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

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	0.8 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
68044	82606	1082606	užpildytas švirkštas	0,8 ml N1		Receptinis	EU/1/16/1164/002	Netiekiama	-	-	No	-	-
68045	82607	1082607	užpildytas švirkštas	0,8 ml N2		Receptinis	EU/1/16/1164/003	Netiekiama	-	-	No	-	-
68046	82608	1082608	užpildytas švirkštas	0,8 ml N4		Receptinis	EU/1/16/1164/004	Netiekiama	-	-	No	-	-
68047	82609	1082609	užpildytas švirkštas	0,8 ml N6 (3x2)		Receptinis	EU/1/16/1164/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas