Rybrevant

Medicinal product

(Invented) name

Rybrevant

Active substance (s)

Amivantamabas

Strength

350 mg

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)

L01FX18, Amivantamab

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2021-12-09

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

Concentrate for solution for infusion	7 ml
Amivantamabas	350 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
107758	93863	1093863	flakonas	7 ml N1		Receptinis	EU/1/21/1594/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-09	Registruotas