Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - verenvuotokuume ebola - rokotteet - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - abirateroniasetaatti - prostatiset kasvaimet - endokriinihoito - zytiga on merkitty prednisoni tai prednisoloni:metastasoituneen kastraation kastraatioresistentin eturauhassyövän aikuiset miehet, jotka ovat oireettomia tai lievästi oireileva jälkeen epäonnistuminen androgeenideprivaatiohoito joille kemoterapiaa ei ole vielä kliinisesti indicatedthe metastasoituneen kastraation kestävä eturauhassyövän hoitoon aikuisilla miehillä, joiden tauti on edennyt, tai kun docetaxel perustuu solunsalpaajahoito.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunaviiri, cobicistat - hiv-infektiot - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, tarkoitettu käytettäväksi yhdessä muiden antiretroviruslääkkeiden lääkkeiden hoitoon 1 tyypinvasta (hiv 1) infektio aikuisilla 18 vuoden ikäinen tai vanhempi. genotyyppinen testaus olisi oppaan käytön rezolsta.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karsinooma, ei-pienisoluinen keuhko - antineoplastiset aineet - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multiple myeloma - antineoplastiset aineet - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - eturauhasen kasvaimet, kastraatio-resistentin - antineoplastiset aineet - treatment of adult patients with prostate cancer.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multiple myeloma - antineoplastiset aineet - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpiviriinihydrokloridi - hiv-infektiot - antiviraalit systeemiseen käyttöön - edurant, yhdessä muiden antiretroviruslääkkeiden lääkevalmisteiden ilmoitetaan sillä hoito immuunikatoviruksen virus tyyppi 1 (hiv‑1) tartunnan antiretroviraalisen treatment‑naïve potilailla 12-vuotias tai vanhempi viruskuormaa ≤ 100 000 hiv‑1 rna kopiota/ml. kuten muiden antiretroviraalisten lääkevalmisteiden kanssa, genotyyppinen resistenssitestaus olisi oppaan käytön edurant.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidoni-palmitaatti - skitsofrenia - psyykenlääkkeiden - xeplion on tarkoitettu skitsofrenian ylläpitohoitoa varten aikuispotilailla, jotka on stabiloitu paliperidoniin tai risperidoniin. in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviiria - hiv-infektiot - antiviraalit systeemiseen käyttöön - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.