ELREXFIO

Medicinal product

(Invented) name

ELREXFIO

Active substance (s)

Elranatamabas

Strength

40 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX32, elranatamab

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2023-12-07

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Elranatamabas	40 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
112319	98434	1098434	flakonas	1,1 ml N1		Receptinis	EU/1/23/1770/001	Netiekiama	-	2026-04-01	No	-	-
112320	98435	1098435	flakonas	1,9 ml N1		Receptinis	EU/1/23/1770/002	Netiekiama	-	2026-04-01	No	-	-

Stadijos

Data	Stadija
2023-12-07	Registruotas