Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Stemline Therapeutics B.V., Basisweg 10, 1043 AP Amsterdam, The Netherlands
ORSERDU 86 mg film-coated tablets.
ORSERDU 345 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. ORSERDU 86 mg film-coated tablets: Blue to light blue biconvex round shaped film-coated tablet with ME debossed on one side and plain face on the opposite side. Approximate diameter: 8.8 mm. ORSERDU 345 mg film-coated tablets: Blue to light blue biconvex oval shaped film-coated tablet with MH debossed on one side and plain face on the opposite side. Approximate size: 19.2 mm (length), 10.8 mm (width). |
ORSERDU 86 mg film-coated tablets: Each film-coated tablet contains elacestrant dihydrochloride equivalent to elacestrant 86.3 mg.
ORSERDU 345 mg film-coated tablets: Each film-coated tablet contains elacestrant dihydrochloride equivalent to elacestrant 345 mg.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Elacestrant |
Elacestrant, a tetrahydronaphthalene compound, is a potent, selective and orally active estrogen receptor-α (ERα) antagonist and degrader. Elacestrant inhibits the estradiol-dependent and independent growth of ERα-positive breast cancer cells, including models harbouring estrogen receptor 1 (ESR1) gene mutations. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose [E460] Film-coating: Opadry II 85F105080 Blue containing polyvinyl alcohol [E1203], titanium dioxide [E171], macrogol [E1521], talc [E553b] and brilliant blue FCF aluminium lake [E133]. |
ORSERDU is packaged in aluminium-aluminium blisters packed into a cardboard box.
ORSERDU 86 mg film-coated tablets:
Packs containing 28 film-coated tablets: 4 blisters with 7 tablets each.
ORSERDU 345 mg film-coated tablets:
Packs containing 28 film-coated tablets: 4 blisters with 7 tablets each.
Stemline Therapeutics B.V., Basisweg 10, 1043 AP Amsterdam, The Netherlands
EU/1/23/1757/001
EU/1/23/1757/002
Date of first authorisation: 15 September 2023
| Drug | Countries | |
|---|---|---|
| ORSERDU | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United States |
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