AMGEVITA

Medicinal product

(Invented) name

AMGEVITA

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

Amgen Europe B.V., Nyderlandai

Date of authorisation

2017-03-22

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

Vienkartinės dozės užpildytame švirkšte (0,4 ml) tirpalo yra	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
113726	99845	1099845	užpildytas švirkštas	0,4 ml N1		Receptinis	EU/1/16/1164/011	Netiekiama	-	-	No	-	-
113728	99846	1099846	užpildytas švirkštas	0,4 ml N2		Receptinis	EU/1/16/1164/012	Tiekiama	2025-05-06	-	No	-	-
113729	99847	1099847	užpildytas švirkštas	0,4 ml N6 (3×2)		Receptinis	EU/1/16/1164/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas