EMEA-000872-PIP01-10-M03
Key facts
| Invented name |
HyQvia
|
| Active substance |
Human normal immunoglobulin
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0186/2015
|
| PIP number |
EMEA-000872-PIP01-10-M03
|
| Pharmaceutical form(s) |
Solution for infusion
|
| Condition(s) / indication(s) |
Treatment of primary immunodeficiency (PID) as model for replacement therapy
|
| Route(s) of administration |
Subcutaneous use
|
| Contact for public enquiries |
Baxalta Innovations GmbH
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000872-PIP01-10-M03
|
| Compliance opinion date |
30/10/2015
|
| Compliance outcome |
positive
|