EMEA-000994-PIP01-10-M01
Key facts
| Invented name |
Gadovist
|
| Active substance |
Gadobutrol
|
| Therapeutic area |
Diagnostic
|
| Decision number |
P/0311/2013
|
| PIP number |
EMEA-000994-PIP01-10-M01
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Diagnostic evaluation of tissue pathologies with contrast-enhanced magnetic resonance imaging (MRI)
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Bayer harma AG
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000994-PIP01-10-M01
|
| Compliance opinion date |
20/06/2014
|
| Compliance outcome |
positive
|