EMEA-002755-PIP01-19-M01
Key facts
| Active substance |
Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
|
| Therapeutic area |
Infectious diseases
|
| Decision number |
P/0554/2021
|
| PIP number |
EMEA-002755-PIP01-19-M01
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Prevention of lower respiratory tract infection caused by respiratory syncytial virus
|
| Route(s) of administration |
Intramuscular use
|
| Contact for public enquiries |
Merck Sharp & Dohme (Europe), Inc.
Tel. +33 180464738 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|