NEXPOVIO

Medicinal product

(Invented) name

NEXPOVIO

Active substance (s)

Selineksoras

Strength

20 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)

L01XX66, selinexor

Marketing authorisation holder

Stemline Therapeutics B.V., Nyderlandai

Date of authorisation

2021-03-26

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.
Selineksoras	20 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
106219	92320	1092320	lizdinė plokštelė	N12 (4×3) (60 mg dozė)		Receptinis	EU/1/21/1537/001	Netiekiama	-	-	No	-	-
106220	92321	1092321	lizdinė plokštelė	N16 (4×4) (80 mg dozė)		Receptinis	EU/1/21/1537/002	Netiekiama	-	-	No	-	-
106221	92322	1092322	lizdinė plokštelė	N20 (4×5) (100 mg dozė)		Receptinis	EU/1/21/1537/003	Netiekiama	-	-	No	-	-
106222	92323	1092323	lizdinė plokštelė	N32 (4×8) (80 mg dozė)		Receptinis	EU/1/21/1537/004	Netiekiama	-	-	No	-	-
109072	95178	1095178	lizdinė plokštelė	N8 (4×2) (40 mg dozė)		Receptinis	EU/1/21/1537/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas