Copalia HCT Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

copalia hct

novartis europharm limited - amlodipin, валсартан, hidroklorotiazid - hipertenzija - antagonisti angiotenzina ii u kombinaciji, agenti koji djeluju na ренин-ангиотензиновую sustav, antagonisti angiotenzina ii i antagonisti kalcija - liječenje esencijalne hipertenzije kao zamjena terapija u odraslih bolesnika čiji krvni tlak odgovarajuće kontroliran na kombinaciji amlodipin, valsartan i hidroklorotiazid (hct), uzeti kao tri pojedinačnih formulacije ili je dvojan-komponenta i pojedinačnih formulacija.

Cabometyx Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

cabometyx

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.

Cometriq Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

cometriq

ipsen pharma - cabozantinib - neoplazme štitnjače - antineoplastična sredstva - liječenje odraslih bolesnika s progresivnim, neosjetljivim lokalno naprednim ili metastaznim karcinomom medularnog štitnjače.

Increlex Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

increlex

ipsen pharma - mecasermin - laronov sindrom - hipofiza i hipotalamusni hormoni i analozi - za dugotrajno liječenje zatajenja rasta u djece i adolescenata s teškim primarne inzulin-kao-rasta-faktor-1 nedostatak (primarni igfd). teška primarne igfd određuje:standardna visina odstupanja rezultat ≤ -3. 0;bazalni inzulin-sličan faktor rasta-1 (igf-1) razine ispod 2. 5. percentile za dob i spol;hormon rasta (gh) adekvatnost;iznimka je sekundarni oblik igf-1 deficit, kao što su гипотрофия, hipotireoza, ili kronični tretman farmakološke doze anti steroida. izražene igfd uključuje bolesnika s mutacije u genu gr receptor (usd), stup-blaženstvo signalnog putu, i igf-1, gen nedostatke; oni ne gh nedovoljan, i tako oni ne mogu odgovoriti adekvatno экзогенным hormon rasta, liječenje. preporučljivo je potvrditi dijagnozu, provode test igf-1 generacija .

NutropinAq Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

nutropinaq

ipsen pharma - somatropin - turner syndrome; dwarfism, pituitary - hipofiza i hipotalamusni hormoni i analozi - dugoročno liječenje djece s neuspjehom rasta zbog neadekvatne endogene sekrecije hormona rasta. dugotrajno liječenje zatajenja rasta povezane s turnerovim sindromom. liječenje kod djece u препубертатном dobi s povećanjem srca, povezana s kroničnom bubrežnom insuficijencijom do transplantacije bubrega. zamjena endogenog hormona rasta kod odraslih osoba s nedostatkom hormona rasta ili dječjoj ili odrasloj dobi etiologije. nedostatak hormona rasta mora biti na odgovarajući način potvrđena prije početka liječenja.

Bylvay Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

bylvay

albireo - odevixibat - cholestasis, intrahepatic - bile i jetrena terapija - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 i 5.

Cancidas (previously Caspofungin MSD) Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

cancidas (previously caspofungin msd)

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.

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

prepandemic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted) novartis vaccines and diagnostics

novartis vaccines and diagnostics s.r.l. - antigeni virusa influence (hemaglutinin i neuraminidaza) soja a / viet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - cjepiva - aktivna imunizacija protiv h5n1 podtipa virusa gripe a. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.