OMEPRAZOL ARENA

Medicinal product

(Invented) name

OMEPRAZOL ARENA

Active substance (s)

Omeprazolas

Strength

20 mg

Pharmaceutical form

skrandyje neirios kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC01, Omeprazole

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2023-02-08

Date of renewal

Documents

1827-002_OMEPRAZOL ARENA OTC_2024-08-22_K.docx

1827-001_OMEPRAZOL ARENA Rx_2024-08-22_K.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
110343	96454	1096454	lizdinė plokštelė	N30		Receptinis	LT/L/23/1827/001	Netiekiama	2025-09-22	2025-12-15	No	-	-	Download
114873	100977	1100977	lizdinė plokštelė	N10		Nereceptinis	LT/L/23/1827/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-08	Registruotas