Esmapren

Medicinal product

(Invented) name

Esmapren

Active substance (s)

Naproksenas/Ezomeprazolas

Strength

500 mg/20 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)

M01AE52, Naproxen and esomeprazole

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2024-11-27

Date of renewal

Documents

5652 Pakuotės lapelis 2025 02 21.docx

5652 Esmapren PCS PL 2025 02 21.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/1253/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Naproksenas	500 mg
Ezomeprazolas	20 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
115822	101925	1101925	buteliukas	N30		Receptinis	LT/1/24/5652/001	Netiekiama	-	2025-11-30	No	-	-
115823	101926	1101926	buteliukas	N60		Receptinis	LT/1/24/5652/002	Netiekiama	-	2026-03-31	No	-	-

Stadijos

Data	Stadija
2024-11-27	Registruotas