The European Medicines Agency (EMA) has recommended
granting marketing authorisation for LysaKare (L-arginine
hydrochloride/L-lysine hydrochloride) to protect against nephrotoxicity in
patients treated with lutetium (177Lu) oxodotreotide.
If approved, LysaKare will be
available as a 25 g/25 g solution for infusion. The full indication is:
“Reduction of renal radiation exposure during peptide-receptor radionuclide
therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.”
LysaKare has been shown to
decrease reabsorption and retention of lutetium-177 oxodotreotide in the
kidney tubules. The most common side effects are nausea and vomiting.
The EMA opinion will now be
sent to the European Commission for the adoption of a decision on an EU-wide
marketing authorisation. Once the marketing authorisation has been granted,
decisions about price and reimbursement will take place at the national level.
Detailed recommendations for
the use of the product will be described in the summary of product
characteristics (SmPC), which will be published in the European public
assessment report (EPAR) and made available in all official EU languages after
the marketing authorisation has been granted.
Fonte:univadis.com.br
0 comentários:
Postar um comentário