Hyrimoz Unjoni Ewropea - Malti - EMA (European Medicines Agency)

hyrimoz

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - immunosoppressanti - 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 jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. 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 jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. - 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 ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' x-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda, u li jtejjeb il-funzjoni fiżika. 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.

Bevespi Aerosphere Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bevespi aerosphere

astrazeneca ab - glycopyrronium, formoterol fumarate dihydrate - mard tal-pulmun, obstructive kronika - formoterol u glycopyrronium bromide - bevespi aerosphere huwa indikat bħala l-manutenzjoni bronkodilatur-kura biex ittaffi s-sintomi fil-pazjenti adulti bil-marda pulmonari ostruttiva kronika (copd).

Qtrilmet Unjoni Ewropea - Malti - EMA (European Medicines Agency)

qtrilmet

astrazeneca ab - metformin hydrochloride, saxagliptin, dapagliflozin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - qtrilmet huwa indikat f'adulti ta ' 18-il sena u akbar b'dijabete mellitus tip 2:biex ittejjeb il-kontroll gliċemiku meta l-metformina flimkien jew mingħajr sulfonilurea (su) u jew saxagliptin jew dapagliflozin ma jipprovdux kontroll gliċemiku adegwat. meta diġà qed jiġu kkurati b'metformin u saxagliptin u dapagliflozin.

Lyumjev (previously Liumjev) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

lyumjev (previously liumjev)

eli lilly nederland b.v. - insulina lispro - diabetes mellitus - drogi użati fid-dijabete - trattament tad-dijabete mellitus f'adulti, adolexxenti u tfal ta 'sena u aktar. trattament tad-dijabete mellitus fl-adulti.

Trixeo Aerosphere Unjoni Ewropea - Malti - EMA (European Medicines Agency)

trixeo aerosphere

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Riltrava Aerosphere Unjoni Ewropea - Malti - EMA (European Medicines Agency)

riltrava aerosphere

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - riltrava aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.

Sitagliptin / Metformin hydrochloride Accord Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sitagliptin / metformin hydrochloride accord

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Locametz Unjoni Ewropea - Malti - EMA (European Medicines Agency)

locametz

novartis europharm limited  - gozetotide - radjonuklidi imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Pluvicto Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pluvicto

novartis europharm limited  - lutetium (177lu) vipivotide tetraxetan - prostatika neoplażmi, il-kastrazzjoni-reżistenti - radjofarmaċewtiċi terapewtiċi - pluvicto in combination with androgen deprivation therapy (adt) with or without androgen receptor (ar) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with ar pathway inhibition and taxane based chemotherapy.

Columvi Unjoni Ewropea - Malti - EMA (European Medicines Agency)

columvi

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - aġenti antineoplastiċi - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.