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

evoltra

sanofi b.v. - klofarabin - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - zdravljenje akutno limfoblastno levkemijo, (vse), pri pediatričnih bolnikih, ki so ponovila ali so ognjevarni po prejemu vsaj dve predhodni režimi in če ni druge možnosti zdravljenja, predvidene za posledico trajno odgovor. varnost in učinkovitost sta bili ocenjeni pri študijah pri bolnikih ≤ 21 let pri začetni diagnozi.

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

fabrazyme

sanofi b.v. - agalsidaza beta - fabryjeva bolezen - drugi zdravljene bolezni prebavil in presnove izdelki, - zdravilo fabrazyme je indicirano za dolgoročno nadomestno encimsko dajanje pri bolnikih s potrjeno diagnozo fabryjeve bolezni (pomanjkanje α-galaktozidaze-a).

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

fasturtec

sanofi winthrop industrie - razburicaza - hiperurikemija - vsi drugi terapevtski izdelki - zdravljenje in preprečevanje akutne hiperurikemija, da se prepreči akutna ledvična odpoved, pri odraslih, otrocih in mladostnikih (starih od 0 do 17 let) z hematološke maligne bolezni z visoko tumor breme in tveganje za tumor hitro lizo ali krčenje v uvedbe kemoterapije.

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

mozobil

sanofi b.v. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation; lymphoma - immunostimulants, - mozobil je naveden v kombinaciji z granulocitne kolonije stimulirajoči faktor za povečanje mobilizacije krvotvornih matičnih celic v periferni krvi za zbiranje in nadaljnje avtologno presaditvijo pri bolnikih z limfomi in več mielom, katerih celic aktiviranje slabo.

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

renvela

sanofi b.v. - sevelamerijev karbonat - hyperphosphatemia; renal dialysis - vsi drugi terapevtski izdelki - zdravilo renvela je indicirano za nadzor hiperfosfatemije pri odraslih bolnikih, ki prejemajo hemodializo ali peritonealno dializo. renvela je bilo tudi navedeno, za nadzor hyperphosphataemia pri odraslih bolnikih s kronično ledvično boleznijo, ki niso na dializi s serumom fosfor ≥ 1. 78 mmol/l. renvela je treba uporabljati v okviru več terapevtski pristop, ki bi vključeval kalcijev dodatek, 1,25-dihydroxy vitamin d3 (ali eno od njenih analogov nadzor razvoj ledvične bolezni kosti.

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

thyrogen

sanofi b.v. - tirotropin alfa - Širokopasemske neoplazme - spodnjega režnja hipofize hormoni in analogi, hipofize in hypothalamic hormoni in analogi - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.

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

renagel

sanofi b.v. - sevelamer - renal dialysis; hyperphosphatemia - vsi drugi terapevtski izdelki - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

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

supemtek

sanofi pasteur - influenza a virus subtype h1n1 haemagglutinin, recombinant, influenza a virus subtype h3n2 haemagglutinin, recombinant, influenza b virus victoria lineage haemagglutinin, recombinant, influenza b virus yamagata lineage haemagglutinin, recombinant - gripa, človek - cepiva - supemtek is indicated for active immunization for the prevention of influenza disease in adults. supemtek should be used in accordance with official recommendations.

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

xenpozyme

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - drugi zdravljene bolezni prebavil in presnove izdelki, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

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

aubagio

sanofi winthrop industrie - teriflunomide - multiple skleroza - selektivni imunosupresivi - aubagio 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).