Европейски съюз - хърватски - EMA (European Medicines Agency)

jensonr+ limited - ivabradin hidroklorid - angina pectoris; heart failure - srčana terapija - simptomatsko liječenje kronične stabilne angine pektoris u koronarne bolesti odraslih normalni sinusni ritam i puls ≥ 70 otkucaja u minuti. ivabradin je indiciran: - u odraslih osoba ne podnosi ili kontraindikacija za korištenje beta-blokatori - ili u kombinaciji s beta-blokatora u bolesnika nedovoljno kontroliranih uz optimalno beta-blokator dozu. liječenje kroničnog zatajenja srca ivabradin je indiciran u kroničnom zatajenju srca nyha ii do iv sa sistoličkom u bolesnika u sinusni ritam i čiji je ≥ 75 otkucaja u minuti, u kombinaciji sa standardnom terapijom uključujući terapiju beta-blokator ili kada se beta-blokator terapija kontraindicirana ili ne podnosi.

Европейски съюз - хърватски - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (kao fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastična sredstva - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Полицитемия vjera (mf)jakavi indiciran za liječenje odraslih bolesnika s полицитемия vjera, koje su otporne na ili netoleranciju hidroksiurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Европейски съюз - хърватски - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - Толваптан - policistični bubreg, autosomno dominantan - diuretici, - jinarc je naznačeno da se usporiti napredovanje cista razvoj i bubrežnom insuficijencijom autosomno dominantnom policističnom bolešću bubrega (adpkd) u odraslih osoba s ckd pozornica 1 do 3 na početak liječenja s dokazima o brzo napreduje bolest.

Европейски съюз - хърватски - EMA (European Medicines Agency)

alexion europe sas - sebelipaza alfa - metabolizam lipida, urođene pogreške - drugi gastrointestinalni trakt i metabolizam, lijekovi, - kanuma je indiciran za dugoročnu zamjensku enzimsku terapiju (ert) u bolesnika svih dobnih skupina s nedostatkom lipaze lizosomalne kiseline (lal).

Европейски съюз - хърватски - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - cangrelor - acute coronary syndrome; vascular surgical procedures - antitrombotska sredstva - kengrexal, primijenjen istodobno s acetilsalicilnom kiselinom (asa), je indiciran za smanjenje trombotski kardiovaskularnih događaja u odraslih bolesnika s bolesti koronarnih arterija prolazi kroz perkutana koronarna intervencija (pci) koji su primali oralne p2y12 inhibitora prije pci postupak i u kojem oralne terapije inhibitorima p2y12 nije moguće ili poželjno.

Европейски съюз - хърватски - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonazolom - cushingov sindrom - antimikotika za sustavnu uporabu - ketokonazol hra je indiciran za liječenje endogenog cushingovog sindroma u odraslih i adolescenata starijih od 12 godina.

Европейски съюз - хърватски - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastična sredstva - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacijenata sa egfr ili ala pozitivnih tumora mutacije također treba primili таргетную terapiju prije dobivanja Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Европейски съюз - хърватски - EMA (European Medicines Agency)

bayer ag  - octocog alfa - hemofilija a - antihemorrhagics - liječenje i profilaksu krvarenja u bolesnika s hemofilijom a (nedostatak prirođenih faktora viii). ovaj lijek ne sadrži faktor Виллебранда i stoga nije navedeno u bolest pozadina Виллебранда .

Европейски съюз - хърватски - EMA (European Medicines Agency)

retrophin europe ltd - kolesku kiselinu - metabolizam, urođene pogreške - bile i jetrena terapija - Холевая kiselina ФГК indiciran za liječenje prirođenih pogrešaka primarnih žučnih kiselina sinteza, kod djece od jednog mjeseca za kontinuirano doživotno liječenje do punoljetnosti, uključuje sljedeće jedan ферментных grešaka:balzam 27-hidroksilaze (predstavljajući kao церебротендинальный ксантоматоз, СТХ) deficit;2- (ili alfa-) methylacyl-koa racemase (protein amacr) deficit;kolesterol-7-alfa-hidroksilaze (cyp7a1) deficit.

Европейски съюз - хърватски - EMA (European Medicines Agency)

teva b.v.  - lamivudin - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - lamivudin teva pharma b. naznačena je kao dio antiretrovirusne kombinacijske terapije za liječenje odraslih i djece s infekcijom virusom humane imunodeficijencije (hiv).