EMEA-001491-PIP01-13-M02
Key facts
| Invented name |
Nulibry
|
| Active substance |
Fosdenopterin (ORGN001)
|
| Therapeutic area |
Other
|
| Decision number |
P/0132/2022
|
| PIP number |
EMEA-001491-PIP01-13-M02
|
| Pharmaceutical form(s) |
Powder for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of molybdenum cofactor deficiency type A
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Zydus France S.A.S.
philippe.dupont@zydusfrance.com +33 141191860 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001491-PIP01-13-M01
|
| Compliance opinion date |
15/10/2021
|
| Compliance outcome |
positive
|