Sugammadex Accord

Medicinal product

(Invented) name

Sugammadex Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2025-01-20

Date of renewal

Documents

5669_Sugammadex Accord.docx

5669_pakuotes lapelis_2025-01-20.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/7695/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml injekcinio 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
116319	102421	1102421	flakonas	2 ml N1		Receptinis	LT/1/25/5669/001	Netiekiama	-	-	No	-	-
116320	102422	1102422	flakonas	2 ml N10		Receptinis	LT/1/25/5669/002	Netiekiama	-	-	No	-	-
116321	102423	1102423	flakonas	5 ml N1		Receptinis	LT/1/25/5669/003	Netiekiama	-	-	No	-	-
116322	102424	1102424	flakonas	5 ml N10		Receptinis	LT/1/25/5669/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-20	Registruotas