Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artritas, reumatas - imunosupresantai - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 ir 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

samsung bioepis nl b.v. - adalimumabas - spondylitis, ankylosing; arthritis, rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; hidradenitis suppurativa; arthritis - imunosupresantai - reumatoidinis arthritisimraldi kartu su metotreksatu, yra nurodyta:gydyti vidutinio sunkumo ar sunkiu, aktyviu reumatoidiniu artritu suaugusių pacientų, kai reakcija į ligos-pakeisti anti-reumato vaistų, įskaitant metotreksato buvo netinkamas. gydymas sunkus, aktyvūs ir progresyvūs, reumatoidiniu artritu, suaugusieji ne anksčiau gydomi metotreksatu. imraldi gali būti suteikiamas kaip monotherapy atveju netolerancija, kad metotreksato ar kai tolesnis gydymas metotreksatu netinka. adalimumabas buvo įrodyta, kad sumažinti greitį progresavimą, bendrą žalą, vertinant pagal x-ray ir gerinti fizinę funkciją, skiriant kartu su metotreksatu. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisimraldi 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). imraldi 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. adalimumabas nebuvo tirtas pacientams, jaunesniems negu 2 metų. enthesitis-related arthritisimraldi 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 spondyloarthritisankylosing spondylitis (as)imraldi 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 asimraldi 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 (nsaids). psoriazinis arthritisimraldi nurodomas gydymo aktyvūs ir progresyvūs psoriaziniu artritu suaugusiesiems, kai atsakas į ankstesnius ligos pakeisti anti-reumato narkotikų terapija buvo netinkamas. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5. 1), ir gerinti fizinę funkcija. psoriasisimraldi fluorouracilu gydyti vidutinio sunkumo arba sunkus lėtinis plokštelinės psoriazės suaugusiųjų pacientams, kurie yra kandidatai sisteminės terapijos. vaikų apnašas psoriasisimraldi fluorouracilu ir folino sunkių lėtinių plokštelinės psoriazės vaikams ir paaugliams nuo 4 metų amžiaus, kurie buvo nepakankama arba yra netinkami kandidatai vietiniam terapijos ir phototherapies. hidradenitis suppurativa (hs)imraldi 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 ir 5. krono diseaseimraldi nurodomas gydymo vidutiniškai labai aktyvus krono liga, suaugusiųjų pacientų, kurie nebuvo atsakyta nepaisant visišką ir tinkamą gydymo kursas su kortikosteroidų ir (arba immunosuppressant; arba kurie netoleruoja arba turėti medicininių kontraindikacijų, dėl tokios terapijos. paediatric crohn's diseaseimraldi 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 haveulcerative colitisimraldi 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 mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisimraldi 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. uveitisimraldi 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 corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. paediatric uveitisimraldi 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

aimmune therapeutics ireland limited - defatted powder of arachis hypogaea l., semen (peanuts) - peanut hypersensitivity - allergens - palforzia is indicated for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. palforzia may be continued in patients 18 years of age and older. palforzia should be used in conjunction with a peanut-avoidant diet.

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

viasana, uab - sunitinibas - kietosios kapsulės - 25 mg - sunitinib

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

viasana, uab - sunitinibas - kietosios kapsulės - 50 mg - sunitinib

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - kiti antiepileptics - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.