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
|