Esomeprazole Actavis

Medicinal product

(Invented) name

Esomeprazole Actavis

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

Teva B.V., Nyderlandai

Date of authorisation

2016-08-08

Date of renewal

2021-03-05

Documents

3952 Pakuotės lapelis 2025 02 24.docx

3952 Esomeprazole Actavis milt PCS PL 2025 02 24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0349/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 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
62002	76374	1076374	flakonas	N1		Receptinis	LT/1/16/3952/001	Netiekiama	-	-	No	-	-
66167	80689	1080689	flakonas	N10		Receptinis	LT/1/16/3952/002	Netiekiama	-	-	No	-	-	Download
66168	80690	1080690	flakonas	N50	ASPĮ	Receptinis	LT/1/16/3952/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-05	Perregistruotas
2016-08-08	Registruotas