Zenagam

Medicinal product

(Invented) name

Zenagam

Active substance (s)

Sugamadekso natrio druska

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

Zenthique Limited, Malta

Date of authorisation

2023-12-18

Date of renewal

Documents

5298_Zenagam.docx

5298_pakuotes lapelis_2023-12-18.docx

LT_0191_Zenagam_PAR+SD+LT.pdf

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0191/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Sugamadekso natrio druska	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
112303	98418	1098418	flakonas	2 ml N10		Receptinis	LT/1/23/5298/001	Netiekiama	-	-	No	-	-
112304	98419	1098419	flakonas	5 ml N10		Receptinis	LT/1/23/5298/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-30	Išregistruotas
2023-12-18	Registruotas