Asacol

Medicinal product

(Invented) name

Asacol

Active substance (s)

Mesalazinas

Strength

800 mg

Pharmaceutical form

modifikuoto atpalaidavimo 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

Tillotts Pharma AB, Švedija

Date of authorisation

2006-06-21

Date of renewal

2011-04-13

Documents

0283 Pakuotės lapelis 800mg tab 2025 05 23.docx

0283 Asacol 800mg tab PCS PL 2025 05 23.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	800 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
18039	21778	1021778	lizdinė plokštelė	N10		Receptinis	LT/1/05/0283/004	Netiekiama	-	-	No	-	-
18040	4551	1004551	lizdinė plokštelė	N50		Receptinis	LT/1/05/0283/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-13	Perregistruotas
2006-06-21	Registruotas