Evropska unija - slovenščina - EMA (European Medicines Agency)

qbiotics netherlands b.v. - tigilanol tiglate - tigilanol tiglate - psi - za zdravljenje ne-resectable, non-metastatskim (ki uprizoritev) podkožnega jambor celice tumorji, ki se nahajajo na ali v distalni komolca ali hock, in non-resectable, ne metastatskim kožne jambor celice tumorjev pri psih.

Evropska unija - slovenščina - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinalni stromalni tumorji - druga zdravila z delovanjem na novotvorbe agenti, protein kinaza inhibitorji - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Evropska unija - slovenščina - EMA (European Medicines Agency)

alnylam netherlands b.v. - lumasiran sodium - hyperoxaluria, primary - drugi zdravljene bolezni prebavil in presnove izdelki, - treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

Evropska unija - slovenščina - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - okužbe dihalnih poti - antibacterials za sistemsko uporabo, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - prašiči - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Evropska unija - slovenščina - EMA (European Medicines Agency)

rhythm pharmaceuticals netherlands b.v. - setmelanotide - debelost - preparati za zaščito proti sončenju, prehrambeni izdelki - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

Evropska unija - slovenščina - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinalni stromalni tumorji - antineoplastična sredstva - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Evropska unija - slovenščina - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

Evropska unija - slovenščina - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - zdravila z delovanjem na novotvorbe agenti - lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - cedazuridine, decitabine - leukemija, myeloid - antineoplastična sredstva - inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for standard induction chemotherapy.