Salofalk

Medicinal product

(Invented) name

Salofalk

Active substance (s)

Mesalazinas

Strength

3 g

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

5317 Pakuotės lapelis 2025 05 09.docx

5317 Salofalk 3g gran RPP 2025 05 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0363/007/E/005

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Paketėlyje yra:	1 vnt.
Mesalazinas	3 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
112471	98591	1098591	paketėlis	N10		Receptinis	LT/1/24/5317/001	Netiekiama	-	-	No	-	-
112472	98592	1098592	paketėlis	N15		Receptinis	LT/1/24/5317/002	Netiekiama	-	-	No	-	-
112473	98593	1098593	paketėlis	N20		Receptinis	LT/1/24/5317/003	Netiekiama	-	-	No	-	-
112474	98594	1098594	paketėlis	N30		Receptinis	LT/1/24/5317/004	Netiekiama	-	2025-12-31	Yes	2025-08-25	2025-12-31
112475	98595	1098595	paketėlis	N50		Receptinis	LT/1/24/5317/005	Netiekiama	-	-	No	-	-
112476	98596	1098596	paketėlis	N60		Receptinis	LT/1/24/5317/006	Netiekiama	-	-	No	-	-
112477	98597	1098597	paketėlis	N90		Receptinis	LT/1/24/5317/007	Netiekiama	-	-	No	-	-
112478	98598	1098598	paketėlis	N100		Receptinis	LT/1/24/5317/008	Netiekiama	-	-	No	-	-

Stadijos

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