Imraldi

Medicinal product

(Invented) name

Imraldi

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

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 in pre-filled syringe	0.4 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
108759	94865	1094865	užpildytas švirkštas	0,4 ml N1 (+2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/17/1216/010	Netiekiama	-	-	No	-	-
108760	94866	1094866	užpildytas švirkštas	0,4 ml N2 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/011	Netiekiama	-	-	No	-	-
108761	94867	1094867	užpildytas švirkštas	0,4 ml N4 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/012	Netiekiama	-	-	No	-	-
108762	94868	1094868	užpildytas švirkštas	0,4 ml N6 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-08-24	Registruotas