Tagrisso Kesatuan Eropah - Croat - EMA (European Medicines Agency)

tagrisso

astrazeneca ab - osimertinib mesilate - karcinom, ne-malih stanica pluća - drugi antitumorski lijekovi, inhibitori протеинкиназы - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Vemlidy Kesatuan Eropah - Croat - EMA (European Medicines Agency)

vemlidy

gilead sciences ireland uc - tenofovir alafenamid fumarat - hepatitis b - antivirusni lijekovi za sustavnu uporabu - vemlidy is indicated for the treatment of chronic hepatitis b (chb) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.

Sovaldi Kesatuan Eropah - Croat - EMA (European Medicines Agency)

sovaldi

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.

Xigduo Kesatuan Eropah - Croat - EMA (European Medicines Agency)

xigduo

astrazeneca ab - метформина hidroklorid, monohidrat dapagliflozin пропандиол - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo prikazan kod odraslih za liječenje dijabetesa tipa 2 kao dodatak prehrani i vježbe:• kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой dozi samo метформина • u kombinaciji s drugim lijekovima za liječenje šećerne bolesti kod pacijenata, nedovoljno kontroliranim metforminom i ovi lijekovi• kod pacijenata koji su već лечившихся kombinacijom dapagliflozin i метформина kao zasebne tableta. prema rezultatima istraživanja u odnosu na kombinovanu terapiju, utjecaj na glikemijski kontrolu i kardiovaskularnih događaja, a u ispitivanih skupina, vidi 4. 4, 4. 5 i 5.

Onglyza Kesatuan Eropah - Croat - EMA (European Medicines Agency)

onglyza

astrazeneca ab - Саксаглиптин - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Ravicti Kesatuan Eropah - Croat - EMA (European Medicines Agency)

ravicti

immedica pharma ab - glicerol fenilbutirat - poremećaji ciklusa ureje, umrli - drugi gastrointestinalni trakt i metabolizam, lijekovi, - ravicti prikazan na primjenu kao dodatna terapija za liječenje kroničnih bolesnika urea ciklusa poremećaja (ucds), uključujući nedostatke карбамоильную fosfat-sintaze-ja (sp), ornitin carbamoyltransferase (otn), argininosuccinate синтетазы (stražnjicu), argininosuccinate ЛиАЗы (АСЛ), аргиназы sam (aug) i ornitin translocase deficit hyperornithinaemia-hyperammonaemia homocitrullinuria sindrom (ННН), koje se ne može upravljati s hranom proteina ograničenje i/ili aminokiselinskih dodataka u miru. ravicti treba koristiti uz ograničenje proteina i, u nekim slučajevima, prehrambenih dodataka (e. , esencijalne aminokiseline, arginin, citrulin, dodatke bez kalorija bez proteina).

Vihuma Kesatuan Eropah - Croat - EMA (European Medicines Agency)

vihuma

octapharma ab - simoktookog alfa - hemofilija a - antihemorrhagics - liječenje i profilaksu krvarenja u bolesnika s hemofilijom a (nedostatak kongenitalnog faktora viii). vihuma može se koristiti za sve dobne skupine.

Vosevi Kesatuan Eropah - Croat - EMA (European Medicines Agency)

vosevi

gilead sciences ireland uc - Софосбувир, velpatasvir, voxilaprevi - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (vidi 4. 2, 4. 4 i 5.

Fasenra Kesatuan Eropah - Croat - EMA (European Medicines Agency)

fasenra

astrazeneca ab - benralizumab - astma - lijekovi za opstruktivne plućne bolesti dišnih putova, - fasenra navodi kao dodatne terapije kod odraslih pacijenata s teškim eozinofilni astmom, adekvatno kontrolirati, bez obzira na visoke doze udahnuti glukokortikoidi plus dugog djelovanja β-адреномиметиков.

Lokelma Kesatuan Eropah - Croat - EMA (European Medicines Agency)

lokelma

astrazeneca ab - циркониевые cyclosilicate korisnih natrija - hiperkalijemija - svi ostali terapeutski proizvodi - lokelma indiciran za liječenje гиперкалиемию kod odraslih pacijenata.