Libmeldy Evropska unija - slovenščina - EMA (European Medicines Agency)

libmeldy

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.

Skysona Evropska unija - slovenščina - EMA (European Medicines Agency)

skysona

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - druga zdravila na živčnem sistemu - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Lutetium (177Lu) chloride Billev (previously Illuzyce) Evropska unija - slovenščina - EMA (European Medicines Agency)

lutetium (177lu) chloride billev (previously illuzyce)

billev pharma aps - lutetium (177lu) chloride - radionuklidno slikanje - terapevtski radiofarmacevtiki - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Locametz Evropska unija - slovenščina - EMA (European Medicines Agency)

locametz

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.