Glidipion (previously Pioglitazone Actavis Group) Evropska unija - hrvaščina - EMA (European Medicines Agency)

glidipion (previously pioglitazone actavis group)

actavis group ptc ehf    - pioglitazon hidroklorid - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:as monotherapy:in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone također pokazala da kombinacija inzulina u tip-2 dijabetesa kod odraslih pacijenata s nedostatnim nadzorom glukoze na inzulin, za koje je metformin nepraktično zbog kontraindikacija ili netolerancije. nakon početka terapije s пиоглитазоном, pacijenti moraju biti revidirani kroz 3-6 mjeseci za procjenu adekvatnosti odgovora na liječenje (e. smanjenje pokazatelja hba1c). kod bolesnika koji ne pokazuju adekvatan odgovor treba da se ukine pioglitazone. u svjetlu potencijalnih rizika za dugotrajno liječenje, propisane lijekove treba potvrditi u kasnijim rutinske inspekcije da dobro pioglitazone sprema.

Nucala Evropska unija - hrvaščina - EMA (European Medicines Agency)

nucala

glaxosmithkline trading services - mepolizumab - astma - lijekovi za opstruktivne plućne bolesti dišnih putova, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Abiraterone Krka Evropska unija - hrvaščina - EMA (European Medicines Agency)

abiraterone krka

krka, d.d., novo mesto - abirateron acetat - prostatske neoplazme - endokrinska terapija - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Tepkinly Evropska unija - hrvaščina - EMA (European Medicines Agency)

tepkinly

abbvie deutschland gmbh & co. kg - epcoritamab - lymphoma, large b-cell, diffuse - antineoplastična sredstva - tepkinly 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.

Olumiant Evropska unija - hrvaščina - EMA (European Medicines Agency)

olumiant

eli lilly nederland b.v. - baricitinib - artritis, reumatoidni - imunosupresivi - 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 se može koristiti kao monoterapija ili u kombinaciji s metotreksatom. 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.

SomaKit TOC Evropska unija - hrvaščina - EMA (European Medicines Agency)

somakit toc

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. nakon radiolabelling s галлием (68га) otopina natrij klorid, malter arsenid (68га) edotreotide dobiti dizajniran za pozitronska emisijska tomografija (pet) vizualizacija receptora somatostatina сверхэкспрессия kod odraslih pacijenata s potvrđene ili percipirane высокодифференцированных gastro-enteropancreatic нейроэндокринные tumora (gap-net) za lokalizaciju primarnog tumora i njihovih metastaza.

Retsevmo Evropska unija - hrvaščina - EMA (European Medicines Agency)

retsevmo

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - antineoplastična sredstva - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Omvoh Evropska unija - hrvaščina - EMA (European Medicines Agency)

omvoh

eli lilly nederland b.v. - mirikizumab - kolitis, ulcerativni - imunosupresivi - omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.