EMEA-000687-PIP01-09-M02
Key facts
| Invented name |
Arepanrix
|
| Active substance |
Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
|
| Therapeutic area |
Vaccines
|
| Decision number |
P/148/2010
|
| PIP number |
EMEA-000687-PIP01-09-M02
|
| Pharmaceutical form(s) |
Suspension and emulsion for emulsion for injection
|
| Condition(s) / indication(s) |
Influenza
|
| Route(s) of administration |
Intramuscular use
|
| Contact for public enquiries |
GlaxoSmithKline Biologicals S.A. (UK)
E-mail: eu.paediatric-plans@gsk.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000687-PIP01-09-M02
|
| Compliance opinion date |
12/12/2014
|
| Compliance outcome |
positive
|