AMGEVITA

Medicinal product

(Invented) name

AMGEVITA

Active substance (s)

Adalimumabas

Strength

40 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

Amgevita paciento priminimo kortele vaikams.pdf

Amgevita paciento priminimo kortele suaugusiems.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 pen	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
68048	82610	1082610	užpildytas švirkštiklis	0,8 ml N1 (SureClick)		Receptinis	EU/1/16/1164/006	Netiekiama	-	-	No	-	-
68049	82611	1082611	užpildytas švirkštiklis	0,8 ml N2 (SureClick)		Receptinis	EU/1/16/1164/007	Tiekiama	-	-	No	-	-
68050	82612	1082612	užpildytas švirkštiklis	0,8 ml N4 (SureClick)		Receptinis	EU/1/16/1164/008	Netiekiama	-	-	No	-	-
68051	82613	1082613	užpildytas švirkštiklis	0,8 ml N6 (3x2) (SureClick)		Receptinis	EU/1/16/1164/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas