Salofalk

Medicinal product

(Invented) name

Salofalk

Active substance (s)

Mesalazinas

Strength

500 mg

Pharmaceutical form

skrandyje neirios tabletės

Route (s) of administration

vartoti per burną

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

1995-02-15

Date of renewal

2010-09-08

Documents

0445 Salofalk 500mg tab PCS PL 2025 01 28.docx

0445 Pakuotės lapelis tab 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

Tabletėje yra	1 vnt.
Mesalazinas	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
17393	1736	1001736	lizdinė plokštelė	N50		Receptinis	LT/1/95/0445/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-09-08	Perregistruotas
1995-02-15	Registruotas