Eiropas Savienība - čehu - EMA (European Medicines Agency)

biopartners gmbh - somatropin - růst - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners je indikován pro substituční léčbu endogenního růstového hormonu u dospělých s nedostatkem růstového hormonu dětství nebo dospělosti (ghd). v dospělosti: pacienti s ghd v dospělosti jsou definováni jako pacienti se známou hypothalamo-hypofyzární patologie a alespoň jeden další známý nedostatek hormonu hypofýzy, s výjimkou prolaktinu. tito pacienti by měli podstoupit dynamický test k diagnóze nebo vyloučení ghd. dětství-nástup: u pacientů s dětství-nástup izolovaný ghd (bez zjištěného hypothalamo-hypofyzárního onemocnění nebo kraniálního ozařování), dva dynamické testy by měly být provedeny po dokončení růstu, s výjimkou těch, které mají nízké insulin-like-growth-faktor-i (igf-i) v séru (< -2 standardní odchylka skóre (sds)), kdo může být považován za jeden test. mezní bod dynamického testu musí být přísný.

Čehija - čehu - SUKL (Státní ústav pro kontrolu léčiv)

noridem enterprises limited, nikosia array - 404 sodnÁ sŮl kolistimethÁtu - prášek pro roztok k rozprašování - 1miu - kolistin

Čehija - čehu - SUKL (Státní ústav pro kontrolu léčiv)

noridem enterprises limited, nikosia array - 404 sodnÁ sŮl kolistimethÁtu - prášek pro roztok k rozprašování - 2miu - kolistin

Eiropas Savienība - čehu - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karcinom, plicní jiná než malobuněčná - jiná cytostatika, inhibitory proteinkinázy - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystická fibróza - jiné produkty dýchacích cest - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanom - antineoplastická činidla - 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-malá buňka rakovina plic (nsclc)trametinib v kombinaci s dabrafenib je indikován k léčbě dospělých pacientů s pokročilým nemalobuněčným karcinomem plic s mutací braf v600.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukémie, lymfocytární, chronická, b-buňka - antineoplastická činidla - 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.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanom - antineoplastická činidla - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 a 5. adjuvantní léčba melanomadabrafenib v kombinaci s trametinib je indikován k adjuvantní léčbě dospělých pacientů s stadiu iii melanomu s braf v600 mutaci, po kompletní resekci. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

eigerbio europe limited - lonafarnib - progeria; laminopathies - jiné zažívací trakt a produkty metabolismu, - zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of hutchinson-gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous lmna mutation with progerin-like protein accumulation or a homozygous or compound heterozygous zmpste24 mutation.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastická činidla - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.