EMEA-002268-PIP02-18-M01
Key facts
| Invented name |
Zejula
|
| Active substance |
Niraparib (tosilate monohydrate)
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0184/2021
|
| PIP number |
EMEA-002268-PIP02-18-M01
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
GlaxoSmithKline (Ireland) Limited
E-mail: eu.paediatric-plans@gsk.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|