Piperacillin/Tazobactam Sandoz

Medicinal product

(Invented) name

Piperacillin/Tazobactam Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2008-10-29

Date of renewal

2014-05-14

Documents

1321 Piperacillin_Tazobactam Sandoz PCS PL 2023 01 18.docx

1321 Pakuotės lapelis 2023 01 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/0856/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone/buteliuke 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
19722	22924	1022924	buteliukas	100 ml N1		Receptinis	LT/1/08/1321/001	Netiekiama	-	-	No	-	-
32171	34564	1034564	buteliukas	100 ml N5		Receptinis	LT/1/08/1321/002	Netiekiama	-	-	No	-	-
32172	34565	1034565	buteliukas	100 ml N10		Receptinis	LT/1/08/1321/003	Tiekiama	-	-	No	-	-	Download
32173	34566	1034566	buteliukas	100 ml N12		Receptinis	LT/1/08/1321/004	Netiekiama	-	-	No	-	-
32174	34567	1034567	buteliukas	100 ml N50		Receptinis	LT/1/08/1321/005	Netiekiama	-	-	No	-	-
59171	73394	1073394	flakonas	50 ml N1		Receptinis	LT/1/08/1321/006	Netiekiama	-	-	No	-	-
59172	73395	1073395	flakonas	50 ml N5		Receptinis	LT/1/08/1321/007	Netiekiama	-	-	No	-	-
59173	73396	1073396	flakonas	50 ml N10		Receptinis	LT/1/08/1321/008	Netiekiama	-	-	No	-	-
59174	73397	1073397	flakonas	50 ml N12		Receptinis	LT/1/08/1321/009	Netiekiama	-	-	No	-	-
59175	73398	1073398	flakonas	50 ml N50		Receptinis	LT/1/08/1321/010	Netiekiama	-	-	No	-	-
65160	79658	1079658	buteliukas	50 ml N1		Receptinis	LT/1/08/1321/011	Netiekiama	-	-	No	-	-
65161	79659	1079659	buteliukas	50 ml N5		Receptinis	LT/1/08/1321/012	Netiekiama	-	-	No	-	-
65162	79660	1079660	buteliukas	50 ml N10		Receptinis	LT/1/08/1321/013	Netiekiama	-	-	No	-	-
65163	79661	1079661	buteliukas	50 ml N12		Receptinis	LT/1/08/1321/014	Netiekiama	-	-	No	-	-
65164	79662	1079662	buteliukas	50 ml N50		Receptinis	LT/1/08/1321/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-05-14	Perregistruotas
2008-10-29	Registruotas