Ordspono

Medicinal product

(Invented) name

Ordspono

Active substance (s)

Odronekstamabas

Strength

320 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	16 ml
Odronekstamabas	320 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
114715	100822	1100822	flakonas	16 ml N1		Receptinis	EU/1/24/1843/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas