AMGEVITA

Medicinal product

(Invented) name

AMGEVITA

Active substance (s)

Adalimumabas

Strength

80 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 (0,8 ml) tirpalo yra	0.8 ml
Adalimumabas	80 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
113733	99851	1099851	užpildytas švirkštas	0,8 ml N1		Receptinis	EU/1/16/1164/017	Netiekiama	-	-	No	-	-
113734	99852	1099852	užpildytas švirkštas	0,8 ml N2		Receptinis	EU/1/16/1164/018	Netiekiama	-	-	No	-	-
113735	99853	1099853	užpildytas švirkštas	0,8 ml N3 (3×1)		Receptinis	EU/1/16/1164/019	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas