Pantoprazole Kalceks

Medicinal product

(Invented) name

Pantoprazole Kalceks

Active substance (s)

Pantoprazolas

Strength

40 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC02, Pantoprazole

Marketing authorisation holder

AS KALCEKS, Latvija

Date of authorisation

2023-06-15

Date of renewal

Documents

5189 Pantoprazole Kalceks PL 2024 10 01, VRA rastas 17041.docx

5189 Pakuotės lapelis 2024 10 01.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3303/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Pantoprazolas	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
111139	97250	1097250	flakonas	N1		Receptinis	LT/1/23/5189/001	Netiekiama	-	-	No	-	-
111140	97251	1097251	flakonas	N5		Receptinis	LT/1/23/5189/002	Netiekiama	-	-	No	-	-
111141	97252	1097252	flakonas	N10		Receptinis	LT/1/23/5189/003	Tiekiama	-	-	No	-	-	Download
111142	97253	1097253	flakonas	N50		Receptinis	LT/1/23/5189/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-15	Registruotas