EMEA-001147-PIP02-20
Key facts
| Active substance |
Dabrafenib
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0423/2020
|
| PIP number |
EMEA-001147-PIP02-20
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of glioma
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Novartis Europharm Limited
E-mail: paediatric.enquiries@novartis.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
| Compliance procedure number |
EMEA-C-001147-PIP02-20
|
| Compliance opinion date |
27/09/2022
|
| Compliance outcome |
positive
|