Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesylátu - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastická činidla - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. pacienti, kteří mají nízkou nebo velmi nízkým rizikem recidivy by neměli dostávat adjuvantní léčba. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. 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.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - jiná hypnotika a sedativa - psi - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirotika pro systémové použití - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 a 5. tecovirimat siga should be used in accordance with official recommendations.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - pneumokokové infekce - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. viz kapitoly 4. 4 a 5. 1 pro informace o ochraně proti specifickým pneumokokovým sérotypům. the use of vaxneuvance should be in accordance with official recommendations.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - pneumokokové infekce - vakcíny - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. viz kapitoly 4. 4 a 5. 1 pro informace o ochraně proti specifickým pneumokokovým sérotypům. apexxnar should be used in accordance with official recommendations. .

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

vbi vaccines b.v. - povrchový antigen hepatitidy b - Žloutenka typu b - vakcíny - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vakcíny - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriparatid - osteoporóza - vápníková homeostáza - sondelbay is indicated in adults. léčba osteoporózy u postmenopauzálních žen a u mužů se zvýšeným rizikem zlomenin. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. léčba osteoporózy spojené s trvalou terapií systémovými glukokortikoidy u žen a mužů se zvýšeným rizikem zlomenin.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - dengue - vakcíny - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. the use of qdenga should be in accordance with official recommendations.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - vápníková homeostáza - léčba osteoporózy u postmenopauzálních žen se zvýšeným rizikem zlomenin.