Unia Europejska - polski - EMA (European Medicines Agency)

advanz pharma limited - kwas obeticholic - marskość wątroby, żółć - terapia żółci i wątroby - ocaliva jest wskazany w leczeniu podstawowym dróg żółciowych zapalenie dróg żółciowych (znany również jako pierwotną marskość żółciową) w połączeniu z kwas ursodeoksycholowy (kwas ursodeoksycholowy) u dorosłych pacjentów z niewystarczającą odpowiedzią na kwas ursodeoksycholowy lub w monoterapii u dorosłych nie tolerują kwas ursodeoksycholowy.

Unia Europejska - polski - EMA (European Medicines Agency)

biogen netherlands b.v. - fumaran dimetylu - stwardnienie rozsiane - leki immunosupresyjne - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Unia Europejska - polski - EMA (European Medicines Agency)

biogen netherlands b.v. - peginterferon beta-1a - stwardnienie rozsiane - Иммуностимуляторы, - leczenie rzutowo-remisyjnej postaci stwardnienia rozsianego u dorosłych pacjentów.

Unia Europejska - polski - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - stwardnienie rozsiane - selektywne leki immunosupresyjne - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 i 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Unia Europejska - polski - EMA (European Medicines Agency)

biogen idec ltd - daklizumab - stwardnienie rozsiane - leki immunosupresyjne - zinbryta jest wskazana u dorosłych pacjentów w leczeniu nawracających postaci stwardnienia rozsianego (rms).

Unia Europejska - polski - EMA (European Medicines Agency)

biogen netherlands b.v. - sól sodowa nusinersen - zanik mięśni, kręgosłup - inne leki na układ nerwowy - spinraza jest wskazany w leczeniu 5-rdzeniowego zaniku mięśni.

Unia Europejska - polski - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - rak, płaskonabłonkowy - Środki przeciwnowotworowe - 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.

Unia Europejska - polski - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - Środki przeciwnowotworowe - 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.

Unia Europejska - polski - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - okulistyka - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Unia Europejska - polski - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).