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	0.8 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
97701	83796	1083796	užpildytas švirkštas	0,8 ml N1 (+2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/17/1216/001	Netiekiama	-	-	No	-	-
97702	83797	1083797	užpildytas švirkštas	0,8 ml N2 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/002	Netiekiama	-	-	No	-	-
97703	83798	1083798	užpildytas švirkštas	0,8 ml N4 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/003	Netiekiama	-	-	No	-	-
97704	83799	1083799	užpildytas švirkštas	0,8 ml N6 (+alkoholiu suvilgytas tamponas)		Receptinis	EU/1/17/1216/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-08-24	Registruotas