ORSERDU

Medicinal product

(Invented) name

ORSERDU

Active substance (s)

Elacestrantas

Strength

345 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L02BA04, elacestrant

Marketing authorisation holder

Stemline Therapeutics B.V., Nyderlandai

Date of authorisation

2023-09-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Elacestrantas	345 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
111686	97799	1097799	lizdinė plokštelė	N28		Receptinis	EU/1/23/1757/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas