URSOGRIX

Medicinal product

(Invented) name

URSOGRIX

Active substance (s)

Ursodeoksicholio rūgštis

Strength

250 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)

A05AA02, Ursodeoxycholic acid

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2017-02-13

Date of renewal

2022-12-08

Documents

4048 URSOGRIX PL 2024 10 01, VRA_17041.docx

4048 Pakuotės lapelis 2024 10 01, VRA_17041.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3712/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Ursodeoksicholio rūgštis	250 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
64987	79478	1079478	lizdinė plokštelė	N50		Receptinis	LT/1/17/4048/001	Netiekiama	2025-12-14	2026-02-28	No	-	-
67732	82288	1082288	lizdinė plokštelė	N60		Receptinis	LT/1/17/4048/002	Netiekiama	-	-	No	-	-
67733	82289	1082289	lizdinė plokštelė	N100		Receptinis	LT/1/17/4048/003	Netiekiama	2025-12-14	2026-04-30	Yes	2026-01-16	2026-04-30

Stadijos

Data	Stadija
2022-12-08	Perregistruotas
2017-02-13	Registruotas