Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - rokotteet - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. käyttö tämä rokote tulee virallisten suositusten mukaisesti.

Euroopan unioni - suomi - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft hylkääminen - immunosuppressantit - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. yhdessä bortetsomibin kanssa, talidomidin ja deksametasonin hoitoon aikuispotilailla, joilla on äskettäin diagnosoitu multippeli myelooma, jotka ovat oikeutettuja autologisen kantasolujen siirto. yhdessä lenalidomidin ja deksametasonin tai bortetsomibi ja deksametasoni, hoitoon aikuisille potilaille, joilla on multippeli myelooma, jotka ovat saaneet vähintään yhtä aiempaa hoitoa. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. monoterapiana aikuispotilaille, joilla oli uusiutunut ja refraktorinen multippeli myelooma, joiden aiempi hoito, mukana proteasomin estäjä ja immunomoduloivan aineen, ja jotka ovat osoittaneet taudin etenemistä viimeinen hoito. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Euroopan unioni - suomi - EMA (European Medicines Agency)

itm medical isotopes gmbh - lutetium (177lu) chloride - radionuklidien kuvantaminen - terapeuttiset radiofarmaseuttiset valmisteet - endolusiinibeta on radiofarmaseuttinen prekursori, eikä sitä ole tarkoitettu suoraan potilaille. sitä on tarkoitus käyttää vain sellaisten kantajamolekyylien radioaktiiviseen merkintään, jotka on erityisesti kehitetty ja sallittu radiolabeloitavaksi lutetium (177lu) -kloridilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - imatinibi - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastiset aineet - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. , glivecin vaikutusta lopputulokseen luuydinsiirto ei ole määritetty. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. potilaat, joilla on alhainen tai hyvin alhainen riski toistumisen pitäisi saada adjuvantti hoito; hoitoon aikuisille potilaille, joilla on leikattavissa oleva dermatofibrosarcoma protuberans (dfsp) ja aikuispotilaille, joilla on uusiutunut ja / tai metastasoitunut dfsp, jotka eivät ole oikeutettuja leikkaus. , aikuis-ja lapsipotilailla, tehokkuutta näyttö glivecin tehosta perustuu hematologisten ja sytogeneettisten vasteiden määrään ja progression-free survival, kml -, hematologinen ja sytogeneettinen vaste ph+ all, mds / mpd, hematologinen vaste hes / cel ja objektiivinen hoitovaste aikuispotilailla, joilla on ei-leikattavissa oleva ja / tai metastaattinen gist ja dfsp ja recurrence-free survival, adjuvanttia ydin. kokemusta glivec-hoitoon potilailla, joilla on mds / mpd, jotka liittyvät pdgfr-geenin uudelleenjärjestäytymisen yhteydessä järjestelyt on hyvin rajallinen (ks. kohta 5. paitsi äskettäin diagnosoitu kroonisen vaiheen kml, ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sanofi pasteur msd, snc - puhdistettu difteriatoksoidi, puhdistettua tetanustoksoidia, puhdistettu hinkuyskä-kurkkumätä, puhdistettu hinkuyskä rihmamaiset hemagglutiniini -, hepatiitti b-pinta-antigeeni, inaktivoitu tyypin 1 poliovirus (mahoney), inaktivoitu tyypin 2 poliovirus (mef-1), inaktivoitu tyypin 3 poliovirus (saukett), haemophilus influenzae tyyppi b-polysakkaridia - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - rokotteet - tämä yhdistetty rokote on tarkoitettu ensisijainen ja kehua rokotusten lasten kurkkumätä, jäykkäkouristus, hinkuyskä, hepatiitti b aiheuttama kaikki tunnetut alatyyppejä, polio ja invasiivisia infektioita johtuu haemophilus influenzae tyyppi b.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinibi (fosfaatteina) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastiset aineet - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polysytemia vera (pv)jakavi on tarkoitettu aikuisille potilaille, joilla on polysytemia vera, jotka ovat resistenttejä tai intolerantteja ja hydroksiurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sanofi belgium - alemtutsumabille - multippeliskleroosi - selektiiviset immunosuppressantit - lemtrada on tarkoitettu aikuispotilaille, joilla esiintyy relapsoivaa remitting-multippeliskleroosia (rrms), jolla on aktiivinen sairaus, jonka kliiniset tai kuvantamisominaisuudet.

Euroopan unioni - suomi - EMA (European Medicines Agency)

i.d.b. radiopharmacy b.v. - lutetium (177lu) chloride - radionuklidien kuvantaminen - terapeuttiset radiofarmaseuttiset valmisteet - lumark on radiofarmaseuttinen prekursori. sitä ei ole tarkoitettu suoraan potilaille. tätä lääkettä on käytettävä vain radiolabeloitavaksi kantajamolekyyleille, jotka on erityisesti kehitetty ja sallittu radiolabeloitavaksi tällä radionuklidilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

astrazeneca ab - olaparib - munasarjojen kasvaimet - antineoplastiset aineet - munasarjojen cancerlynparza on tarkoitettu monoterapiana:huolto aikuisille potilaille, joilla on pitkälle edennyt (figo vaiheet iii ja iv) brca1/2-mutaation (ituradan ja/tai somaattisten) korkea-asteen epiteelin munasarjojen, munanjohtimien tai ensisijainen vatsakalvon syöpä, jotka ovat vaste (täydellinen tai osittainen) jälkeen ensilinjan platinapohjaisen kemoterapian. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 ja 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. potilaita on aikaisemmin hoidettu antrasykliineillä ja taxane in (neo)adjuvantti-tai metastasoitunut asetus, ellei potilaat eivät sovellu näihin hoitoihin (ks. kohta 5. potilaat, joilla on hormoni-reseptori (hr)-positiivinen rintasyöpä pitäisi myös olla edennyt tai sen jälkeen ennen hormonaalisen hoidon, tai katsotaan sopimattomaksi hormonaalisen hoidon. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.