Evropska unija - slovenščina - EMA (European Medicines Agency)

biomarin international limited - pegvaliase - fenilketonurije - drugi proizvodi prebavnega trakta in metabolizma - palynziq je indiciran za zdravljenje bolnikov z phenylketonuria (pku), starih 16 let in več, ki imajo neustrezne krvi fenilalanin nadzor (kri fenilalanin ravni večji od 600 micromol/l) kljub pred upravljanje z razpoložljive možnosti zdravljenja.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotična sredstva - preprečevanje venska trombembolija (vte) pri odraslih bolnikih, ki so v postopku izbirni kirurški zamenjavi kolka ali kolena. zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih. (see section 4. 4 for haemodynamically unstable pe patients. zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih. (see section 4. 4 za haemodynamically nestabilno pe bolnikov). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 in 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

prašek za peroralno suspenzijo - hranila brez fenilalanina

Evropska unija - slovenščina - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - sapropterin dihydrochloride - fenilketonurije - drugi zdravljene bolezni prebavil in presnove izdelki, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Evropska unija - slovenščina - EMA (European Medicines Agency)

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.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

lek d.d. - klorheksidin; lidokainijev klorid - oralno pršilo, raztopina - klorheksidin 1,12 mg / 1 ml  lidokainijev klorid0,5 mg / 1 ml; lidokainijev klorid 0,5 mg / 1 ml - klorheksidin

Evropska unija - slovenščina - EMA (European Medicines Agency)

krka, d.d., novo mesto - irbesartan hidroklorid - hipertenzija - sredstva, ki delujejo na sistem renin-angiotenzin - zdravljenje esencialne hipertenzije. zdravljenje ledvične bolezni pri bolnikih s hipertenzijo in tip 2 sladkorna bolezen kot del antihypertensive zdravila režim.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - ošpice virus enders' edmonston sev (v živo, zmanjšan), mumpsu virus jeryl lynn (raven b) sev (v živo, zmanjšan), virus rdečk wistar ra 27/3 sev (v živo, zmanjšan) - rubella; mumps; immunization; measles - cepiva - m-m-rvaxpro je označen za sočasno cepljenje proti ošpicam, mumpsu in rdečkam pri posameznikov 12 mesecev ali več. za uporabo v ošpice izbruhov, ali za post-izpostavljenost cepljenje, ali za uporabo v prej necepljenih otrocih, starejših od 12 mesecev, ki so v stiku z dovzetni nosečnice in osebe verjetno, da je dovzetna za mumpsu in rdečkam.

Evropska unija - slovenščina - EMA (European Medicines Agency)

cis bio international  - besilesomab - osteomyelitis; radionuclide imaging - diagnostični radiofarmacevtiki - to zdravilo je za samo diagnostična uporaba in odobrene indikacije scintigraphic slikanje, v povezavi z druge primerne načine slikanja, za določitev vnetje/okužbe v perifernih kosti pri odraslih z suma osteomielitisa. zdravila scintimun ne smete uporabljati za diagnozo okužbe z diabetičnim nogam.

Evropska unija - slovenščina - EMA (European Medicines Agency)

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. axumin je označen za positron emission tomografija (pet) slikanje za odkrivanje ponovitve raka na prostati pri moških odraslih z suma ponovitve, ki temelji na zvišan krvni prostato specifični antigen (psa) ravni po primarni kurativnega zdravljenja.