COLTOWAN

Medicinal product

(Invented) name

COLTOWAN

Active substance (s)

Ezetimibas

Strength

10 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C10AX09, Ezetimibe

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2011-01-26

Date of renewal

2017-07-27

Documents

2305_1 COLTOWAN 10mg tab RPP 200117.docx

2305_1 Pakuotės lapelis 200117.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/1759/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ezetimibas	10 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
34441	36789	1036789	lizdinė plokštelė	N30		Receptinis	LT/1/10/2305/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-08-31	Išregistruotas
2017-07-27	Perregistruotas
2011-01-26	Registruotas