Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Shionogi B.V., Kingsfordweg 151, 1043GR, Amsterdam, Netherlands
Senshio 60 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed with “60” on one side. |
Each film-coated tablet contains 60 mg ospemifene.
Excipient with known effect: Each film-coated tablet contains 1.82 mg lactose as monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ospemifene |
Ospemifene and its major metabolite have an oestrogen like effect in the vagina increasing the cellular maturation and mucification of the vaginal epithelium. Ospemifene’s biological actions are mediated through the binding of ospemifene and its major metabolite to oestrogen receptors leading to activation of some oestrogenic pathways (agonism) and blockade of other (antagonism). |
| List of Excipients |
|---|
|
Tablet core: Colloidal silicon dioxide (E551) Film coating: Hypromellose (E464) |
PVC/PVdC-Aluminium blister. Pack sizes of 7, 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.
Shionogi B.V., Kingsfordweg 151, 1043GR, Amsterdam, Netherlands
EU/1/14/978/001
EU/1/14/978/002
EU/1/14/978/003
Date of first authorisation: 15 January 2015
Date of latest renewal: 21 October 2019
| Drug | Countries | |
|---|---|---|
| SENSHIO | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland, Singapore, United Kingdom |
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