Ocaliva Európska únia - slovenčina - EMA (European Medicines Agency)

ocaliva

advanz pharma limited - obeticholic kyseliny - cirhóza pečene, žlčové - liečba žlčou a pečeňou - ocaliva je indikovaný na liečbu primárnej biliárnej cholangitída (tiež známy ako primárna biliárna cirhóza) v kombinácii s kyselinou ursodeoxycholovou sa však (udca) u dospelých pacientov s nedostatočnou odpoveďou na udca alebo ako monoterapia u dospelých neschopných tolerovať udca.

Onpattro Európska únia - slovenčina - EMA (European Medicines Agency)

onpattro

alnylam netherlands b.v. - patisiran sodíka - amyloidosis, rodinné - Ďalšie lieky na nervový systém - onpattro je indikovaný na liečbu dedičných transthyretin-sprostredkované amyloidosis (hattr amyloidosis) u dospelých pacientov s fáza 1 alebo 2. etapa polyneuropathy.

Libtayo Európska únia - slovenčina - EMA (European Medicines Agency)

libtayo

regeneron ireland designated activity company (dac) - cemiplimab - karcinóm, šquamózna bunka - antineoplastické činidlá - 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.

Givlaari Európska únia - slovenčina - EMA (European Medicines Agency)

givlaari

alnylam netherlands b.v. - givosiran - porphyrias, pečeňové - rôzne alimentárny trakt a metabolizmus produkty - liečba akútnej pečeňové neskorá (ahp) u dospelých a dospievajúcich vo veku 12 rokov a starší.

Oxlumo Európska únia - slovenčina - EMA (European Medicines Agency)

oxlumo

alnylam netherlands b.v. - lumasiran sodium - hyperoxaluria, primary - iné alimentárny trakt a metabolizmus výrobky, - treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

Tukysa Európska únia - slovenčina - EMA (European Medicines Agency)

tukysa

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastické činidlá - 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.

Amvuttra Európska únia - slovenčina - EMA (European Medicines Agency)

amvuttra

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - Ďalšie lieky na nervový systém - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.