Ursofalk

Medicinal product

(Invented) name

Ursofalk

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

A05B, LIVER THERAPY, LIPOTROPICS

Marketing authorisation holder

Dr. Falk Pharma GmbH, Vokietija

Date of authorisation

1996-02-15

Date of renewal

2008-12-18

Documents

1390 Pakuotės lapelis 250mg 2025 02 21.docx

1390 Ursofalk 250mg kaps 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

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
9557	2229	1002229	lizdinė plokštelė	N50		Receptinis	LT/1/96/1390/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-12-18	Perregistruotas
1996-02-15	Registruotas