Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - arzenov trioksid - levkemija, promyelocytic, akutna - antineoplastična sredstva - arzenov trioksid mylan je primerna za indukcijo remisije, in konsolidacije pri odraslih bolnikih z:- na novo diagnosticirana nizko ali srednje tveganje akutna promyelocytic levkemijo (apl) (belih krvnih telesc, ≤ 10 x 103/µl) v kombinaciji z vsemi trans retinojske kisline (atra)- relapsed/ognjevzdržni akutna promyelocytic levkemijo (apl) (prejšnje zdravljenje mora imeti vključen retinoid in kemoterapijo)značilna prisotnost t(15;17) translokacija in/ali prisotnosti promyelocytic levkemijo/retinojske kisline receptorjev alfa (pml/rar alfa) gena. odgovor stopnja drugih akutnih myelogenous levkemijo podtipov, da arzenov trioksid ni beenexamined.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistična fibroza - drugi proizvodi dihal - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, pljučni pljuč - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - vsi drugi terapevtski izdelki - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastična sredstva - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinuks natrij - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - antitrombotična sredstva - 5 mg / 0. 3 ml in 2. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. preprečevanje vte pri odraslih, ki opravljajo abdominalno kirurgijo, ki so presodilo, da je velika verjetnost, thromboembolic zapletov, kot bolnikov, ki abdominalno operacijo raka. preprečevanje vte pri odraslih bolnike, ki so presodilo, da je na visoko tveganje za vte in ki so immobilised zaradi akutne bolezni, kot so srčno insuficienco in / ali akutne dihalne motnje in / ali akutne nalezljive ali vnetnih bolezni. zdravljenje odraslih z akutno simptomatsko spontano površno-venska tromboza spodnjih okončin brez sočasnega globoko vensko trombozo. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. infarkt (stemi) pri odraslih bolnikih, ki se upravljajo z thrombolytics ali ki sprva so prejeli nobena druga oblika reperfusion terapija. 5 mg / 0. 4-ml, 7. 5 mg / 0. 6-ml in 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

akebia europe limited - koordinatni kompleks železovega citrata - hyperphosphatemia; renal dialysis - zdravila za zdravljenje hiperkaliemije in hiperfosfatemije - fekeric je indiciran za nadzor hiperfosfatemije pri odraslih bolnikih s kronično ledvično boleznijo (ckd).

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer limited  - metaflumizone, amitraz - ectoparasiticides za lokalno uporabo, vključno. insekticidi - psi - za zdravljenje in preprečevanje infestacij z bolhami (ctenocephalides canis in c. felis) in klopi (ixodes ricinus, ixodes hexagonus, rhipicephalus sanguineus, dermacentor reticulatus in dermacentor variabilis), zdravljenje demodicosis (zaradi demodex spp. ) in uši (trichodectes canis) pri psih. zdravilo za uporabo v veterinarski medicini se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad).

Evropska unija - slovenščina - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticaza - protin - antigout pripravki - krystexxa je indicirano za zdravljenje hude izčrpavajoče kronične tophaceous protina pri odraslih bolnikih, ki imajo tudi erozivnih skupno udeležbo in ki ni bilo mogoče normalizirati seruma sečne kisline z ksantin monoaminooksidaze največja medicinsko primerno odmerek ali za katere so kontraindicirana teh zdravil.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - nepafenac - pain, postoperative; ophthalmologic surgical procedures - oftalmologi - nevanac is indicated for: , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.