Imaavy

Medicinal product

(Invented) name

Imaavy

Active substance (s)

Nipokalimabas

Strength

185 mg/ml

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)

L04AL03, nipocalimab

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2025-11-28

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

1 ml koncentrato yra:	1 ml
Nipokalimabas	185 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
119369	105474	1105474	flakonas	1,62 ml N1		Receptinis	EU/1/25/1989/001	Netiekiama	-	-	No	-	-
119370	105475	1105475	flakonas	6,5 ml N1		Receptinis	EU/1/25/1989/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-11-28	Registruotas