Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkuloza, odporna proti multidrugom - antimikobakterij - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemija, srčna celica - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - sredstva za spreminjanje lipidov - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Evropska unija - slovenščina - EMA (European Medicines Agency)

aimmune therapeutics ireland limited - defatted powder of arachis hypogaea l., semen (peanuts) - peanut hypersensitivity - allergens - palforzia is indicated for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. palforzia may be continued in patients 18 years of age and older. palforzia should be used in conjunction with a peanut-avoidant diet.

Evropska unija - slovenščina - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedem, dedno - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Evropska unija - slovenščina - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastična sredstva - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

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)

novartis europharm limited  - gozetotide - radionuklidno slikanje - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

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.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

astrazeneca uk limited - acetilsalicilna kislina; esomeprazol - kapsula, trda - acetilsalicilna kislina 81 mg / 1 kapsula  esomeprazol20 mg / 1 kapsula; esomeprazol 20 mg / 1 kapsula - acetilsalicilna kislina, kombinacije z zaviralci protonske črpalke