Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

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.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

dechra regulatory b.v. - betamethasone acetate, terbinafine, florfenicol - kortikosteroidy a antiinfektíva v kombinácii - psy - liečba akútnej otitis externa.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - guanfacín hydrochlorid - porucha pozornosti s hyperaktivitou - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv musí byť použitý ako súčasť komplexnej liečby adhd programu, zvyčajne vrátane psychologické, sociálne a vzdelávacie opatrenia.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hydrochlorid - kolorektálne novotvary - antineoplastické činidlá - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

gsk vaccines s.r.l. - meningokokovej skupiny a, c, w-135 a y konjugovanej vakcíny - immunization; meningitis, meningococcal - bakteriálne vakcíny - vialsmenveo je indikovaný na aktívnej imunizácie detí (od dvoch rokov veku), dospievajúcich a dospelých v riziku expozície na neisseria meningitidis skupiny a, c, w135 a y, aby sa zabránilo invazívne ochorenia. použitie tejto vakcíny by mali byť v súlade s oficiálne odporúčania.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv infekcie - antivirotiká na systémové použitie - 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.

Unjoni Ewropea - Slovakk - 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.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

viiv healthcare b.v. - dolutegravir sodium, lamivudine, abacavir (as sulfate) - hiv infekcie - antivirotiká na systémové použitie - triumeq is indicated for the treatment of human immunodeficiency virus (hiv) infected adults,  adolescents and children  weighing at least 25 kg who are antiretroviral treatment-naïve or are infected with hiv without documented or clinically suspected resistance to any of the three antiretroviral agents in triumeq.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

bayer pharma ag - regorafenib - kolorektálne novotvary - antineoplastic agents, protein kinase inhibitors - stivarga je označené ako monotherapy na liečbu dospelých pacientov s metastatickým kolorektálnym (crc), ktorí boli v minulosti liečení, alebo nie sú považované za kandidátov na, k dispozícii terapie - tieto zahŕňajú fluoropyrimidine založené na chemoterapiu, anti-vegf terapia a anti-egfr terapia;unresectable alebo metastatickým gastrointestinálne stromal nádory (podstatu), ktorí postúpili na alebo netolerujú pred zaobchádzanie s imatinib a sunitinib;hepatocellular karcinóm (hcc), ktorí boli predtým liečení sorafenib.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

pharming group n.v. - rekombinantný ľudský c1-inhibítora - angioedémy, dedičné - drugs used in hereditary angioedema, other hematological agents - liek ruconest je indikovaný na liečbu akútnych záchvatov angioedému u dospelých s dedičným angioedémom (hae) v dôsledku nedostatku inhibítora c1-esterázy.