Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international n.v. - o esposti per lungo tempo, cobicistat - infezioni da hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, è indicato in associazione con altri medicinali antiretrovirali per il trattamento dell'infezione da virus dell'immunodeficienza umana 1 (hiv 1) negli adulti di età pari o superiore a 18 anni. genotipica test devono guidare l'uso di rezolsta.

Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatica neoplasie, castrazione-resistente - agenti antineoplastici - treatment of adult patients with prostate cancer.

Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinoma, polmone non a piccole cellule - agenti antineoplastici - 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.

Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - mieloma multiplo - agenti antineoplastici - 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.

Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirina cloridrato - infezioni da hiv - antivirali per uso sistemico - edurant, in associazione con altri medicinali antiretrovirali, è indicato per il trattamento del virus dell'immunodeficienza umana di tipo 1 (hiv‑1) infezione in pazienti treatment‑naïve antiretrovirale 12 anni di età ed oltre con una carica virale ≤ 100.000 hiv‑1 rna copie/ml. come con altri medicinali antiretrovirali, test di resistenza genotipica devono guidare l'uso di edurant.

Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabina - leucemia, mieloide - agenti antineoplastici - trattamento di pazienti adulti con lmc de novo o leucemia mieloide acuta secondaria (aml), secondo la classificazione dell'organizzazione mondiale della sanità (oms), che non sono candidati per la chemioterapia di induzione standard.

Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidone palmitato - schizofrenia - psicolettici - xeplion è indicato per il trattamento di mantenimento della schizofrenia in pazienti adulti stabilizzati con paliperidone o risperidone. 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.

Union européenne - italien - EMA (European Medicines Agency)

janssen cilag international nv - selexipag - ipertensione, polmonare - agenti antitrombotici - uptravi è indicato per il trattamento a lungo termine dell'ipertensione arteriosa polmonare (pah) in pazienti adulti con chi funzionale classe (fc) ii – iii, sia come terapia di combinazione in pazienti non adeguatamente controllati con un antagonista del recettore dell'endotelina (era) e/o della fosfodiesterasi di tipo 5 (pde-5) inibitore, o come monoterapia in pazienti che non sono candidati per queste terapie. l'efficacia è stata dimostrata in un pah della popolazione idiopatica e pah ereditari, pah associata a disturbi del tessuto connettivo, e pah associata a corretti semplice malattia di cuore congenita.

Italie - italien - AIFA (Agenzia Italiana del Farmaco)

janssen-cilag international n.v. - epoprostenolo - epoprostenolo

Union européenne - italien - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - infezioni da hiv - antivirali per uso sistemico - 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.