P/198/2011
Key facts
| Invented name |
ellaOne
|
| Active substance |
ulipristal acetate
|
| Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
| Decision number |
P/198/2011
|
| PIP number |
P/198/2011
|
| Pharmaceutical form(s) |
Tablet
|
| Condition(s) / indication(s) |
Contraception
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Laboratoire HRA Pharma
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000305-PIP01-08-M02
|
| Compliance opinion date |
08/11/2013
|
| Compliance outcome |
positive
|