EMEA-001103-PIP01-10-M03
Key facts
| Invented name |
Exjade
|
| Active substance |
deferasirox
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0175/2016
|
| PIP number |
EMEA-001103-PIP01-10-M03
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of chronic iron overload requiring chelation therapy
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Novartis Europharm Limited
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001103-PIP01-10-M03
|
| Compliance opinion date |
14/10/2016
|
| Compliance outcome |
positive
|