Evropská unie - čeština - EMA (European Medicines Agency)

bayer animal health gmbh - imidakloprid, moxidektin - antiparazitární přípravky, insekticidy a repelenty - dogs; cats; ferrets - dogsfor psy trpící nebo ohrožené smíšenými parazitárními infekcemi:léčba a prevence napadení blechami (ctenocephalides felis),léčba infestace všenkami (trichodectes canis),léčba ušního roztoče napadení (otodectes cynotis), sarkoptového svrabu (způsobená sarcoptes scabiei var.. canis), demodikózy (způsobené demodex canis),prevence onemocnění vyvolaných dirofiláriemi (l3 a l4 larvy vlasovec psí),léčba cirkulujících mikrofilárií (vlasovec psí),léčba kožních dirofilariosis (dospělá stádia vlasovec repens)prevence kožních dirofilariosis (l3 larvy vlasovec repens),snížení cirkulujících mikrofilárií (vlasovec repens),prevence angiostrongylosis (l4 larvy a nedospělé dospělé angiostrongylus vasorum),léčba angiostrongylus vasorum a crenosoma vulpis,prevence spirocercosis (spirocerca lupi),léčba eucoleus (syn. capillaria) boehmi (dospělí),léčba oka worm thelazia callipaeda (dospělí),léčba infekce gastrointestinální hlístice (l4 larvy, nezralé dospělé a dospělé toxocara canis, ancylostoma caninum a uncinaria stenocephala, dospělé toxascaris leonina a tenkohlavec vulpis). produkt lze použít jako součást léčebné strategie pro alergickou dermatitidu blech (fad). catsfor kočky trpící nebo ohrožené smíšenými parazitárními infekcemi:léčba a prevence napadení blechami (ctenocephalides felis),léčba ušního roztoče napadení (otodectes cynotis),léčba notoedric svrabu (notoedres cati),léčba lungworm eucoleus aerophilus (syn. capillaria aerophila) (dospělí),prevence lungworm onemocnění (l3/l4 larvy aelurostrongylus abstrusus),léčba lungworm aelurostrongylus abstrusus (dospělí),léčba oka worm thelazia callipaeda (dospělí),prevence onemocnění vyvolaných dirofiláriemi (l3 a l4 larvy vlasovec psí),léčba infekce gastrointestinální hlístice (l4 larvy, nezralé dospělé a dospělé toxocara cati a ancylostoma tubaeforme). produkt lze použít jako součást léčebné strategie pro alergickou dermatitidu blech (fad). ferretsfor fretky trpící nebo ohrožené smíšenými parazitárními infekcemi:léčba a prevence napadení blechami (ctenocephalides felis),prevence onemocnění vyvolaných dirofiláriemi (l3 a l4 larvy vlasovec psí).

Evropská unie - čeština - EMA (European Medicines Agency)

laboratorios hipra, s.a. - živé oslabené infekční burzitidě drůbeže virus (ibdv), napětí 1052 - imunopreparát pro aves, kur domácí, Živé virové vakcíny, ptačí infekční burzitidě drůbeže virus (nemoc gumboro) - chicken; embryonated chicken eggs - pro aktivní imunizaci 1-jednodenních brojlerových kuřat a oplodněná brojlerů kuře, vejce účelem snížení klinických příznaků a lézí bursa z fabricius způsobené velmi virulentního viru ptačí infekční burzitidě drůbeže virus infekce.

Evropská unie - čeština - 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.

Evropská unie - čeština - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomid - roztroušená skleróza - selektivní imunosupresiva - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Evropská unie - čeština - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiol monohydrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - léky užívané při diabetu - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. kromě jiných léčivých přípravků pro léčbu diabetu 2. typu. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Evropská unie - čeština - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiol monohydrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - léky užívané při diabetu - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. kromě jiných léčivých přípravků pro léčbu diabetu 2. typu. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Evropská unie - čeština - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovariální nádory - antineoplastická činidla - ovariální cancerlynparza je indikován jako monoterapie pro:udržovací léčbě dospělých pacientů s pokročilým (figo stadia iii a iv) brca1/2-mutované (germline a/nebo somatickou) high-grade epiteliální vaječníků, vejcovodů nebo primární peritoneální rakovinou, kteří jsou v odpovědi (úplné nebo částečné) po ukončení první linie chemoterapie na bázi platiny. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 a 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacienti by byli dříve léčeni antracyklin a taxan v (neo)adjuvantní nebo metastatického onemocnění, s výjimkou pacientů, nejsou vhodné pro tyto léčby (viz bod 5. pacienti s hormonální receptory (hr)-pozitivním karcinomem prsu by měly mít také postupoval na nebo po předchozí endokrinní léčbě nebo být považovány za nevhodné pro endokrinní terapii. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Evropská unie - čeština - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - transplantace hematopoetických kmenových buněk - antineoplastická činidla - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Evropská unie - čeština - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - antivirotika pro systémové použití - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Evropská unie - čeština - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - odmítnutí štěpu - imunosupresiva - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.