Salofalk

Medicinal product

(Invented) name

Salofalk

Active substance (s)

Mesalazinas

Strength

1000 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

5315 Salofalk 1000mg gran RPP 2025 05 09.docx

5315 Pakuotės lapelis 2025 05 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0363/002/E/005

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Paketėlyje yra:	1 vnt.
Mesalazinas	1000 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
112455	98575	1098575	paketėlis	N20		Receptinis	LT/1/24/5315/001	Netiekiama	-	-	No	-	-
112456	98576	1098576	paketėlis	N50		Receptinis	LT/1/24/5315/002	Netiekiama	-	-	No	-	-
112457	98577	1098577	paketėlis	N60		Receptinis	LT/1/24/5315/003	Netiekiama	-	-	No	-	-
112458	98578	1098578	paketėlis	N100		Receptinis	LT/1/24/5315/004	Netiekiama	-	-	No	-	-
112459	98579	1098579	paketėlis	N150		Receptinis	LT/1/24/5315/005	Netiekiama	-	-	No	-	-

Stadijos

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