Olezela

Medicinal product

(Invented) name

Olezela

Active substance (s)

Omeprazolas

Strength

20 mg

Pharmaceutical form

skrandyje neirios kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC01, Omeprazole

Marketing authorisation holder

SIA Ingen Pharma, Latvija

Date of authorisation

2020-11-20

Date of renewal

Documents

4632 Olezela kaps Rp PCS PL 2025 01 09.docx

4632 Pakuotės lapelis Rp 2025 01 09.docx

4632 Pakuotės lapelis OTC 2025 01 09.docx

Omeprazole Ingen Pharma_20 mg kietosios kapsules_viesas AR.pdf

4632 Olezela kaps OTC PCS PL 2025 01 09.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė 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
105239	91341	1091341	lizdinė plokštelė	N14		Nereceptinis	LT/1/20/4632/001	Tiekiama	-	-	No	-	-	Download
105240	91342	1091342	lizdinė plokštelė	N28		Receptinis	LT/1/20/4632/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-11-20	Registruotas