Salofalk

Medicinal product

(Invented) name

Salofalk

Active substance (s)

Mesalazinas

Strength

500 mg

Pharmaceutical form

pailginto atpalaidavimo granulės

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

2024-01-05

Date of renewal

2024-05-21

Documents

5314 Pakuotės lapelis 2025 05 09.docx

5314 Salofalk 500mg gran RPP 2025 05 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0363/001/E/005

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Paketėlyje 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
112452	98572	1098572	paketėlis	N50		Receptinis	LT/1/24/5314/001	Netiekiama	-	-	No	-	-
112453	98573	1098573	paketėlis	N100		Receptinis	LT/1/24/5314/002	Netiekiama	-	-	No	-	-
112454	98574	1098574	paketėlis	N300		Receptinis	LT/1/24/5314/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-21	Perregistruotas
2024-01-05	Registruotas