Esomeprazole Hexal

Medicinal product

(Invented) name

Esomeprazole Hexal

Active substance (s)

Ezomeprazolas

Strength

20 mg

Pharmaceutical form

skrandyje neirios kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC05, Esomeprazole

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2025-02-20

Date of renewal

Documents

5709_Esomeprazole Hexal.docx

5709_pakuotes lapelis_2025-02-20.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/7802/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
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
116690	102791	1102791	lizdinė plokštelė	N7		Nereceptinis	LT/1/25/5709/001	Netiekiama	-	-	No	-	-
116691	102792	1102792	lizdinė plokštelė	N14		Nereceptinis	LT/1/25/5709/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-20	Registruotas