EMEA-002493-PIP01-18-M01

Table of contents

Key facts

Active substance
Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues (DCR-PHXC)
Therapeutic area
Uro-nephrology
Decision number
P/0342/2020
PIP number
EMEA-002493-PIP01-18-M01
Pharmaceutical form(s)
Solution for injection/infusion
Condition(s) / indication(s)
Treatment of primary hyperoxaluria
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Dicerna Ireland Limited

E-mail: contact@dicerna.com
Tel: +353 12314691

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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