Enbrel

Medicinal product

(Invented) name

Enbrel

Active substance (s)

Etanerceptas

Strength

50 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB01, Etanercept

Marketing authorisation holder

Pfizer Limited, Jungtinė Karalystė

Date of authorisation

2005-04-28

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for solution for injection	1 vnt.
Etanerceptas	50 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
25383	27991	1027991	flakonas	N2+4 tamponai, suvilgyti spiritu		Receptinis	EU/1/99/126/006	Netiekiama	-	-	No	-	-
25384	27992	1027992	flakonas	N4+8 tamponai, suvilgyti spiritu		Receptinis	EU/1/99/126/007	Netiekiama	-	-	No	-	-
25385	27993	1027993	flakonas	N12 +24 tamponai, suvilgyti spiritu		Receptinis	EU/1/99/126/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2005-04-28	Registruotas