Meropenem Kalceks

Medicinal product

(Invented) name

Meropenem Kalceks

Active substance (s)

Meropenemas

Strength

500 mg

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DH02, Meropenem

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2023-03-07

Date of renewal

Documents

5128_5129 Meropenem Kalceks PL 2024 10 01, VRA rastas 17041.docx

5128_5129 Pakuotės lapelis 2024 10 01.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3270/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Meropenemas	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
110510	96620	1096620	flakonas	N1		Receptinis	LT/1/23/5128/001	Netiekiama	-	-	No	-	-
110511	96621	1096621	flakonas	N10		Receptinis	LT/1/23/5128/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-03-07	Registruotas