Asacol

Medicinal product

(Invented) name

Asacol

Active substance (s)

Mesalazinas

Strength

400 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

2005-09-05

Date of renewal

2011-04-13

Documents

0283 Pakuotės lapelis 400mg tab 2025 05 23.docx

0283 Asacol 400mg 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	400 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
12345	16722	1016722	lizdinė plokštelė	N20		Receptinis	LT/1/05/0283/001	Netiekiama	-	-	No	-	-
12346	4333	1004333	lizdinė plokštelė	N100		Receptinis	LT/1/05/0283/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-13	Perregistruotas
2005-09-05	Registruotas