Ekterly

Medicinal product

(Invented) name

Ekterly

Active substance (s)

Sebetralstatas

Strength

300 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)

B06AC08, sebetralstat

Marketing authorisation holder

Kalvista Pharmaceuticals (Ireland) Limited, Airija

Date of authorisation

2025-09-17

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.
Sebetralstatas	300 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
118821	104928	1104928	lizdinė plokštelė	N4		Receptinis	EU/1/25/1975/001	Netiekiama	-	-	No	-	-
118822	104929	1104929	lizdinė plokštelė	N6		Receptinis	EU/1/25/1975/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-17	Registruotas