Union européenne - polonais - EMA (European Medicines Agency)

mylan ire healthcare limited - sól sodowa fondaparynuksu - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - Środki przeciwzakrzepowe - 5 mg / 0. 3 ml i 2. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. profilaktyka powikłań zakrzepowo-zatorowych u dorosłych pacjentów poddawanych operacji na narządach jamy brzusznej, które liczą się z wysokim ryzykiem powikłań zakrzepowo-zatorowych, takich jak pacjenci narażeni chirurgii jamy brzusznej raka. profilaktyka powikłań zakrzepowo-zatorowych u dorosłych pacjentów medycznych, które są z wysokim ryzykiem powikłań zakrzepowo-zatorowych i które unieruchomieni z powodu ostrej choroby, takie jak niewydolność serca i / lub ostre choroby układu oddechowego i / lub ostrych chorób zakaźnych lub chorób zapalnych. leczenie dorosłych z ostrym objawowym spontaniczny powierzchowne zakrzepica żył kończyn dolnych, bez jednoczesnego zakrzepicy żył głębokich. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. zawał serca (zawał mięśnia sercowego) u dorosłych pacjentów, które są sterowane za pomocą trombolitikov lub które początkowo powinny otrzymywać żadnych innych form terapii реперфузионной. 5 mg / 0. 4 ml, 7. 5 mg / 0. 6-ml i 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Union européenne - polonais - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - stwardnienie rozsiane - selektywne leki immunosupresyjne - 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).

Union européenne - polonais - EMA (European Medicines Agency)

n.v. organon - desloratadyna - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - leki przeciwhistaminowe do stosowania systemowego, - azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5. 1)urticaria (see section 5.

Union européenne - polonais - EMA (European Medicines Agency)

gedeon richter plc. - folitropina alfa - anovulation - hormony płciowe i modulatory układu rozrodczego, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. w badaniach klinicznych u tych pacjentów oceniali poziom endogennego lh w surowicy < 1. 2 iu / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

Union européenne - polonais - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belimumab - liszaj rumieniowaty, układowy - leki immunosupresyjne - benlysta jest wskazany jako uzupełnienie terapii u pacjentów w wieku 5 lat i starszych z aktywnej, pozytywnej autoprzeciwciał toczeń rumieniowaty układowy (sle) z wysokim stopniem aktywności choroby (e. pozytywne anty-sondy dna i niski poziom dopełniacza), pomimo standardowej terapii. benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Union européenne - polonais - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - preparaty do obturacyjne choroby dróg oddechowych, - asthma biresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists. orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists. copdbiresp spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev₁).

Union européenne - polonais - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursor komórkowy limfoblastyczny białaczka-chłoniak - Środki przeciwnowotworowe - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Union européenne - polonais - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - astma - preparaty do obturacyjne choroby dróg oddechowych, - budesonide / formoterol teva pharma b. jest wskazany tylko dla dorosłych w wieku 18 lat i starszych. asthmabudesonide/fumaranu teva pharma b.. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

Union européenne - polonais - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - Środki przeciwnowotworowe - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Union européenne - polonais - EMA (European Medicines Agency)

viiv healthcare b.v. - marawirok - infekcje hiv - Środki przeciwwirusowe do użytku ogólnoustrojowego - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.