Rybrevant

Medicinal product

(Invented) name

Rybrevant

Active substance (s)

Amivantamabas

Strength

1600 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 (10 ml) injekcinio tirpalo yra	10 ml
Amivantamabas	1600 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
117199	103299	1103299	flakonas	10 ml N1		Receptinis	EU/1/21/1594/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-09	Registruotas