Europska Unija - hrvatski - EMA (European Medicines Agency)

advanz pharma limited - kiselina obeticholic - ciroza jetre, biliary - bile i jetrena terapija - ocaliva je indiciran za liječenje primarne bilijarne kolangitis (također poznat kao primarna bilijarna ciroza) u kombinaciji s ursodeoksikolnom kiselinom (udca) u odraslih osoba s neadekvatnim odgovorom udca ili kao monoterapija u odraslih osoba ne podnosi udca.

Europska Unija - hrvatski - EMA (European Medicines Agency)

alnylam netherlands b.v. - patisiran natrija - Амилоидоз, obiteljska - ostali lijekovi protiv živčanog sustava - onpattro indiciran za liječenje nasljednih транстиретина-посредничанного амилоидоза (hattr амилоидоз) u odraslih bolesnika s fazi 1 ili 2 fazi полинейропатии.

Europska Unija - hrvatski - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karcinom, squamous cell - antineoplastična sredstva - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

alnylam netherlands b.v. - givosiran - Порфирий, zatajenje - različite dijelove probavnog trakta i metabolizma proizvodi - liječenje akutnog zatajenja порфирии (АХА) kod odraslih i adolescenata u dobi od 12 godina i stariji.

Europska Unija - hrvatski - EMA (European Medicines Agency)

alnylam netherlands b.v. - lumasiran sodium - hyperoxaluria, primary - drugi gastrointestinalni trakt i metabolizam, lijekovi, - treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

Europska Unija - hrvatski - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastična sredstva - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

Europska Unija - hrvatski - EMA (European Medicines Agency)

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - ostali lijekovi protiv živčanog sustava - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.