Imipenem/Cilastatin Actavis

Medicinal product

(Invented) name

Imipenem/Cilastatin Actavis

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

Teva B.V., Nyderlandai

Date of authorisation

2010-10-12

Date of renewal

2015-07-28

Documents

2181 Pakuotės lapelis 2023 03 03.docx

2181 Imipenem_Cilastatin Actavis PCS 2023 12 15.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0555/002

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
30002	32474	1032474	flakonas	N1		Receptinis	LT/1/10/2181/001	Netiekiama	-	-	No	-	-
43330	57101	1057101	flakonas	N10		Receptinis	LT/1/10/2181/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-02-27	Išregistruotas
2015-07-28	Perregistruotas
2010-10-12	Registruotas