Europeiska unionen - slovenska - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - karcinom, pljučni pljuč - antineoplastična sredstva - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - imunosupresivi - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - leuprorelin mesilate - prostatične neoplazme - endokrini terapija - camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi, selektivno imunosupresivi - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Europeiska unionen - slovenska - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - drugi antiepileptics - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - zdravila z delovanjem na novotvorbe agenti - 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.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 in 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

forte healthcare limited - fluoksetin - psihoanaleptiki - psi - kot pomoč pri zdravljenju motenj v zvezi z ločevanjem pri psih, ki se kažejo z uničenjem in neustreznim vedenjem (vokalizacija in neprimerno odstranjevanje in / ali uriniranje) in samo v kombinaciji s tehnikami vedenjskih sprememb.

Slovenien - slovenska - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

aspen pharma trading limited - lidokainijev klorid - gel - lidokainijev klorid 20 mg / 1 g - lidokain