Esomeprazole Hospira

Medicinal product

(Invented) name

Esomeprazole Hospira

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

Hospira UK Limited, Jungtinė Karalystė

Date of authorisation

2014-09-04

Date of renewal

Documents

3609_1-4 Esomeprazole_Hospira_DP.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1304/001/DC

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
53991	67977	1067977	flakonas	N1		Receptinis	LT/1/14/3609/001	Netiekiama	-	-	No	-	-
59963	74234	1074234	flakonas	N5		Receptinis	LT/1/14/3609/002	Netiekiama	-	-	No	-	-
59964	74235	1074235	flakonas	N10		Receptinis	LT/1/14/3609/003	Netiekiama	-	-	No	-	-
59965	74236	1074236	flakonas	N25		Receptinis	LT/1/14/3609/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-05	Išregistruotas
2014-09-04	Registruotas