Sugammadex Mylan

Medicinal product

(Invented) name

Sugammadex Mylan

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2021-11-15

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
107588	93693	1093693	flakonas	2 ml N1		Receptinis	EU/1/21/1583/001	Netiekiama	-	-	No	-	-
107589	93694	1093694	flakonas	2 ml N10		Receptinis	EU/1/21/1583/002	Netiekiama	-	-	No	-	-
107590	93695	1093695	flakonas	5 ml N1		Receptinis	EU/1/21/1583/003	Netiekiama	-	-	No	-	-
107591	93696	1093696	flakonas	5 ml N10		Receptinis	EU/1/21/1583/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-15	Registruotas