Ordspono

Medicinal product

(Invented) name

Ordspono

Active substance (s)

Odronekstamabas

Strength

80 mg

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01FX34, odronextamab

Marketing authorisation holder

Regeneron Ireland Designated Activity Company (DAC), Airija

Date of authorisation

2024-08-22

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Vienadoziame flakone yra	4 ml
Odronekstamabas	80 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
114714	100821	1100821	flakonas	4 ml N1		Receptinis	EU/1/24/1843/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas