Esomeprazole Siromed [Esomeprazole PharmSol]

Medicinal product

(Invented) name

Esomeprazole Siromed [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 Siromed 20 OTC RPP 2025 10 06.docx

5597_5598 Esomeprazole Siromed 20,40 Rp RPP 2025 10 06.docx

5597 Pakuotės lapelis 20 OTC 2025 10 06.docx

5597_5598 Pakuotės lapelis 20,40 Rp 2025 10 06.docx

Esomeprazole PharmSol 20mg 40mg_viešas_AR.pdf

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