Kromeya

Medicinal product

(Invented) name

Kromeya

Active substance (s)

Adalimumabas

Strength

40 mg/0,8 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Purpose for use

vaikams

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB04, Adalimumab

Marketing authorisation holder

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2019-04-02

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	0.8 ml
Adalimumabas	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
101378	87481	1087481	flakonas	0,8 ml N1 (injekcinis švirkštas, adata, flakono adapteris ir 2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/19/1357/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-17	Išregistruotas
2019-04-02	Registruotas