Sugammadex Fresenius Kabi

Medicinal product

(Invented) name

Sugammadex Fresenius Kabi

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

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2022-07-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	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
109013	95119	1095119	flakonas	1 ml N10		Receptinis	EU/1/22/1663/001	Netiekiama	-	-	No	-	-
109014	95120	1095120	flakonas	2 ml N10		Receptinis	EU/1/22/1663/002	Tiekiama	-	-	No	-	-
109015	95121	1095121	flakonas	5 ml N10		Receptinis	EU/1/22/1663/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-15	Registruotas