EMEA-001855-PIP01-15-M01

Key facts

Active substance
Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran)
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0424/2019
PIP number
EMEA-001855-PIP01-15-M01
Pharmaceutical form(s)
Subcutaneous use
Condition(s) / indication(s)
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
Route(s) of administration
Solution for injection
Contact for public enquiries
Genzyme Europe B.V.

Tel. +31 (0) 20 245 3917
E-mail: EUmedinfo@genzyme.com

 

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

How useful was this page?

Add your rating