Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastična sredstva - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Evropska unija - slovenščina - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - druga zdravila na živčnem sistemu - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Evropska unija - slovenščina - EMA (European Medicines Agency)

biogen netherlands b.v. - dimetil fumarat - multiple skleroza - imunosupresivi - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Evropska unija - slovenščina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - okužbe s citomegalovirusom - antivirusi za sistemsko uporabo - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). upoštevati je treba uradne smernice za ustrezno uporabo protivirusnih agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin, pioglitazone - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i. trojna kombinacija terapija), kot dodatek k prehrani in vadbi za izboljšanje glycaemic nadzor pri odraslih bolnikih (zlasti prekomerno telesno težo bolnikov) neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in pioglitazone. poleg tega incresync mogoče zamenjati ločenih tablet alogliptin in pioglitazone v tistih odraslih bolnikih, starih 18 let in starejših s tipa 2 sladkorna bolezen že zdravijo s to kombinacijo. po začetku terapije z incresync, bolnike je treba pregledati in po treh do šestih mesecih, da oceni ustreznost odziva na zdravljenje (e. zmanjšanje hba1c). pri bolnikih, ki ne kažejo ustrezen odgovor, incresync, je treba prekiniti,. v luči možnih tveganj z daljšo pioglitazone terapije, predpisovalce morajo potrditi na kasnejše redne preglede, da je korist incresync je ohranjena (glej poglavje 4.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - leukemija, myeloid, akutna - antineoplastična sredstva - xospata je označen kot monotherapy za zdravljenje odraslih bolnikov, ki so relapsed ali ognjevzdržni akutno mieloično levkemijo (aml), z flt3 mutacija.

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)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - priprave za zdravljenje ran in razjed - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Evropska unija - slovenščina - EMA (European Medicines Agency)

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.