EMEA-000987-PIP01-10-M04
Key facts
| Invented name |
Strensiq
|
| Active substance |
asfotase alfa
|
| Therapeutic area |
Endocrinology-Gynaecology-Fertility-Metabolism
|
| Decision number |
P/0176/2019
|
| PIP number |
EMEA-000987-PIP01-10-M04
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Treatment of hypophosphatasia
|
| Route(s) of administration |
Subcutaneous use
|
| Contact for public enquiries |
Alexion Europe SAS
Tel. +33 153643800 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000987-PIP01-10-M04
|
| Compliance opinion date |
18/10/2019
|
| Compliance outcome |
positive
|