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
|