Dupixent Europska Unija - hrvatski - EMA (European Medicines Agency)

dupixent

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agenti za dermatitis, isključujući kortikosteroide - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Alofisel Europska Unija - hrvatski - EMA (European Medicines Agency)

alofisel

takeda pharma a/s - darvadstrocel - Прямокишечный fistula - imunosupresivi - alofisel indiciran za liječenje najtežih параректальных свищей u odraslih bolesnika s aktivnom/umjereno aktivan lumena crohnova bolest, fistula, kada su pokazala neadekvatan odgovor na barem jednog običnog ili biološka terapija. alofisel treba koristiti nakon klima свищей.

Set za proizvodnju kapi za oči iz autolognog seruma Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

set za proizvodnju kapi za oči iz autolognog seruma

biognost d.o.o., zagreb - priprema alikvota kapi za oči iz autolognih krvnih komponenti krvnog seruma, plazme bogate trombocitima (prp), koncentrata tromb

Ultomiris Europska Unija - hrvatski - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektivni imunosupresivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

FOLLIGON 1000 i.j. Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

folligon 1000 i.j.

intervet international b.v., podružnica u republici hrvatskoj, ivana lučića 2a, 10000 zagreb, hrvatska - liofilizat: serumski gonadotropin ždrebnih kobila (pmsg); otapalo: fosfatni pufer - liofilizirani prašak i otapalo za injekciju - vmp za mokraćno-spolni sustav i spolni hormoni - goveda, svinja, ovaca, koza, kunića, vidrica i jelena

Rispoval IBR-Marker Inactivatum Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

rispoval ibr-marker inactivatum

zoetis b.v., podružnica zagreb za promidžbu, petra hektorovića 2, zagreb, hrvatska - inaktivirani herpes virus goveda (bhv-1), tip 1, soj difivac (ge negativan)-inducira geometrijsku sredinu neutralizirajućeg titra u serumu goveda najmanje 1:160 - suspenzija za injekciju - imunološki vmp - goveda (teladi)

PrioCHECK CSFV Ab Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

priocheck csfv ab

hermes analitika d.o.o., zagreb, hrvatska - dijagnostički vmp - elisa komplet za dokazivanje protutijela za glikoprotein e2 virusa klasične svinjske kuge u serumu i plazmi svinja - neprimjenjivo

PrioCHECK CSFV Ab 2.0 Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

priocheck csfv ab 2.0

hermes analitika d.o.o., zagreb, hrvatska - dijagnostički vmp - elisa komplet za dokazivanje protutijela za virus klasične svinjske kuge (domena a gp e2 ovojnice) u serumu i plazmi svinja - neprimjenjivo

PrioCHECK FMDV NS Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

priocheck fmdv ns

hermes analitika d.o.o., zagreb, hrvatska - dijagnostički vmp - elisa komplet za dokazivanje protutijela za nestrukturni protein virusa slinavke i šapa u serumu goveda, ovaca, koza i svinja - neprimjenjivo