Ceftriaxone Kalceks

Medicinal product

(Invented) name

Ceftriaxone Kalceks

Active substance (s)

Ceftriaksonas

Strength

2 g

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DD04, Ceftriaxone

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2023-01-31

Date of renewal

Documents

5109_5110 Pakuotės lapelis 2024 10 01.docx

5109_5110 Ceftriaxone Kalceks PL 2024 10 01, VRA_17041.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

FI/H/1128/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Ceftriaksonas	2 g

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
110278	96389	1096389	flakonas	N1		Receptinis	LT/1/23/5110/001	Netiekiama	-	-	No	-	-
110279	96390	1096390	flakonas	N10		Receptinis	LT/1/23/5110/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-31	Registruotas