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

locametz

novartis europharm limited  - gozetotide - radionuklidové zobrazovanie - diagnostické rádiofarmaká - tento liek je určený len na diagnostické účely. 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.

Ebvallo Európska únia - slovenčina - EMA (European Medicines Agency)

ebvallo

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Eladynos Európska únia - slovenčina - EMA (European Medicines Agency)

eladynos

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - homeostáza vápnika - liečba osteoporózy u postmenopauzálnych žien so zvýšeným rizikom zlomeniny.

Teriparatide Sun Európska únia - slovenčina - EMA (European Medicines Agency)

teriparatide sun

sun pharmaceutical industries europe b.v. - teriparatid - osteoporosis; osteoporosis, postmenopausal - homeostáza vápnika - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Kauliv Európska únia - slovenčina - EMA (European Medicines Agency)

kauliv

strides pharma (cyprus) limited - teriparatid - osteoporosis; osteoporosis, postmenopausal - homeostáza vápnika - kauliv is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Bimervax Európska únia - slovenčina - EMA (European Medicines Agency)

bimervax

hipra human health s.l. - sars-cov-2 virus recombinant spike (s) protein receptor binding domain (rbd) fusion heterodimer – b.1.351-b.1.1.7 strains - covid-19 virus infection - vakcíny - bimervax is indicated as a booster for active immunisation to prevent covid-19 in individuals 16 years of age and older who have previously received a mrna covid-19 vaccine.

Akeega Európska únia - slovenčina - EMA (European Medicines Agency)

akeega

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatic neoplasms, kastrácia-odolný - antineoplastické činidlá - treatment of adult patients with prostate cancer.

Pedmarqsi Európska únia - slovenčina - EMA (European Medicines Agency)

pedmarqsi

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - všetky ostatné terapeutické produkty - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Lytgobi Európska únia - slovenčina - EMA (European Medicines Agency)

lytgobi

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - antineoplastické činidlá - 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.

Degarelix Accord Európska únia - slovenčina - EMA (European Medicines Agency)

degarelix accord

accord healthcare s.l.u. - degarelix acetate - prostatické nádory - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.