Esomeprazole Siromed [Esomeprazole PharmSol]

Medicinal product

(Invented) name

Esomeprazole Siromed [Esomeprazole PharmSol]

Active substance (s)

Ezomeprazolas

Strength

40 mg

Pharmaceutical form

skrandyje neirios tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

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_5598 Esomeprazole Siromed 20,40 Rp RPP 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	40 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
115217	101326	1101326	lizdinė plokštelė	N14		Receptinis	LT/1/24/5598/001	Netiekiama	-	-	No	-	-
115219	101328	1101328	lizdinė plokštelė	N28		Receptinis	LT/1/24/5598/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-02	Registruotas