AMGEVITA

Medicinal product

(Invented) name

AMGEVITA

Active substance (s)

Adalimumabas

Strength

80 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 švirkštiklyje (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
113736	99854	1099854	užpildytas švirkštiklis	0,8 ml N1 (SureClick)		Receptinis	EU/1/16/1164/020	Netiekiama	-	-	No	-	-
113737	99855	1099855	užpildytas švirkštiklis	0,8 ml N2 (SureClick)		Receptinis	EU/1/16/1164/021	Netiekiama	-	-	No	-	-
113739	99856	1099856	užpildytas švirkštiklis	0,8 ml N3 (3×1) (SureClick)		Receptinis	EU/1/16/1164/022	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas