CARMUSTINE OBVIUS (carmustine)

Opinions on drugs - Posted on Mar 12 2021

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the new MA indication.

What therapeutic improvement?

No clinical added value in the therapeutic strategy for conditioning prior to autologous haematopoietic stem cell transplantation (HSCT) in malignant haematological diseases (Hodgkin's disease/Non-hodgkin's lymphoma).

Clinical Benefit

Substantial

The Committee deems that the clinical benefit of CARMUSTINE OBVIUS 100 mg is substantial in the new MA indication.

Clinical Added Value

no clinical added value

This medicinal product is a eurogeneric that provides no clinical added value (CAV V) in the therapeutic strategy for conditioning prior to autologous haematopoietic stem cell transplantation (HSCT) in malignant haematological diseases (Hodgkin's disease/Non-hodgkin's lymphoma).