Imraldi

Medicinal product

(Invented) name

Imraldi

Active substance (s)

Adalimumabas

Strength

40 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 pen	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
108763	94869	1094869	užpildytas švirkštiklis	0,4 ml N1 (+2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/17/1216/014	Netiekiama	-	-	No	-	-
108764	94870	1094870	užpildytas švirkštiklis	0,4 ml N2 (alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/015	Netiekiama	-	-	No	-	-
108765	94871	1094871	užpildytas švirkštiklis	0,4 ml N4 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/016	Netiekiama	-	-	No	-	-
108766	94872	1094872	užpildytas švirkštiklis	0,4 ml N6 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-08-24	Registruotas