Evropská unie - čeština - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - hiv infekce - antivirotika pro systémové použití - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 a 5.

Evropská unie - čeština - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - lopinaviru, ritonavir - hiv infekce - antivirals for systemic use, protease inhibitors - kaletra je indikován v kombinaci s ostatními antiretrovirovými léčivými přípravky pro léčbu virus lidské imunodeficience (hiv-1) infikovaných dospělých, dospívajících a dětí ve věku od 14 dnů a více. volba přípravku kaletra k léčbě inhibitory proteázy hiv-1 infikovaných pacientů by měla být založena na individuálním testování virové rezistence a na posouzení předchozí léčby pacienta.

Evropská unie - čeština - EMA (European Medicines Agency)

aziende chimiche riunite angelini francesco s.p.a. - lurasidon - schizofrenie - psycholeptika - léčba schizofrenie u dospělých ve věku 18 let a více.

Evropská unie - čeština - EMA (European Medicines Agency)

mylan pharmaceuticals limited - lopinaviru, ritonavir - hiv infekce - antivirotika pro systémové použití - lopinavir/ritonavir je indikován v kombinaci s ostatními antiretrovirovými léčivými přípravky pro léčbu virus lidské imunodeficience (hiv-1) infikovaných dospělých, mladistvých a dětí starších 2 let věku. výběr lopinavir/ritonavir k léčbě inhibitory proteázy hiv-1 infikovaných pacientů by měla být založena na individuálním testování virové rezistence a na posouzení předchozí léčby pacienta.

Evropská unie - čeština - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovariální nádory - antineoplastická činidla - ovariální cancerlynparza je indikován jako monoterapie pro:udržovací léčbě dospělých pacientů s pokročilým (figo stadia iii a iv) brca1/2-mutované (germline a/nebo somatickou) high-grade epiteliální vaječníků, vejcovodů nebo primární peritoneální rakovinou, kteří jsou v odpovědi (úplné nebo částečné) po ukončení první linie chemoterapie na bázi platiny. 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 a 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacienti by byli dříve léčeni antracyklin a taxan v (neo)adjuvantní nebo metastatického onemocnění, s výjimkou pacientů, nejsou vhodné pro tyto léčby (viz bod 5. pacienti s hormonální receptory (hr)-pozitivním karcinomem prsu by měly mít také postupoval na nebo po předchozí endokrinní léčbě nebo být považovány za nevhodné pro endokrinní terapii. 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.

Evropská unie - čeština - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ritonavir - hiv infekce - antivirotika pro systémové použití - ritonavir je indikován v kombinaci s dalšími antiretrovirovými látkami pro léčbu pacientů infikovaných hiv-1 (dospělí a děti ve věku dvou let a starší).

Evropská unie - čeština - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevirem - hepatitida c, chronická - antivirotika pro systémové použití - victrelis je indikován k léčbě infekce chronické hepatitidy c (chc) genotypu-1, v kombinaci s peginterferonem alfa a ribavirinem u dospělých pacientů s kompenzovaným onemocněním jater dříve léčeni nebo u kterých selhala předchozí léčba.

Evropská unie - čeština - EMA (European Medicines Agency)

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

Evropská unie - čeština - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, kobicistat - hiv infekce - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta je indikován v kombinaci s dalšími antiretrovirovými léčivými přípravky pro léčbu infekce virem lidské imunodeficience 1 (hiv 1) u dospělých ve věku 18 let nebo starší. genotypové testování by se mělo řídit použití rezolsta.

Evropská unie - čeština - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.