Elacestrant

ORSERDU 345 mg filmomhulde tabletten

Filmomhulde tabletNetherlandsAuthorisedAuthorised 16 Nov 2023

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

OrserduEuropean UnionAuthorised

OrserduEuropean Union · Stemline Therapeutics B.V.Same brand
OrserduCroatiaSame brand
OrserduItaly · Compressa rivestita con film · Stemline Therapeutics BVSame brand
Orserdu Film-Coated Tablet 345 MGSingapore · 345 MG · tablet, film coated · A. Menarini Singapore Pte. LTD.Same brand
Orserdu Film-Coated Tablet 86 MGSingapore · 86 MG · tablet, film coated · A. Menarini Singapore Pte. LTD.Same brand
OrserduUnited States · 345MG BASE, 86MG BASE · tablet · Stemline Therap

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Elacestrant

ORSERDU 345 mg filmomhulde tabletten

Filmomhulde tabletNetherlandsAuthorisedAuthorised 16 Nov 2023

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

OrserduEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Elacestrant
Dosage form: Filmomhulde tablet
Route: Oraal gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 16 Nov 2023
Registration: EU/1/23/1757
Marketing authorisation holder: Stemline Therapeutics B.V.
ATC code: L02BA04
Group: Antineoplastic and immunomodulating agents
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/005898
EU number: EU/1/23/1757