Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

laboratoires thea, clermont-ferrand array - 90 antazolin-hydrochlorid; 2681 tetryzolin-hydrochlorid - oční kapky, roztok - 0,5mg/ml+0,4mg/ml - tetryzolin, kombinace

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

mcneil healthcare (ireland) limited, dublin array - 2681 tetryzolin-hydrochlorid - oční kapky, roztok - 0,5mg/ml - tetryzolin

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

johnson & johnson lda, porto salvo array - 2681 tetryzolin-hydrochlorid - oční kapky, roztok - 0,5mg/ml - tetryzolin

Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

zoetis Česká republika s.r.o. (2) - moxidektin, kombinace - perorální gel - milbemycins - koně

Evropská unie - čeština - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. kromě nově diagnostikované chronické fáze cml nejsou k dispozici kontrolované studie, které by prokázaly klinický přínos nebo prodloužené přežití u těchto uvedených onemocnění. .

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

theramex ireland limited, dublin array - 8468 alfakalcidol - měkká tobolka - 0,25mcg - alfakalcidol

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

theramex ireland limited, dublin array - 8468 alfakalcidol - měkká tobolka - 1mcg - alfakalcidol

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

octapharma (ip) sprl, brusel array - 3530 lidskÝ imunoglobulin anti-d - injekční roztok - 625iu/ml - anti-d (rh) imunoglobulin

Evropská unie - čeština - EMA (European Medicines Agency)

teva b.v. - kyselina zoledronová - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - léky na léčbu nemocí kostí - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. léčba pagetovy choroby kostí u dospělých.

Česká republika - čeština - Ecolab

ecolab deutschland gmbh -