Eziclen

Medicinal product

(Invented) name

Eziclen

Active substance (s)

Natrio sulfatas, bevandenis/Magnio sulfatas heptahidratas/Kalio sulfatas

Strength

17,51 g/3,276 g/3,13 g

Pharmaceutical form

koncentratas geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A06AD10, Mineral salts in combination

Marketing authorisation holder

MAYOLY PHARMA FRANCE, Prancūzija

Date of authorisation

2013-04-26

Date of renewal

2018-07-12

Documents

3275 Eziclen RPP 2025 02 16.docx

Eziclen mokomoji medžiaga pacientams.pdf

3275 Pakuotės lapelis 2025 02 16.docx

Eziclen mokomoji medžiaga sveikatos priežiūros specialistams.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0511/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Buteliuke yra	176 ml
Natrio sulfatas, bevandenis	17,51 g
Magnio sulfatas heptahidratas	3,276 g
Kalio sulfatas	3,13 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
49164	63031	1063031	buteliukas	apie 176 ml N2 ir taurelė N1		Receptinis	LT/1/13/3275/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-12	Perregistruotas
2013-04-26	Registruotas