EMEA-002079-PIP01-16

Key facts

Invented name
Active substance
Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA that is covalently linked to a ligand containing three N-acetylgalactosamine residues (ALN-GO1)
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0373/2017
PIP number
EMEA-002079-PIP01-16
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of hyperoxaluria
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Alnylam UK Limited
Tel. +1  8663300326
E-mail: clinicaltrials@alnylam.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