Union européenne - slovène - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplazme dojke - antineoplastična sredstva - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Union européenne - slovène - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplazme dojke - antineoplastična sredstva - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Union européenne - slovène - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karcinoma, 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.

Union européenne - slovène - 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.

Union européenne - slovène - EMA (European Medicines Agency)

pfizer europe ma eeig - ritlecitinib tosilate - alopecia areata - imunosupresivi - litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

Union européenne - slovène - EMA (European Medicines Agency)

tigenix n.v. - značilne živahne avtologne hrustančne celice, ekspresirane ex vivo, ki izražajo specifične markerjeve proteine - hiruške bolezni - druga zdravila za motnje mišično-skeletnega sistema - popravila posameznih simptomatskih hrustančnih napak iz stegnenice kosti kolena (mednarodna organizacija za popravilo hrustanca [icrs] razreda iii ali iv) pri odraslih. sočasno asimptomatsko poškodb hrustanca (icrs razred i ali ii) je lahko prisoten. prikaz učinkovitosti, ki temeljijo na naključnih nadzorovano preskušanje ocenjevanje učinkovitosti chondrocelect pri bolnikih z poškodb med 1 in 5 cm2.

Union européenne - slovène - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Union européenne - slovène - EMA (European Medicines Agency)

molmed spa - alogenskih t celice, gensko spremenjene z retrovirusni vektor kodiranje za skrajšani obliki ljudi nizko afiniteto živca rastni faktor receptor (Δlngfr) in herpes simplex virus timidin-kinazo (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastična sredstva - zalmoxis je indiciran kot dodatno zdravljenje pri haploidentični hematopoetski presaditvi matičnih celic (hsct) pri odraslih bolnikih z visokim tveganjem hematoloških malignomov.

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

servier pharma d.o.o. - diosmin, flavonoidi, izraženi kot hesperidin - filmsko obložena tableta - diosmin 450 mg / 1 tableta; flavonoidi, izraženi kot hesperidin 50 mg / 1 tableta - diosmin, kombinacije

Union européenne - slovène - EMA (European Medicines Agency)

dendreon uk ltd - avtologni mononuklearnih celic periferne krvi, vključno z najmanj 50 milijonov avtologna cd54 + celice activated s prostate kisline fosfataze makrofagov granulocitne kolonije stimulirajoči faktor - prostatične neoplazme - drugi imunostimulanti - za zdravljenje asimptomatskega ali minimalno simptomatskega metastatskega (nestardalnega) kastratnega odpornega raka na prostati pri odraslih moških, pri katerem kemoterapija še ni klinično indicirana.