EMEA-001397-PIP03-14-M06
Key facts
| Invented name |
Imbruvica
|
| Active substance |
Ibrutinib
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0337/2021
|
| PIP number |
EMEA-001397-PIP03-14-M06
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of mature B-cell neoplasms
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Janssen-Cilag International N.V.
E-mail: contact@Janssen-emea.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001397-PIP03-14-M06
|
| Compliance opinion date |
25/02/2022
|
| Compliance outcome |
positive
|