vent504 schreef op 26 oktober 2016 12:54:
New self administration kit evaluated by EMA !
On google with "ema WC500215117"
Extract :
5.3.7. Conestat alfa - RUCONEST (CAP) - EMEA/H/C/001223/X/0034
Applicant: Pharming Group N.V PRAC Rapporteur: Rafe Suvarna
Scope: Addition of a new pharmaceutical form ‘powder and solvent for solution for injection’ with self-administration kit
Action: For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP
Is it for prophylaxis ?