Rybrevant

Medicinal product

(Invented) name

Rybrevant

Active substance (s)

Amivantamabas

Strength

2400 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

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

Flakone (15 ml tirpalo) yra:	15 ml
Amivantamabas	2400 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
120117	106222	1106222	flakonas	15 ml N1		Receptinis	EU/1/21/1594/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-09	Registruotas