Imipenem/Cilastatin Venus Pharma

Medicinal product

(Invented) name

Imipenem/Cilastatin Venus Pharma

Active substance (s)

Imipenemas/Cilastatinas

Strength

500 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)

J01DH51, Imipenem and cilastatin

Marketing authorisation holder

Venus Pharma GmbH, Vokietija

Date of authorisation

2021-09-07

Date of renewal

Documents

4804 Pakuotės lapelis 2024 09 06.docx

4804 Imipenem_Cilastatin Venus Pharma II PL 2024 09 06.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0311/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Imipenemas	500 mg
Cilastatinas	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
107191	93295	1093295	flakonas	N1		Receptinis	LT/1/21/4804/001	Netiekiama	-	-	No	-	-
107192	93296	1093296	flakonas	N5		Receptinis	LT/1/21/4804/002	Netiekiama	-	-	No	-	-
107193	93297	1093297	flakonas	N10		Receptinis	LT/1/21/4804/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-09-07	Registruotas