Salofalk

Medicinal product

(Invented) name

Salofalk

Active substance (s)

Mesalazinas

Strength

4 g/60 ml

Pharmaceutical form

tiesiosios žarnos suspensija

Route (s) of administration

vartoti į tiesiąją žarną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07EC02, Mesalazine

Marketing authorisation holder

Dr. Falk Pharma GmbH, Vokietija

Date of authorisation

1997-12-22

Date of renewal

2010-09-08

Documents

0445 Pakuotės lapelis susp 2025 01 28.docx

0445 Salofalk zarnos susp PCS PL 2025 01 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Buteliuke (60 ml) yra	60 ml
Mesalazinas	4 g

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
5392	1734	1001734	buteliukas	60 ml N7		Receptinis	LT/1/95/0445/005	Tiekiama	2024-11-20	-	No	-	-	Download

Stadijos

Data	Stadija
2010-09-08	Perregistruotas
1997-12-22	Registruotas