Ogsiveo

Medicinal product

(Invented) name

Ogsiveo

Active substance (s)

Nirogacestatas

Strength

100 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)

L01XX81, nirogacestat

Marketing authorisation holder

SpringWorks Therapeutics Ireland Limited, Airija

Date of authorisation

2025-08-14

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

Tabletėje yra:	1 vnt.
Nirogacestatas	100 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
118401	104507	1104507	lizdinė plokštelė	N56		Receptinis	EU/1/25/1932/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-14	Registruotas