Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutiid - malabsorptsiooni sündroomid - muud alimentary seedetrakti ja ainevahetust tooted, - revestive on näidustatud patsientidel vanuses 1 aasta ja üle lühikese soole sündroom (sbs). patsiendid peavad pärast operatsiooni järgima soole kohandumist. revestive on näidustatud ravi patsientidel vanuses 1 aasta ja üle selle lühikese soole sündroom. patsiendid peavad pärast operatsiooni järgima soole kohandumist.

Euroopa Liit - eesti - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - atosiban (as acetate) - enneaegne sünnitus - muud gynecologicals - tractotile, mis on märgitud viivitus peatselt enneaegsetele sündi rasedatel täiskasvanud naistel, kellel on:regulaarsed emaka kokkutõmbed vähemalt 30 sekundit kestus kiirusega vähemalt 4% ja 30 minutit;emakakaela avanenud 1 3 cm (0-3 jaoks nulliparas) ja effacement ≥ 50%;gestational vanuses 24 kuni 33 lõppenud nädala jooksul;normaalne loote südame löögisagedus.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - asatsitidiin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastilised ained - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.

Euroopa Liit - eesti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - tsüstiline fibroos - muud hingamisteede tooted - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Euroopa Liit - eesti - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - vaktsiinid - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. kasutamist see vaktsiin peaks olema kooskõlas ametlike soovitustega.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - sclerosis multiplex, relapsing-remitting - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

biomarin international limited - vosoritide - achondroplasia - narkootikumid luuhaiguste raviks - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Euroopa Liit - eesti - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastilised ained - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Euroopa Liit - eesti - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - muud 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastilised ained - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.