Uni Eropa - Esti - EMA (European Medicines Agency)

virbac s.a. - kasside päritolu rekombinantne oomega interferoon - immunostimulants, - dogs; cats - dogsreduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. catstreatment of cats infected with feline leukaemia virus (felv) and / or feline immunodeficiency virus (fiv), in non-terminal clinical stages, from the age of nine weeks. in a field study conducted, it was observed that there was:a reduction of clinical signs during the symptomatic phase (four months);a reduction of mortality:in anaemic cats, mortality rate of about 60% at four, six, nine and 12 months was reduced by approximately 30% following treatment with interferon;in non-anaemic cats, mortality rate of 50% in cats infected by felv was reduced by 20% following treatment with interferon. fiv-i nakatunud kassides oli suremus madal (5%) ja ravi ei mõjutanud.

Uni Eropa - Esti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - interferoon alfa-2b - carcinoid tumor; leukemia, hairy cell; lymphoma, follicular; hepatitis b, chronic; hepatitis c, chronic; leukemia, myelogenous, chronic, bcr-abl positive; melanoma; multiple myeloma - immunostimulants, - kroonilise hepatiidi btreatment täiskasvanud patsientidel, kellel on krooniline b-hepatiidi seotud tõendid hepatiit-b viiruse replikatsiooni (esinemine dna-hepatiit-b viiruse dna (hbv-dna) ja hepatiit-b antigeeni (hbeag), suurenenud alaniini kontsentratsioon (alt) ja histoloogiliselt tõestatud aktiivne maksapõletik ja / või fibroos. kroonilise hepatiidi cenne algatamise ravi introna, tuleks kaaluda tulemused kliinilistes uuringutes võrreldi introna koos pegylated interferoon. täiskasvanud patientsintrona on näidustatud ravi täiskasvanud patsientidel, kellel on krooniline hepatiit c, kes on kõrgenenud transaminases ilma maksa dekompensatsiooni ja kes on positiivsed c-hepatiidi viiruse rna (hcv-rna). parim viis kasutada introna see märge on koos ribavirin. lapsed kolme-aastased ja vanemad ning adolescentsintrona on märgitud kombinatsioon raviskeemi, mille ribavirin, laste ravimiseks kolme-aastased ja vanemad) ja noorukid, kellel on krooniline hepatiit c, ei ole varem töödeldud, ilma maksa dekompensatsiooni, ja kes on positiivsed hcv-rna. kui otsustatakse, et ei ravi edasi lükata, kuni täiskasvanueani, on tähtis arvestada, et kombineeritud ravi põhjustatud kasvu inhibeerimine, mille tulemusena vähendatud lõplik täiskasvanud kõrgus mõnedel patsientidel. otsus ravida, tuleb teha iga juhtumi puhul eraldi. karvane-cell leukaemiatreatment patsientidele, kellel karvane raku leukeemia. kroonilise müeloidse leukaemiamonotherapytreatment täiskasvanud patsientidel philadelphia-kromosoom - või bcr/abl-translokatsioon-positiivse kroonilise müeloidse leukeemia. kliiniline kogemus näitab, et hematoloogiline ja tsütogeneetiline suur / väike vastus on kättesaadav enamik patsiente ravida. oluline tsütogeneetiline vastus on defineeritud < 34 % ph+ leukaemic rakud luuüdis, arvestades, et alaealine vastus on ≥ 34 %, kuid < 90 % ph+ rakkude üdi. kombinatsioon therapythe kombinatsioonis interferoon alfa-2b ja cytarabine (ara-c), mida manustatakse esimese 12 kuu jooksul ravi on tõestatud, et oluliselt suurendada määra suurt tsütogeneetiline vastused ja oluliselt pikendavad üldine elulemus kolm aastat ja võrreldes interferoon alfa-2b monotherapy. mitu myelomaas hooldus ravi patsientidel, kes on saavutatud objektiivne remissioon (rohkem kui 50% võrra myeloma valk) pärast esialgset induktsiooni-kemoteraapiat. praegune kliiniline kogemus näitab, et säilitusravi interferoon alfa-2b pikendab platoo etapp; kuid toimet üldisele elulemusele ei ole veenvalt tõendanud,. follikulaarne lymphomatreatment suure-kasvaja-koormuse follikulaarne lümfoom, nagu täiendust sobiva koostisega induktsioon kemoteraapia, nagu karbonaad-nagu raviskeemi. kõrge tuumori koormus on määratletud, millel on vähemalt üks järgmine omadus: mahukad kasvaja mass (> 7 cm), kaasamine kolm või rohkem sõlmpunkti saidid (igaüks > 3 cm), süsteemsed sümptomid (kaalulangus > 10 %, pyrexia > 38°c rohkem kui kaheksa päeva, või öine higistamine), splenomegaly kaugemale moodustisi, oluline organ obstruktsiooni või kompressiooni sündroom, orbiidi või epiduraalsed kaasamine, seroossest efusioon või leukeemia. carcinoid tumourtreatment, carcinoid kasvajad koos lümfisõlmede või maksa metastases ja "carcinoid sündroomi". pahaloomuliste melanomaas abiaine ravi patsientidel, kes on vaba haiguse pärast operatsiooni, kuid on suur oht süsteemsete juhtumite kordumist e. patsiendid, kellel on esmane või korduv (kliinilistel või patoloogilistel) lümfisõlmede.

Uni Eropa - Esti - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonasool - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimükoosid süsteemseks kasutamiseks - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 ja 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasiivsed aspergillosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b või itraconazole, või patsientidel, kes ei talu neid ravimeid;- fusariosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b, või patsientidel, kes ei talu, amphotericin b;- chromoblastomycosis ja mycetoma patsientidel, kellel on haigus, mis on tulekindlad, et itraconazole, või patsientidel, kes ei talu, itraconazole;- coccidioidomycosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b, itraconazole või fluconazole, või patsientidel, kes ei talu neid ravimeid;- farüngeaalne kandidoos: kui esimese rea ravi patsientidel, kellel on raske haigus, või on immunocompromised, kelle vastus aktuaalne ravi on oodata halb. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Uni Eropa - Esti - EMA (European Medicines Agency)

dendreon uk ltd - autoloogse perifeerse vere mononukleaarsete rakkude, sealhulgas vähemalt 50 miljonit autoloogset cd54 + rakke aktiveeritud ja eesnäärme happeline fosfataas granulotsüütide-makrofaagide kolooniaid stimuleeriv faktor - eesnäärmevähk - muud immunostimulaatorid - provenge on näidustatud minimaalselt sümptomaatiline või asümptomaatiline (mittevistseraalse) kastreerida-resistentse metastaatilise eesnäärmevähi meessoost täiskasvanutel, kellel kemoteraapia ei ole veel kliiniliselt näidustatud.

Uni Eropa - Esti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirens - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - stocrin on näidustatud viirusevastase kombinatsioonravi korral inimese immuunpuudulikkuse viiruse-1 (hiv-1) -infektsiooniga täiskasvanutele, noorukitele ja kolmeaastastele lastele. stocrin ei ole piisavalt uuritud patsientidel, kaugelearenenud hiv-haigus, nimelt patsientidel, kellel cd4 arv < 50 rakku/mm3) või pärast rikke proteaas-inhibiitori (pi)-sisaldavad raviliikide. kuigi rist-resistentsust, efavirenz, mille pis ei ole dokumenteeritud, on praegu piisavad andmed efektiivsuse edasine kasutamine, pi-põhinevad kombineeritud ravi pärast rikke raviskeemi, mis sisaldab stocrin.

Uni Eropa - Esti - EMA (European Medicines Agency)

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vaktsiinid - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz. kasutada shingrix peab olema kooskõlas ametlike soovitustega.

Uni Eropa - Esti - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - kartsinoom, squamous cell - antineoplastilised ained - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Uni Eropa - Esti - EMA (European Medicines Agency)

janssen-cilag international n.v.   - paliperidoonpalmitaat - skisofreenia - psühhoeptikumid - byannli (previously paliperidone janssen-cilag international) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.

Uni Eropa - Esti - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vaktsiinid - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. kasutamist see vaktsiin peaks olema kooskõlas ametlike soovitustega.

Uni Eropa - Esti - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirine - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.