cholerae serogroup o1 in adults and children aged 2 years and older. Šī vakcīna ir jālieto atbilstoši oficiālajām rekomendācijām.

Ultifend ND IBD Європейський Союз - латвійська - EMA (European Medicines Agency)

ultifend nd ibd

ceva-phylaxia veterinary biologicals co. ltd - turkey herpes virus, strain rhvt/nd/ibd, expressing the fusion protein of newcastle disease virus and the vp2 protein of infectious bursal disease virus, live recombinant - imunoloģisks aves - embryonated chicken eggs; chicken - for the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by newcastle disease virus (ndv) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (ibdv); to reduce mortality, clinical signs and lesions caused by classical marek’s disease virus (mdv).

Zeffix Європейський Союз - латвійська - EMA (European Medicines Agency)

zeffix

glaxosmithkline (ireland) limited - lamivudine - b hepatīts, hronisks - pretvīrusu līdzekļi sistēmiskai lietošanai - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. uzsākšanas lamivudīnu ārstēšanai, jāapsver tikai tad, kad izmantot alternatīvu pretvīrusu līdzeklis ar augstāku ģenētisko barjeru nav pieejami, vai arī ir nepieciešams;, decompensated aknu slimība kopā ar otro aģents, bez krusteniskās rezistences pret lamivudīnu.

Lamivudine Teva Європейський Союз - латвійська - EMA (European Medicines Agency)

lamivudine teva

teva b.v. - lamivudine - b hepatīts, hronisks - pretvīrusu līdzekļi sistēmiskai lietošanai - lamivudīnu teva ir indicēts, lai ārstētu hronisku b hepatītu pieaugušajiem ar:kompensēta aknu slimība, ar pierādījumi par aktīvu vīrusu replikāciju, pastāvīgi paaugstinātu seruma alanīna aminotransferase (alat) līmeni un histoloģiski pierādījumi par aktīvu aknu iekaisumu un / vai fibroze. uzsākšanas lamivudīnu ārstēšanai, jāapsver tikai tad, kad izmantot alternatīvu pretvīrusu līdzeklis ar augstāku ģenētisko barjeru nav pieejams, vai gadījumā (skatīt 5. nodaļā.

Aflunov Європейський Союз - латвійська - EMA (European Medicines Agency)

aflunov

seqirus s.r.l.  - gripas vīrusa virsmas antigēnu (hemaglutinīna un neiraminidāzes) celms: a/turcija/turcija/1/05 (h5n1)-kā celms (nibrg-23) - influenza, human; immunization; disease outbreaks - vakcīnas - aktīvā imunizācija pret gripas vīrusa h5n1 apakštipu. Šī norāde ir balstīta uz immunogenicity datus no veseliem vecumā no 18 gadiem pēc administrācijas divas devas vakcīnas, kas satur a/turcija/turcija/1/05 (h5n1)-kā celms. aflunov būtu jāizmanto saskaņā ar oficiālās rekomendācijas.

Keytruda Європейський Союз - латвійська - EMA (European Medicines Agency)

keytruda

merck sharp & dohme b.v. - pembrolizumabs - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastiski līdzekļi - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacientiem ar egfr vai bĀziskĀ pozitīvas mutācijas audzēja arī būtu saņēmuši mērķtiecīgu terapiju, pirms saņem keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Dukoral Європейський Союз - латвійська - EMA (European Medicines Agency)

dukoral

valneva sweden ab - rekombinanto holēras toksīna b apakšvienības, vibrio cholerae 01 - cholera; immunization - vakcīnas - dukoral ir indicēts aktīvai imunizācijai pret vibrio cholerae serogrupas o1 izraisītu slimību pieaugušajiem un bērniem no 2 gadu vecuma, kuri apmeklēs endēmiskās / epidēmiskās zonas. izmantot dukoral, būtu jānosaka, pamatojoties uz oficiālajām rekomendācijām, ņemot vērā, mainīgumu, epidemioloģijas un risku inficēties ar slimības dažādās ģeogrāfiskās zonās un ceļošanas nosacījumi. dukoral nedrīkst aizstāt standarta drošības pasākumi. gadījumā, ja caureja pasākumi rehidratāciju ir jāuzsāk.

Fatrovax RHD Європейський Союз - латвійська - EMA (European Medicines Agency)

fatrovax rhd

fatro s.p.a - rabbit hemorrhagic disease virus 2 vp1ab, rabbit hemorrhagic disease virus vp1a - immunologicals par zaķu dzimtas dzīvnieki - truši - for active immunisation of rabbits from the age of 28 days to reduce mortality, infection, clinical signs and organ lesions of rabbit haemorrhagic disease caused by rhdv1 and rhdv2.