Omeprazole Zentiva

Medicinal product

(Invented) name

Omeprazole Zentiva

Active substance (s)

Omeprazolas

Strength

20 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC01, Omeprazole

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2024-04-30

Date of renewal

Documents

5422 Pakuotės lapelis 2024 06 07.docx

5422 Omeprazole Zentiva PCS 2024 10 23.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/2319/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Omeprazolas	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
113513	99632	1099632	lizdinė plokštelė	N7		Nereceptinis	LT/1/24/5422/001	Netiekiama	-	-	No	-	-
113514	99633	1099633	lizdinė plokštelė	N14		Nereceptinis	LT/1/24/5422/002	Tiekiama	2025-02-01	-	No	-	-

Stadijos

Data	Stadija
2024-04-30	Registruotas