AMGEVITA

Medicinal product

(Invented) name

AMGEVITA

Active substance (s)

Adalimumabas

Strength

20 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

Amgevita paciento priminimo kortele suaugusiems.pdf

Amgevita paciento priminimo kortele vaikams.pdf

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	20 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
68043	82605	1082605	užpildytas švirkštas	0,4 ml N1		Receptinis	EU/1/16/1164/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas