Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastična sredstva - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis b površinski antigen - hepatitis b; immunization - cjepiva - fendrix je indiciran u adolescenata i odraslih osoba u dobi od 15 godina pa nadalje za aktivnu imunizaciju protiv infekcije virusom hepatitisa b (hbv) uzrokovane svih poznatih podvrsta u bolesnika s bubrežnom insuficijencijom (uključujući pre-hemodijaliza i hemodijalizi bolesnika).

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

infai, institut für biomedizinische analytik nmr-imaging gmbh - urea (13c) - breath tests; helicobacter infections - dijagnostička sredstva - Хеликобактер test infai može se koristiti za прижизненного dijagnoze гастродуоденальной zone helicobacter pylori infekcija:odrasli;tinejdžeri koji su, vjerojatno, imaju peptičkog ulkusa. Хеликобактер test infai za djecu u dobi od tri do 11 godina, može se koristiti za прижизненного dijagnoze gastrduodenal helicobacter pylori infekcija:za procjenu uspješnosti эрадикационной terapije, ili kada neinvazivni testovi ne mogu biti ispunjeni, ili kada postoji дискордантные rezultati koji proizlaze iz invazivnih testova. ovaj je lijek samo za dijagnostičku uporabu.

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

zoetis belgium sa - tulathromycin - antibakterijska sredstva za sistemsku uporabu - pigs; cattle; sheep - goveda: liječenje i метафилактики bolesti dišnih organa goveda (БРД), povezana je s mannheimia haemolytica, bakterija pasteurella multocida, odaberite histophilus somni i Микоплазмы бовис osjetljivi na тулатромицин. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. liječenje infektivnog goveđeg keratokonjunktivitisa (ibk) povezanog s moraxella bovis osjetljivim na tulatromicin. svinja: liječenje i метафилактики respiratorne bolesti svinja (срд), povezana je sa actinobacillus плевропневмонии, bakterija pasteurella multocida, hyopneumoniae Микоплазмы uzrokovane haemophilus parasuis i Бордетеллы bronchiseptica osjetljivi na тулатромицин. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. draxxin treba koristiti samo ako se od svinja očekuje da razviju bolest u roku od 2-3 dana. ovce: liječenje ranih stadija infektivnog pododermitisa (trbuha nogu) povezanih s virulentnim dichelobacter nodosusom koji zahtijeva sustavno liječenje.

Եվրոպական Միություն - խորվաթերեն - 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.

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - cjepiva - twinrix pedijatrijskih je indiciran za uporabu u sobe imunološki dojenčadi, djece i adolescenata od jedne godine do i uključujući 15 godina koji su u opasnosti od oba hepatitisa a i hepatitisa b infekcije.

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

novartis europharm limited - everolimus - tuberoza skleroza - antineoplastična sredstva - zatajenje angiomyolipoma povezane s клубневой kompleks skleroze (tsc)votubia indiciran za liječenje odraslih bolesnika s bubrežnim angiomyolipoma povezane s клубневой kompleks skleroze (tsc), koje se nalaze u grupi rizika za razvoj komplikacija (na temelju čimbenika kao što su veličina tumora ili postojanje aneurizme, ili prisutnost multi-i bilateralnih tumora), ali koji ne zahtijevaju hitnu kiruršku intervenciju. dokaz se oslanja na analizu promjena iznos volumena angiomyolipoma . Субэпендимальные гигантоклеточные astrocitom (СЭГА), koji su povezani s клубневой kompleks skleroze (tsc)votubia indiciran za liječenje bolesnika s субэпендимальные гигантоклеточные astrocitom (СЭГА), koji su povezani s клубневой kompleks skleroze (tsc), koji zahtijevaju terapijske intervencije, ali ne može biti kirurško liječenje. dokaz se oslanja na analizu promjena volumena sega . daljnja klinička prednosti, kao što je poboljšanje u bolesti povezane sa simptomima, nije dokazano.

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

ceva santé animale - флорфеникол, meloxicam - amphenicols, kombinacije, antibakterijski lijekovi za sistemsku primjenu - stoka - za terapeutsko liječenje bolesti goveđeg dišnog sustava (brd) povezano s pireksom zbog mannheimia haemolytica, pasteurella multocida i histophilus somni osjetljivih na florfenikol.

Եվրոպական Միություն - խորվաթերեն - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus inaktiviran, koji sadrži ekvivalent antigena s a / california / 07/2009 (h1n1) - dobivenog soka korištenog nymc x-179a - influenza, human; immunization; disease outbreaks - cjepiva protiv gripe - profilaksa influence uzrokovana virusom a (h1n1) v 2009. pandemrix treba se koristiti samo ako preporučena godišnja sezonske gripe nego kad se trovalentno / rekombinantno cjepivo nisu dostupne i ako cijepljenje protiv (h1n1) v smatra potrebnim (vidjeti dio 4. 4 i 4. cjepivo pandemrix mora se koristiti u skladu sa službenim vodstvom.