Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Esmya 5 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white, round biconvex tablet of 7 mm engraved with “ES5” on one face. |
Each tablet contains 5 mg of ulipristal acetate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ulipristal |
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 |
|---|
|
Microcrystalline cellulose |
Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Pack of 28, 30 and 84 tablets.
Not all pack sizes may be marketed.
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
EU/1/12/750/001
EU/1/12/750/002
EU/1/12/750/003
EU/1/12/750/004
EU/1/12/750/005
Date of first authorisation: 23 February 2012
Date of latest renewal: 14 November 2016
| Drug | Countries | |
|---|---|---|
| ESMYA | Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom |
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