EMEA-001309-PIP01-12
Key facts
| Invented name |
Synagis
|
| Active substance |
palivizumab
|
| Therapeutic area |
Neonatology-Paediactric Intensive care
|
| Decision number |
P/0111/2013
|
| PIP number |
EMEA-001309-PIP01-12
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Prevention of lower respiratory tract disease caused by respiratory syncytial virus
|
| Route(s) of administration |
Intramuscular use
|
| Contact for public enquiries |
AbbVie Ltd
E-mail: paediatricteam@abbvie.com
Country: United Kingdom Tel. +44 (0)1628 644475 Fax: +44 (0)1628 642566 |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
| Compliance procedure number |
EMEA-C-001309-PIP01-12
|
| Compliance opinion date |
09/08/2013
|
| Compliance outcome |
positive
|