Sugammadex Kalceks

Medicinal product

(Invented) name

Sugammadex Kalceks

Active substance (s)

Sugamadeksas

Strength

100 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AB35, Sugammadex

Marketing authorisation holder

AS KALCEKS, Latvija

Date of authorisation

2023-08-08

Date of renewal

Documents

5231 Sugammadex Kalceks PL 2024 10 01, VRA rastas 17041.docx

5231 Pakuotės lapelis 2024 10 01.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3316/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Sugamadeksas	100 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
111500	97613	1097613	flakonas	2 ml N1		Receptinis	LT/1/23/5231/001	Netiekiama	-	-	No	-	-
111501	97614	1097614	flakonas	2 ml N10		Receptinis	LT/1/23/5231/002	Netiekiama	-	-	No	-	-	Download
111502	97615	1097615	flakonas	5 ml N1		Receptinis	LT/1/23/5231/003	Netiekiama	-	-	No	-	-
111503	97616	1097616	flakonas	5 ml N10		Receptinis	LT/1/23/5231/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-08-08	Registruotas