België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

alliance pharma (ireland) ltd. - terlipressineacetaat 1 mg - eq. terlipressine 0,85 mg - oplossing voor injectie - 0,2 mg/ml - terlipressineacetaat 1 mg - terlipressin

Europese Unie - Nederlands - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple myeloma - antineoplastische middelen - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.