EMEA-002493-PIP01-18-M03
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/0541/2021
|
| PIP number |
EMEA-002493-PIP01-18-M03
|
| Pharmaceutical form(s) |
Solution for injection
|
| 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 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|