EMEA-001056-PIP02-12-M01
Key facts
| Invented name |
Lamzede
|
| Active substance |
velmanase alfa
|
| Therapeutic area |
Endocrinology-Gynaecology-Fertility-Metabolism
|
| Decision number |
P/0407/2020
|
| PIP number |
EMEA-001056-PIP02-12-M01
|
| Pharmaceutical form(s) |
Powder for solution for injection
|
| Condition(s) / indication(s) |
Treatment of alpha-mannosidosis
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Chiesi Farmaceutici S.p.A.
Tel. +39 0521 2791 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001056-PIP02-12-M01
|
| Compliance opinion date |
23/04/2021
|
| Compliance outcome |
positive
|