Lyvdelzi [Seladelpar Gilead]

Medicinal product

(Invented) name

Lyvdelzi [Seladelpar Gilead]

Active substance (s)

Seladelparas

Strength

10 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A05AX07, seladelpar

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2025-02-20

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

Kapsulėje yra:	1 vnt.
Seladelparas	10 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
116752	102855	1102855	buteliukas	N30		Receptinis	EU/1/24/1898/001	Netiekiama	-	-	No	-	-
117616	103719	1103719	buteliukas	N90 (3×30)		Receptinis	EU/1/24/1898/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-20	Registruotas