ELLAONE Tablet Ref.[6456] Active ingredients: Ulipristal

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: LABORATOIRE HRA PHARMA, 200 avenue de Paris, 92320, CHATILLON, France

Product name and form

ellaOne 30 mg tablet.

Pharmaceutical Form

Tablet.

White to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.

Qualitative and quantitative composition

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.

Active Ingredient

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.
List of Excipients

Lactose monohydrate
Povidone
Croscarmellose sodium
Magnesium stearate

Pack sizes and marketing

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.

Marketing authorization holder

LABORATOIRE HRA PHARMA, 200 avenue de Paris, 92320, CHATILLON, France

Marketing authorization dates and numbers

EU/1/09/522/001
EU/1/09/522/002

Date of first authorisation: 15 May 2009
Date of latest renewal: 21 March 2014

Drugs

Drug Countries
ELLAONE Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom
 
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