Dexdor Európska únia - dánčina - EMA (European Medicines Agency)

dexdor

orion corporation - dexmedetomidine hydrochloride - bevidst sedation - psykoleptika - til sedation af voksne intensivplejepasienter, der kræver et sedationsniveau ikke dybere end ophidselse som følge af verbal stimulation (svarende til richmond agitation-sedation scale (rass) 0 til -3).

Tractocile Európska únia - dánčina - EMA (European Medicines Agency)

tractocile

ferring pharmaceuticals a/s - atosiban (as acetate) - for tidlig fødsel - andre gynecologicals - tractotile er angivet til at forsinke overhængende præ-term fødsel hos gravide voksne kvinder med:regelmæssig uterine kontraktioner af mindst 30 sekunders varighed med en hastighed på ≥ 4 per 30 minutter;en cervikal dilatation af 1 til 3 cm (0-3 til nulliparas) og udslettelsen af ≥ 50%;en gestationsalder fra 24 indtil 33 afsluttet uger;en normal føtale hjertefrekvens.

Locametz Európska únia - dánčina - EMA (European Medicines Agency)

locametz

novartis europharm limited  - gozetotide - radionuklidbilleddannelse - diagnostiske radioaktive lægemidler - dette lægemiddel er kun til diagnostisk brug. 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.

Pluvicto Európska únia - dánčina - EMA (European Medicines Agency)

pluvicto

novartis europharm limited  - lutetium (177lu) vipivotide tetraxetan - prostatic neoplasmer, kastration-resistent - terapeutiske radioaktive lægemidler - pluvicto in combination with androgen deprivation therapy (adt) with or without androgen receptor (ar) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with ar pathway inhibition and taxane based chemotherapy.