Union européenne - slovène - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - anagrelide - trombocitemija, esencialna - antineoplastična sredstva - xagrid je indicirano za zmanjšanje zvišane trombocitov šteje v ogroženih eteričnih-thrombocythaemia (et) bolnikov, ki so prenašali na svoje sedanje zdravljenje ali katerih visok trombocitov šteje ne zmanjšajo na sprejemljivo raven z njihovega trenutnega zdravljenja. at-risk patientan na tveganja in je opredeljena z enim ali več od naslednjih značilnosti:> > 60 let starosti ali je trombocitov count >1000 x 109/l ali;zgodovina thrombohaemorrhagic dogodkov.

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eurovet animal health bv -

Union européenne - slovène - EMA (European Medicines Agency)

intervet international b.v. - fluralaner, moxidectin - antiparasitic products, insecticides and repellents, endectocides, milbemycins - mačke - za mačke z ali na tveganje, mešani parazitske infestations s klopi ali bolhe in uho pršic, prebavne nematodes ali heartworm. zdravilo je izključno navedeno pri uporabi proti klopi ali bolhe in enega ali več drugih ciljnih parazitov, ki je naveden na istem času. za zdravljenje klopi in bolh infestations pri mačkah, ki zagotavlja takojšnje in dolgotrajne bolh (ctenocephalides felis) in klopi (ixodes ricinus) ubijanje dejavnosti za 12 tednov. bolhe in klopi mora priložiti gostiteljice in začne hranjenje, da bi izpostavljene aktivni snovi,. izdelek se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad). za zdravljenje infestations z uho pršic (otodectes cynotis). za zdravljenje okužb s črevesnimi roundworm (4. stopnji ličinke, nezreli odraslih od toxocara cati) in hookworm (4. stopnji ličinke, nezreli odraslih od ancylostoma tubaeforme). ko tretma večkrat na 12-tedenski interval, izdelek nenehno preprečuje heartworm bolezni, ki jih povzročajo dirofilaria immitis.

Union européenne - slovène - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetat - diagnostične tehnike, endokrine - macimorelin - to zdravilo je samo za diagnostično uporabo.  ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

Union européenne - slovène - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimetil fumarat - multiplo sklerozo, recidivno-nakazila - imunosupresivi - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Union européenne - slovène - EMA (European Medicines Agency)

mendelikabs europe ltd - nitizinon - tyrosinemias - drugi zdravljene bolezni prebavil in presnove izdelki, - zdravljenje odraslih in pediatričnih bolnikov s katero je bila potrjena diagnoza dedne tipografije tipa 1 (ht 1) v kombinaciji s prehransko omejitvijo tirozina in fenilalanina.

Union européenne - slovène - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Union européenne - slovène - EMA (European Medicines Agency)

novartis europharm ltd - midostaurin - leukemia, myeloid, acute; mastocytosis - antineoplastična sredstva - rydapt je navedeno:v kombinaciji s standardno daunorubicin in cytarabine indukcije in visok odmerek cytarabine konsolidacije kemoterapijo, in za bolnike v popolni odgovor sledi rydapt en agent za vzdrževanje terapija, pri odraslih bolnikih, ki so na novo zboleli za akutno mieloično levkemijo (aml), ki so flt3 mutacije pozitivna (glej poglavje 4. 2);kot monotherapy za zdravljenje odraslih bolnikov z agresivno sistemske mastocytosis (asm), sistemsko mastocytosis s povezanimi hematoloških neoplasm (sm ahn), ali jambor celice levkemijo (mcl).

Union européenne - slovène - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - karcinom, pljučni pljuč - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Union européenne - slovène - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastična sredstva - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.