Unió Europea - romanès - EMA (European Medicines Agency)

biocodex - stiripentol - epilepsia mioclonică, minoră - antiepileptice, - diacomit este indicat pentru utilizarea în legătură cu clobazam şi valproat ca terapie adjuvantă de refractare generalizate convulsii tonic clonic la pacienţii cu epilepsie severa myoclonic în copilărie (smei, sindromul dravet pe) a căror crize nu sunt în mod adecvat controlate cu clobazam şi valproat de.

Unió Europea - romanès - EMA (European Medicines Agency)

dr. friedrich eberth arzneimittel gmbh - tartrat de lasofoxifen - osteoporoza, postmenopauză - hormoni sexuali și modulatori ai sistemului genital, - fablyn este indicat pentru tratamentul osteoporozei la femeile aflate în postmenopauză cu risc crescut de fractură. sa demonstrat o reducere semnificativă a incidenței fracturilor vertebrale și non-vertebrale, dar nu a fracturilor de șold (vezi secțiunea 5. la determinarea alegerea fablyn sau alte terapii, inclusiv estrogeni, pentru o postmenopauză femeie, ar trebui luate în considerare simptomele de menopauză, efectele asupra uterin și de sân țesuturi, și cardiovascular riscurilor și beneficiilor (a se vedea secțiunea 5.

Unió Europea - romanès - EMA (European Medicines Agency)

instituto grifols s.a. - imunoglobulina umană normală - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - seruri imune și imunoglobuline, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Unió Europea - romanès - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - gută - preparate antigut - krystexxa este indicat pentru tratamentul de severă debilitante tofacee la pacienţii adulţi care poate avea, de asemenea, implicarea comună erozive şi care nu au reuşit să normalizeze acid uric seric cu inhibitori de monoaminoxidază xantină la maxim medical caz doza sau pentru care aceste medicamente sunt contraindicate.

Unió Europea - romanès - EMA (European Medicines Agency)

nordic group b.v. - metotrexat - arthritis, psoriatic; psoriasis; arthritis, juvenile rheumatoid; arthritis, rheumatoid - agenți antineoplazici - nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (jia), when the response to nonsteroidal anti-inflammatory drugs (nsaids) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Unió Europea - romanès - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - artrita, reumatoida - imunosupresoare - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant poate fi utilizat ca monoterapie sau în asociere cu metotrexat. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Unió Europea - romanès - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - imunosupresoare - rheumatoid arthritis  amgevita 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. tratamentul de active, severe și progresive, artrita reumatoidă la adulți netratați anterior cu metotrexat. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita reduce rata progresiei distrucției articulare prin x-ray și îmbunătățește funcția fizică, atunci când este administrat în asociere cu metotrexat. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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). amgevita poate fi administrat în monoterapie în caz de intoleranță la metotrexat sau atunci când tratamentul continuu cu metotrexat este inadecvat (pentru eficacitate în monoterapie a se vedea secțiunea 5. adalimumab nu a fost studiat la pacienții cu vârsta mai mică de 2 ani. enthesitis-related arthritis amgevita 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 (see section 5. axial spondyloarthritis ankylosing spondylitis (as) amgevita 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 as amgevita 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 non-steroidal anti-inflammatory drugs. psoriatic arthritis amgevita 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. amgevita reduce rata de progresie a distrugerii articulare periferice măsurată prin x-ray la pacienții cu artrită simetrică subtipuri ale bolii (a se vedea secțiunea 5. 1) și îmbunătățește funcția fizică. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita 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) amgevita 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 (see sections 5. 1 și 5. crohn’s disease amgevita 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 disease amgevita 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 colitis amgevita 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. uveitis amgevita 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 uveitis amgevita 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.

Unió Europea - romanès - EMA (European Medicines Agency)

eisai gmbh - alitretinoinei - sarcoma, kaposi - agenți antineoplazici - panretin gel este indicat pentru tratamentul local al leziunilor cutanate la pacienții cu dobândit-imuno-deficienta-sida (sindromul)-legate de sarcom kaposi (sk) atunci când:leziunile nu sunt ulcerate sau lymphoedematous, și;tratamentul viscerală ks nu este necesară, și;leziunile nu răspund la sistemice terapia antiretrovirală, și;radioterapie sau chimioterapie nu sunt adecvate.

Unió Europea - romanès - EMA (European Medicines Agency)

leo pharma a/s - tacrolimus - dermatita, atopică - alte preparate dermatologice - flare treatmentadults and adolescents (16 years of age and above)treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. children (two years of age and above)treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. maintenance treatmentmaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i. loc de patru sau de mai multe ori pe an), care au avut un răspuns inițial la un maxim de șase săptămâni de tratament de două ori pe zi tacrolimus unguent (leziuni eliminate, aproape șterse sau ușor afectate).

Unió Europea - romanès - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - idebenonă - atrofia optică, ereditară, leber - alte psihostimulante și nootropics, psychoanaleptics, - raxone este indicat pentru tratamentul insuficienței vizuale la adolescenți și pacienți adulți cu neuropatia optică ereditară leber (lhon).