Ursofalk

Medicinal product

(Invented) name

Ursofalk

Active substance (s)

Ursodeoksicholio rūgštis

Strength

250 mg/5 ml

Pharmaceutical form

geriamoji suspensija

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

2009-04-24

Date of renewal

2014-06-19

Documents

1390 Pakuotės lapelis ger susp 2025 02 21.docx

1390 Ursofalk geriam susp 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

5 ml suspensijos yra	5 ml
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
25061	5473	1005473	buteliukas	250 ml ir matavimo taurelė N1		Receptinis	LT/1/96/1390/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2014-06-19	Perregistruotas
2009-04-24	Registruotas