ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - immunosoppressori - rheumatoid arthritislibmyris in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab ha dimostrato di ridurre il tasso di progressione del danno articolare misurato da x-ray e di migliorare la funzione fisica, quando somministrato in combinazione con metotressato. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritislibmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab non è stato studiato in pazienti di età inferiore a 2 anni. enthesitis-related arthritislibmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of aslibmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumab ha dimostrato di ridurre il tasso di progressione del danno articolare periferico misurata da x-ray nei pazienti con poliarticolare simmetrica sottotipi della malattia e di migliorare la funzione fisica. psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasislibmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 e 5. crohn’s diseaselibmyris is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaselibmyris is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitislibmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitislibmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitislibmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitislibmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

sanofi winthrop industrie - lixisenatide - diabete mellito, tipo 2 - drugs used in diabetes, glucagon-like peptide-1 (glp-1) analogues - lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

viiv healthcare b.v. - dolutegravir sodium, lamivudine, abacavir (as sulfate) - infezioni da hiv - antivirali per uso sistemico - triumeq is indicated for the treatment of human immunodeficiency virus (hiv) infected adults,  adolescents and children  weighing at least 25 kg who are antiretroviral treatment-naïve or are infected with hiv without documented or clinically suspected resistance to any of the three antiretroviral agents in triumeq.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

n.v. organon - ganirelix - reproductive techniques, assisted; ovulation induction; infertility, female - ormoni ipofisari e ipotalamici e analoghi - la prevenzione dei picchi di ormone luteinizzante prematuri in donne sottoposte a iperstimolazione ovarica per tecniche di riproduzione assistita controllata. negli studi clinici, orgalutran è stato utilizzato con ricombinante umano ormone follicolo-stimolante o corifollitropin alfa, sostenuta follicolo stimolante.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

mylan pharmaceuticals limited - efavirenz, emtricitabina, tenofovir disoproxil maleate - infezioni da hiv - antivirali per uso sistemico - efavirenz / emtricitabine / tenofovir disoproxil mylan è una combinazione a dose fissa di efavirenz, emtricitabina e tenofovir disoproxil. È indicato per il trattamento dell'infezione da virus dell'immunodeficienza umana-1 (hiv-1) negli adulti di età compresa tra 18 anni e over con soppressione virologica a livelli di hiv-1 rna < 50 copie/ml il loro attuale terapia antiretrovirale di combinazione per più di tre mesi. i pazienti non devono avere sperimentato fallimento virologico su qualsiasi terapia antiretrovirale preventiva e deve essere noto che non hanno harboured ceppi virali con mutazioni che conferiscono resistenza significativa ad uno qualsiasi dei tre componenti contenuti in efavirenz / emtricitabina/tenofovir disoproxil mylan prima dell'inizio del loro primo regime terapeutico antiretrovirale. la dimostrazione del beneficio di efavirenz/emtricitabina/tenofovir disoproxil è principalmente basato su 48 settimane di dati provenienti da uno studio clinico in cui i pazienti con soppressione virologica stabile in terapia antiretrovirale di combinazione cambiato efavirenz/emtricitabina/tenofovir disoproxil (vedere la sezione 5. al momento non sono disponibili dati da studi clinici con efavirenz / emtricitabina / tenofovir disoproxil in pazienti naïve al trattamento o in pazienti pesantemente pretrattati. non sono disponibili dati che supportano la combinazione di efavirenz/emtricitabina/tenofovir disoproxil e altri agenti antiretrovirali.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - immunosoppressori - rheumatoid arthritishyrimoz in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz può essere somministrato come monoterapia in caso di intolleranza al metotressato o quando il trattamento continuato con metotressato è inappropriato. adalimumab ha dimostrato di ridurre il tasso di progressione del danno articolare misurato da x-ray e di migliorare la funzione fisica, quando somministrato in combinazione con metotressato. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz può essere somministrato come monoterapia in caso di intolleranza al metotressato o quando il trattamento continuato con metotressato è inappropriato. adalimumab non è stato studiato in pazienti di età inferiore a 2 anni. - enthesitis-related arthritishyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritis- ankylosing spondylitis (as)hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - axial spondyloarthritis without radiographic evidence of ashyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. psoriatic arthritishyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab ha dimostrato di ridurre il tasso di progressione del danno articolare periferico misurata da x-ray nei pazienti con poliarticolare simmetrica sottotipi della malattia e di migliorare la funzione fisica. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s diseasehyrimoz is indicated for treatment of moderately to severely active crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.  paediatric ulcerative colitishyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. ulcerative colitishyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - radiofarmaci diagnostici - questo medicinale è solo per uso diagnostico. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. nei pazienti adulti, per aiutare a differenziare probabile demenza con corpi di lewy dal morbo di alzheimer.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicina cloridrato - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - agenti antineoplastici - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

ইউরোপীয় ইউনিয়ন - ইতালীয় - EMA (European Medicines Agency)

mylan ire healthcare limited - sodio fondaparinux - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - agenti antitrombotici - 5 mg / 0. 3 ml e 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. la prevenzione del tev in adulti sottoposti a chirurgia addominale considerati ad alto rischio di complicanze tromboemboliche, quali pazienti sottoposti a chirurgia addominale per patologie tumorali. la prevenzione del tev in adulti medica i pazienti che sono considerati ad alto rischio di tev e che sono immobilizzati a causa di una malattia acuta, ad esempio insufficienza cardiaca e / o respiratoria acuta disturbi e / o infettive acute o di malattia infiammatoria. il trattamento di adulti con acuta sintomatica spontanea superficiale-trombosi venosa profonda degli arti inferiori, senza somministrazione concomitante di trombosi venosa profonda. 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. miocardico acuto (stemi) in pazienti adulti che non sono gestiti con trombolitici o che sono inizialmente per ricevere nessuna altra forma di terapia di riperfusione. 5 mg / 0. 4-ml, 7. 5 mg / 0. da 6 ml e 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.