Esomeprazole Accord

Medicinal product

(Invented) name

Esomeprazole Accord

Active substance (s)

Ezomeprazolas

Strength

40 mg

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC05, Esomeprazole

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2014-12-23

Date of renewal

Documents

3668_1_3 Pakuotės lapelis 190712.docx

3668_1_3 Esomeprazole Accord 40mg II PL 190712.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4544/001/

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Ezomeprazolas	40 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
56851	70958	1070958	flakonas	N1		Receptinis	LT/1/14/3668/001	Netiekiama	-	-	No	-	-
61018	75329	1075329	flakonas	N10		Receptinis	LT/1/14/3668/002	Netiekiama	-	-	No	-	-
61019	75330	1075330	flakonas	N50		Receptinis	LT/1/14/3668/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-01	Išregistruotas
2014-12-23	Registruotas