Piperacillin/Tazobactam Kalceks

Medicinal product

(Invented) name

Piperacillin/Tazobactam Kalceks

Active substance (s)

Piperacilinas/Tazobaktamas

Strength

4000 mg/500 mg

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01CR05, Piperacillin and beta-lactamase inhibitor

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2023-01-31

Date of renewal

Documents

5107_5108 Pakuotės lapelis 2024 10 01.docx

5107_5108 Piperacillin_Tazobactam Kalceks PL 2024 10 01, VRA_17041.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3290/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Piperacilinas	4000 mg
Tazobaktamas	500 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
110274	96385	1096385	flakonas	N1		Receptinis	LT/1/23/5108/001	Tiekiama	-	-	No	-	-
110275	96386	1096386	flakonas	N10		Receptinis	LT/1/23/5108/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-31	Registruotas