Omeprazole Sandoz

Medicinal product

(Invented) name

Omeprazole Sandoz

Active substance (s)

Omeprazolas

Strength

40 mg

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC01, Omeprazole

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2016-11-10

Date of renewal

Documents

3995_1_4 Omeprazole Sandoz 40 milt RPP 170601.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/0719/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kiekviename flakone yra	1 vnt.
Omeprazolas	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
67056	81598	1081598	flakonas	N1		Receptinis	LT/1/16/3995/001	Netiekiama	-	-	No	-	-
67057	81599	1081599	flakonas	N5		Receptinis	LT/1/16/3995/002	Netiekiama	-	-	No	-	-	Download
67058	81600	1081600	flakonas	N10		Receptinis	LT/1/16/3995/003	Netiekiama	-	-	No	-	-
67059	81601	1081601	flakonas	N20		Receptinis	LT/1/16/3995/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-11	Išregistruotas
2016-11-10	Registruotas