Esomeprazole PharmSol

Medicinal product

(Invented) name

Esomeprazole PharmSol

Active substance (s)

Ezomeprazolas

Strength

20 mg

Pharmaceutical form

skrandyje neirios tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC05, Esomeprazole

Marketing authorisation holder

Pharmsol Europe Limited, Malta

Date of authorisation

2024-10-02

Date of renewal

Documents

5597 Esomeprazole PharmSol 20 OTC II PL 2025 07 18.docx

5597_5598 Esomeprazole PharmSol 20, 40 Rp II PL 2025 07 18.docx

5597_5598 Pakuotės lapelis 20, 40 Rp 2025 07 18.docx

Esomeprazole PharmSol 20mg 40mg_viešas_AR.pdf

5597 Pakuotės lapelis 20 OTC 2025 07 18.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Ezomeprazolas	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
115215	101324	1101324	lizdinė plokštelė	N14		Nereceptinis	LT/1/24/5597/001	Netiekiama	-	-	No	-	-
115216	101325	1101325	lizdinė plokštelė	N28		Receptinis	LT/1/24/5597/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-02	Registruotas