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 nv - rilpivirine - hiv-infektiot - antiviraalit systeemiseen käyttöön - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabetes mellitus, tyyppi 2 - diabeetilla käytettävät lääkkeet - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 ja 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin, metformiinihydrokloridia - diabetes mellitus, tyyppi 2 - diabeetilla käytettävät lääkkeet - vokanamet on tarkoitettu aikuisille 18-vuotiaat ja vanhemmat, joilla on tyypin 2 diabetes lisänä ruokavalio ja liikunta parantaa glukoositasapainoa:potilailla, joilla ei ole saatu riittävästi hallintaan niiden suurinta siedettyä annosta metformiinia yksin potilaille heidän suurinta siedettyä annosta metformiinia yhdessä muiden verensokeria alentavien lääkevalmisteiden kanssa, mukaan lukien insuliini, kun nämä eivät tarjoa riittävää glukoositasapainoa. potilaille, joita jo hoidettiin yhdistelmä canagliflozin ja metformiinin yhdistelmää erillisinä tabletsfor tutkimuksen tuloksia suhteessa yhdistelmä hoitojen vaikutuksia verensokeritasapainoon ja sydän-ja verisuonitapahtumien, ja väestön tutkittu, ks. kohdat 4. 4, 4. 5 ja 5.

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 - paliperidonia - schizophrenia; psychotic disorders - psyykenlääkkeiden - invega on tarkoitettu skitsofrenian hoitoon aikuisilla ja 15-vuotiailla nuorilla. invega on tarkoitettu hoitoon skitsoaffektiivinen häiriö aikuisilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen cilag international nv - selexipag - hypertensio, keuhkokuume - antitromboottiset aineet - uptravi on tarkoitettu pitkän aikavälin hoitoa pulmonaalihypertensio (pah) aikuisilla kuka toiminnallinen luokka (fc) ii – iii, joko yhdistelmähoito potilailla, joilla on riittävästi hallinnassa endoteliini reseptorin antagonisti (era) ja/tai fosfodiesteraasi tyyppi 5 (pde-5) estäjä tai monoterapiana potilailla, jotka eivät ole hakeneet näitä hoitoja. teho on osoitettu in pah väestöön, mukaan lukien idiopaattinen ja periytyviä pah, pah, johon liittyy sidekudoksen sairaudet, ja pah-korjattu yksinkertainen synnynnäinen sydänvika.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - ceftobiprole medocaril - skin diseases, infectious; soft tissue infections

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.