Imraldi

Medicinal product

(Invented) name

Imraldi

Active substance (s)

Adalimumabas

Strength

40 mg/0,8 ml

Pharmaceutical form

injekcinis tirpalas

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

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2017-08-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

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
102237	88337	1088337	flakonas	0,8 ml, injekcinis švirkštas, adata, flakono adapteris ir 2 alkoholiu suvilgyti tamponai N2		Receptinis	EU/1/17/1216/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-08-24	Registruotas