Asacol

Medicinal product

(Invented) name

Asacol

Active substance (s)

Mesalazinas

Strength

500 mg

Pharmaceutical form

žvakutės

Route (s) of administration

vartoti į tiesiąją žarną

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 Asacol zvakutes PCS PL 2025 05 23.docx

0283 Pakuotės lapelis zvakutes 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

Žvakutėje 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
12344	4332	1004332	lizdinė plokštelė	N20		Receptinis	LT/1/05/0283/003	Tiekiama	-	-	No	-	-	Download

Stadijos

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