Eiropas Savienība - latviešu - EMA (European Medicines Agency)

seqirus s.r.l.  - govju vīrusa virsmas antigēni, inaktivēti: a / viet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - influenza vaccines - gripas profilakse oficiāli paziņotajā pandēmijas situācijā. pandēmiskās gripas vakcīna jāizmanto saskaņā ar oficiālajām vadlīnijām.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - inaktivēts split gripas vīruss, kas satur antigēnu, kas atbilst a / california / 07/2009 (h1n1) -laikā izmantotajam celmam, ko lieto nymc x-179a - influenza, human; immunization; disease outbreaks - influenza vaccines - a (h1n1) v 2009 vīrusa izraisīta gripas profilakse. pandemrix būtu jāizmanto tikai tad, ja ieteicamās gada sezonas trīsvērtīgas / četrvērtīga gripas vakcīnu nav pieejami un ja uzskata par vajadzīgu imunizācija pret (h1n1) v (skatīt apakšpunktus 4. 4 un 4. pandemrix būtu jāizmanto saskaņā ar oficiālās vadlīnijas.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vakcīnas - active immunisation against h5 subtype of influenza a virus.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

intervet international bv - inaktivēta visu putnu gripas vīrusa antigēna (h5n2 apakštipa (celms a/pīļu/potsdam/1402/86) - imunoloģisks aves - cālis - cāļu aktīvai imunizācijai pret putnu gripu a tipa h5 apakštipam. efektivitāte ir novērtēta, pamatojoties uz sākotnējiem rezultātiem cāļiem. klīnisko pazīmju, mirstības un vīrusa izdalīšanās pēc izaicinājuma samazināšana tika parādīta trīs nedēļas pēc vakcinācijas. paredzams, ka seruma antivielas saglabāsies vismaz 12 mēnešus pēc divu vakcīnas devu ievadīšanas.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

intervet international bv - inaktivēts viss h5 apakštipa putnu gripas vīrusa antigēns (h5n6 celms, a / pīle / potsdam / 2243/84) - imunoloģisks aves - cālis - cāļu aktīvai imunizācijai pret putnu gripu a tipa h5 apakštipam. klīnisko pazīmju, mirstības un vīrusa ekskrēcijas samazināšanās pēc izaicinājuma ar vīrusu h5n1 celmu tika parādīta divu nedēļu laikā pēc vienas devas vakcinācijas. seruma antivielas, ir pierādīts, ka pastāv vistas vismaz 7 mēnešus un veikti pētījumi ar citu vakcīnu celmi, kas liecina, ka seruma antivielas, iespējams, varētu saglabāties vistas vismaz 12 mēnešus pēc tam, kad administrācija divas devas vakcīnas.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

ceva-phylaxia oltóanyagtermelõ zrt. - inaktivēta cūku cirkovīrusa 2. tips (pcv2) - imunoloģiskie līdzekļi suidae - cūkas (cūkas un sivēnmātes) - sivēnmātes un giltspassive imunizācijas, sivēnu ar jaunpienu, pēc aktīvās imunizācijas par sivēnmātēm un jauncūkām, lai samazinātu bojājumus limfoīdo audu, kas saistīti ar pcv2 infekcija, un, kā atbalsts, lai samazinātu pcv2 saistītas mirstības. pigletsactive imunizācijas sivēnu samazināt izkārnījumu izdalīšanās pcv2 un vīrusu slodze asinīs, un kā atbalsts, lai samazinātu pcv2 saistīti klīniskās pazīmes, tostarp novājēšanas, svara zudums un mirstības rādītājus, kā arī samazināt vīrusu slodzi un bojājumi limfoīdo audu, kas saistīti ar infekcija pcv2.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastiski līdzekļi - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

roche registration gmbh  - pertuzumab - krūts audzējs - antineoplastic agents, monoclonal antibodies - metastātisku krūts vēzi:perjeta ir norādīts lietošanai kopā ar trastuzumab un docetaxel pieaugušo pacientiem ar her2 pozitīvu metastātisku vai lokāli recidivējošu unresectable krūts vēzi, kuri nav saņēmuši iepriekšējās anti-her2 terapiju vai ķīmijterapiju to metastātiska slimība. neoadjuvant attieksmi pret krūts vēzi:perjeta ir norādīts lietošanai kopā ar trastuzumab un ķīmijterapiju, lai neoadjuvant ārstēšanai pieaugušiem pacientiem ar her2 pozitīvu, lokāli uzlabotas, pretiekaisuma, vai agrīno stadiju krūts vēža augsts risks atkārtoties.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostatas audzēji - citi hormonu antagonisti un tiem līdzīgas vielas - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Latvija - latviešu - Zāļu valsts aģentūra

sandoz d.d., slovenia - doksorubicīna hidrohlorīds - koncentrāts infūziju šķīduma pagatavošanai - 2 mg/ml