EMEA-002575-PIP03-21
Key facts
Invented name |
Gavreto
|
Active substance |
pralsetinib
|
Therapeutic area |
Oncology
|
Decision number |
P/0428/2021
|
PIP number |
EMEA-002575-PIP03-21
|
Pharmaceutical form(s) |
Capsule, hard
|
Condition(s) / indication(s) |
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Roche Registration GmbH
E-mail: global.paediatrics@roche.com |
Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|