Benlysta Evropská unie - čeština - EMA (European Medicines Agency)

benlysta

glaxosmithkline (ireland) limited - belimumab - lupus erythematosus, systémový - imunosupresiva - benlysta je indikován jako přídatná terapie u pacientů ve věku 5 let a starších s aktivní, pozitivní autoprotilátka systémový lupus erythematodes (sle) s vysokým stupněm aktivity onemocnění (e. pozitivní anti dsdna a nízké komplementu) navzdory standardní léčbě. benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Celsentri Evropská unie - čeština - EMA (European Medicines Agency)

celsentri

viiv healthcare b.v. - maraviroc - hiv infekce - antivirotika pro systémové použití - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.

Imbruvica Evropská unie - čeština - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Tivicay Evropská unie - čeština - EMA (European Medicines Agency)

tivicay

viiv healthcare bv - dolutegravir - hiv infekce - antivirotika pro systémové použití - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Tremfya Evropská unie - čeština - EMA (European Medicines Agency)

tremfya

janssen-cilag international nv - guselkumab - psoriáza - imunosupresiva - plaque psoriasis tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritis tremfya, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (dmard) therapy (see section 5.

Vocabria Evropská unie - čeština - EMA (European Medicines Agency)

vocabria

viiv healthcare b.v. - cabotegavir sodium, cabotegravir - hiv infekce - antivirotika pro systémové použití - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna.

Rekambys Evropská unie - čeština - EMA (European Medicines Agency)

rekambys

janssen-cilag international nv - rilpivirine - hiv infekce - antivirotika pro systémové použití - 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.

Rukobia Evropská unie - čeština - EMA (European Medicines Agency)

rukobia

viiv healthcare b.v. - fostemsavir trometamol - hiv infekce - antivirotika pro systémové použití - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Apretude Evropská unie - čeština - EMA (European Medicines Agency)

apretude

viiv healthcare b.v. - cabotegravir - hiv infekce - antivirotika pro systémové použití - apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4. 2, 4. 4 a 5.