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PRODUCT DETAIL

ORSERDU 345 mg filmom obalené tablety

Code 4545E
MA number EU/1/23/1757/002
Product Form: tbl flm 28x345 mg (blis.Al/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L02 ENDOCRINE THERAPY
L02B HORMONE ANTAGONISTS AND RELATED AGENTS
L02BA Anti-estrogens
L02BA04 Elacestrant
Shelf life: 24
Container: blister Al/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 15.09.2023
Validity: 15.09.2028
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 11.10.2023
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