Európska únia - slovenčina - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonazol - cushingov syndróm - antimykotika na systémové použitie - ketokonazol hra je indikovaný na liečbu endogénneho cushingovho syndrómu u dospelých a adolescentov vo veku nad 12 rokov.

Európska únia - slovenčina - EMA (European Medicines Agency)

warner chilcott  deutschland gmbh - testosterón - sexuálne dysfunkcie, psychologické - pohlavné hormóny a modulátory z genitálny systém, - livensa je indikovaný na liečbu hypoactive sexuálnou túžbou ochorenia (hsdd) u dvojstranne oophorectomised a po hysterektómii (chirurgicky vyvolaná menopauza) žien súbežné estrogén terapia.

Európska únia - slovenčina - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - edoxaban tosilate - stroke; venous thromboembolism - antitrombotické činidlá - prevencia mozgovej príhody a systémovej embólie u dospelých pacientov s nevalvulárnou fibriláciou predsiení (nvaf) s jedným alebo viacerými rizikovými faktormi, ako je kongestívne srdcové zlyhanie, hypertenzia, vek ≥ 75 rokov, diabetes mellitus, predchádzajúca mozgová príhoda alebo prechodný ischemický záchvat ( tia). liečba hlbokej žilovej trombózy (dvt) a pľúcna embólia (pe), a prevencia opakujúcich sa dvt a pe u dospelých.

Európska únia - slovenčina - 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.

Európska únia - slovenčina - EMA (European Medicines Agency)

vericel denmark aps - autológne kultivované chondrocyty - zlomeniny, chrupavka - iné lieky na poruchy muskuloskeletálneho systému - oprava symptómov porúch chrupavky kolena.

Európska únia - slovenčina - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanóm - antineoplastické činidlá - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 a 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. non-small cell lung cancer (nsclc)trametinib v kombinácii s dabrafenib je indikovaný na liečbu dospelých pacientov s pokročilým non-small cell lung cancer s braf v600 mutácie.

Európska únia - slovenčina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - agalsidáza alfa - fabryho choroba - iné alimentárny trakt a metabolizmus výrobky, - replagal je indikovaný pre dlhodobú enzým-substitučnú liečbu u pacientov s potvrdenou diagnózou fabryho choroby (deficit α-galaktozidázy a).

Európska únia - slovenčina - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - narkolepsie - Ďalšie lieky na nervový systém - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

Európska únia - slovenčina - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukémia, lymfocytárna, chronická, b-bunka - antineoplastické činidlá - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

mallinckrodt pharmaceuticals ireland limited - ľudský fibrinogén, ľudský trombín - hemostáza, chirurgická - antihemoragiká - podporná liečba, pri ktorej štandardné chirurgické techniky nepostačujú na zlepšenie hemostázy. raplixa musí byť použitý v kombinácii so schváleným želatína huba. raplixa je indikovaný u dospelých vo veku nad 18 rokov.