NYXTHRACIS [Obiltoxaximab SFL]

Medicinal product

(Invented) name

NYXTHRACIS [Obiltoxaximab SFL]

Active substance (s)

Obiltoksaksimabas

Strength

100 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BC04, Obiltoxaximab

Marketing authorisation holder

SFL Pharmaceuticals Deutschland GmbH, Vokietija

Date of authorisation

2020-11-18

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Obiltoksaksimabas	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
105249	91351	1091351	flakonas	6 ml N1		Receptinis	EU/1/20/1485/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-10	Išregistruotas
2020-11-18	Registruotas