Europska Unija - hrvatski - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - tumori gastrointestinalnog stroma - drugi antitumorski lijekovi, inhibitori протеинкиназы - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastična sredstva - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Europska Unija - hrvatski - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastična sredstva - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Europska Unija - hrvatski - EMA (European Medicines Agency)

viatris limited - tadalafil - hipertenzija, plućna - urologicals - talmanco je indiciran kod odraslih osoba za liječenje plućne arterijske hipertenzije (pah) klasificiranog kao who funkcionalna klasa ii i iii, kako bi se poboljšao kapacitet vježbanja. učinkovitost je pokazana u idiopatskom pah (ipah) i pah povezanoj na vaskularnu bolest kolagena.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

aop orphan pharmaceuticals gmbh, leopold-ungar-platz 2, beč, austrija - tadalafil - filmom obložena tableta - 20 mg - urbroj: jedna filmom obložena tableta sadrži 20 mg tadalafila

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

alkaloid d.o.o., ulica grada vukovara 226f, zagreb - ciclosporinum - oralna otopina - 100 mg/ml - urbroj: 1 ml oralne otopine sadržava 100 mg ciklosporina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - ciclosporinum - kapsula, meka - 10 mg - urbroj: svaka meka kapsula sadrži 10 mg ciklosporina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - ciclosporinum - kapsula, meka - 100 mg - urbroj: svaka meka kapsula sadrži 100 mg ciklosporina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - ciclosporinum - kapsula, meka - 25 mg - urbroj: svaka meka kapsula sadrži 25 mg ciklosporina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - ciclosporinum - kapsula, meka - 50 mg - urbroj: svaka meka kapsula sadrži 50 mg ciklosporina