Active ingredients: Ulipristal
ellaOne 30 mg tablet.
Tablet.
White to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Each tablet contains 30 mg ulipristal acetate.
Excipients with known effect: Each tablet contains 237 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Ulipristal is an orally-active synthetic selective progesterone receptor modulator which acts via high-affinity binding to the human progesterone receptor. When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone (LH) surge. Pharmacodynamic data show that even when taken immediately before ovulation is scheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone follicular rupture for at least 5 days.
Lactose monohydrate
Povidone
Croscarmellose sodium
Magnesium stearate
PVC-PE-PVDC-Aluminium blister of 1 tablet.
PVC-PVDC-Aluminium blister of 1 tablet.
Each carton contains one blister.
Not all pack sizes may be marketed.
LABORATOIRE HRA PHARMA, 200 avenue de Paris, 92320, CHATILLON, France
EU/1/09/522/001
EU/1/09/522/002
Date of first authorisation: 15 May 2009
Date of latest renewal: 21 March 2014