Europska Unija - hrvatski - EMA (European Medicines Agency)

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viatris healthcare limited - Тобрамицин - cystic fibrosis; respiratory tract infections - antibakterijski lijekovi za sistemsku primjenu, - tobi podhaler je indiciran za supresivnu terapiju kronične plućne infekcije zbog pseudomonas aeruginosa kod odraslih i djece u dobi od 6 godina i starijih s cističnom fibrozom. pogledajte odjeljke 4. 4 i 5. 1 u vezi s podacima u različitim dobnim skupinama. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - danmavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastična sredstva - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 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)

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)

nordic group b.v. - тегафур, gimeracil, oteracil - neoplazme želuca - antineoplastična sredstva - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pari pharma gmbh - Тобрамицин - cystic fibrosis; respiratory tract infections - antibakterijski lijekovi za sistemsku primjenu, , Аминогликозидные antibakterijski lijekovi - vantobra je indiciran za liječenje kronične plućne infekcije zbog pseudomonas aeruginosa u bolesnika starijih od 6 godina i starijih s cističnom fibrozom (cf). treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

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.