EMEA-000725-PIP01-09-M03
Key facts
| Invented name |
Pandemrix
|
| Active substance |
Split influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like strain (X-179A)
|
| Therapeutic area |
Vaccines
|
| Decision number |
P228/2011
|
| PIP number |
EMEA-000725-PIP01-09-M03
|
| Pharmaceutical form(s) |
Suspension and emulsion for injection
|
| Condition(s) / indication(s) |
Influenza
|
| Route(s) of administration |
Intramuscular use
|
| Contact for public enquiries |
GlaxoSmithKline Biologicals S.A. (Belgium)
Tel. +1 438 899 8201 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-000725-PIP01-09-M03
|
| Compliance opinion date |
12/12/2014
|
| Compliance outcome |
positive
|