Unione Europea - italiano - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - carcinoma, polmone non a piccole cellule - agenti antineoplastici - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Unione Europea - italiano - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - pegfilgrastim - neutropenia - immunostimolanti, , stimolante le colonie di fattori - riduzione della durata della neutropenia e dell'incidenza di neutropenia febbrile in pazienti adulti trattati con chemioterapia citotossica per neoplasie (con l'eccezione di croniche mieloide leucemia e delle sindromi mielodisplastiche).

Unione Europea - italiano - EMA (European Medicines Agency)

biomarin international limited - valoctocogene roxaparvovec - antiemorragici - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Unione Europea - italiano - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - carcinoma, polmone non a piccole cellule - agenti antineoplastici - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Unione Europea - italiano - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leucemia, myelogenous, chronic, bcr-abl positive - agenti antineoplastici - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Unione Europea - italiano - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - agenti antineoplastici - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.

Unione Europea - italiano - EMA (European Medicines Agency)

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - agenti antineoplastici - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. pemetrexed baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. pemetrexed baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.

Unione Europea - italiano - EMA (European Medicines Agency)

plusultra pharma gmbh - sirolimus - angiofibroma; tuberous sclerosis - hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

Unione Europea - italiano - EMA (European Medicines Agency)

laboratoire hra pharma - ulipristal - contraccezione, postcoital - ormoni sessuali e modulatori del sistema genitale, , contraccettivi di emergenza - contraccezione d'emergenza entro 120 ore (cinque giorni) di rapporti sessuali non protetti o fallimento contraccettivo.

Unione Europea - italiano - EMA (European Medicines Agency)

audevard - firocoxib - anti-inflammatory and anti-rheumatic products, non-steroids - cavalli - alleviamento del dolore e dell'infiammazione associati all'osteoartrosi e riduzione della zoppia associata nei cavalli.