Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - danas tvrtka otvara, razvija, grazoprevir - hepatitis c, kronični - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip-specifične aktivnosti vidi 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc - Софосбувир - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip određene aktivnosti, vidi 4. 4 i 5. sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip određene aktivnosti, vidi 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinone - tyrosinemias - drugi gastrointestinalni trakt i metabolizam, lijekovi, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - imunosupresivi - 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. tretman teških, aktivnog i uznapredovalog reumatoidnog artritisa kod odraslih, ne ranije liječenih metotreksat. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita smanjuje brzinu progresije oštećenja zglobova kao što se mjeri x-ray i poboljšava fizičke funkcije, imenovanje u kombinaciji s metotreksatom. 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 može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično (na učinkovitost u monoterapija vidi odjeljak 5. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. 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 smanjuje brzinu progresije periferne lezije zgloba, mjereno pomoću x-zraka u bolesnika s полиартикулярным mogućnost simetrične podtipovi bolesti (vidi odjeljak 5. 1) i poboljšava fizičke značajke. 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 i 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibakterijski lijekovi za sistemsku primjenu, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 i 5. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - пэгинтерферон alfa-2b - hepatitis c, kronični - Иммуностимуляторы, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. molimo vas, obratite se ribavirin i боцепревир kratke specifikacije robe (smpcs), kada пегинтрон mora se koristiti u kombinaciji s tim lijekovima. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. Пегинтрон u kombinaciji s ribavirinom (bitherapy) indiciran za liječenje ХГС-infekcije kod odraslih pacijenata koji nisu prethodno tretirani tretman, uključujući i bolesnike s klinički stabilan hiv-infekcije i kod odraslih pacijenata koji nisu prethodno liječenje interferonom alfa (пегилированным ili пегилированным) i ribavirinom ili kombinirane terapije interferonom-alfa kao monoterapija. Монотерапия interferonom, uključujući пегинтрон, prikazan je uglavnom prilikom netolerancije ili kontraindikacija za рибавирину. molimo vas, obratite se Смпц ribavirinom пегинтрон, kada se koristi u kombinaciji s ribavirinom. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. donošenju odluke da se neće odgoditi liječenje do odrasle dobi, važno je uzeti u obzir da je kombinirana terapija uzrokuje zadržavanje rasta, koji može biti nepovratan u nekih bolesnika. odluka mora biti donesena na individualnoj osnovi. molimo vas, obratite se Смпц ribavirin kapsule ili usmeno rješenje, kada пегинтрон bi trebao biti korišten u kombinaciji s ribavirinom.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - imunosupresivi - molimo pogledajte odjeljak 4. 1 sažetak značajki proizvoda u dokumentu o informacijama o proizvodu.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - sucroferric oxyhydroxide - hyperphosphatemia; renal dialysis - lijekovi za liječenje hiperkalemiju i гиперфосфатемии - velcro je indiciran za kontrolu razine serumskog fosfora u bolesnika s hemodijalizom (hd) ili peritonejskom dijalizom (pd) u odraslih kroničnih bubrežnih bolesti (ckd). velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with ckd stages 4-5 (defined by a glomerular filtration rate.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp dohme ltd  - пэгинтерферон alfa-2b - hepatitis c, kronični - Иммуностимуляторы, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. molimo vas, obratite se ribavirin i боцепревир kratke specifikacije robe (smpcs), kada viraferonpeg se koristi u kombinaciji s ovi lijekovi. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg u kombinaciji s ribavirinom (bitherapy) indiciran za liječenje ХГС-infekcije kod odraslih pacijenata koji nisu prethodno tretirani tretman, uključujući i bolesnike s klinički stabilan hiv-infekcije i kod odraslih pacijenata koji nisu prethodno liječenje interferonom alfa (пегилированным ili пегилированным) i ribavirinom kombinirana terapija ili монотерапия interferonom alfa. Монотерапия interferonom, uključujući viraferonpeg, navedeno je u slučaju netolerancije ili kontraindikacija za рибавирину. molimo vas, obratite se Смпц ribavirinom, kada viraferonpeg se koristi u kombinaciji s ribavirinom. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. donošenju odluke da se neće odgoditi liječenje do odrasle dobi, važno je uzeti u obzir da je kombinirana terapija uzrokuje zadržavanje rasta, koji može biti nepovratan u nekih bolesnika. odluka mora biti donesena na individualnoj osnovi. molimo vas, obratite se Смпц ribavirin kapsule ili usmeno rješenje, kada viraferonpeg se koristi u kombinaciji s ribavirinom.