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
|