Ursofalk

Medicinal product

(Invented) name

Ursofalk

Active substance (s)

Ursodeoksicholio rūgštis

Strength

500 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)

A05AA02, Ursodeoxycholic acid

A05B, LIVER THERAPY, LIPOTROPICS

Marketing authorisation holder

Dr. Falk Pharma GmbH, Vokietija

Date of authorisation

2010-07-02

Date of renewal

2014-12-30

Documents

1390 Pakuotės lapelis 500mg 2025 02 21.docx

1390 Ursofal 500mg tab RPP 2025 02 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ursodeoksicholio rūgštis	500 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
34628	36970	1036970	lizdinė plokštelė	N50		Receptinis	LT/1/96/1390/003	Tiekiama	-	-	No	-	-	Download
41409	55167	1055167	lizdinė plokštelė	N100		Receptinis	LT/1/96/1390/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-12-30	Perregistruotas
2010-07-02	Registruotas