🇪🇺 Chemotherapy and antibodies in European Union

EMA authorised Chemotherapy and antibodies on 16 November 2020

Marketing authorisations

Application: EMEA/H/C/005173
Marketing authorisation holder: ADIENNE S.r.l. S.U.
Local brand name: Phelinun
Indication: High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of: multiple myeloma, malignant lymphoma (Hodgkin, non-Hodgkin lymphoma), acute lymphoblastic and myeloblastic leukemia, childhood neuroblastoma, ovarian cancer, mammary adenocarcinoma. Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults. Phelinun in c
Status: approved

Application: EMEA/H/C/005434
Marketing authorisation holder: Esteve Pharmaceuticals GmbH
Local brand name: Thiotepa Riemser
Indication: Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning trea
Status: approved

Is Chemotherapy and antibodies approved in European Union?

Yes. EMA authorised it on 16 November 2020; EMA authorised it on 26 March 2021.

Who is the marketing authorisation holder for Chemotherapy and antibodies in European Union?

ADIENNE S.r.l. S.U. holds the EU marketing authorisation.