Unjoni Ewropea - Slovakk - 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.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - fentanyl - pain; cancer - analgetiká - pecfent je indikovaný na zvládnutie prelomovej bolesti u dospelých, ktorí už dostávajú udržiavaciu opiátovú terapiu pri chronickej bolesti s rakovinou. prelomová bolesť je prechodná exacerbácia bolesti, ktorá sa vyskytuje na pozadí inak kontrolovanej pretrvávajúcej bolesti. pacientov, ktorí dostávajú výživné opiátov terapie sú tí, ktorí užívajú aspoň 60 mg orálneho morfín denne, minimálne 25 mikrogramov transdermálna fentanyl za hodinu, aspoň 30 mg oxycodone denne aspoň 8 mg orálneho hydromorphone denne alebo equi-analgetický dávka iného opiátov na týždeň alebo dlhšie.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastické činidlá - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

almirall, s.a. - eflornithine - nadmerné ochlpenie - ostatné dermatologické prípravky - liečba hirsutizmu tváre u žien.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

piramal critical care b.v. - miglustat - gaucherova choroba - iné alimentárny trakt a metabolizmus výrobky, - yargesa je indikovaný na ústnej liečbe dospelých pacientov s mierne až stredne typ 1 gaucher ochorenia. yargesa môže byť použitý iba v liečbe pacientov, pre ktorých je enzým substitučná terapia je nevhodné. yargesa je indikovaný na liečbu progresívne neurologické prejavy u dospelých pacientov a pediatrických pacientov s niemann-pick typ c ochorenia.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

janssen cilag international nv - miglustat - gaucher disease; niemann-pick diseases - iné alimentárny trakt a metabolizmus výrobky, - liek zavesca je indikovaný na perorálnu liečbu dospelých pacientov s miernym až stredne závažným gaucherovým ochorením typu 1. liek zavesca sa môže používať iba na liečbu pacientov, u ktorých nie je vhodná enzýmová substitučná liečba. zavesca je indikovaný na liečbu progresívne neurologické prejavy u dospelých pacientov a pediatrických pacientov s niemann-pick typ-c ochorenia.

Unjoni Ewropea - Slovakk - EMA (European Medicines Agency)

gen.orph - miglustat - gaucherova choroba - iné alimentárny trakt a metabolizmus výrobky, - miglustat gen. orph je indikovaný na perorálnu liečbu dospelých pacientov s miernym až stredne ťažkým gaucherovým ochorením typu 1. miglustat gen. orph môže byť použitý iba v liečbe pacientov, pre ktorých je enzým substitučná terapia je nevhodné. miglustat gen. orph je indikovaný na liečbu progresívne neurologické prejavy u dospelých pacientov a pediatrických pacientov s niemann-pick typ c ochorenia.

Slovakkja - Slovakk - ŠÚKL (Štátny ústav pre kontrolu liečiv)

desitin arzneimitttel gmbh, nemecko - diazepam - 70 - anxiolytica

Slovakkja - Slovakk - ŠÚKL (Štátny ústav pre kontrolu liečiv)

zentiva, k.s., Česká republika - kodeín, kombinácie okrem psycholeptík - 07 - analgetica, antipyretica

Slovakkja - Slovakk - ŠÚKL (Štátny ústav pre kontrolu liečiv)

pfizer europe ma eeig, belgicko - metylprednizolón - 56 - hormona (lieČiva s hormonÁlnou aktivitou)