EMEA-001474-PIP01-13-M01
Key facts
| Invented name |
Keytruda
|
| Active substance |
Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0043/2018
|
| PIP number |
EMEA-001474-PIP01-13-M01
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Merck Sharp & Dohme (Europe), Inc
Tel. +33 1804 64738
E-mail: pip.information@merck.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001474-PIP01-13-M01
|
| Compliance opinion date |
01/02/2019
|
| Compliance outcome |
positive
|