EMEA-001425-PIP01-13-M05
Key facts
| Invented name |
Cotellic
|
| Active substance |
Cobimetinib
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0119/2021
|
| PIP number |
EMEA-001425-PIP01-13-M05
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) with Ras, Raf or MEK pathway activation
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Roche Registration GmbH
E-mail: info.paediatrics@roche.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001425-PIP01-13-M05
|
| Compliance opinion date |
25/06/2021
|
| Compliance outcome |
positive
|