Ursogep

Medicinal product

(Invented) name

Ursogep

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

UAB Niromed, Lietuva

Date of authorisation

2025-12-11

Date of renewal

Documents

3065_Ursogep_PZ.docx

3065_Ursogep_PL.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
119456	105561	1105561	lizdinė plokštelė	N50		Receptinis	LT/L/25/3065/001	Netiekiama	-	-	No	-	-	Download
119457	105562	1105562	lizdinė plokštelė	N100		Receptinis	LT/L/25/3065/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-12-11	Registruotas