Kromeya

Medicinal product

(Invented) name

Kromeya

Active substance (s)

Adalimumabas

Strength

40 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

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 in pre-filled syringe	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
101379	87482	1087482	užpildytas švirkštas	0,8 ml N2 (ir 2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/19/1357/002	Netiekiama	-	-	No	-	-
102477	88578	1088578	užpildytas švirkštas	0,8 ml N6 (ir 6 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/19/1357/004	Netiekiama	-	-	No	-	-

Stadijos

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